quality manual 90012000 rank

7/28/2019 Quality Manual 90012000 Rank

http://slidepdf.com/reader/full/quality-manual-90012000-rank 1/22

Rank-Rite®® manuals CONTROLLED DOCUMENT

[IF THIS MARK IS IN RED]

Copyright© 2001, 2002 Rank-Rite®® manuals Revision 07-02/11/02

All rights reserved Page1of 22

QQuuaalliittyy MMaannaaggeemmeenntt PPaacckkaaggee™™

Copyright ©© 2001, 2002 by Rank-Rite®

manuals

All rights reserved. This document package may only be reproduced in the instance of using the product

for its intended means by the original purchaser as a document template. This product is not licensed to

any third party for resale or multiple client use. If you purchase this product from someone other thanRank-Rite®manuals, you should be aware that the author/publisher has not received payment for the sale

of this package.

Quality Management Package™ and Business Management Package™ are full Trademarks of Rank-

Rite®manuals.







CCCOOONNNTTTEEENNNTTTSSS

SSSeeeccctttiiiooonnn PPPaaagggeee

Introduction 4

8 Management Principles 5

F Y I 6

Customer Focus 7

Leadership 10

Involvement of People 12

Process Approach 15

System Approach to Management 19

Continual Improvement 24

Factual Decision Making 33

Mutually Beneficial Supplier Relationships 35

5 Levels of Documentation 43

How to Implement 44

Templates: 46

Quality Policies Manual 47

Standard Operating Procedures 71

Best Practices Checklists 167

Corrective Action Report 205







[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Customer Focus – pg. 7]]]

111... Customer Focus – Companies must focus their resources on customer

satisfaction. The best companies are able to efficiently focus their resources on

adding value to the product or service for the customer. The Quality ManagementPackage™ from Rank-Rite®manuals provides examples of ‘Best Practices’ for

Customer Focus.

1.1 Key Benefits of Customer Focus include:

§ Increased revenue and market share obtained through flexible and fast

responses to market opportunities§ Increased effectiveness in the use of the organization's resources to enhance

customer satisfaction§ Improved customer loyalty leading to repeat business

1.2 Applying the principle of Customer Focus typically leads to:

§ Researching and understanding customer needs and expectations

§ Ensuring that the objectives of the organization are linked to customer needs

and expectations§ Communicating customer needs and expectations throughout the

organization§ Measuring customer satisfaction and acting on the results§ Systematically managing customer relationships§ Ensuring a balanced approach between satisfying customers and other

interested parties (such as owners, employees, suppliers, financiers, localcommunities and society as a whole)







[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Quality Manual – pg. 47]]]

Quality Policies Manual Formal Quality Manual







Quality Policies Manual Section: 4 Rev.: 4R Date: 01/03/02 Page: 1 of 3

Title: Quality Management System

4.1 General Requirements

COMPANYhas implemented a Quality Management System that is continuously maintained for

effectiveness and process improvements in accordance with the requirements of ISO 9001:2000.

4.2 Documentation Requirements

4.2.1 General

The Quality System Documentation consists of five levels; the Company Policy (level one), the

Quality Policies Manual (level two), Quality Procedures (level three), Work Instructions (levelfour) and Records (level five). Supplemental to these documents are the Inspection and Test Plans

and Master Lists.

LEVEL I Company Policy – A documented Policy Statement

LEVEL II Quality Policies Manual – The Quality Policies Manual establishes

requirements and guidelines for the overall Quality System objectives. These requirements

and guidelines are applicable to the operations at COMPANY.

LEVEL III Quality Procedures – The Quality Procedures Manual is a collection of

Standard Operating Procedures (SOP’s), which are documented in conformance with, and

support of the Quality Policies Manual’s requirements and guidelines. The QualityProcedures Manual details the implementation of requirements and guidelines for the

operation. (Quality Procedures are placed as hard copies at relevant workstations).

LEVEL IV Work Instructions – Work Instructions are documented as necessary to support

each applicable Quality Procedure. They detail specific quality or inspection information

and specific instructions for performance of individual tasks.

LEVEL V Records – Completed Forms provide the objective evidence of compliance.

4.2.2 Quality Manual

The President of COMPANYdelegates the responsibi lity for the preparation, distribution and the

maintenance of the Quality Policies Manual to the Quality Assurance Manager.

