Corrective Action and Preventive Action

Program Implementation:

BELMARK, inc

by

Matthew S. Weckwerth

A Research Paper Submitted in Partial Fulfillment of the

Requirements for the Master of Science Degree

111

Technology Management

Approved : 2 Semester Credits

~LY Dr. John Dzissah

The Graduate School

University of Wisconsin-Stout

August, 2010

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Author:

Title:

The Graduate School University of Wisconsin-Stout

Menomonie, WI

Weckwerth, Matthew S.

Corrective Action and Preventive Action Program Implementation:

BELMARX, inc

Graduate Degree/ Major: MS Technology Management

Research Adviser: John Dzissah, Ph.D.

MonthlYear: August, 2010

Number of Pages: 66

Style Manual Used: American Psychological Association, 6th edition

Abstract

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BELMARK, inc is a rapidly growing company that prints and converts pressure

sensitive labels, flexible packaging and folding cartons. Their primary markets are the food and

consumer goods markets. With this rapid growth it is imperative that productivity, throughput,

waste, and quality continuously improve in order to ensure customer satisfaction and continued

growth. Effective corrective action and preventive action (CAPA) systems are a key component

to continuous improvement. Without a CAP A process, focusing on quality improvement efforts

may not improve customer satisfaction. An analysis was perfOlmed to define the current

components of CAP A that are in place at BELMARl<, understand the requirements of ISO

9001 :2008 in regards to CAP A and to benchmark successful CAP A programs. The end goal was

to propose a CAP A system that meets the ISO requirement and improves customer satisfaction.

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Table of Contents

........................ ... .. .. .. ... .................. .............................................................. .. .................. ............ Page

Abstract ............................................................................................................................................ 2

Chapter I: Introduction ......... ...... ....... ..................................... ... ...... ..... ............... ...... ....... .. ............. 5

Statement of the Problem ...... ................... ....................... ... ....... ... .. .... .. ... .... ...... ................... 6

Objectives ........ .. .. ..... ....... ............... .............. ... ......................... ........................................... 6

Purpose of the Study ... ..... ..... .... ... ........................ ....... .... ................... .. ............ .. ... ........ ....... 7

Assumptions of the Study .................................................................................................... 7

Definition of Telms .............................................................................................................. 8

Limitations of the Study ....................................................................................................... 9

Chapter II: Literature Review ................................................................ ...... .... ....... ....................... 10

Corrective Action and Preventive Action - ISO 9001 :2008 Requirement. ....................... 10

CAPA System Structure .................................................................................................... 14

CAP A System Implementation .......................................................................................... 18

Summary ... ..... ...... .... .......... ............. ... ...... ... .... ....... ...... ................ ... ..... ..... .. ....... .. .. ..... ....... 22

Chapter III: Methodology .......................................................................... .................................... 24

Data Required ....... ......... .... ......................................................................................... ....... 24

Methods .............................................................................................................................. 25

S uilllnary ............................................................................................................................ 26

Chapter IV: Results ........................................................................... ......... ............... ..... ................ 27

Define Current State ......................................................................................................... 27

Plan Future State ............................................................................................................... 30

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Chapter V: Discussion ................................................................................................................... 35

Limitations ......................................................................................................................... 35

Conclusions ........................................................................................................................ 36

Recommendations .............................................................................................................. 3 7

References ...................................................................................................................................... 3 8

Appendix A: CAP A Project Chmier .............................................................................................. 40

Appendix B: Process Flow Diagrams ............................................................................................ 44

Appendix C: Q.TI -4.14.104 ............................................................................................................. 46

Appendix D: Customer Complaint and Quality Event Data .......................................................... 56

Appendix E: Risk Assessment Calculator ..................................................................................... 61

Appendix F: CAP A Request Form ................................................................................................ 62

Appendix G: Open Quality Events ................................................................................................ 63

Appendix H: Quality Event Risk Distribution ............................................................................... 64

Appendix I: Open CAPAs ............................................................................................................. 65

Appendix.T: Weeldy Quality Event RepOli ................................................................................... 66

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Chapter I: Introduction

BELMARK, inc is one of the fastest growing converters of pressure sensitive

labels, flexible packaging, and folding cartons. Visionary leadership along with four primary

key values: speed-to-market, product development, service development, and quality has allowed

BELMARK to distance themselves from their competition.

BELMARK's mission carves out a very special and unique position in the marketplace.

This has resulted in providing the best value for their customer base primarily through offering

better and easier ways of doing business, providing the fastest lead times possible, and permitting

quick response to customer needs. From a customer perspective, this translates into lower

inventories, faster turnaround, on-time shipments, improved cash flow, good communications,

and overall satisfaction.

In order to develop this position in the market, BELMARI( has a commitment to

selecting the best people, facilities, equipment, and maintenance systems in the industry. In

addition, there has been dedication to developing those hard to imitate proprietary capabilities to

further enhance this competitive advantage. From a single press in a garage with two employees

in 1977 to 450 plus employees in 2010, clearly this commitment has resulted in rapid growth

within the organization.

With Quality being one of the four cornerstones of the value that BELMARK provides

their customers, there is a large amount of focus on continuously improving Quality and

exceeding customer expectations. BELMARK follows the ISO 9001 :2008 intemational quality

standard, but is not celtified to the standard. A key component of the ISO standard is having a

Corrective Action and Preventive Action system in place CCAPA). Formal systems are in place

to implement corrective and preventive action reactively, such as customer complaints, internal

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complaints or internal change requests. Potential improvements to these systems include the

documentation of root cause, corrective action and effectiveness verification of internal pulls,

reruns, and internal change requests (ICRs).

The current paper distribution process associated with customer complaint resolution is

too reliant on administrative functions that would serve as a restraint to the necessary speed

needed in regards to correcting the issues associated with pulls, reruns, and ICRs. The critical

components of root cause identification, effectiveness of corrective action, trend analysis, and

preventive action is lost in some cases. Addressing these components is an 0ppOliunity.

A proactive approach to complaint reduction, preventive action initiatives, and process

improvement can be addressed through a CAP A system. The ability to spot negative trends and

the 20% of the issues that cause 80% of the problems is needed in order to help initiate the

appropriate CAP A requests.

Statement of the Problem

A structured Corrective Action and Preventive Action program at BELMARI(,

inc is not in place for all quality events resulting in a nonconformance to the ISO 9001:2008

International Quality Standard and prohibiting a proactive approach to complaint reduction,

preventive action, and process improvement initiatives.

Objectives

The objectives of this study were to:

1. Create a quality event management system for the documentation of root cause,

corrective action and effectiveness verification of pulls, reruns, ICRs, audit

results, programming requests, nonconfOlmances, and any other quality event that

requires CAP A.

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2. Create a quality event management system where CAP As are issued to

Depmtment Managers to proactively reduce quality issues and initiate process

improvement.

3. Improve current internal and external complaint trend analysis tools for

Department Managers and Quality in order to identify CAPA oppOltunities.

Purpose of the Study

The purpose of the study is to develop a CAPA process to help BELMARK achieve their

goal of lowering customer complaints, reducing waste, and increasing productivity. CAP A is

more than a system that is needed to meet the requirements of the ISO 9001 :2008 quality

standard; it is a continuous improvement initiative using the problem solving methodology to

improve the business. Although CAP A is viewed as a quality function, it touches on all four

cornerstones of BELMARK's mission statement: speed-to-market, product development, service

development, and quality. The identification of problems through numerous quality events,

analyzing risk, following the problem solving process, and implementing corrective and

preventive action with a comprehensive measurement of effectiveness should result in improving

all four cornerstones moving into the future.

Assumptions of the Study

There were a number of assumptions made throughout the course of this study. It was

assumed that CAPAs are viewed as a tool to improve processes, not as a negative occurrence. It

is also assumed that managers will take ownership of following through with the CAPA process.

The assumption that deadlines will be established and people will be held accountable for

meeting the deadlines was made. Probably the most important assumption made is that upper

level management sees value in the process and will make it a priority.

Definition of Terms

Audit - An on-site verification activity based upon a sample used to determine the

effective implementation of a documented quality system (Powerway Suite, 2009).

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Certification - Procedure by which a third party gives written assurance that a product,

process or service conforms to specific requirements (Powerway Suite, 2009).

Corrective Action - Action taken to eliminate the causes of an existing nonconformity,

defect or other undesirable situation in order to prevent recurrence (Powerway Suite, 2009).

Corrective Action Plan - Document specifying actions to be implemented for correcting a

process or part quality issue, with responsibilities and target dates assigned (Powerway Suite,

2009).

Customer Satisfaction - Customer's perception of the degree to which the customer's

requirements have been fulfilled (Powerway Suite, 2009).

Defective Product - Product that through evaluation is detennined to be unusable,

incorrect, irreparable, or otherwise unacceptable by an external customer and requires credit or

replacement of product (Powerway Suite, 2009).

Internal Change Request - A directive from an internal depattment to change information

previously submitted on a product specification (Powerway Suite, 2009) ..

ISO 9001 - An internationally recognized standard. The standard is intended for use in

any organization which designs, develops, manufactures, installs and/or services any product or

provides any form of service. It provides a number of requirements which an organization needs

to fulfill if it is to achieve customer satisfaction through consistent products and services which

meet customer expectations. It includes a requirement for the continual (i.e. planned)

improvement of the Quality Management System (Powerway Suite, 2009).

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Preventive Action - Action taken to eliminate the cause of a potential nonconformity or

other undesirable potential situation (Powerway Suite, 2009).

Quality Management System - Management system to direct and control an organization

with regard to quality (Powerway Suite, 2009).

Quality System - Organizational structure, responsibilities, procedures, processes and

resources needed to implement the quality system (Powerway Suite, 2009).

Limitations of the Study

The primary limitations of the study were time and resources. There are existing systems

such as the customer complaint system, pulls, reruns, and ICRs that are intended to be

incorporated into the CAP A system in the future, but the time and resources needed to fully

convert these systems over to the CAP A system fall outside the scope of this study due to these

constraints. The goal of the study was to design a CAP A system structure that can be executed

with the support of internal resources and potentially external software vendors.

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Chapter II: Literature Review

In order to determine what ISO deems as required elements of CAP A, the structure of a

CAP A system, and potential ways of implementing a CAPA system within an organization, a

review ofliterature was conducted. Being that ISO 9001 :2008 is an internationally recognized

quality system and has been the chosen quality system for a wide variety of manufacturers across

the globe, there is extensive literature in regards to this standard. The literature that was

reviewed demonstrated some clear cut themes that will be further explained in this chapter.

Corrective Action and Preventive Action - ISO 9001 :2008 Requirement

During the 1980s and 1990s the creation of Quality Management Systems (QMS)

sparked the attention of the industry and academy sectors. In the United States the favored QMS

was Total Quality Management (TQM), which was a management concept ofW. Edwards

Deming focusing on reducing errors. The Intemational Standard Organization's (ISO) answer to

TQM was a set of norms published in 1987 called ISO 9000 (Cachadinha, 2009).

The focus of the literature review in particular is the ISO 9001 norm, which is the Quality

Management Systems requirement intended for use in any organization which designs, develops,

manufactures, installs, and/or services any product or provides any form of service. This

standard has gone through four major revisions with probably the most drastic change occurring

in the year 2000. This revision put a focus on customer satisfaction through eight quality

management principles: customer focus, leadership, involvement of people, process approach,

system approach to management, continual improvement, factual approach to decision-making,

and mutually beneficial supplier relationships (West, 2008). For the purpose of defining the ISO

9001 requirements in regard to CAP A, the most current version will be referenced (ISO, 2008).

The continual improvement principle falls under section 8.5 of the ISO 9001 :2008

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standard and entails two key requirements; COlTective Action and Preventive Action. The

following is what the ISO 9001 :2008 standard states in sections 8.5.2 and 8.5.3 as requirements

in order to conform to the standard (ISO, 2008, pg 14):

8.5.2 COITective action

The organization shall take action to eliminate the causes of nonconfonnities in order to

prevent recurrence. COlTective actions shall be appropriate to the effects of the nonconformities

encountered.

A documented procedure shall be established to define requirements for

a) reviewing nonconformities (including customer complaints),

b) determining the causes of nonconformities,

c) evaluating the need for action to ensure that nonconformities do not recur,

d) determining and implementing action needed,

e) records of the results of action taken (see 4.2.4), and

f) reviewing the effectiveness of the corrective action taken.

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential

nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to

the effects of the potential problems.

A documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,

b) evaluating the need for action to prevent occurrence of nonconformities,

c) determining and implementing action needed,

d) records ofresults of action taken (see 4.2.4), and

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e) reviewing the effectiveness of the preventive action taken.

As stated in the standard, ISO does differentiate between corrective action and preventive

action. This is due to the fact that although many times they are lumped into the same process,

there is a difference between the two. Corrective action is action taken to eliminate the causes of

an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence

(9001 Quality, 201 Oa). Preventive action is action taken to eliminate the cause of a potential

nonconformity or other undesirable potential situation (9001 Quality, 201 Oa). In both situations,

the documentation required is the same. There must be a written procedure defining the

requirements defined in chapter 8.5 of the standard. ISO does not define if this needs to be

separate procedures or if it can be covered under a single procedure. According to IS0900 l.com

the following is a summary of the key steps that need to be documented in both the corrective

action and the preventive action processes to fulfill ISO 9001 :2008 requirements (9001 Quality,

2010a, pg 1):

Corrective Action

1. Nonconformity Record

a. Nonconformity Details - Documenting the product's characteristics along with

any information that would help in investigating the nonconformity later on.

b. Description of the NonconfOlmity - A detailed description of the issue along with

any supporting documentation.

c. Categorization of the Nonconformity - This is not required by the ISO standard,

but it is considered best practice. The categorization allows for future statistical

analysis of nonconformities.

d. Investigation Details - All nonconformities must be followed with a documented

investigation in order to identify the cause of the nonconformity.

2. Corrective Action Record

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a. Corrective Action Description - After the root cause is defined a corrective action

plan must be initiated and documented in order to eliminate the issue.

b. Conective Action Objectives - The requirements of the corrective action taken

must be defmed and documented. This can be a numerical, quantitative or a

quality requirement depending on the situation.

c. Closing Date for Conective Action - The time frame to examine the effectiveness

ofthe corrective action must be defined.

d. Corrective Action Results - The standard requires an observation of the corrective

action and a verification ofthe results in comparison to the objectives. Indication

and documentation must occur of the status of the corrective action. At this point

the corrective action may be closed. If the corrective action plan fails, a new

corrective action plan should be initiated (9001 Quality, 2010a, pg 1).

Preventive Action

1. Preventive Action Record

a. Preventive Action Plan - Define what is determined to be the requirements of the

preventive action taken.

b. Preventive Action Objectives - The requirements of the preventive action taken

must be defined and documented. This can be a numerical, quantitative, or a

quality requirement depending on the situation. It may be determined that cost or

other factors may prohibit the preventive action plan as long as customer

requirements are maintained. In this situation the decision not to proceed must be

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documented.

c. Closing Date for Preventive Action - The time frame to examine the effectiveness

of the preventive action must be defined.

d. Preventive Action Results - The standard requires an observation of the

preventive action and a verification of the results in comparison to the objectives.

Indication and documentation must occur of the status of the preventive action.

At this point the preventive action may be closed. If the preventive action plan

fails a new preventive action plan should be initiated (9001 Quality, 201 Ob, pg 1).

BELMARI( follows the ISO 9001:2008 international quality standard and intends to be

considered ceIiifiable as pari of this study, which requires a procedure documenting the CAP A

process. To ensure consistency with the format of existing procedures at BELMAR!(, the

procedure will be documented following the Quality Job Instruction (QJI) format. This format is

used for all standard operating procedures at BELMAR!( which directly impact the quality

system. Documenting in this format ensures proper document control and approval processes

which are essential to ISO conformance.

CAP A System Structure

Identifying, troubleshooting, correcting, and preventing potential problems are typical

activities for most businesses. To ensure continued customer satisfaction and efficient business

practices, it is essential to have the ability to correct existing problems or implement controls to

prevent potential problems in order to minimize financial loss. Many times the missing element

of this process is suffIcient documentation of the actions taken. This documentation provides

impoliant historical data for a continuous quality improvement plan and also meets ISO

requirements (Master Control, 2008b).

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The most important aspect of a CAP A system is that it must identify why a problem

occurred or why something may go wrong and ensure that it does not happen again. Three basic

rules are followed to accomplish this: identify the problem, correct the problem, and prevent the

problem. These are consistent with all CAP A processes, but in order for CAP A to be a powerful

management tool that focuses on continuous improvement, there needs to be seven distinct

actions that need to be developed through plans and procedures. These actions include:

Identification, Evaluation, Investigation, Analysis, Action Plan, Implementation and Follow Up

(Master Control, 2008b).

The first action that needs to be completed is to clearly identify the problem or potential

problem. This action step should document the source of the information, a detailed explanation

of the problem, and evidence that the problem is indeed a problem. The source of the

information could be from a number of events such as customer complaints, staff observations,

QA inspections, quality audits, trend data, process monitoring, or an outcome from meetings or

internal complaints. This is impOliant for the investigation and ultimately the action plan, but it

is also useful for effectiveness evaluation and communicating problem resolution. The

explanation of the problem must be concise and complete at the same time. It must be written in

a fashion that allows for the information to be easily understood. Supporting evidence of the

problem can be in the form of pictures, email, statistical data, or many other forms that help

clarify that the problem exists (R. M. Baldwin, Inc, 2009).

The identification of the problem as described above typically is distributed in the form

of a CAP A request form, which is intended to collect the preliminary information. Once this

occurs the information needs to be evaluated, which is the second step of the process. The need

for action and the level of action required is determined as part of this step. The potential impact

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and risks to the company or customer needs to be determined in terms of cost, product quality,

safety, and customer satisfaction. A high risk item may be assigned a high priority and require

immediate remedial action, such as an issue where the safety of employees is at risk. On the

opposite end of the spectrum an employee observation that a particular piece of equipment is

experiencing increasing levels of downtime of late may take a low priority. If immediate

remedial action occurs, this may remedy the situation until thorough investigation and a

permanent solution is determined or it may be determined that this is all that is needed.

Typically the gatekeeper who receives the CAP A request and makes the risk assessment will

determine this. It is impOltant that if the CAP A is closed as a result of the remedial action that

rational for this decision is documented and appropriate follow-up occurs (Master Control,

2008b).

After remedial action occurs, the next step in the process is the investigation of the

problem. This exists in the form of a written procedure which includes the objectives for the

action, investigation strategy, assignment of responsibility, and required resources. The

objective is a written statement of the desired outcome of the corrective or preventive action.

Action will be complete when all aspects of the objective have been achieved and verified. The

investigation strategy is essentially instructions for determining the potential root causes of the

problem by directing a comprehensive review of all circumstances related to the problem

(equipment, personnel, materials, procedures, training, etc). Someone must be assigned as the

person responsible for investigation to ensure accountability (R. M. Baldwin, Inc, 2009).

The next step is analysis and root cause identification. The goal of the analysis is to

determine the root cause of the problem, but to also identify any contributing causes as well. It is

important to distinguish between the root cause of the problem and observed symptoms of the

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problem. There are many tools and methods for performing root cause analysis, but many times

it will involve identifying every possible cause of the problem, collecting appropriate data,

organizing the results of the data, and analyzing the data to determine the root cause (Master

Control, 2008b). A series of' why?' questions are typically utilized to dig deep until the

fundamental reason for the problem occUlTing is found. The 5-Why analysis is a simple process

of logically linking elements into a cause-and-effect analysis. The idea is to look at a problem

and ask "Why did this happen?", then analyze the answer to determine if the answer is the root

cause and not simply a symptom of the issue. Continue to ask why until the root of the issue is

determined (Casey, 2008). Documenting the root cause of the issue is essential in determining

the appropriate action that must be taken.

Using the results from the analysis phase, the best method for correcting the problem or

preventing a future occurrence is determined and considered as the c011'ective/preventive action

plan. The action plan must identify all of the tasks required to correct the problem and prevent it

from happening again. Changes that need to be made and the people assigned to execute the

changes are assigned. Many times changes to documentation, processes, procedure, training, or

other systems will be part of the action plan. It is important that these steps are detailed and

clearly documented in the CAP A request in order to ensure it is clearly understood what must be

done, what the outcomes should be, and who is responsible. Effective training associated with

the changes and clear communications between depatiments are key components of a successful

action plan (R. M. Baldwin, Inc, 2009).

The action plan then needs to be implemented. Once all of the activities associated with

the action plan have been implemented this needs to be listed and summarized in the CAP A

documentation. Complete records of the actions that were taken need to be documented. In

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addition all documents, specifications, or procedures that were modified should also be listed or

attached as a suppOJiing document. This will help facilitate verification of the changes during

the next step of the process (Master Control, 2008b).

The final step of the CAP A process is the follow up step, which is also one of the most

fundamental steps of the process. Implementation and the completion of all changes needs to be

verified along with the effectiveness of these changes. According to Master Control several key

questions must be answered (Master Control, 2008b):

1. Have all of the objectives of this CAPA been met?

2. Have all recommended changes been completed and verified?

3. Has appropriate communications and training been implemented to assure that all

relevant employees understand the situation and the changes that have been

made?

4. Is there any chance that the actions taken may have had any additional adverse

effect on the product or service?

Effective documentation is critical to effectively execute a CAP A process according to

the above mentioned seven steps, but this also conflicts with the non-bureaucratic culture of

BELMARK. The implementation of a CAP A program at BELMARK will need to ensure that all

seven phases of CAP A are incorporated into the program and effectively documented to ensure

ISO compliance, but it needs to be performed in a flexible manner to minimize non-value added

bureaucratic activities.

CAP A System Implementation

When evaluating history many organizations rely on the wisdom and experience of their

internal experts to identify root causes. Identifying the root cause of an issue is the heart of

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offering effective solutions. The problem with this approach is that the solution they are able to

develop is dependent on and limited by their expertise. If the root cause of the issue extends

beyond their level of expertise, they are not likely to identify the root cause (Rooney, & Vanden

Heuvel, 2004). Another problem with relying on internal expertise is that these experts at some

point will leave the company. Others who are then responsible to identify the root cause of an

issue without the necessary level of expertise tend to revert to trial-and-error or guess work

hoping that they will get to the root of the issue (Peterson, 2008b). For effective root cause

analysis a systematic approach must be utilized to conduct effective root cause analysis such as

8D, 5-Why, and the Fishbone Analysis. These are critical in that they allow the investigators to

identify not only what and how an issue occurred, but also why it happened which is the key to

effective corrective or preventive action. If one is able to understand why an event OCCUlTed they

are able to offer effective recommendations to prevent reoccurrence (Rooney, & Vanden

Heuvel, 2004).

Once the CAP A system structure is defined and the method for root cause investigation is

defined, the organization must choose a system to issue CAPAs and route them through the

process of Identification, Evaluation, Investigation, Analysis, Action Plan, Implementation and

Follow Up. Just as impOliant there needs to be a means of trending of the issues to allow for the

development of systematic improvements and the assessment of the impact of the previously

implemented corrective action plans (Rooney, & Vanden Heuvel, 2004). The three primary

approaches to accomplish this is the paper approach, the electronic approach, and the hybrid

approach (Master Control, 2008a).

The primary advantages of a paper-based approach to a CAP A process is that the initial

implementation cost is low and they are very flexible to allow for customization to the process.

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Due to the administrative costs associated with maintaining the system and tracking the CAPAs,

the maintenance costs begin to outweigh the initial startup costs, which is a primary

disadvantage. Systems administrators are responsible for extensive follow-up on open CAPAs to

determine the status and ensure the CAPA is progressing. There is a lack of control once the

CAP A is issued for root cause investigation and low visibility in regards to system bottlenecks.

Reporting and trend analysis becomes labor intensive. Overall the system visibility is low to

management, many times resulting in a lack of buy-in and accountability from employees

(Master Control, 2008a).

The hybrid approach in most cases is primarily a paper based system in which some

electronic tracking and reporting capabilities exist through common software such as Microsoft®

Excel® or Access®. Like the paper-based approach there are low startup costs, but the majority

of the disadvantages remain the same, with the exception of improved tracking and trend

reporting. There is still a restriction in the ability of the system to electronically distribute and

track tasks, resulting in extensive follow-up challenges, employee buy-in, and accountability

issues (Master Control, 2008a).

The step that companies will take after the hybrid approach is to create a custom

application or purchase a software package to address their CAP A needs. According to Master

Control the following are seven key features that should be available with a home grown or

software solution (Master Control, 2008a):

I. Distributed task assignment - a system that enables tasks associated with a CAP A to

be individually assigned to employees to facilitate buy-in and accountability.

Management also has greater visibility of where the bottlenecks are in the process

because they have access to real-time data.

