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Chapter III Quality Systems Summary
Chapter III Quality Systems Summary
Chapter III
Quality Systems:
Table of Contents
The Quality Function....................................................................................................................2
Elements of Quality System (pg 5)...............................................................................................3
Documentation Systems..............................................................................................................6
Configuration Management......................................................................................................6
Documentation Control.............................................................................................................7
Control of Quality Records...................................................................................................7
Revision Control.......................................................................................................................7
Marking changes......................................................................................................................7
Document formats....................................................................................................................7
Correlation Matrix documents...................................................................................................7
Quality Standards and other Guidelines.......................................................................................8
Specifications .....................................................................................................................8
Industry Standards...............................................................................................................8
International/Industry Standards..........................................................................................8
Industry/National Standards.................................................................................................8
Major industry and international standards..........................................................................8
ISO 9001:2000 Summary............................................................................................................8
Malcolm Baldridge National Quality Award (MBNQA)................................................................10
Audit Purpose and Benefits........................................................................................................12
Audit Philosophy.....................................................................................................................13
Types of Audits.......................................................................................................................13
Audit Program Administration.................................................................................................15
Audit Standards......................................................................................................................15
Audit Responsibilities.............................................................................................................15
Audit Scope............................................................................................................................16
Audit Frequency.....................................................................................................................16
Preparing the Audit.................................................................................................................16
Executing the Audit................................................................................................................17
Closing Meeting......................................................................................................................18
Audit report preparation..........................................................................................................18
Corrective action/follow-up.....................................................................................................18
Cost of Quality...........................................................................................................................18
Quality cost categories...........................................................................................................19
Optimum Quality Costs..........................................................................................................20
Quality Cost improvement......................................................................................................21
Quality cost comparison bases...............................................................................................21
Quality Cost Responsibilities..................................................................................................21
Advantages of quality cost system.........................................................................................21
Limitations of Quality cost system..........................................................................................21
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• Any group larger than 25 will require a formal, documented quality system.
• Def from ISO 9000:1987 of quality system is the organizational structure,
responsibilities, procedures, processes, and resources for implementing quality management.
• Ansi/ISo/ASQ/ Q9000-2000 states
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Formal quality system is document and freeze operations of company. ISO 9001:2000 or
ISO/TS 16949 are the most common formal quality systems.
Formal quality system is important when product liability is high.
Documents: 1) standard operation procedures 2) procedures 3) work instructions 4) manual
Quality Manual
• Policy documents (quality policy, commitment to quality and system)
• Goal to inform company employees and customers of the management vision and
approach to operating the business.
• And define how management intends to satisfy customers for continued business
success.
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Documentation Systems
• Configuration management (for design intensive companies)
• Document control (for design and all other companies)
Configuration Management
• “collection of activities needed to define, identify, manage, record, or approve the
hardware and software characteristics of a product.”
• Described via 2 questions: what constitutes the product at any point in time and what
changes have been made to the product
o Implies that a system must exist to track the entire product life cycle
• Once product baseline approved, changes to the design will fall under configuration
control.
• Change go through product engineer and other departments- then to configuration board
(rep from various departments)
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• Is tracking all of the proposed changes and the implementation status of every approved
change.
• Details of every change are recorded and reviewed for existing and future compatibility.
• One department (quality) responsible to make sure changes implemented and
documentation complete
Documentation Control
• Configuration management requires an immense amount of information and requires
documentation to be in written form. SO need a methd to file, store, and retrieve
documents.
• ISO 9001:2000 requries following control of docs and records
o Document: QMS document must be controlled. A document procedure must exist
to approve, review, update, and identify the current revision level of QMS docs.
o Docs must have relevant versions available, be legible, readily identifiable, and
retrievable.
• Control of Quality Records
o Must control and maintain QMS records to provide evidence of conformance oto
requirements and of effective QMS operation
o Create procedure to identify, store, retrieve, protect, retain, and dispose of them.
• Revision Control
o Keep track of revision and make them available.
o Can revise by section (long docs like quality manual also docs that require
frequent updates) or by total document (quality procedures and work instructions)
• Marking changes
o ISO 9001:2000 requires that changes to quality system docs be identified along
with the revision level.
o Allows documentation to be of any form or medium.
Most use electronic. One danger is of employees printint out a document
and keeping that version handy
• Document formats
o Keep all document format consistent. Makes it easy to use and makes it look
professional
• Correlation Matrix documents
o Where every requirement of the standard should be identified and “broken-out”
Sequence goes as follows”
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o What section of quality manual what procedures including equip, records, and
responsibilities any specific work instructions, providing adequate detail to
perform work, record information, etc
o Particularly important requirements are the quality records (used to determine
compliance to quality system).