Assigned holders of the Quality Policies Manual are responsible for maintaining controlled copies

and for the communication/training required by the most recent revisions.

Initial Review/Approval – The Quality Assurance Manager approves the Quality Policies Manual.

The President approves the Quality Policy.

Review/Approval of Revisions – Revisions to the Quality Policies Manual are subject to the same

review and approval process as the original.









Revisions are subject to the following:

a) Manual revisions are controlled by page and only revised pages of a section have a

revision level, (i.e. Rev.: 2R).

b) Revision levels are assigned in numeric order, starting with “1” for the original issue and

increasing by one with each revision.

c) Section: 0.1, (Index) is also revised to incorporate identification of the changed

section/page and to document the revision status of the manual.

Change Identification – Where practical, revision to sections is indicated byusing an italic font. If changes are extensive, the section is rewritten completely and

designated by the addition of an “R” to the revision number on the page and in the

index, (i.e. 2R). Grammatical changes are not designated.

Record of Changes – The Quality Assurance Department maintains a history of revisions and a

file of superceded documents.

Controlled/Uncontrolled Copies:

a) The Quality Assurance Manager issues only Controlled Copies of the Quality Assurance

Manual.

b) Controlled copies are assigned according to the Quality Manual Distribution List. TheQuality Assurance Manager maintains the Quality Manual Distribution List.

c) Serial numbers of copies downgraded from controlled to uncontrolled are not reused.

d) Only controlled copies of the Quality Policies Manual are distributed and used by

COMPANYpersonnel.e) Uncontrolled copies are not maintained with subsequent revisions and are not issued to

personnel.

Revision Distribution:

a) The Quality Assurance Manager revises all copies of the Quality Policies Manual and

distributes as required.

It is the responsibility of the General Manager and the Quality Assurance Manager to implement

and maintain the Quality System defined in the Quality Policies Manual.

The Quality Assurance Manager is responsible for the issuance and control of the Quality Policies

Manual.

A record is maintained by the Quality Assurance Manager for all controlled copies of the Quality

Policies Manual.

Manuals are either controlled or uncontrolled issues. COMPANY’s personnel use only controlled

copies unless otherwise authorized









4.2.3 Control of Documents

COMPANYestablishes, implements and maintains documented procedures to control all

documentation and data that relate to Quality System requirements, to include documents of

external origin such as standards and customer drawings.

It is the responsibility of the Quality Assurance Manager and the assigned holders of Quality

System Documents to maintain Quality System Documentation.

Documents and data are reviewed and approved for adequacy by the Quality Assurance Manager

and the appropriate Department Supervisors as per the documented procedures. These controls

ensure that:

a) all documents, instructions and procedures are adequate for their intended purpose.

b) correct documents, instructions and procedures are available at effected work locations

and/or accessible to appropriate personnel.

c) obsolete documents are promptly removed from all points of issue or used) revision levels of documents can be readily identified.

Document Revisions are subject to:

a) Approval – Revisions to documents are reviewed and approved by the same approval

process and/or authority as the original.

b) Revision Identification – Revised documents reflect the nature of revisions, where

practical.

c) Record of Revisions – Records of revisions are maintained by the issuing function whereappropriate.

4.2.4 Control of Records

COMPANYestablishes, implements and maintains documented procedures for the identification,

collection, indexing, filing, storage, maintenance and disposition of quality records.

The Quality Assurance Manager is responsible for the Control of Quality Records.

Department/Function Managers are also responsible for documentation, accumulation and

maintenance of quality records.








Title: Measurement, Analysis and Improvement

8.1 General

COMPANYdetermines the monitoring, measurement, analysis and improvement processes,

including methods such as statistical techniques that are needed to:

a) demonstrate conformity of the product

b) ensure conformity of the Quality Management System

c) continually improve the effectiveness of the Quality Management System

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

COMPANYdetermines methods for monitoring, measuring and improving customer satisfaction.

This measurement of process performance shall include the analysis of customer complaints.

8.2.2 Internal Audits

COMPANYestablishes, implements and maintains documented procedures for a comprehensive

system of internal audits at planned intervals to verify the effectiveness of the Quality

Management System.

The Quality Assurance Manager is responsible for administering the Internal Audit system per

documented procedures. The Quality Assurance Manager develops a schedule for internal audits

according to Quality Management System requirements and conducts unscheduled audits (internaland external) when reasons for such audits exist.