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2. Web-based - the software package should be web-based so that employees from all

site locations can access and use the same data repository. Depar1mental CAP A

solutions keep quality data in a silo that can prevent systemic problems from being

identified.

3. Built-in Reporting and Analytics - the system should have robust rep0l1ing and

analytic capabilities. Each data field tracked by the system should be able to be

reported on. On-line charting should be available to enable users to easily trend

quality data.

4. Signature Manifestations - signature manifestations should be automatically

appended to each document including the printed name, date, time, and meaning of

the electronic signature. ISO-certified organizations promote good business practices

by displaying the record approval status at a glance when users view a record.

5. Audit Trail- the system should have a secure, time-stamped audit trail of all changes

made to any record and should be accessible to the appropriate users and depar1ments.

This information should be automatically captured and secured.

6. Email Notifications - real-time notifications should be provided to alert users of

specific tasks they need to complete. In addition, unlimited escalation workflow rules

should be an option. By ensuring the appropriate users are notified of pending tasks

and that tasks escalate when necessary should help reduce turnaround times for

corrective action processes.

7. Security - access should be allowed to be individually tailored for each user.

Administration tools should exist to easily group users together with the same

security rights. Automatic time-out options, minimum password settings, intruder

login detection, and SSL (secure socket layer - provides secure internet

communication) should all be standard features.

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The final component of implementing a successful CAP A system is ensuring that there is

an effective event management of incoming CAP A requests. Every complaint, nonconformance

or other event needs the data to be collected immediately and easily transferred into the system.

With this there needs to be effective risk assessment to ensure that "Death by CAPA" does not

occur. Without effective risk assessment the system can be overloaded by every event being

loaded into the system regardless of risk and potential impact to the business or customer. The

goal is to work on the higher risk items to ensure the best use of time and resources. If there is

an event that is relatively low impact and does not occur often, there needs to be a process within

the system to perform interim-type action, close it out, track, and trend the issue. The

investigative work associated with a CAP A would not be needed in those situations (Peterson,

2008b).

During the define and plan phases of this research problem it will be imp0l1ant that a

systematic approach to root cause determination utilizing a proven method such as the 5-Why

method be incorporated into the system to reduce a reliance on internal experts. The best

approach to initiate CAP As and route them through the system will need to be determined to best

meet the needs of the business. Lastly, effective event management at the front end of the

process that incorporates risk assessment will be needed to ensure that the "Death by CAPA"

phenomenon does not occur.

Summary

In summary the ISO 9001:2008 standard has a clear definition as to the requirements of a

CAPA system including a written procedure to define an organization's CAPA system.

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Identifying, troubleshooting, correcting, and preventing potential problems are typical activities

for most businesses that typically include the seven key actions of Identification, Evaluation,

Investigation, Analysis, Action Plan, Implementation, and Follow Up. These actions must be

properly documented to meet the ISO requirement and this can be accomplished through a paper

based system, a hybrid system or an electronic system.

24

Chapter III: Methodology

BELMARI(, inc is one of the fastest growing converters of pressure sensitive labels,

flexible packaging and folding cartons. A structured Corrective Action and Preventive Action

program at BELMAR!(, inc is not in place for all quality events resulting in a nonconformance

to the ISO 9001 :2008 International Quality Standard and prohibiting a proactive approach to

complaint reduction, preventive action, and process improvement initiatives.

The objectives of this study were to:

1. Create a quality event management system for the documentation of root cause,

corrective action and effectiveness verification of pulls, reruns, ICRs, audit

results, programming requests, nonconformances, and any other quality event that

requires CAP A.

2. Create a quality event management system where CAPAs are issued to

Department Managers to proactively reduce quality issues and initiate process

improvement.

3. Improve current internal and external complaint trend analysis tools for

Department Managers and Quality in order to identify CAP A opportunities.

An improved CAP A process was needed to ensure ISO compliance and to meet the

business needs outlined in the four cornerstones of the company mission statement. This chapter

describes the methodology utilized to achieve the tlu-ee objectives of the study.

Data Required

To better define the current state of the corrective action processes that are currently in

place at BELMAR!(, data was collected defining the average number of pulls, reruns, internal

change requests (ICRs), and customer complaints entered per month for the past three years. In

25

addition, the average completion time by month was captured to better understand how well this

compares to the company objective of closing out all quality issues in less than 30 days.

Qualitative data was obtained through discussions with key members of BELMARK's

Operations Team (steering committee) and through Process Flow Diagramming exercises to

define the current state and better define the expectations of the ideal CAP A system (future

state). Key metrics such as the number of people who participate in the CAP A process and the

time expectations of each step in the process were defined.

Methods

Process Flow Diagramming and Project Management methodology was utilized for this

project. "Define", "Plan", "Implement" and "Close" are typically considered the four steps of

project management. Due to time constraints associated with the study, only the "Define" and

part of the "Plan" phases were conducted. The "Implement" and "Close" phase, although, will

be part of the project in the future as it falls outside the scope of this study.

The "Define" phase consisted of analyzing the opportunity that CAP A presents and

developing a Project Charter that was presented to the Quality Systems Manager and CEO to

offer additional project direction. See Appendix A for a copy of the Project Charter. A

commitment of resources was required in order to move to the next phase of the project.

The "Plan" phase centered on researching ISO requirements of CAPA, what CAP A

systems consist of, and how to implement an effective CAP A system. A major part of the

planning phase consisted of identifying what current BELMARK systems fell into a CAP A

system and how they could be transitioned into this system. Process Flow Diagramming was

conducted to identify the "culTent state" of CAP A within the organization, brainstorm

improvement oppOliunities, and map the "future state" of the system. See Appendix B for a

26

copy of the "crn-rent state" and "future state" process flow diagrams. The "future state" of the

CAPA system was documented utilizing BELMARK's Quality Job Instruction (QJI) format for

future employee training purposes and ISO 9001 :2008 compliance. See Appendix C for a copy

ofQJI-4.14.104 - CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCEDURE.

Summary

In summary Process Flow Diagramming and two of the major four phases of project

management were utilized to meet the tlU'ee objectives of the study. This methodology was used

to develop a CAP A process that seamlessly integrated existing processes, meet the requirements

ofthe ISO 9001 :2008 quality standard, and was viewed as a continuous improvement initiative

to ensure the continued growth of the business.

27

Chapter IV: Results

The results of this project have lead to an upper management commitment to proceeding

with the remaining phases of the project. A major hurdle to overcome was to present the current

system state, the problem and the oppOliunity in a fashion that could easily be grasped by all of

those who would be impacted by the future state of the system. Upfront it was known that

primary concerns moving forward with the implement and close phases would be adding non­

value added bureaucracy through additional documentation. Another concern would be

determining if the number of quality events that would flow through the system would be

manageable. The key to addressing these concerns was to present effective graphical displays of

the current state and future state systems via process flow diagrams. Data analysis of current

quality event data was also an impOliant aspect to address the known concerns. The results of

the project as how they relate to the stated goals and methodology are further discussed below.

Define Current State

In order to best plan what the future state of the system will be is to stmi with defining

the current state of the system. Through this process it was possible to uncover the strengths and

the weaknesses of the current system. By identifying the weaknesses this allowed for a clear

identification of the oppOliunities and laid the groundwork for defining the future state of Quality

Event Management at BELMARK. There are clearly some formal processes in place that

demonstrate key aspects of what ISO expects from a CAP A process, but there are others that fail

to meet the ISO requirement. Overall the biggest oppOliunity identified was the need for a

formalized proactive approach to complaint reduction, preventive action, and process

improvement initiatives that would be visible at the highest level of the organization and

throughout the organization.

28

The cunent system that most closely meets the ISO requirements for corrective and

preventive action is the customer complaint system at BELMARK. There is a documented

Quality Job Instruction that defines the process for handling customer complaints according to

the ISO 9001 :2008 standard. The requirements of reviewing nonconformities, determining the

causes of nonconformities, evaluating the need for action to ensure that nonconformities do not

recur, determining and implementing action needed, records of the results of action taken and

reviewing the effectiveness of the conective action taken (ISO, 2008, pg 14) are all documented

in the procedure and practiced on a daily basis.

The opportunity that a CAP A system will provide from a customer complaint standpoint

is that preventive action plans can be implemented through the CAP A system based on trend

analysis of customer complaints. The current system lends itself well to providing remedial

action to specific issues, but many times lacks the implementation of preventive action measures.

It is more of a reactive approach to customer complaint resolution than a proactive approach.

Although the customer complaint process, when analyzed as a single entity, would more than

likely meet the ISO requirements for corrective action as detelmined by an ISO auditor, the

system would more than likely result in an audit nonconformance due to the lack of documented

preventive action measures. It was determined that more effective trend analysis tools need to be

in place in the future to allow for effective trend analysis to suppoli CAP A requests based on this

information.

In addition to customer complaints, there are also internal complaints at BELMARK that

has some components of a CAP A system. The two types of internal complaints are classified as

Pulls and Reruns. An internal Pull occurs when a job is scheduled for press, but for one of a

number of reasons, will be pulled from the schedule to conect the problem and be rescheduled at

29

a later date. Pulls negatively impact productivity, costs and ultimately customer satisfaction if a

delivery date is missed. The other internal complaint is called a Rerun, which occurs when a

defect is detected during a finishing operation that results in the customer's order quantity not

being met. There is a need to rerun the defective product with also negatively impacts

productivity, cost and customer satisfaction. Due to BELMARK utilizing a primarily paper­

based system when documenting customer complaints and the Speed-to-Market objective of the

organization, the ISO requirement of records of the results of action taken and reviewing the

effectiveness of the corrective action taken is not in place. Conforming to the ISO standard is an

0ppOltunity with the current internal complaint system.

Another quality event that currently occurs at BELMARK is titled an Internal Change

Request or ICR. ICRs are a directive from an internal department to change infOlmation

previously submitted on a product specification (Powerway Suite, 2009). Many times the

changes requested could be viewed as oppOltunities for improvement or proactive measures to

ensure a complaint does not occur when the product is produced the next time. The changes

requested typically are not preventing jobs from running in production. The ICR process does

have a documented Quality Job Instruction and does meet some of the ISO requirements, but it

fails to address detelmining the root cause of the OCCUlTence, categorize the issue and establish

required completion dates. There are ICR requests that are many years old that are sitting idle in

the system due to employees not being held accountable for processing the requests as well as a

lack of visibility. Aligning the ICR process with ISO requirements is an opportunity.

There are other quality events that occur more on an informal basis such as internal

nonconfOlmances, vendor nonconformances, audit results and opportunities for improvement.

These activities occur, but are not documented per ISO requirements and the visibility is less in

30

comparison to the customer complaint process. Aligning these events with ISO requirements is

an oppOitunity.

In addition to defining the CUlTent state system, data was collected defining the average

number of pulls, reruns, internal change requests (ICRs), and customer complaints entered per

month for the past tlu·ee years. In addition, the average completion time by month was captured

to better understand how well this compares to the company objective of closing out all quality

issues in less than 30 days. See Appendix D for a copy of the Customer Complaint and Quality

Event Data summary. It was clear that there was a steady increase in the number of quality

events over the past tlu·ee years and a decrease in the average completion time of customer

complaints. The increase in events is not a surprise due to the substantial increase in sales and

jobs produced over the last tlu·ee years. The decrease in closure time was a positive and an

indicator that although the complaint volume has increased, the company has become more

efficient at resolving the issues that occur. To fUlther increase efficiency, it was determined that

it is important to drive out non-value added time spent on low risk complaints as part of the

future state plan.

Plan Future State

As described above and pictorially depicted in the CUlTent state flow chalt, the CUlTent

state of the Quality Event Management system lacks important aspects of the ISO standard.

There are separate systems as described above that should flow through a common system due to

the fact that all of the events center on a problem that may warrant corrective action and/or

preventive action. The future state map in Appendix B shows how all of the events are entered

into a common system and follow the same process flow. This will allow all quality events to

pass tlu·ough risk analysis and have the opportunity to launch a CAP A request.

31

One of the most important additions to the proposed process flow map is the addition of

risk analysis. As determined through the literature review process an effective risk assessment

process must take place in order to effectively address the problem. The Quality DepaIiment at

BELMARK would serve as the gatekeeper for all incoming quality events that would flow into

the system. Quality would analyze the issue and utilize a risk assessment calculator to quantify

the level of risk associated with the event. Appendix E displays the risk calculator that was

developed to quantify the level of risk associated with customer complaints based on key

attributes that are deemed to be imp01iant by Management. Each factor is on a weighed scale to

fmiher quantify the level of impoliance. For instance any issue that involves a product recall or

would be considered a mislabeling risk would have a weight of 12, which would push the overall

risk level into the "red" section. The key at the bottom of the calculator describes the color

coded risk levels by severity. The risk level determination would then determine if the issue is to

be routed through the remedial action process or if it is to be closed.