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o Must Plan the seq of processes to achieve the product, be consistent with
QMS req and documented
o Must determine products quality] objectives, processes, documentation,
verification and validation activities.
o Determine, customer requirements, product, regulatory and legal
requirements
o Must plan and control design and development of the product stages
• Inputs to requirements- outputs that enable verification of input req- reviews
of design and evelopment held at states to evalution capability of req,
identify problems and propose follow up actions- validation to show can
meet intended use requirements – changes documented, controlled, verified
and validated
o Control its purchasing processes to ensure that the purchased product
conforms to requirements
o Control production and service operations through availability of product
characteristic information. Production by using and maintaining suitable
equipment by use of measuring and monitoring devices.
o Org must preserve product conforminy to customer req during internal
processing and delivery to the intended destination. (handling, storage,
packaging and protection)
o Measuring and monitoring devices must be used and controlled to ensure
that measurement capability is consistent with measurement req.
• Measurement Analysis and Improvement
o Organization must conduct periodic internal audits to determine if the QMS conforms to ISO
9001 and has been effectively implement and maintained
o Audit take into consideration status and importance of activities, areas to be audited, result of
previous audits. Procedure, scope, freq, and methodology must be defined. Peformed by
someone other than who performs activities.
- Signed to law in 1987 (Public Law 100-107). This us award was modeled after Deming prize in
Japan and focuses on organization excellence. Based on:
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-It is divided into seven categories with 1,000 possible scoring points. There are 19 items, each
focusing into a major requirement and addressing one or more areas. Pre-screening of
applicants and four-stage review process
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Requirement comparisons
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• Audit Philosophy
o Quality Audits are formal, systematic, and independent.
o Effectiveness and integrity of audit depends on skills and training of auditor.
Auditors must be fact finders, not fault-finders
Audits should not be conducted in a covert manner, avoid secrecy.
• Types of Audits
o System Audits
Largest and most extensive of audits (2-5days)
Conducted to verify, through objective evidence, whether or not the quality
management systems and organizational plans are indeed carried out to the
requirements set forth.
Can be external (supplier or internal (in-house).
o Process Audits
Large and significant portion of the system audit is devoted to the process
audit. One or more processes audited by systems audit.
Process audit, conducted by itself yield swift results. Since easier to compy
with specific process modifications than tackle the deep-rooted management
system problems
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o Product Audits
Assessment of final product or service and its “fitness for use” evaluated
against intent of the product or service
Customer oriented
can be done by one auditor or by team of auditors; or internal or external.
o Internal Audits
Performed within an organization to measure its own performance, strengths,
and weaknesses against its own established procedures and systems.
Can be performed by in-house personnel or the company may hire outside
auditors.
Considered to be a first-party audit; an audit conducted by the party of the
first part.
o External Audit
By company directive and performed on an outside source, such as a
supplier. Or can be performed by company reps or hire auditors from outside
Considered second-party audit; an audit conducted on behalf of the party of
the first part (client comp) on the party of the second part (supplier).
o Third party audits
When outside source, or third-party is used to conduct audit; independent
source not associated with the auditee’s company business.
Used to obtain more independent and objective assessment or achieve
certification to a recognized standard.
o Specific Objective Audits (chpII pg 38)
General Audit matrix (pg 39) – major category(system, process, product) of specific Audits
System Audit Matrix (Pg 40) – types of system Audits
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• Audit Standards
o ISO 19011:2002
Combines criteria for quality and environmental systems auditing
Address: standards to use in audit process, auditors criteria, monitoring and
maintenance of auditors performance, and code of ethics
o ISO 9001: 2000
Provide international requirements as to what elements are to be audited.
Identifies the requirement to perform internal audits and addresses:
• Audit Responsibilities
o Lead auditor responsible for all phases of audit. Responsibilities include:
o The client:
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• Audit Scope
o Client makes final decision on the scope and depth of an audit, which quality system
elements, physical locations, and org activities are to be audited.
• Audit Frequency
o Determined by client, taking into consideration changes in management,
organization, policies, techniques, technologies, as well as changes to the system
itself, and result of recent audits.
• Preparing the Audit
o Plan includes:
o Working documents may include: flowcharts and checklists and reporting forms
o Flowchart usuage
Starting point of a system or major audit is important decision. If time start at
beginning if not start at most important time.
Widely used and effective forms of field investigation activities are called
tracing
Flowcharts helpful for trace forwards or backwards audits
Advantages vs disadvantage of flow chart on page 44
o Checklists
Distinguishing feature between an audit and other less formal methods of
performing monitoring.
Guide to each auditor, to ensure full scope of audit is covered. Place to
record data
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Checklist question are not open ended questions, they are individual facts
necessary to form conclusions
Advantages:
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Cost of Quality
o Difference between actual and budgeted costs is variance. A lot-> management
action
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o Earlier Juran depicted that lowest total quality cost point to be at some value less
than 100% good. May be true for some unsophisticated products
o Some say for ever $1 in prevent save $7 in failure costs
o Typical ratios for American companies
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Quality Training
− Good training is a planned and ordered process where the trainee is guided along a
path of learning
− Quality engineer involved in departmental development training or training for the
entire workforce.
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