Audits are conducted utilizing documented checklists and/or audit plans. Audit results are

documented in audit reports per established procedures. Copies of all audit reports including

completed corrective action requests are forwarded to management of the audited area and

maintained by the Quality Assurance Manager.

Audit personnel are qualified per documented procedures and do not have direct responsibility for

or control of the area to be audited.

Management personnel responsible for the audited area determine and implement timely

corrective actions for any reported nonconformance and follow-up activities include verification

of the corrective actions taken and reporting of the results.

8.2.3 Monitoring and Measurement of Proces se s

COMPANY implements and maintains comprehensive methods for monitoring and measuring

the Quality Management System processes, which demonstrate the ability of the processes to

achieve planned results.

When planned results are not achieved, corrective actions are implemented and monitored for

effectiveness.









8.2.4 Monitoring and Measurement of Product

COMPANY implements and maintains comprehensive methods for monitoring and measuring

the characteristics of product to verify that product requirements are achieved throughout all

phases of product realization in accordance with quality procedures.

Evidence of conformity with the acceptance criteria is maintained in the records and indicate the

person authorizing the release. Product release and delivery are dependant upon compliance with

the appropriate quality procedures set forth.

8.3 Control of Nonconforming Product

COMPANYestablishes, implements and maintains documented procedures to ensure that

nonconforming materials, parts or products are prevented from inadvertent use and/or additional

processing without review and disposition from authorized personnel.

The Production Manager is responsible for the Control of Nonconforming Product. Nonconforming materials, parts or products are reviewed in accordance with documented

procedures and may be accepted under concession by a relevant authority, and where applicable,

by the customer only if all regulatory requirements are met.

Records of the nature of nonconformities and any subsequent actions taken, including concessions

obtained are maintained according to quality procedures.

Reworked/repaired items are re-inspected in accordance with the same documented procedures as

conforming products to ensure conformance.

Product found to be nonconforming after delivery will require corrective actions.

8.4 Analysis of Data

COMPANYutilizes statistical techniques and methods for the analysis of appropriate data

collected to demonstrate the suitability and effectiveness of the Quality Management System.

Methods used to generate relevant data are reviewed periodically to ensure the information

provided relates to:

a) customer satisfaction

b) conformity to product requirementsc) characteristics and trends of processes and products including opportunities for

preventive action

d) suppliers

The Quality Assurance Manager is responsible for Statistical Techniques and the methods utilized

at COMPANYare identified and supported by appropriate documentation according to

procedures.









8.5 Improvement

8.5.1 Continual Improvement

COMPANYcontinually improves the effectiveness of its Quality Management System through

the use of the Quality Policy, quality objectives, audit results, analysis of data, corrective and

preventive actions and management reviews.

8.5.2 Corrective Action

COMPANYestablishes, implements and maintains documented procedures to initiate corrective

and preventive actions for conditions adverse to quality.

Corrective Action Procedures define the requirements for:

a) reviewing nonconformities (including customer complaints)

b) determining causes of nonconformities

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

d) determining and implementing the action needed

e) records of the results of action implemented

f) review of corrective action implemented

The Quality Assurance Manager is responsible for Corrective Actions and a feedback system is

used to provide early warning of quality problems and for input into the corrective action system.

8.5.3 Preventive Action

COMPANYestablishes and maintains documented procedures to determine the appropriate

preventive actions required to eliminate the causes of potential nonconformities in order to prevent

their occurrence.

Preventive Action Procedures define the requirements for:

a) determining potential nonconformities and their causes

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

c) determining and implementing the action needed

d) records of the results of action implemented

e) reviewing preventive action implemented

The Quality Assurance Manager is responsible for Preventive Action at COMPANY.







[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Standard Procedures – pg. 71]]]

Standard Operating Procedures Quality Procedures







Quality Procedure # SOP 8.2A

Origin Date: 06/10/98Rev. Date: 01/08/02

Page: 1 of 4

Title: M, A & I – Internal Audits

1.0 Purpose

1.1 The purpose of this procedure is to define the system used for internalaudits at COMPANY.

2.0 Responsibility

2.1 The Quality Assurance Department is responsible for this procedure.

3.0 Requirements

3.1 The Flowchart contained in 6.0 Method (Flowchart and/or Narrative)

defines the methods used at COMPANYfor internal audits.