Upon completion of risk assessment, if the Quality Depatiment determines that the issue

is of low risk and no fmiher action is needed, the issue will be closed, tracked and trended.

Many times low risk events are passed through the system adding little to no value to the

process. They simply create a bureaucratic pile of paperwork and unnecessary time spent

processing the paperwork. The idea behind tracking and trending the issues is to still capture the

concern for trend analysis purposes and provide the feedback to the appropriate depaliment

without adding additional paperwork that will not add value. If the problem can be addressed at

the time of entry it should be. There is no sense in routing through formal root cause analysis

and corrective action if Quality is able to identify the root cause and resolve the issue. This

change would immediately improve the capacity of the entire quality event management system.

32

In the situations where formal remedial action is determined through risk assessment,

Quality would direct the quality event to the appropriate person(s) to complete the tasks of data

gathering, recommending a course of action and implementing corrective action. The Quality

Depat1ment would then review the completed remedial action to determine if the issue has been

resolved and closed. At this point it may also be determined by Quality or the Area Manager

who completed the corrective action that the risk is higher than what was previously detelmined

and that launching a CAP A request is warranted. This process prior to CAP A launch would be

similar to the CUlTent processing of customer complaints, although it is recommended that

BELMARK move towards a 100% electronic system to increase the quality and speed of

comm unication.

Once a CAP A request is launched the analysis of the request would occur at the

Operations Team level to verify that the request is warranted, assign a CAP A Manager to lead

the project and assign a target completion data. The CAP A Manager would be responsible to

lead the project which would involve the steps of investigation, data gathering, root cause

description, corrective/preventive action plan, plan approval, implementation and verification.

Through this process other individuals may be included in the project and assigned action items

with associated due dates as determined by the CAPA Manager. The CAPA Manager will hold

the team members accountable for associated due dates and the Operations Team will hold the

CAPA Manager accountable for meeting the established due date of the project.

CAP A projects will be high level projects based on previous risk analysis, remedial

action and trend analysis. These are the 20% of the issues that cause 80% of the problems. As a

result, the data captured through each step of the process will follow a similar format to proj ect

management. Appendix F provides an example of what information may be captured during the

33

CAP A process at BELMARK. The representation shows how a paper-based system would look,

but a hybrid or electronic system would capture the same information. It was recommended that

BELMARK pursue an electronic approach to increase the efficiencies of the system, allow for

electronic attachments to the CAP A, electronically linl( the CAP A to the quality event(s) that

initiated it, set user permissions on the fields available and to reduce the labor time associated

with reporting functions.

The final aspect of the future state recommendation is the repOiting mechanisms

associated with quality events and CAPAs. Accountability for all associated actions involved

with remedial action and CAP A projects needs effective reporting mechanisms. Appendix G

shows the proposed Open Quality Event report sorted by risk level and color coded

appropriately. Although the repOit only shows one action item per event, there may be multiple

action items associated that may be assigned to different people. Each of the individual actions

would be tracked separately, but tied to the quality event. This is an impOitant change in

comparison to the current customer complaint system is that each action can be tracked as a

separate component and that a person is assigned as opposed to a depaltment. Once an action

reaches overdue status, this action will be visible to management. Appendix H shows the

distribution of this data by risk, Appendix I represents the proposed Open CAPA repOit and

Appendix J display the proposed Weekly Quality Event RepOlt that would be reviewed on a

weekly basis by the Operations Team at BELMARK. Ultimately the Operations Team should

only be focusing on open CAP As, high risk incidences and overdue incidences, which is the

logic behind the layout of this proposed report. Similar layouts would be distributed to area

managers displaying only items that pertain to their respective areas.

34

In summary if a Quality Event Management System with the incorporation of CAP A

initiation is fully implemented according to the above mentioned summary, the benefits to

BELMARK should be substantial. Improvements should be realized through a reduction in both

internal and external quality complaints, decreases in material and time waste, increased

productivity, increased press tlu'oughput, increased profits, improved quality records, and the

ability to hold employees/depatiments more accountable for quality. The handling of quality

events and CAP As in this malU1er will require somewhat of a paradigm shift across the

organization, but the flexibility and a culture that embraces change should allow for successful

implementation and closure of the project in the future.

35

Chapter V: Discussion

BELMARK, inc is a rapidly growing company that prints and converts pressure sensitive

labels, flexible packaging and folding cartons. With this rapid growth it is imperative that

productivity, throughput, waste, and quality continuously improve in order to ensure customer

satisfaction and continued growth. Effective corrective action and preventive action CCAPA)

systems are a key component to continuous improvement. Without a CAPA process, focusing

quality improvement efforts on the biggest opportunities becomes a challenge and customer

satisfaction may not improve. An analysis was performed to define the current components of

CAP A that are in place at BELMARK, understand the requirements of ISO 9001 :2008 in regards

to CAP A and to benchmark successful CAP A programs. The end goal was to propose a CAP A

system that meets the ISO requirement and improves customer satisfaction.

The objectives of this study were to create a quality event management system for the

documentation of root cause, corrective action and effectiveness verification of all quality events,

issue CAPAs to proactively reduce quality issues and initiate process improvement, and improve

intemal and external complaint trend analysis tools for management to identify CAP A

oppOliunities. The implementation of this was not realized due to time constraints, but the

results of this study provide a proposal that lays the foundation for successful project

implementation and closure.

Limitations

The primary limitations of the study were time and resources. There are existing systems

such as the customer complaint system, pulls, reruns, and ICRs that are intended to be

incorporated into the CAP A system in the future, but the time and resources needed to fully

convert these systems over to the CAP A system fall outside the scope of this study due to these

36

constraints. The goal of the study was to design a CAPA system structure that can be executed

with the support of internal resources and potentially external software vendors.

Conclusions

Once implemented, the potential biggest impacts from the findings will be a result of the

risk analysis function, the addition of the CAP A process and the improved rep011ing

mechanisms. These are components that do not exist or pa11ially exist in the current state of the

BELMARK Quality Event Management system and should be powerful additions once the

future state is fully implemented.

As determined through the literature review, the potential impact and risks to the

company or customer needs to be determined in telms of cost, product quality, safety, and

customer satisfaction. A high risk item may be assigned a high priority and require immediate

remedial action, such as an issue where the safety of employees is at risk. On the opposite end of

the spectrum an employee observation that a particular piece of equipment is experiencing

increasing levels of downtime of late may take a low priority. If immediate remedial action

occurs, this may remedy the situation until thorough investigation and a permanent solution is

determined or it may be determined that this is all that is needed. The risk assessment

calculation and the ability for the Quality DepaI1ment to track and trend issues or send them

through the remedial action flow correlates to the risk assessment element determined through

the literature review.

The concept of initiating CAP A requests as a result of risk assessment, management

discretion or trend analysis is another concept that will add value to the organization once fully

implemented. As determined through the literature review Identification, Evaluation,

Investigation, Analysis, Action Plan, Implementation and Follow Up are elements that need to

37

exist in an effective CAPA system. These elements are incorporated into the CAPA request

form that was developed . Capturing all of these actions in writing and the development of a

CAP A procedure will also ensure compliance to the ISO 9001 :2008 standard.

Due to time constraints, the third objective of the study to improve current internal and

external complaint trend analysis tools was not met. The proposed reporting mechanisms of

quality events and CAPAs ties into the increased visibility of the events to management and

should lead to improved trend analysis tools once there is an electronic system in place to house

all of the data. Once the data exists in a database, creating trend analysis chatis should be

achievable tlu'ough pivot table analysis in Microsoft® Excel®.

Recommendations

Moving forward it is recommended that BELMARK develop a cross-functional project

team to work on implementing the proposed future state. Determinations will need to be made in

regards to what aspects of the system should be paper-based or electronic. Although the results

of this study are specific to BELMARIZ, the concepts and the overall structure of the future state

as depicted in the flow chati could be implemented in similar organizations who have the desire

or need to implement a CAP A program to meet the ISO 9001 :2008 international quality

standard.

38

References

9001 Quality (2010a). CAPA: Corrective action - the ISO 9001 Standard requirements. CAP A -

Corrective preventive action. Retrieved from http://www.9001quality.com/capa-

conecti ve-preventi ve-actionl5 3 -correcti ve-acti onl8 O-capa -correcti ve-acti on -the-iso-9 001-

standard -req uiremen ts. htm I

9001 Quality (2010b). CAPA: Preventive action - the ISO 9001 Standard requirements. CAPA­

Corrective preventive action. Retrieved from http://www.9001quality.com/capa­

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9001-standard-requirements.html

Cachadinha, N. (2009). Implementing Quality Management Systems in Small and Medium

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Casey, J.J. (2008). Leveraging five whys. Quality Digest, Retrieved from

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whys.html

ISO (2008). International Standard ISO 9001:2008(E) . Quality management systems­

Requirements (4th ed.). Geneva Switzerland: ISO Copyright Office.

Master Control (2008a). Does your capa system need a capa: automating corrective and

preventive actions in fda environments . Retrieved from

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Master Control (2008b) . Simplifying capa: seven steps to a comprehensive capa plan. Retrieved

from http://www.mastercontrol.com/capa-software/corrective-action-capa-software.html

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Peterson, K. (2008). The Capa engine and your qms system - is it driving your company forward.

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software/colTective-action-capa-software.html

Powerway Suite (2009). Instruction Writer Definitions [computer software]. Indianapolis:

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R. M. Baldwin, Inc. (2009). Corrective and preventive actions. Powerpoint slideshow, Retrieved

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Rooney, J.1., & Vanden Heuvel, L.N. (2004). Root cause analysis for beginners. Quality

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West,1. (2008). Standards Column. Quality Engineering, 20(1), 128-133.

doi: 1 0.1 08010898211 070 1734651.

40

Appendix A: CAPA Project Charter

PROJECT CHARTER

Project Contact and Approval Information Project Name/Number Corrective Action Preventive Action (CAPA) System Implemento!ion

Sponsoring Organization BEUvlARK, Inc.

Project Sponsor Name: Nome, CEO Phone: 920-336-2848

Office Address: PO BOX 5310 De Pere, WI 54415-5310

Email: name@belmork.com

Project Leader Name: Mot! Weckwerth, Quality Process Mgr Phone: 920-336-2848

Office Address: PO BOX 5310 De Pere, WI 54415-5310

Email: mottw@belmark.com

Team Members (Name) Title/Role Phone Email Matt Weckwerth Quolity Process Mgr. 920-336-2848 mattw@belmark.com Nome Quality Systems Mgr. 920-336-2848 nome@belmork.com Nome Quality Admin Asst 920-336-2848 name@belmmk.com Nome Quality Admin Ass! 920-336-2848 name@belmmkcom Other Members TBD

Principal Stakeholders Title/Role Phone Email Nome PresidenllCEO 920-336-2848 nome@belmork.com Nome Founder/COB 920-336-2848 nome@belmork.com

Date Chartered: Project Start Date: 10/1/10 I Target Completion Date: 10/11"11

Revision: Date:

Sponsor Approval Signature: Date:

Updates & Approval Log Revision Date Sponsor Approval Signature

Page 1 of 4

41

1.0 BUSINESS ANALYSIS 1.1 Busi ness Problem/O pportu n Ity

Fonnal systems ore in place to implement corrective and preventive action reactively, SllCh as customer complaints, internal complDints or intemal change requests. Potential improvements to these systems include the documentation of root couse, corrective action and effectiveness verificotion of pulls, reruns and ICRs.

The current paper distribution process ossociated with customer complaint resolution is too reliant on administrative functions that would serve as a restraint to the necessary speed needed in regards to correcting the issues associated with pulls, reruns and ICRs. The critical components of root cause identification, effectiveness of corrective action, trend onolysis and preventive action is lost in some cases. Addressing these components is an opportunity.

A proactive approacl1 to complnint reduction, preventive action initinlives ond process improvement is an opportunity through a CAPA system. The ability to spot negative trends and the 20% of the issues that cause 80% of the problems is needed in order to help initiate the appropriate CAPA requests.

1.2 Project Scope/Objective The gool of this initiative is to:

.1. Improve current internal and external comploint trend anolysis tools for Department Manogers and Quality in order to identify CAPA opportunities.

