training. corrective action training how to implement, process and administer the corrective action...

Training

Corrective Action TrainingHow to Implement, Process and Administer

the Corrective Action Process

What we will coverO Introduction to Corrective Action

O Corrective versus Preventive ActionO Types of Corrective Action

O History of the Corrective Action ProcessO The ISO 9001:2008 Standard’s Requirement for

Corrective ActionO The Corrective Action ProcessO Implementation and Administration of the

Corrective Action ProcessO Data Gathering, Measurement and Analysis

O Tools for Corrective Action

Isocert Solutions © Rev C 3

Introduction to Corrective Action

O Corrective Action is not just an ISO 9001 requirementO It is a fundamental management tool for ensuring your

organizations vitality and growthO It is the orchestration of various activities within

the organization to assure the business processes function smoothly O A process has no end, it is continuousO A formal process that has been defined and controlled

with Management InvolvementO The key words are that it is a PROCESS and

MANAGEMENT INVOLVEMENT



O Corrective Action versus Preventive ActionO Corrective Action is taken to eliminate the cause of

nonconformities in order to avoid recurrenceO In other words correcting something that has already

happenedO Preventive Action is taken to eliminate POTENTIAL

nonconformities in order to Preempt their occurrenceO To keep them from happening in the first place

O It deals with abstractions, inhabiting the realm of “potentiality”O Examples are Failure Modes Effects Analysis, Packaging

Design, or Mistake Proofing; there are many more examplesO A Quality System deals with 2 unique requirements –

actuality versus potentiality



O Types of Corrective ActionO Customer Requested Corrective Action

O Returned Materials, Field failures or design errors are examples

O Quality System Corrective ActionO Third Party AuditO Second Party AuditO Internal Audit

O Supplier Corrective ActionO Management Requested Corrective Action



O Who Should be involved with Corrective ActionO The entire organizationO The entire Product Development TeamO Chaired by the Quality Assurance department

O Most of all YOU!



O Types of Corrective Action SystemsO Corrective Action Review BoardO Failure Analysis Review BoardO Material Review BoardO Returned Material Review Board

O Corrective Action can be a vehicle for Continuous Improvement


The History of Corrective ActionO 1930s – Joseph M Duran and W Edward Deming

formalize the Corrective Action ProcessO It is institutionalized in Japan after WW2O Quality concepts were rejected in the United States after

WW2O 1960s – With the advance of the space era, the

Defense Department and NASA determined a Quality System was necessary for their contractorsO Corrective Action was formalized in the Creation of Mil-

Std-1520, Corrective ActionO 1980s – Total Quality Management becomes a basis

for Quality Improvement and Corrective Action


The History of Corrective ActionO 1987 – ISO 9000 establishes an international

requirement for corrective action in clause 14, Corrective/Preventive Action

O 1996 – DOD and NASA accept its’ version of corrective action making Mil-Std-1520 obsolete

O 2000 – ISO 9001 adopts the Plan-Do-Check-Act formula and process approach of TQM and forms Corrective Action as a basic business processO Formalizes Customer Satisfaction as a means of

Continuous Improvement and Corrective Action


The ISO 9001:2008 Standard’s Requirement for Corrective Action

O The requirement states:O 8.5.2 Corrective ActionO The organization shall take corrective action to eliminate the

cause of nonconformities in order to prevent recurrence. Corrective action shall be appropriate to the impact of the problem encountered.

O The document ed procedure for corrective action shall define requirements for;O Identifying nonconformities (including customer complaints)O Determining the causes of nonconformityO Evaluating the need for actions to ensure that nonconformities

do not recurO Determining and implementing the corrective action neededO Recording results of action takenO Reviewing corrective action taken



O What does this mean?O Identifying nonconformities

O Based upon objective evidenceO Can be based upon a single occurrence or a

trendO Quality System nonconformitiesO Product nonconformitiesO Customer dissatisfaction (complaints)O Returned material or field failures



O Determining the causes of nonconformityO What went wrong

O Getting to the root of the problem, not a quick fixO Identifying the nature and risk involved with the

causeO Can involve the 8-step Problem Solving Process,

depending on the nature of the problemO In looking at the cause it is useful to look at the

common thread that runs through the analysis of the cause of the problem

O This thread represents a logical process that can be obvious, presumed inherent by the nature of the situation, or incorporated into the corrective action



O Determining the causes of nonconformityO Is it a one time occurrence?O Has a trend developed?

O If so, what are the common characteristics of the cause and how are they related?

O Use data analysis to determine the causeO Collect data to use and create chartsO A useful tool is the Corrective Action Cause

Matrix



O Evaluating the need for actions to ensure that nonconformities do not recurO This is commonly referred to as “correction as to

cause”O May involve a Corrective Action Plan depending

upon the complexity of the cause of the nonconformity

O Training is NOT a Corrective ActionO It is a band aid. You need to look at the process to

correct the nonconformity



O Determining and implementing the corrective action neededO The Corrective Action required is dependent

upon the nature of the nonconformity

O Determine what resources are necessary to to carry out the Corrective ActionO Personnel, machinery, documentation,

technologyO What is the timeframe for determining and

implementing the Corrective Action



O Determining and implementing the corrective action neededO Is customer communication or approval

requiredO Who will ultimately authorize this action plan



O Recording the results of action(s) takenO What did you do to implement the corrective

action?O What actions did you take in response to the

data that was collected?O Were they effective?