3.1.1 Internal Audits are scheduled on a quarterly basis and increased as

deemed necessary based on the status and importance of theactivity to be audited.

3.1.2 Individual(s) independent of the area or activity perform internalaudits.

3.1.3 Corrective actions are implemented without undue delay and

follow-up is conducted and recorded.

3.1.4 Monitoring and measurement methods are maintained to

demonstrate the suitability of the Quality Management System.

4.0 Definitions

4.1 Audit – systematic, independent and documented process for obtaining

evidence and evaluating it objectively to determine the extent to whichrequirements are fulfilled.

4.2 Nonconformity – non-fulfillment of a requirement.

4.3 Corrective Action – action taken to correct the occurrence of

noncompliance and conditions adverse to quality.

4.4 Preventive Action – action to eliminate the cause of a potential

nonconformity or other undesirable potential situation.









Page: 2 of 4


5.0 Records

5.1 Their respective departments maintain records accordingly:

Record Description Location Retention

internal audit reports record of internalaudits

quality office 5 years minimum

audit schedules schedule of audits quality office 5 years minimum

Corrective ActionReport [CAR ]

request for corrective action


list of qualifiedauditors

list of qualifiedauditors


training records record of training personnel office length of employment

6.0 Method

6.1 The Flowchart on the following page defines the Internal Audit system.









Page: 3 of 4


Internal Audit System

Audit Schedule DevelopmentAn audit schedule is developed by Quality Assurance and

approved by The General Manager. All functions and/or

departments within COMPANY’s operations are audited once

per year minimum. The schedule is based on quarterly audits

and altered when an activity’s importance requires increased

audits. An unscheduled audit only requires notification to the

effected function and personnel.

Audit Plan Development- Date and time of each audit location

- Scope of the audit (activities to audit)

- Basis for the audit (requirements)

- Designated contact within audited area/function

- Auditors

Audit ChecklistQuality Assurance and the Audit Team review

applicable documentation (including previousaudit reports), and develop audit checklists.

Conduct AuditThe Audit Team determines the overall effectiveness of the Quality

Management System using the audit checklists and previous audit results.

Audit Results / Corrective ActionThe Audit Team reviews audit findings for verification while completing the Audit Checklist

Report and determines if a Corrective Action Report form, (CAR) is required, in accordance

with OPM 8.5A. Then the Audit Checklist Report and CAR(s) are reviewed with theauditee(s). Corrective Actions are then assigned and implemented without undue delay.

Program ReviewQuality Assurance reviews all reports and adjusts Quality

System documentation and audit schedules accordingly.

Audit Checklist Report

The completed Audit Checklist

becomes a formal report for

Management Reviews. It

contains all nonconformancesand is maintained by Quality

Assurance.









Page: 4 of 4


7.0 References

7.1 Audit Checklist Report form

7.2 Corrective Action Report [CAR ] form

Revision History:

Rev. Date Description

1 06/10/98 original

2 06/25/98 revised procedure – flowchart format3 07/14/98 added text in flowchart to include management reviews4 01/18/99 eliminated audit team leader and assigned audit team responsibility

5 01/08/02 revised to align with ISO 9000:2000 requirements

Originator: Date:

Approval: Date:









Page: 1 of 3

Title: Improvement – Corrective Action

1.0 Purpose

1.1 This procedure defines the system used for corrective action and continualimprovements at COMPANY.

2.0 Responsibility

2.1 The Quality Assurance Department is responsible for this procedure.

3.0 Requirements

3.1 The Management System is continuously improved through the use of the

Company Policy, quality objectives, audit results, analysis of data,corrective and preventive actions and management reviews.

3.2 The Flowchart contained in 6.0 Method (Flowchart and/or Narrative)defines the method(s) used at COMPANYfor corrective actions.

4.0 Definitions

4.1 Corrective Action – action taken to correct the occurrence of noncompliance and conditions adverse to quality.

5.0 Records

Record Description Location Retention

Corrective ActionReport [CAR ]

record of correctiveactions

quality assuranceoffice

5 years minimum

6.0 Method

6.1 The following Flowchart defines the Corrective Action process.









Page: 2 of 3


NO

YES

Corrective Action

Identification of NonconformitiesIndividuals within the organization identify any

nonconformance. Nonconformities are formallyidentified through internal audits, customer

complaints, observations, and all other applicable

means of analysis and identification.