2. Implement the documentation of root cause, corrective action and effectiveness verification of pulls, reruns and ICRs.

3. Creote a system where CAPAs are issued to Deportment Managers to proactively reduce complaints and initiate process improvement.

1.3 Benefits & Potential Value(s) .1. Reduction in both internal and extemal qUfllity complaints 2. Decreases in material ond time waste 3. Incrensed productivity 4. Increased throughput 5. Increased profits 6. Improved quality records and Ihe ability to hold employees/depflrtments more accountable

for quality

1.4 Impacts of Doing Nothing -Internal to the Business Productivity, throughput, wosle and quolity flll need to improve as we continue to grow. Effective proactive corrective nction ond preventive action is tl key component to these improvements. CAPA introduces internal occountability that is critical in ensuring corrective and preventive action is successful. Without CAPA accountability is minimized and implementing qUDlity improvement efforts becomes a bigger challenge.

1.5 Impacts of Doing Nothing - External to the Business Our customers continue to push us on improving speed and quality. The expectation is continuous improvement and CAPA introduces fln improved level of accountability. CAPA focuses on improving internol processes ond sl10uld increose customer sntisfaction. WitllOut a CAPA process, focusing quality improvement efforts on the biggest opportunities becomes a challenge and customer satisfaction may not improve.

Page 2 of 4

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2.0 PHASES & MAJOR DELIVERABLES 2.1 Dellverables

1. Improved trend onolysis charts to be distributed by Quality to Department Monagers on a monthly basis.

2. Pivot Tobie customization of quality dato for the Quolity Department to create customized trend chorts per Manoger, Customer and CAPA request.

3. Trend charts that get to the individual employee level to mensure trends in regards to quolity performance ond comparisons to peers.

4. Define target lines in all trend chnns. 5. Trend chorts tllat display measurables (incidences, defective dollars, defective footnge) os a

percent of <1 whole Gobs, grapllic orders, sales dollars, run footage), This allows for better trend analysis in comparison to history factoring out growth This also "levels the playing field" in regards to throughput os a result of equipment differences or operator skill sets.

6. Incorporote root cause, corrective nction and effectiveness verification into the job pull system. It needs to be defined by job pull category who is the "owner" of implementing ~md documenting root cnuse and corrective action. A Lend/Supervisor/Manager would have the authority to verify the effectiveness prior to the pull being considered closed.

7. Incorpornte root calise, assigning it category ond assigning employee # to ICRs. These nonconformances would be 1rocked the same as complaints.

8. Develop a CAPA process where CAPAs ore genemted as a result of customer request, trend analysis or Manogement discretion.

9. Implement on open ICR, Pull ond CAPA report \h<1\ is reviewed by the Operations Teom on Q

weekly basis to ensure they are being addressed. ICRs ond Pulls need to be addressed in 0

timely fashion (measured by days open), while the CAPA Wallie! have a pr&determined target completion date. The goal is to have no overdue CAPAs.

10. CAPA initiators, responders and appropriate Managers would receive a closed sLimmory of the CAPA upon completion.

2.2 Activities (list In sequence order if known) I. Coordinate a project launch meeting to define the scope of the project, roles and

responsibilities of team members, delivery dates and necessary resources. 2. Establish a cross-functional team for this effort. 3. Define the deliverables of the CAPA sys1em. 4. Determine possible vendors (if opplicoble). 5. Determine who has authority to initiate, distribute, respond to nnd verify the effectiveness of the

CAPA.

3.0 PROJECT VITAL SIGNS 3.1 Overview of Schedule

• Requested Start: 10/1/10

• Required Delivery: 10/1/11

• Timing Concerns:

3.2 AS5umptions / Dependencies • CAPAs are viewed as a tool to improve processes, not as (1 neg(1nve occurrence. • Monogers toke ownership of following through with the CAPA. • Deadlines will be establislled and people will be held accountable for meeting the deadline. • Man~gement sees value in the process.

3.3 Major Quality Assurance Reviews and Roles • Need to determine if QA will filter 011 CAPA submission to determine validity or if they ore to go

direc1 to deportment managers.

P~ge 3 of4

43

• 3.4 Risks and Contingency Plans to Cover Them

1. Risk: CAPA submission becomes 0 personol comploint system mther thon 0 process improvement opportunity Contingency: QA filters all CAPAs or CAPA submission is limited to manager level.

2. 3.5 Estimated Labor Costs (# Hours)

• 3.6 Estimated non·Labor Costs

• 3.7 Interdependencies with Other Projects

3.8 Functional Areas Impacted by Request

• Alloreos

4.0 Project Staffing 4.1 Project Staffing and Time Commitments

• 4.2 Special Resources Needed

• 4.3 Project Organization (Roles & Responsibilities)

Matt Weckwerth: Responsible to manage project and provide in depth evaluation of project performance.

5.0 Project Manaaement Approach 5.1 Approach

5.2 Status or Progress Reporting Plan

• The primary meDns of progress reporting will be verbol between the Project Monoger and teom members during monthly meetings. Emoils will be provided os necessory.

• Quontitotive woste, throughput Elnd defective comploint nllmbers by press will be evoluoted monthly by operations teom members to determine the improvements in each cotegory ond gouge the effectiveness of the project.

5.3 Change Management Approach • Chonges in the project scope ond deliverobles will be determined by teom members ond

monoged by the Project Monoger Chonges must be documented and thorough plonning must occompony eoch chonge with defined meosurobles. This con be documented through emoil discussions.

Page 4 of4

44

Appendix B: Process Flow Diagrams

Current State - Quality Event Management System

Confidenll.1 06/11/10 rre pared By: Matt Weckwert.1-a

45

Future State - Quality Event Management System

_ belmarh I ~-~. "-""'-

Confldentl.1 05/ 11/10

Appendix C: QJI-4.14.104

belmar'l~ L1VJ<!{ 5oM,Ct~ 10 OLiV.m5 P:T,Jt)i'f(ns~

Instruction: Page 1 of 10 QJI-4.14.104

Date Printed: ReleJsed: N/A 0611112010 Rev. Num: 0.6

Approved By:

CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCEDURE

1. Purpose and Scope Purpose

This procedure describes the process for the resolution of nonconformnJ1ces, both real and perceived, through n corrective nction process. This procedure describes the responsibility for the investigation of causes for nonconformnnces, the design Jnd implement<ltion of corrective nctions <Jnd the effective closure of the <Jssociated nonconform<lnces. This procedure also defines the practices utilized in 031) O3ltempt to eliminate the CJuses of potential nonconformities before problems occur through preventive action.

Scope

Documented corrective action is considered when:

Formal customer concem is received;

Intemal complnints (i .e. Pulls & Reruns);

Intern<ll chnnge requests;

Significant problem impacting the Quality System occurs;

Vendor performance becomes <In issue;

AlB nonconformance;

Safety violntion;

Significant incident of downtime or SCfJP occurs;

Operations Llctivities;

Nonconforming materials or services;

Audit results;

Opportunities for improvement (OF I);

Performnnce monitoring <Ictivity results;

PlIfch<lsed materials, conslimables, and services;

Food snfety;

Employee s<lfety;

Equipment malfunctions.

Issued To: N/A Issue Numller: NlA

46

belmar'l~ Instruction: Page 2 of 10

0:.11-4.14.104 Date Printed: Relensed: NfA

UW)fi ~"'15 10 fjrn.i:).:JfS PlOO'tY1)S" 06/11/2010 Rev. Num: 0.6 ApprOved By:

CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCEDURE

2. Definitions

Action Plan

AlB

Audit

Containment Action

Corrective Action

Corrective Action PI .. n

Defective Product

External Product COMpl:!in!

Gatekeeper

Internal Change Request

Nonconform~nce

Nonconforming Product

Plan for improving;) quality issue rel;)ted to a process or product.

Ame ricGn Institute Of Bnking

An on-site verification activity b<1sed upon a sample used to determine the effective implementation of LI suppliers documented qU4llity system.

Short-term ;)ctions put in pl;)ce to ;)ddress J qu;)lity issue until perm4lnent corrective 41ctions nre delermined LInd implemented.

Action taken to eliminale Ihe cnuses of an existing nonconformity. defect or other undesiruble situation in order to prevent recurrence.

Documenl specifying 41ctions to be implemented for correc'ling a process or part quality issue. with responsibilities and target dotes assigned.

Product that through evnluntion is detemlined to be unus<lble. incorrect. irreparable. or otherwise ul1acceptable by an external customer and requires credit or replacement of product.

Product thLlt h4ls been shipped to n Cllstomer who enters a concern over the product but is willing to accept the product as is or [) product rework. This product does not require credit or replacement of the product.

Collects <III Nonconformance reports and distributes each to a Final Approval Authority.

A directive from an internal depnrtmentto chGnge infonmation previously submitted on a product specificLltion.

Product or material which does not conform to custome r requ irements or specifications .

Produclwhich does not conform to customer requirements or specifications.

Dmn ISS\IOO To; N/A Issue Num ()er: NI A

47

belmar'I.~ Instruction: Page 3 0110

Q.J1-4.14.104 D<lte Printed: Rete<lsecl: N/A

LN>t;I Sc*.Jf-(l<IlJ 10 O(;$l(WU PIrx.r-: .... ~.'7~ 06/1112010 Rev. Num: 0.6

Approvecl By:

CORRECTIVE ACrlON PREVENrlVE ACrlON (CAPA) PROCEDURE Definitions (Continued)

Nonconformity

Objective Evidence

OFI

Preventive Action

Pulled Job

QU:lllty M:ln:lgement System

Remedt:lt Action

Rerun Job

Steering Committee

A process which does not conform to a qUCllity system requirer'lent

(ISO 9000:2005) D<lta supporting the existence or verity of something.

Opportunity for improvement.

(ISO 9000:2005) Action taken to eliminate the C<luse of <l potentiat nonconformity or otller undesirable potential situ<ltion.

Any job pulled from the press schedule due to component or qU<llity issues that prohibit producing <l qU<l lity product

(ISO 9000:2005) Management system to direct and control an orgnnizution with regnrd to qUillity.

Change mLlde to a nonconforming product or service to <lddress the deficiency_

Jobs <lre rerun any time <l quality issue prohibits Shipment of the requested minimum order qUClntity (including +/­tolerance) unless <lpproved by <l customer.

BELMARK's Operations Team serves ns it's Steering Committee.

3, Responsibilities

BUS ANALY Business An<llyst

CORP SERV MGR Corporate Services M<ln<lger

DEPT MGR 8. SUP All Department M<lnagers and Supervisors

HR DIR Hum<ln Resources Director

INFO SYS DIR Information Systems Director

MARK DEV MGR Market Development ManCiger

MARK SERV MGR Mmketing Services M<lll<lger

OP MGR CART Operations Milnager Carton

Or<Jft Issued To: N/A Issue NumlJer: NlA

48

belmar'l? Instruction: P.lge4 otl0

QJI-4.14.104 O;:ate Printed: Released: NfA

i.~" ScJutO.I, S 10 (~'I$4..JItI1'S P101'Jt,Y'U- OG/11/2010 Rev. Num: O.G Approved By:

CORRECTIVE ACTION PREVENTlVE ACTION (CAPA) PROCEDURE Responsibllltl@s(Contlnued)

OP MGR FP Operotions M;anager FP

OP MGR PS Oper.ltions Manager PS

PRES/CEO President,. CEO

PROD MGR FILM Product Manager Film

PROD MGR PS

aUALADMIN ASST

Product Manager PS

Quality Administrative Assistant

QUAL PROe MGR Quality Process Manager

QUAL SYST MGR Quality Systems Manager

SLS MGR Sales Manoger

4. Authority QUAL SYST MGR Qu;:ality Systems Manager

5. Instructions

Ora"

1. Identify Problem All employees me responsible to identify initio I problem symptoms from internnl sources. Customer Service Representative (CSRs) and Silies Reps me responsible to identity problems as identified thl'Ough tormal customer complOlints. It is the responsibility ot all employees to take or request the appropriate contninment action commensurote with the potenti<ll impnc1.

1.1. Docum~nt NonconformOlnce (CAP A Request) Silies Reps and CSRs me responsible to initiate <I CAPA request electroni<:ally throllgh the CAPA Manilgement System to document the customer complaint. All employees have the allthority to initiOlte a CAPA request through this system tor internal problems.

1.1.1. Define the Problem The problem must be clearly defined 3S it currently exists. It is required that the source of the informotion. a detailed explanation of the problem und objective evidence is documented.

