QUALITY MANUAL

QUALITY MANUALQUALITY MANUAL

Presented by:Presented by:

• VillaVilla

• TeresaTeresa

• DavidDavid

• VladimirVladimir

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1.1. IntroductionIntroduction• DefinitionsDefinitions

• QualityQuality• Quality SystemQuality System• Quality ManualQuality Manual

• Brief historyBrief history

2.2. Overview Overview • Quality ManualQuality Manual

3.3. Elements of a Quality ManualElements of a Quality Manual4.4. Advantages & SummaryAdvantages & Summary

What is quality?What is quality?

Quality is a series of characteristics of an Quality is a series of characteristics of an element which make it capable of element which make it capable of satisfying explicit and implicit satisfying explicit and implicit requirementsrequirements

Quality SystemQuality System

The organization, structure, The organization, structure, responsibilities, procedures, and responsibilities, procedures, and resources, for ensuring the quality resources, for ensuring the quality of a product or service.of a product or service.

• The first step in building a Quality The first step in building a Quality System is a System is a Quality Manual.Quality Manual.

What is a Quality Manual?What is a Quality Manual?

• A Quality Manual is the main, top-A Quality Manual is the main, top-level document which establishes level document which establishes the quality policies and objectives the quality policies and objectives of an organization.of an organization.

HistoryHistory

• 1818thth century B.C. century B.C.

““if anyone give another silver, gold if anyone give another silver, gold or anything else to keep, he shall or anything else to keep, he shall show everything to some witness, show everything to some witness, draw up a contract and then hand it draw up a contract and then hand it over for safe keeping.”over for safe keeping.”

HistoryHistory

• 1959 – quality system for U.S. 1959 – quality system for U.S. Defence and aerospace industry was Defence and aerospace industry was implementedimplemented

• 1987 – ISO 1987 – ISO was establishedwas established

What is ISO?What is ISO?

• ISO produces international standards ISO produces international standards for business, government, and for business, government, and society.society.

• The number one requirement is a: The number one requirement is a: – Quality ManualQuality Manual

AGENDAAGENDAAGENDAAGENDA

1.1. IntroductionIntroduction• DefinitionsDefinitions

• QualityQuality• Quality SystemQuality System• Quality ManualQuality Manual

• Brief historyBrief history

2.2. Overview Overview • Quality ManualQuality Manual

3.3. Elements of a Quality ManualElements of a Quality Manual4.4. Advantages & SummaryAdvantages & Summary

What will a What will a Quality ManualQuality Manual provide provide to a company?to a company?

• Overall it provides Overall it provides evidenceevidence of what of what specific controls are implemented specific controls are implemented to to ensure product/service quality.ensure product/service quality.

• Who will benefit Who will benefit ??– CustomersCustomers– SuppliersSuppliers– Employees The CompanyEmployees The Company– ISOISO

A A Quality ManualQuality Manual should…. should….

1.1. Address all Quality System elementsAddress all Quality System elements

2.2. Contain or refer to quality proceduresContain or refer to quality procedures

““Documentation”Documentation”

The Importance of The Importance of DocumentationDocumentation

Benefits of Documentation: Benefits of Documentation: Quality Quality ManualManual

• The The KeyKey is to move towards: is to move towards:

– Consistently repeatingConsistently repeating the best practices the best practices

andand

– ImprovingImproving those processes which are those processes which are lackinglacking

4 Levels of Documents4 Levels of Documents

AGENDAAGENDAAGENDAAGENDA

1.1. IntroductionIntroduction• DefinitionsDefinitions

• QualityQuality• Quality SystemQuality System• Quality ManualQuality Manual

• Brief historyBrief history

2.2. Overview Overview • Quality ManualQuality Manual

3.3. Elements of a Quality ManualElements of a Quality Manual4.4. Advantages & SummaryAdvantages & Summary

So, what exactly do we So, what exactly do we find in a typical Quality find in a typical Quality

Manual?Manual?

You might just find things You might just find things like…like…

Basic Quality Manual Basic Quality Manual OutlineOutline

• 1) Introduction1) Introduction• 2) Policy and Objectives2) Policy and Objectives• 3) Definitions3) Definitions• 4) Quality System4) Quality System• 5) Organization5) Organization• 6) Authority and Responsibilities6) Authority and Responsibilities• 7) Compliance7) Compliance• 8) Internal Review and Audit8) Internal Review and Audit• 9) Documentation and Change9) Documentation and Change• 10) Purchasing10) Purchasing• 11) Inspection and Testing11) Inspection and Testing• 12) Training12) Training

1) Introduction 1) Introduction

• Who is the Company?Who is the Company?

• What does it do?What does it do?

2) Objectives2) Objectives

• Why would anyone go to the trouble Why would anyone go to the trouble of assembling a Quality Manual of assembling a Quality Manual anyway?anyway?

3) Definitions 3) Definitions • Maybe you already know exactly Maybe you already know exactly

what ‘technotronic process what ‘technotronic process management’ refers to, but in case management’ refers to, but in case you’re a little foggy… you’re a little foggy…

4) Quality System4) Quality System

• How will we ensure that this How will we ensure that this company produces a quality product? company produces a quality product?

5) Organization 5) Organization • Just use a chart for this one…Just use a chart for this one…

Managing Director

Sales Director

Financial Director

Business Manager

Sales Manager

Support Manager

Credit control

Admini-stration

Purchase Ledger

Support Eng.