O What is the objective evidence?O Is it documented?


The ISO 9001:2008 Standard’s Requirement for Corrective ActionOReviewing the Corrective Action Taken

O This is referred to as Verification and Follow upO A good tool to is to create a Corrective Action

Verification and Effectiveness Matrix ( depending upon the nature of the nonconformity)

O Some corrective actions are simple, such as correcting the procedure or modifying the work instruction. These would not require a Corrective Action Verification and Effectiveness Matrix


The Corrective Action Process

O The Corrective Action ProcessO Let’s review the flow of Corrective Action now

that we have seen what is involved in the steps to taking effective Corrective Action.

Corrective Action Process Flow


Corrective Action Process Flow

Isocert Solutions © Rev C

Internal CARCustomer

Complaint or CAR

Receive CAR

Complete

Submit to Quality Manager for

Approval

Approved

End Of CAR Process

Request Clarification

Return to CAR Coordinator, CAR Number Assigned

Submit to Department

Manager

Accepted

Sales

Car Coordinator

CAR Coordinator

Director of Quality

Department Manager

CAR AssignedCAR Response or Plan in 30 Days or Request Extension

Submit Response to Department

Manager

Accepted

Forward to CAR Coordinator

Review for Completeness

Acceptable

Submit to Director of Quality

Department Manager

CAR Coordinator

Car Coordinator

Assignee Assignee

No

Yes

Yes

NoYes

No

Yes

No

Yes Department Manager

Acceptable

Return to CAR Coordinator

CAR Coordinator

Quality Manager

Forward to Originator for

ClosureCAR

Coordinator

CAR Coordinator

Yes

No

CAR Verified and Closed

OriginatorNotify CAR

Coordinator the CAR is Closed

Typical Corrective Action

No

21

The Corrective Action Process

O Reviewing the Corrective Action takenO Management Review

O Depending upon the nature of the nonconformity, this can be just the area manager or, if it is serious enough, senior management

O Should always be a positive experience for everyone


Implementation and Administration of the Corrective Action ProcessO 5.1 Management Commitment

O Top management shall provide evidence of its commitment to the development and improvement of the quality management system

O Corrective Action cannot be effectively implemented and administered without Management Commitment


Implementation and Administration of the Corrective Action ProcessO Implementation

O Identification of a Corrective Action Coordinator

O Creation of and training in the Corrective Action procedureO 1 of 6 required by ISO 9001:2008


Implementation and Administration of the Corrective Action ProcessO Timeliness of Corrective Action ResponsesO Includes an escalation process

O Management MUST respond when the escalation process is implemented

O Can be either area management or senior management


Implementation and Administration of the Corrective Action ProcessO The first step is to Define the ProblemO The next step, if serious enough, is to

implement a containment actionO What must we do to protect the customer

O Depending upon the nature of the Corrective Action Request, data gathering for analysis is implementedO There are many tools available for data gathering

O Measurement analysis of the data to determine the trends or isolate the root cause


Implementation and Administration of the Corrective Action ProcessO Define and Analyze the root cause

O How was the root cause verifiedO Plan and implement a solution

O What is the Corrective Action Plan and what is its’ current status

O Evaluate the solutionO This is the verification by the team or

responder that the solution worked


Implementation and Administration of the Corrective Action ProcessO Standardize the solution

O How does the solution work for all situations for which it has been identified to fit

O Can the solution be deployed elsewhere in the organization?


Implementation and Administration of the Corrective Action ProcessO Review, reflect and report

O This is the review of the results versus the problem statement

O What lessons have we learned?O Can we apply this to other problems we

identified along the way?O Should we do it again?

O If the solution isn’t 100%, the answer is yes


Implementation and Administration of the Corrective Action ProcessO The final step is for the CAR Coordinator to

verify the corrective actionO If the 8-step process was used to determine

the corrective action, a formal presentation to Management needs to be made as part of the verification

O Can be part of the Management Review process


Tools for Corrective ActionNot every Corrective Action Request will require these, they are examples of tools available to youO 8-step problem solving processO CAR Cause matrixO Parking lotO Nominal group techniquesO Affinity DiagramsO Process mapping and capability studiesO Flow charting


ConclusionO Corrective Action is the process by which you

handle problems and issues arising during the course of conducting business

O The manner in which the problems are handled is, in part, a measure of the effectiveness of your Quality Management System


ConclusionO The resources required for an efficient, cost

effective Corrective Action process currently exist within your organizationO You are already performing corrective actions,

just not in a formal mannerO They just need to be defined, controlled and

most importantly, be consistent


ConclusionO The following requirements apply to both the

organizational commitment to corrective action and to the individual actions takenO Requirements of the process are clearly definedO Responsibilities are assignedO Monitoring of data is appropriate and consistentO Resources are allocatedO Objectives are establishedO The causes of problems are investigated fully


ConclusionO Requirements Continued

O Action plans, when required, are well developed

O Criteria for implementing actions are determined

O Mechanisms for verification are in placeO Provisions for follow-up are developedO Records are developed and maintained as

defined in your Quality Management System


O For more information visit our website Isocertsolutions.com

O We are a full service provider of products and services to support Quality Assurance in any industry.


training. corrective action training how to implement, process and administer the corrective action...

Documents

history of corrective

o preventive action

o introduction

continuous o

requirement o

growth o

recurrence o

occurrence o