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