1.1.1.1. Source The specific origin of the informiltion that initinted the CAPA request must be

Issued To; N/A Issue Nurnl)er: NfA

49

belmarlls

InstructJon: Page 5 of 10 QJI-4.14.104

Date Printed: Released: N/A l."bd Sci'A.'Or 1,j to 005kKo1S P,r;«ffl'l!-I 06/11/2010 Rev. Num: O.S

Approved By:

CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCEDURE Instructions (Continued)

recorded . This information may come from a number of sources internally and externally. Examples of sources that lead to CAPA requests include:

Service Request

Internal Quality Audit

External Quality Audit

Customer Complaint

Quality Assurance Inspection

St[lff Observations

Trend Data

Risk Assessment

Process Performance Monitoring

M;:magement Review

AlB Audits

1.1.1.2. EV:llu:ltlon of the Problem A complete description of the problem is to be documented. The description is to be concise but contain enough information to ensure that the problem c[ln be easily understood.

1.1.1 .. 3. Evidence

2. Evaluation

Objective evidence, or the specific information [lv[lilable that demonstr[ltes th<lt the problem exists. Appropriate documentation is to be att[lched to the CAPA request.

After the nonconform;:mce hos been documented and a CAPA request entered into the system, U)e QU<llity Deportment is responsible to evalu<lte the request to determine the need for <lction ond the ossoci<lted level of <lction. The Quality Dep<lrtment serves os the gotekeeper for oil entered CAPA requests. The potenti<ll impoct of the problem ond the risks to BELMARK ond/or BELMARK's customers is determined ond documented.

Draft

2.1. Assign COltegory and Type The Quolity Dep<lrtment is responsible to ossign on oppropriote c<ltegory ond CAPA type bosed on the eV<llu[ltion of the request. Multiple cotegories moy be ossigned bosed on the n<lture of ti)e problem. The following me the nine CAPA types thot may be <lssigned to the request:

EXT - Externol Customer Comploint

Issued To: N/A Issue Numl:)er: NJA

50

belmarllp. Instrucllon: Page 6 of 10

0.J1-4.14.104 Date Printed: Released: N/A

L/fI)(lI SCJtll ()"' \J II) LJG.SIf')o}fS P :f)$.)' .. VI)j- 06/11/2010 Rev. Num: 0.6 ApproVed By:

CORREcrlVE ACrlON PREVEN-riVE ACrlON (CAPA) PROCEDURE Instruct ions (COntinUed)

Of<lfl

DEF - Defective Customer Compl(lint

RR - Internal Rerun

PLL - Internal Pull

ICR - Internal ChiJnge Request

NC - Internal Nonconformance

OFI - Opportunity for Improvement

AUD - Audi,t Nonconformance

VCAR - Vendor Corrective Action Request

2.2. Pot&ntl.:tl Imp.:tct As P<lrt of the evalu(ltion process. the QU(llity Department is responsible to document the potential impact th(lt the problem may have in terms of costs, product quality, safety, throughput and ultimately customer satisfaction .

2.3. Assessment of Risk Using the result of the impact evaluation a value defining the seriousness of the problem is 1ied to the CAPA. The level of risk that is i1ssoci"ted with the CAPA will define the i1ctions thiJt are taken. High priority items will require immediate remedial <Jction. Low priority items may not require immedi<Jte <Jction .

2.4. Remedi~1 or Cont~lnment Action Bi1sed on the risk assessment, the Qu"lily Department may determine th"t immedi"te remedial or cont"inll1ent "ction is required to remedy tile situation until iJ more thorough investigatioll and pemlOlllellt solution COln be implemented. If remedial action is necessary, the ilction and resources me to be documented. The Quality Department is responsible to provide written direction as to the steps that mllst be t"ken immedi<ltely to avoid any flirther adverse effects. This is routed to the appropri"te resources and the appropri"te individuals iJre responsible to document the action t"ken .

BiJsed on risk assessment and the outcome of the remedial action, tile Quality Department has the authority to close the CAPA if it has been detemnined that the problem has been resolved and the risk of reoccurrence has been elimimted. The rationale for this decision is to be doclimented in the CAPA.

2.5. Route CAPA If it is determined by the Ou"lily Dep<lrtment or " Functional Area Manager that Corrective Action or Preventive Action is necessary, the CAPA is routed to the appropriate Function,,1 Arei1 Manager(s) for Investigation, Analysis, Action Plan Development and Action Plan Implement:ltion.

3. Investlg;\tlon The Functional Area Manager is responsible to document a procedure for conducting an

Issued To: N/A Issue Numl.Jer: NlA

51

b.lmar'l~ Instruction: Page 7 of 10

Q.J1-4.14.104 D;)te Printed: Rele;)sed: N/A

L~ SOI'1I,1;I '11O iJ(.I$/f)j!1$ PIQ{~~';-'·I}j· 06/11/2010 Rev. Num: 0.6 Approved By:

CORReCTIVe ACTION PReVeNTIVe AC-riON (CAPA) PROCEDURE Instructions (Contlnuedl

investig;)tion into the problem. The purpose of this is to ensure th;)t investigation of the issue is complete. The procedure should include;)n objective for the actions tnken. the procedure to be followed . the individuJI(s) responsible for e<Jch step. required completion dil1es and any other additional informntion.

3.1. Route to Responsible Personnel

The Functionnl AreJ ManJger is responsible to route the CAPA with investigntion plan to the Jssigned personnel.

4. AnOllysls Using the investigation procedure the assigned personnel are responsible to inVestigate the CJuse of the problem ;)nd document the root cause of the problem prior to the required completion dJte. This process includes collecting dJta. investignting all possible causes Jnd using the information to determine the root cnuse of the problem. Although contributing c~lLIses Sl10uld be documented. it is important that observed symptoms of a problem ~lnd the primary root cause of the problem are distinguished.

Dm"

4.1. Possible Causes & Data Collection The listing of possible causes and ;)ssoci;)ted dJtJ is to be documented Jnd org;)nized . This inform"tion is to be utilized to determine the root cause of the problem.

4.2. Root Cause Analysis & Identification

Determining troe root c;)use of the problem requires answering n series of 'why?' questions and digging deep into the issue until the root cause is determined. The root cause of the problem is documented in lhe CAPA by the "ssigned personnel.

15. Action PI;m By using the results from the An;)lysis. the FunctionJI Area Mannger(s) are responsible for determining the optimal method for correcting the problem or preventing n future occurrence through the creation of;)n "etion plan. As needed the plJn mny include :

Items to be completed

Required completion dates

Personnl responsible for each item

Document changes

Process, procedure or system chnnges

Employee tmining

Monitors or controls to prevent reoeeurance

5.1. Route to Responsible Personnel

The Functional Are;) Manager is responsible to route the CAPA with ;)ction plan to the

Issued To: N/A Issue Number: N/A

52

belmar'l~ Inslrucllon: Page 8 0110

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Uoel ~.Jt. (\f1S 10 U.JSInI) f.S Prro'f,Y'I 06/11/2010 Rev. Num: 0.6 ApprOVed By:

CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCE.DURE Instructions (Con1inued)

assigned personnel.

6. Action Plan Implementation All of tile [lctivities that htlve been completed [IS P<lrl of the <lction pl[ln must be listed and summ<lrized . This will provide iJ complete record of the <lctions th<lt were t<lken to correct the problem and ensure that it will not occur again. All modified procedures. specific<ltions or other supporting documents <lre to be attached to the CAPA.

6.1. Action Plan Approval The Functionnl Area Manager and olher assigned approval outhorities me responsible to review the action plan implementiltion summory ond may request additional action from the implementation team. Once it is determined th<lt the action plan h<ls been successfully implemented. the approv<ll authorities approve the CAPA.

7. Follow Up 8. Verification Tile Functional Area Mnnnger(s) is responsible to answer the following questions (lS appropri<lte:

1. Have all of the objectives of the CAPA been met?

2. Have all of tile recommended changes been completed and verified?

3. H<ls appropri<lte communications <lnd training been implemented to ensure that the issue <lnd changes are understood?

4.15 there a (lny chance that the actions taken did not prevent reoccurnnce?

A summary is to be documented within the CAPA under the verific<ltion results section .

8. Effectiveness of Action Plan The Quality Department is responsible to evaluate tile CAPA to ensure that the root cause of the problem h<ls been solved. that proper controls have been est(lblisi1ed and th(lt monitoring of the situ<ltion is in pl(lce. The effectiveness evaluation is to be documented within the CAPA (lnd the CAPA is to be routed to the QU(llity Systems Man<lger.

9. CAPA Disposition The QU(llity Systems Manager is responsible to review the CAPA with the Operations Team to detennine the final disposition. If it is determined that the implemented action plan was effective the CAPA is to be closed. If it is determined that the action plan was not effective or needs further investigation, the CAPA process will be routed back to the responsible Functional Area Mnnt:lger to stUr! the CAPA process over.

10. Weekly CAPA Review

Df<lft

Tile Quality Systems Man<lger is responsible to review all new high risk CAPAs and ov~rdue CAPAs during the weekly Operations Team meetings to ensure visibil ity and th(lt CAPAs stay on track.

Issued To: NJA Issue Numl>er: NfA

53

belmar'l~ L~ 5ct.Jf~)' I$1O Dj.I$K)~t .. ,...'fOl): .. \ 'n

Instruction: Page 9 of 10 0,,)1-4.14.104

Date Printed Released: N/A 06/11/2010 Rev. Num: 0.6

Approved By:

CORREC-rIVE ACTION PREVENTIVE ACTION (CAPA) PROCEDURE

6. Policy References

Corrective and Preventive Action 4.14

7. Procedu re Referen ces

No procedures are referenced by this instruction.

8. Instruction References

No instructions ilre referenced by this instruction.

9. Other Reference Documents

There me no other reference documents for this instruction.

10. Records No records are created by this instruction.

11. Materials No materials are identified for this instruction.

12. Tools No tools are identified for this instruction.

13. Gages No gages are identified for this instruction.

Draft Issued To: NfA Issue Number: NtA

54

belmar'l~ L~ !M:*.Jf .... lSlO O(QJrm-$ Plw' .. '/o,'n$'lt

InslruCUon: Page 100110 0.,11-4.14.104

Date Printed Released: N/A OS/11/2010 Rev. Num: O.S

Approved By:

CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) PROCEDURE

14. Safety Instructions No s(lfety instn.lctions me identified for this instrllction.

15. Notes 1.0 Inlt);.1 Rele:tse.lmplement<ttlon Effective TBD.

Draft Issued To: NfA Issue Number: NlA

55

Fiscal Year Month

2007 Oct

2007 Nov

2007 Dec

2007 Jan

2007 Feb

2007 Mar

2007 Apr

2007 May

2007 Jun

2007 Jul

2007 Aug

2007Sep

2008 Oct

2008 Nov

2008 Dec

2008 Jan

2008 Feb

2008 Mar

2008 Apr

2008 May

2008 Jun

2008 Jul

2008 Aug

2008Sep

2009 Oct

2009 Nov

2009 Dec

2009 Jan

2009 Feb

2009 Mar

2009 Apr

2009 May

2009 Jun

2009 Jul

2009 Aug

2009Sep

2010 Oct

2010 Nov

2010 Dec

2010 Jan

2010 Feb

2010 Mar

2010 Apr

56

Appendix D: Customer Complaint and Quality Event Data

DEF EXT PLL RR

159 151 117

116 57 84

79 68 111

93 100 149

74 76 100

104 111 130

129 91 144

82 102 117

75 69 107

95 102 143

85 95 110

98 70 103

129 104 134

115 110 77

99 98 96

75 125 111

145 148 82

84 105 106

130 140 138

72 120 88

79 103 117

113 128 137

94 120 117

100 86 131

115 138 168

109 128 89

80 116 96

94 149 125

84 94 114

87 102 141

94 137 150

71 105 94

85 112 122

118 115 149

68 102 125

130 142 121

110 136 173

97

90

95

101

120

82

95

103

124

141

87

102

107

133

118

114

103

141

112

75

74

92

85

98

111

92

77

85

81

68

110

80

79

128

81

105

89

72

56

94

100

82

121

62

58

101

70

100

136

92

111

166

103

73

149

125

115

141

111

130

176

ICR Total Cust Comp Avg Days to Close Total Internal Events Grand Total

81 310 22 310 620

79 173 22 238 411

78 147 26 263 410

67 193 25 308 501

71 73

69

85

94

81

101

110

124

71

58

71

72

76

60 57

71

79

63

72

84

84

73

74

79

89

85

85

128 ,

110'