Ware-house

6) Authority / 6) Authority / ResponsibilitiesResponsibilities

• The various departments of a The various departments of a company, such as Sales, company, such as Sales, Engineering, Finance, etc… and what Engineering, Finance, etc… and what the people there are supposed to be the people there are supposed to be doing.doing.

7) Compliance7) Compliance

• Obviously, the company needs to Obviously, the company needs to stay in line with whatever governing stay in line with whatever governing body they’ve been certified by (ISO, body they’ve been certified by (ISO, etc…)etc…)

8) Internal Review / Audit8) Internal Review / Audit

• Things SEEM to be rolling along Things SEEM to be rolling along nicely, but how would we really know nicely, but how would we really know if there was a problem? By waiting if there was a problem? By waiting for our customers to tell us?for our customers to tell us?

9) Documentation and Change 9) Documentation and Change ControlControl

• Obviously, you can’t have people Obviously, you can’t have people fiddling with important documents on fiddling with important documents on a whim, but documents WILL need a whim, but documents WILL need occasional updating, so…occasional updating, so…

10) Purchasing10) Purchasing

• You want to produce a high-quality You want to produce a high-quality product, so do you REALLY want to product, so do you REALLY want to do business with “Jethros baRgun do business with “Jethros baRgun SupPliz” because they’re cheap as SupPliz” because they’re cheap as borscht, or a fully certified and borscht, or a fully certified and accredited company?accredited company?

11) Inspection and Testing11) Inspection and Testing

• Your company may prefer to let its’ Your company may prefer to let its’ customers tell them that last customers tell them that last shipment screwed up $150,000 shipment screwed up $150,000 worth of THEIR production, or…worth of THEIR production, or…

12) Training12) Training

• Who knows? Maybe the company can Who knows? Maybe the company can readily find people who already know readily find people who already know how to operate Zweiger Loopertronic how to operate Zweiger Loopertronic TJ1453-A1F’s, but in case no one has TJ1453-A1F’s, but in case no one has a clue…a clue…

AGENDAAGENDAAGENDAAGENDA

1.1. IntroductionIntroduction• DefinitionsDefinitions

• QualityQuality• Quality SystemQuality System• Quality ManualQuality Manual

• Brief historyBrief history

2.2. Overview Overview • Quality ManualQuality Manual

3.3. Elements of a Quality ManualElements of a Quality Manual4.4. Advantages & SummaryAdvantages & Summary

Customizing your manual ?!Customizing your manual ?!Customizing your manual ?!Customizing your manual ?!

• Meaning – to identify with which Meaning – to identify with which standards your company needs to standards your company needs to comply.comply.

• Consider synchronizing your quality Consider synchronizing your quality manual with the quality standards.manual with the quality standards.

YOU ARE DOOMMED IF YOU DID NOT

COMPLY!

ADVANTAGES OF QUALITY ADVANTAGES OF QUALITY MANUALMANUAL ADVANTAGES OF QUALITY ADVANTAGES OF QUALITY MANUALMANUAL

1.1. To prevent risksTo prevent risks

2.2. To detect deviationsTo detect deviations

3.3. To correct errorsTo correct errors

4.4. To improve efficiency To improve efficiency

5.5. To reduce costsTo reduce costs

6.6. To meet customer needsTo meet customer needs

7.7. To market companyTo market company

SUMMARYSUMMARYSUMMARYSUMMARY

1.1. IntroductionIntroduction• DefinitionsDefinitions

• QualityQuality• Quality SystemQuality System• Quality ManualQuality Manual

• Brief historyBrief history

2.2. Overview Overview • Quality ManualQuality Manual

3.3. Elements of a Quality ManualElements of a Quality Manual4.4. Advantages & SummaryAdvantages & Summary

ReferencesReferences

• www.bizmanualz.comwww.bizmanualz.com

• www.cartoonstock.comwww.cartoonstock.com

• www.Documents and Settings\Computer User\Desktop\presentation\Sample Quality www.Documents and Settings\Computer User\Desktop\presentation\Sample Quality Manual.htmManual.htm

• www.Documents and Settings\Computer User\Desktop\presentation\NIST Weights www.Documents and Settings\Computer User\Desktop\presentation\NIST Weights and Measures Division Quality Manual Template - Type Evaluation Laboratory.htmand Measures Division Quality Manual Template - Type Evaluation Laboratory.htm

• www.Documents and Settings\Computer User\Desktop\presentation\ISO 10013 www.Documents and Settings\Computer User\Desktop\presentation\ISO 10013 Quality Manual Development Guide in Plain English.htmQuality Manual Development Guide in Plain English.htm

• www.benitaepstein.comwww.benitaepstein.com

• www.Documents and Settings\Computer User\Desktop\presentation\dqs.htmwww.Documents and Settings\Computer User\Desktop\presentation\dqs.htm

• www.Earnest John Group of Companies.htm www.Earnest John Group of Companies.htm

• Quality Systems, February, 12th 2003 GQO-PM/ SB Seminar Brazilian HA – Novartis Quality Systems, February, 12th 2003 GQO-PM/ SB Seminar Brazilian HA – Novartis (Global Quality Operations)(Global Quality Operations)

• www.quality-works.comwww.quality-works.com