Nonconformities ReportingWhen a nonconformance is identified it must be

documented on a Corrective Action Report[CAR]. The individual(s) identifying the

nonconformity completes the first section of the

[CAR], with as much detail as possible. The

Corrective Action Report, [CAR] is then

submitted to Quality Assurance for review.

Implementation

The department and the individual(s) that are noted asresponsible on the CAR are required to identify the root cause

and implement corrective action(s) in a timely manner.

Corrective Action ApprovalThe originator approves the implemented Corrective

Action if it is found to be effective upon review.

Implementation

Satisfactory

Corrective Action Report [CAR ](See page 205)

This form contains the nonconformance

identification, implementation responsibility,

and monitoring of implementation. The CAR is

submitted to Quality Assurance for review and

then entered into the CAR LOG and assigned a

number by Quality Assurance.

Corrective Action ReviewCorrective Actions are reviewed for long-term effects

and process improvements in Management Reviews.









Page: 3 of 3


7.0 References

7.1 Corrective Action Report [CAR]

Revision History:

Rev. Date Description

1 05/15/98 original2 06/15/98 revised procedure – flowchart format3 07/16/98 revised procedure to define who initiates a CAR

4 12/09/98 revised procedure to detail the process5 01/18/99 linked the CAR to the CAR LOG

6 07/29/99 changed nonconformance to noncompliance

7 01/16/02 revised to align with ISO 9000:2000

Originator: Date:

Approval: Date:







[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Checklists – pg. 167]]]

Best Practices Checklists Internal Audits







8 – Measurement, Analysis and Improvement Page 1 / 1

ISO ELEMENT OVERALL EFFECTIVENESS RESULTS

InternalAudits

PASS FAIL

QUESTION AUDITOR NOTES - OBJECTIVE EVIDENCE PASS FAIL1 Are documented Quality

Procedures available for

planning and implementing

internal audits to determine

the effectiveness of the

management system and

reporting the results?2 Are internal audits scheduled

on the basis of the status and

importance of the activity to

be audited?3 Do personnel not responsible

for the areas or activities being

audited perform the internal

audits?4 Are the audit results formally

recorded and made available

to the personnel having

responsibility in the area

audited?5 Do management personnel of

the areas audited implementtimely corrective action(s)

when deficiencies /

nonconformities are found

during audit(s)?6 Do follow-up audits verify and

record the implementation and

effectiveness of the corrective

action(s) implemented?

ADDITIONAL COMMENTS AND SUGGESTIONS







8 – Measurement, Analysis and Improvement Page 1 / 1

ISO ELEMENT OVERALL EFFECTIVENESS RESULTS

Monitoring andMeasurement

PASS FAIL

QUESTION AUDITOR NOTES - OBJECTIVE EVIDENCE PASS FAIL1 Has the need for statistical

techniques, which are required

for establishing, controlling

and verifying process

capabilities and product

characteristics been formally

identified?2 Do these methods demonstrate

the ability of the processes toachieve planned results?

3 When planned results are not

achieved, are correctiveactions implemented, as

appropriate, to ensure

conformity of the product?4 Are product characteristics

continually monitored and

measured to ensure conformity

to customer requirements at

appropriate stages of product

realization, in accordance with

planned arrangements?5 Do formal records exist as

evidence of conformity with

the acceptance criteria and the

person authorizing the release?6 Is it ensured that product is not

released until the planned

arrangements have been

satisfactorily completed,

unless otherwise approved by

a relevant authority, and where

applicable, by the customer?

ADDITIONAL COMMENTS AND SUGGESTIONS






Thank You,

q The previous pages are samples of the Quality Management Package™™

q You can purchase and download the Quality Management Package™™ at:

http://www.rank-rite.com/products.html

q If you have any questions about the content of the package contact us at:

(ph.) 716-474-8572 or (e-mail) [email protected] for more info.

q When you purchase and download the Quality Management Package™™ youreceive a computer-generated password that allows you unlimited access to

our secure servers for file upgrades and multiple downloads.

q COMPLETE CUSTOMER SUPPORT is included with the purchase and

download of the Quality Management Package™™ (whenever you need it).

q We look forward to serving you!

Download the Quality Management Package™™ for more Templates