87 '

102 '

lOS ' , 120 , 111 , 117 , 115 108 ' , 106

150

215

220

184

144

197

180

168

233

225

197

200

293

189

270

192

182

241

214

186

253

237

196 243

178

189

231

176

197

233

170

272

246

192

193

219

242

207

184

23

22 24

18

22 24

28

22 28

23

23

23

24

20

22 18

17

20

18

20

22 18

20

14

16

14

19

16

20 ,

19 ' , 18 , 21 17 '

20 ' , 22 23 ' , 29 , 21 18 '

256

301

324

294

278

309

292

281

368

228

233

310

235

287

287

217

244

310

280

285

373

235

227

300

263

330

371 271 361

425

315

296 427

352

359

376

340

341

423

406

516

544

478

422

506

472

449

601 453

430

510

528

476

557

409

426

551

494

471

626

472

423

543

441

519

602 447

558

658

485

568

673

544

552

595

582

548

607

57

Values

Row Labels .... 1 Sum of Total Cust Comp Sum of Total Internal Events

- 2007 2281 3454 Oct 310 310 Nov 173 238 Dec 147 263 Jan 193 308 Feb 150 256 Mar 215 301 Apr 220 324 May 184 294 Jun 144 278 Jul 197 309 Aug 180 292 Sep 168 281

.::1 2008 2622 3284 Oct 233 368 Nov 225 228 Dec 197 233 Jan 200 310 Feb 293 235 Mar 189 287 Apr 270 287 May 192 217 Jun 182 244 Jul 241 310 Aug 214 280 Sep 186 285

-12009 2575 3767 Oct 253 373 Nov 237 235 Dec 196 227 Jan 243 300 Feb 178 263 Mar 189 330 Apr 231 371 May 176 271 Jun 197 361 Jul 233 425 Aug 170 315 Sep 272 296

.::12010 1483 2618 Oct 246 427 Nov 192 352 Dec 193 359 Jan 219 376 Feb 242 340 Mar 207 341 Apr 184 423

Grand Total 8961 13123

58

450 -r--- -- -------------------

--SIIIII oflolal ("'I (oml'

--SIIIIl oflol.llnlern.1 [ 'lelill

-- linear (S lim oflol.1 CUll (omll)

-- linear (SIIII1 of Tolallnlernal [ venti )

100 - -------- - --- --- ----- - -_ .. _---_. __ ...

50 1-------------------------------------------------------------

o

59

Row Labels I-"'l Sum of Avg Days to Close

.::.1 2007 279 Oct 22 Nov 22 Dec 26 Jan 25 Feb 23 Mar 22 Apr 24 May 18 Jun 22 Jul 24 Aug 28 Sep 22

.::.12008 257 Oct 28 Nov 23 Dec 23 Jan 23 Feb 24 Mar 20 Apr 22 May 18 Jun 17 Jul 20 Aug 18 Sep 20

.::.!2009 215 Oct 22 Nov 18 Dec 20 Jan 14 Feb 16 Mar 14 Apr 19 May 16 Jun 20 Jul 19 Aug 18 Sep 21

-::1 2010 151 Oct 17 Nov 20 Dec 22 Jan 23 Feb 29 Mar 21 Apr 18

Grand Total 902

60

Average Days to Close Customer Complaints

35 ~-------------------------------------------------------------------------

30 +--------------------------------------------------------------------------

25 +---~~--------~~~~--------------------------------------------_+_+---

- Total

--- Linear (Total)

10 .~-------------------------------------------------------------------------

~ _______ J

Date:

Customer:

RAil:

Weight

Cost 3

% Defective 2

Customer Dissatisfaction 3

Customer Response Urgency 3

label Failure Probability 4

Reoccurrence Probability 2

Order Pending 3

Product Recall (0 or 5) 12

Mislabeling Risk (0 or 5) 12

Risk level

61

Appendix E: Risk Assessment Calculator

Value

1

1

1

1

1

1

1

1

0

Value Key

2 3 4

< $200 $200-$500 $500-$1,000 $1,000-$5,000 > $5,000

< 5% 5%-10% 10%-25% 25%-50% >50%

Minor Negligible Marginal Critical Catastrophic

< 30 Days < 14 Days < 7 Days < 24hrs Immediate

Improbabl e Remote Occasional Probable Frequent

Improbable Remote Occasional Probable Frequent

< 30 Days < 14 Days < 7 Days < 24hrs Immediate

N/A N/A N/A N/A Yes

N/A N/A N/A N/A Risk

Risk level Key

36to 50 51 to 65 66 to 80

Track and Trend Remedial Action Remedial Action CAPA Probable CAPA Required May Require CAPA

Appendix F: CAPA Request Form

belmar,._ L4."C'I:.ioI,.""" ,,,o:..-nt<Al f 'l):tt.fojjy"

CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) REQUEST FORM

GREEN SECTIONS CO'MPLETED BY CAPA INITIATOR PURPLE SECTrIONS COMPLETED BY CAPA PROJECT LEADER

BLUE CEL.LS SECTIONS BY QUAL.ITY SYSTeMS MANAGeR ORANGE seCTIONS COMPL.ETED BY CEO

CAPA Number CAPA NOime CAPA Inlti.llor MOinOiger N3me: CAPA Approved/Denied If Denied, Reilson for Oenlill

CAPA Project LeOider OIS MOinOiger Name: Assigned byOper:ltlons Te:lm CAPA ProJect Te:lm Members TltlelRole Phone Ext Email (Name)

D3te Submitted: Project Start Date: I T.nget Completion Date:

QU:lllty Systems M:lnager Approv:.1 Slgn:lture: D:lte:

CEO Approvill Signature:

Upd3tes & Approval Log Revision D3te

DOCUMENT APPROVED BY MATT WECKWERTH

Date:

