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Rank-Rite®® manuals CONTROLLED DOCUMENT
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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.
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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
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[[[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)
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[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Quality Manual – pg. 47]]]
Quality Policies Manual Formal Quality Manual
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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.
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Quality Policies Manual Section: 4 Rev.: 4R Date: 01/03/02 Page: 2 of 3
Title: Quality Management System
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
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Quality Policies Manual Section: 4 Rev.: 4R Date: 01/03/02 Page: 3 of 3
Title: Quality Management System
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.
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Quality Policies Manual Section: 8 Rev.: 3R Date: 01/03/02 Page: 1 of 3
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.
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Quality Policies Manual Section: 8 Rev.: 3R Date: 01/03/02 Page: 2 of 3
Title: Measurement, Analysis and Improvement
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.
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Quality Policies Manual Section: 8 Rev.: 3R Date: 01/03/02 Page: 3 of 3
Title: Measurement, Analysis and Improvement
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.
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[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Standard Procedures – pg. 71]]]
Standard Operating Procedures Quality Procedures
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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.
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Quality Procedure # SOP 8.2A
Origin Date: 06/10/98Rev. Date: 01/08/02
Page: 2 of 4
Title: M, A & I – Internal Audits
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
quality office 5 years minimum
list of qualifiedauditors
list of qualifiedauditors
quality office 5 years minimum
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.
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Quality Procedure # SOP 8.2A
Origin Date: 06/10/98Rev. Date: 01/08/02
Page: 3 of 4
Title: M, A & I – Internal Audits
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.
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Quality Procedure # SOP 8.2A
Origin Date: 06/10/98Rev. Date: 01/08/02
Page: 4 of 4
Title: M, A & I – Internal Audits
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:
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Quality Procedure # SOP 8.5A
Origin Date: 05/15/98Rev. Date: 01/16/02
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.
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Quality Procedure # SOP 8.5A
Origin Date: 05/15/98Rev. Date: 01/16/02
Page: 2 of 3
Title: Improvement – Corrective Action
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.
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Quality Procedure # SOP 8.5A
Origin Date: 05/15/98Rev. Date: 01/16/02
Page: 3 of 3
Title: Improvement – Corrective Action
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:
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[[[SSSeeeccctttiiiooonnn EEExxxccceeer r r pppttt::: Checklists – pg. 167]]]
Best Practices Checklists Internal Audits
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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
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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
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Thank You,
q The previous pages are samples of the Quality Management Package™™
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