QU:llitv Systems Manager Approv;!1 Signature

01129/09 OF-DOD

62

Com piN Risk Risk level Entered

63375 70 Orange

63461 69 Orange

63385 68 Orange

63374 67 Orange

63536 66 Orange

62667 65 Yellow

63387 65 Yellow

63553 6S Yellow

63380 64 Yellow

63201 62 Yellow

63404 60 Yellow

63571 60 Yellow

63499 58 Yellow

63509 58 Yellow

63574 58 Yellow

62768 56 Yellow

63465 56 Yellow

63492 56 Yellow

63598 56 Yellow

63352 5S Yellow

63557 55 Yellow

63310 S3 Yellow

63215 52 Yellow

63407 52 Yellow

63250 SI Yellow

Sl Yellow

5/27/2010

5/27/2010

6/7/2010

5/10/2010

6/8/2010

4/22/2010

5/11/2010

6/1/2010

6/7/2010

6/1/2010

6/1/2010

6/9/2010

4/20/2010

6/1/2010

6/10/2010

6/1/2010

5/19/2010

6/2/2010

6/11/2010

6/8/2010

6/8/2010

6/11/2010

4/26/2010

6/7/2010

6/8/2010

6/14/2010

5/28/2010

6/10/2010

5/26/2010

5/20/2010

6/2/2010

5/21/2010

6/8/2010 63503

63311 50 Yellow/Green 5/26/2010

63235 49 Yellow/Green 5/21/2010

63551 49 YellOW/Green 6/10/2010

63239 YellOW/Green 5/21/2010

63240 48,Yellow/Green 5/21/2010

63241 48 Yellow/Green 5/21/2010

63339 47 YellOW/Green 5/27/2010

62832 46 YellOW/Green 4/28/2010

14

27

13

No

No

No

No

No

4 No

50 •

No

Yes

18 No

No

20 No

26 No

13 No

25 No

20

25

5

25

25

25

19

48

No

No

No

No

No

No

No

No

No

63167 45 Yellow/Green 5/18/2010 28 No

63289 45 Yellow/Green 5/25/2010 21 No

62932 44 Yellow/Green 5/4/2010 42 No

63359 44 Yellow/Green 5/28/2010 18 No

63462 43 Ye llow/Green 6/7/2010 No

62890 42 Yellow/Gree n 5/3/2010 43 No

63174 42 Yellow/Green 5/18/2010 28 No

62809 41 Yellow/Green 4/27/2010 49 No

63108 41 Yellow/Green 5/14/2010

63147 41 Yellow/Green 5/17/2010

63148 41 Yellow/Green S/17/201O

63177 41 Yellow/Green 5/18/2010

63176 41 Yellow/Green 5/18/2010

63226 41 Yellow/Green 5/20/2010

63439 41 Yellow/Green 6/4/2010

63194 40 Yellow/Green 5/19/2010

63555 40 Yellow/Green 6/10/2010

62732 39 Yellow/Green 4/23/2010

32 No

29 No

29 No

28 No

28 No

26

11

27

53

No

No

No

No

No

63

Appendix G: Open Quality Events

Customer

20 574547 15 CONfiDENTIAL

20 574259 12 CONfiDENTIAL

o 580228 31 CONfiDENTIAL

1 577077 18 CONfiDENTIAL

30 580690 6 CONfiDENTIAL

o S47660 14 CONfiDENTIAL

o S76f1J7 3 CONfiDENTIAL

o 580942 19 CONfiDENTIAL

20 568568 7 CONfiDENTIAL

o 579892 4 CONfiDENTIAL

o 579132 19 CONfiDENTIAL

o 582530 19 CONfiDENTIAL

30 S74f1J5 6 CONfiDENTIAL

o 580480 25 CONfiDENTIAL

20 578816 9 CONfiDENTIAL

o 580201 19 CONfiDENTIAL

o 579038 25 CONfiDENTIAL

20 572539 24 CONfiDENTIAL

30 568935 7 CONfiDENTIAL

30 582528 9 CONfiDENTIAL

o 582898 19 CONfiDENTIAL

20 578970 35 CONfiDENTIAL

o 573805 19 CONfiDENTIAL

20 580984 3 CONfiDENTIAL

o 582697 19 CONfiDENTIAL

o 581126 19 CONfiDENTIAL

20 575522 8 CONfiDENTIAL

20 576246 9 CONfiDENTIAL

30 577269 9 CONfiDENTIAL

30 545305 2S CONFIDENTIAL

o 579403 17 CONFIDENTIAL

o 5759fIJ 22 CONFIDENTIAL

20 557807

30 570037

3 CONfiDENTIAL

6 CONfiDENTIAL

20 575632 32 CONfiDENTIAL

1 581072 31 CONfiDENTIAL

1 579852 29 CONfiDENTIAL

1 579961 29 CONfiDENTIAL

1 579970 29 CONfiDENTIAL

30 548136 25 CONFIDENTIAL

o 574987 20 CONfiDENTIAL

20 573341 18 CONFIDENTIAL

o 578892 3 CONfiDENTIAL

1 569711 32 CONfiDENTIAL

o 579408 9 CONfiDENTIAL

20 576863 30 CONfiDENTIAL

30 561945 25 CONfiDENTIAL

1 576194 20 CONFIDENTIAL

20 537558 25 CONFIDENTIAL

I 575855 3 CONFIDENTIAL

o 574642 3 CONFIDENTIAL

o 574644 3 CONFIDENTIAL

20 561943 22 CONfiDENTIAL

20 564391 22 CONFIDENTIAL

20 564956 22 CONfiDENTIAL

20 577933 29 CONfiDENTIAL

20 558196 32 CONfiDENTIAL

20 579973 6 CONfiDENTIAL

20 563691 19 CONfiDENTIAL

Cat Reason Cost Type Shipped QIy

S5 WRONG ITEM WAS SHIPPED TO CUSTOMER WRONG I S 24,656.76 DEf

AS01 WRONG LABEL SENTTO CUSTOMER SHOULD HAVE BI S 1,4S2.10 DEf

GOI I SCENTED ITEM IS MISSING THE WORD fRAGRANCE . S 1,024.24 DEf

G21 NEW CRONIC LABEL / ART SHOULD HAVE BEEN ON n S 279.00 DEf

PI6 GLUE fAIUNG - CARTONS POPPING OPEN S 7,190.17 DEf

P05 WRONG STOCK WAS USED ON JOB - LABELS fALLING $ 1,033.89 DEf

RI9 GRAPHICS/HIGHLIGHTING; DIE IS RIPPING THE fiLM; I $ 2,066.95 EXT

VI LABELS ARE STICKING TO THE LINER AND TEARING. RI $ 3,440.54 DEf

V5 SEAL HAS fAILED THE SEAL HAS fAILED ON THE BOD< $ 2,348.72 DEf

P06 COlOR HAS DRifTED TOO fAR fROM COlOR STANDA $ 1,650.87 DEf

VI LABELS ARE STICKINGTO THE LINER ANDTEARING.CI $ 1,175.72 DEf

VI LABELS STICKING TO LINER AND TEARING CUSTOMER $ 2,459.95 DEf

S5 BELMARK REVISED INCORRECT LABEL AND IN TURN P $ 4,424.00 DEf

P06 CUSTOMER IS UNHAPPY WITH THE COLOR (THE CAU5 $ 253.00 DEf

P03 PRINT ON fiLM NOT LEGIBLE REf N555 CUSTOMER REI $ 1,171.60 DEf

VI LABELS ARE STICKING TO THE LINER AND TEARING. $ 551.06 DEf

T501 CUSTOMER IS NOT HAPPY WITH PRINT QUALITY OR V $ 784.98 EXT

T508 SEAL BELOW NOULE IS fAILING ON EVERY 3RD PACK S EXT

PI6 THE GLUE IS fAIUNG ON THE HANG TAG - ADDT RETU S 1,546.17 DEf

PI6 Ref N554 - CARTONS ARE TORN & fLAPS ARE fOlDED $ 1,194.00 DEf

VI LABELS STICKING TO LINER $ 427.99 DEf

P02 HASASPOTTHAT IS NOT COVERED IN WHITE IN EYE ! $ 3,880.52 EXT

VI ADHESIVE SKIP -LINER STICKING TO 8ACK OF LABELS $ EXT

R19 HOLES ARE NOT PUNCHED CORRECTLY DIE CUT HOLP $ DEf

VI LABELS STICKING TO LINER AND TEARING $ EXT

VI LABELS STICKING TO LINER AND TEARING·CU5TOMEF $ EXT

S5 CUSTOMER DIDNT LIKE THE WAY IT LOOKED (PER MA $ 1,424.85 DEf

P03 REGISTRATION ISSUES CUSTOMER HAS THIS FILM ANI $ 838.66 DEf

POI CARTONS ARE NOT UNFOlDING FOR THE CUSTOMER $ EXT

P02 BROWN SOTS ON TOP OF FLAP (DURING PRODUCTIO $ 1,976.04 EXT

POI LINER IS TEARING PLEASE CHECK FOR DEEP DIE STRIK $ EXT

S5 THE LABELS ARE DISCOlORING. THE LABELS ARE Gm $ EXT

P11 UPC SCANNING INCORRECTLY - SEE EMAIL PROVIDEC $ EXT

PIS LAMINATE COMES OFF EASILY WAITING fOR CON FIR $ 1,126.35 DEF

P02 BLACK MARKS ON FILM (DURING PRODUCTION, THEf $ 4,860.53 EXT

P02 CUST REJECTED-LABELS HAVE A PINK LINE RUNNING $ 392.26 DEf

SS THE GRAY IS TOO LIGHT. NEEDS TO MATCH PMS BLAC $ 251.10 DEf

S5 THE GRAY 15 TOO LIGHT. NEEDS TO MATCH PMS BLAC $ 289.80 DEf

S5 THE GRAY IS TOO LIGHT. NEEDS TO MATCH PMS BLAC $ 302.40 DEf

POI fLAP NOTCUT COMPLETELY (DURING PRODUCTION, $ 882.61 DEf

AS05 3 ITEMS 5ENTTO RETAIL DISTRIBUTION CENTER WER $ 200.26 EXT

V5 TOO MUCH OVERRUN ON JOB. CUSTOMER WILL RETl S 1,797.45 EXT

TS06 VARNISH ISSUE SIMILAR TO 59642 POSSIBLY. PLEASE · S 231.00 DEf

P16 CARTON IS NOT fORMING AND SQUARING UP FULLY. S EXT

R18 LABELS STICKING TO LINER CUSTOMER JUST CAllED! S EXT

V4 fiLM WAS DAMAGED AND DIRTY FILM WAS DAMAGI S 2,906.39 DEf

P02 NONCONfORMING H1Q-33: DIE CUTOFF (DURING PR S 616.16 DEf

S5 CUSTOMER IS STATING THEY DID NOT RECEIVE THESE S 277.66 EXT

LA7 ARH-IQ-030: INK SPOTS ON POUCHES (THE POOR ADI S 391.16 DEF

R23 SEAM OVERLAP CUTS OFF TEXT (THE FILM IS RUN lA( S G20 DROP SHADOW IS CREATING PATIERN ON LABEL (Tr S G20 DROP SHADOW IS CREATING PATIERN ON LABEL (TH S LA6 FILM SPLITIlNG, DELAMINATING fiLM SPLITIING, DEI S TS08 EVERY ROlL GOES OUT Of REGISTRATION ON THE LA! S

5.83 EXT

DEf

DEf

EXT

EXT

P20 EYEMARK REPEATlENGTH (DURING PRODUCTION, IT S EXT

P20 EYEMARK IS WALKING - SAMPLES WILL8E HERE ON 6. S EXT

V5 THERE ARE lITILE PIECES OF MATERIAL INSIDE THE BI S 234.87 EXT

V5

S5

INCORRECT PO NUMBER PROVIDED TO ABF FREIGHT S EXT

CUSTOMER STATES TOO MUCH OVERRUN PER NEWC S 1,345.32 EXT

49,353

33,100

170,900

5,300

61,767

11,000

137,700

12,000

1,300

53,BOO

4,000

10,000

lOO,BOO

2,750

40,000

2,000

5,250

20,396

86,BOO

12,000

6,000

95,910

2,000

282,285

2,000

9,000

149,330

31,200

39,550

586,785

66,000

86,600

97,500

96,037

281,130

2,750

310

315

31S

631,749

59,750

21,305

597,600

81,563

67,500

64,BOO

210, 2S2

34,100

1.317,700

22,680

SS,OOO

55,000

108,000

54,100

889,200

65,560

26,690

59,577

60,293

Appendix H: Quality Event Risk Distribution

Risk Level Distribution

~---------.------

64

Orange

Yellow

Yellow/Green

• Green

Appendix I: Open CAPAs

12>< :

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rQ"l'YI!.(D,...)'\.1.·i't.r~·1.nIII

R;.,I.' l.t:.TflJA! I!MS O'~tAt.'JJlT PltJOet D[1U~\~Vf

U ", . OI'X:IO

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~UMtI!;"'ROCf~TOHtRru:TI1:oTC.Cl~

llJ,; r.=-I \V'. ~'1J101 ~~'~~t~:::':~~~~~~;:'~;,~~~f~~~r/Dt 7'.1./20\0

c.p1(jhot:.Tt,\!.I

"" -ll

717/2010 ·~l N~VI

~m"AN! HO ... ,':..rHI1I\! JlID ~OO; !!'KOf'I P.l.Ti!ILmU

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Clfi'\.~" .... trrC'l4..lf

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Ot 1W:'r.,.,ti\t.«'lDn •• n I~"n' .... -:t·/H"J

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c.u'ifvllu,,~ttl1"\J~

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65

hnv"AoIloft,.,.J ",,",y'eLe OWl

CNtrdJ..

,W,1! Vi7F.OJ(l V26i!OI(

'i~/'I1lU ,,>!lV.

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1/4f(lV'ltJ a,r~ ,.'Wt\.

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IlAlU~: .. ,r.o~ e!Ul)10

~'ol 'fKl/:o

1'-"-" SlI~/!OI

tiAt"f ~15no1C

UAL'f 5/1Sj201C

/jAMf 7,1/!OIO

~!n/:ol

"AM' 5/J5/:01

7{1/:0JO

IW.lf 5/1.11/:01 "l1nOl'

,/U/;Ol

7i1/)n

11M'! 5/14/Z01 5iW/!OK

IIAlAI ,/;11JOI

11AJ.\f 7/7/:01

IIAl.tt: SII4!:OI ,111/:01)

""M[ VW101

7,0(':01

CAPM TYPE Root RA Entered

U345 CAPA 62667 4/20/1.fJIO

L2346 CAPA 62710 4/ZZ/1.fJIO

12347 CAPA Multiple 5/10/2010

12348 CAPA Multiple S/U/1.fJIO

123S1 CAPA Multiple 6/1/2010

12352 CAPA Multiple 6/1/2010

12353 CAPA 63452 6/7/2010

12354 CAPA 63461 6/7 2010

12355 CAPA 63508 6/8/2010

CamplU Type Risk Entered

62667 DEF 6S 4/20/2010

62710 DEF 4/22/2010

62732 EXT 39 4/23/2010

62768 EXT SE 4/26/2010

62809 DEF 41 4/27/2010

62809 EXT 37 4/27/2010

62809 EXT 37 4/27/2010

62832 EXT 46 4/28/2010

Appendix J: Weekly Quality Event Report

OPEN CAPAs CAPA Description

D£TERMINE IF A VERIFICATION PROCESS CAN BE IMPLEMENTED TO ENSURE THE CORRECT LAlI£l PAGES ME REVISI'D AS

REQUESTED.

DmAMINEA METHOD TO PREVENT THE USE OF STOCKTHATIS NOT CALLED FOR ON THESTRUcnJRE HARD CARD

DETERMINE A METHOD FOR THE CUSTOMER TO ORDER ACTIVE ITEMS ONLY

MULTIPLE lABEL PlACEMENT ISSUES OF lATE. DmRMlNE IF MACHINE NEEDS REPAIR AND IF PM PROCEDURES NEED TO

REVISED MOVING FORWARD

RAW MATERIAL ISSUES OVER MUlTIPLE JOBS. DETERMINE VENDOR PREVENTIVE ACTION AND POTENTIAL BELMARK OA TESTING

DETERMINE A PROCESS TO ENSURE THAT COlOR STANDARDS ARE PRODUCED TO TARGET DENSITY/DOT/DE AND THAT IN-

PROCESS MEASUREMENTS ARE WITHIN SPECIFICATION

DETERMINE A METHOD TO HOLD CUSTOMER ACCOUNTABLE FOR SIGNING THE PROOF MOVING FORWARD

QUALIFY NEW STRUCTURE AND DETERMINE IF CURRENT QUALIFICATION PROCESS NEEDS TO BE REVISED

DETERMINE HOW ADHESIVE AND STOCK INCOMPATIBIlITIES WILL BE IDENTIFIED AND TESTED FOR CUSTOMERS MOVING

IFORWARD

• OPEN HIGH RISK INCIDENCES

I 30 DAYS OVERDUE INCIDENCES · ACTIONS

Reason

BELMARK REVI SED INCORRECT LABEL AND IN TURN PRODUCED THE INCORRECT LABEL. PRODUCT WAS

WRONG STOCK WAS USED ON JOB - LABELS FALLING OFF PRODUCT (WHEN THE JOB WAS BEING SET UP

CUSTOMER STATES TOO MUCH OVERRUN PER NEW OVERRUN TOLERANCES FOR FORMING BAGS THE I

ADHESIVE SKIP -LINER STICKI NG TO BACK OF LABELS (THIS APPEARS TO BE A RAW MATERIAL ISSUE WI

ARH-l0·03(): INK SPOTS ON POUCHES (THE POOR ADHESIVE COVERAGE WAS LIKELY DUE TO SOME WO

ARH·ID-03(): INK SPOTS ON POUCHES (DURING PRODUCTION THERE WERE SOME INK SPOTS THAT WE

ARH-1D-03(): INK SPOTS ON POUCHES (THE POOR ADHESIVE COVERAGE WAS LIKELY DUE TO SOME WO

3 ITEMS SENTTO RETAIL DISTRIBUTION CENTER WERE REWOUND AT 250 PER ROLL SHOULD HAVE BEEN

Days

o Jpen

56

54

53

50

49

49

49

48

Risk level .----! __ 'Jl ... ~ 36 1050

Risk Level Key

5lt06S 661080

Due Date

5/4/2010

5/6/2010

5/7/2010

5/10/2010

5/11/2010

5/11/2010

5/11/2010

5/12/2010

Open

56

54

36

35

14

14

8

8

7

Days

d Over ue

42

40

39

36

3S

35

35

34

Track and Trend Remedial Action Remedial Action CAPA Probable CAPA Required May Require CAPA

66

Due Date

5/20/2010

S/U/1.fJ10

6/9/2010

6/10/2010

7/1/2010

7/1/2010

7/7/2010

7/7/2010

7/8/2010

Customer

CONFIDENnAL

CONFIDENTIAL

CONFIDENTIAL

CONFIDENTIAL

CONFIDENTIAL

CONFIDENTIAL

CONFIDENTIAL

CONFIDENnAl