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Quality Assurance in the standardised field

(the ISO series)

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ISO

• International Standardisation Organization, assembly of national standardisation organisations

• No 9000 series (EN 45,000), also No10,000, 14,000, 19,000 series

• In Europan Union: European Committee for Standardization CEN, and for electronic issues CENELEC

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ISO 9000

• It is a series of standards 9001, 9002 etc.)

• Its first variation was adopted in 1987• Used in more than 100 countries• It is taken as a tool of the global

competition• According to it „document what you

done, then work in line with the document”

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Why standard „series”?

E.g. • QA dictionary• general QA principles for manufacturing -

purchasing – certifcation model• different standard if there is R&D and if

there is none• different if there is final QC• QA of measuring instruments, • QA of software development services, etc.,altogether about 50 individual standards!

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E.g.

• ISO 9000:2000 Quality management systems - principles and terms

• ISO 14 050:2002 Environmental QA• ISO 19 011:2002 Guidelines for the

audit of quality or environmental quality management systems

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How to work with the ISO series

• Select from the series the standard, which closely applies to your activities (e.g. manufacturing without development, or providing legal advices, etc.)

• Help: introductory part of the individual standards plus a separate standard for this

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The ISO total Quality Management (TQM)

• In contrast to “Good Practices”, may be applied for every manufacture or service

• E.g. book-keeping, administration

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TQM, ISO 8402:1994

• Quality is in the centre• everybody participates• aiming, ensuring the

consumer/purchaser satisfaction…• …the long-term success of the

Organisation, that…• …is useful for every member of the

Organisation, as well as…• …the Society

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Specific ISO terminology

• QA for manufacture/services, training/education, etc.: TQM

• If extended to management (managerial activities): Quality Assurance

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In other words

Quality Assurance (QA): as it was in the “Good Practices”, but also: how the customer is satisfied, providing assurance in quality = management of quality

Typical for the „standardised field”

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Quality assurance on ISO basis

Definition of terms• ProductProduct: result of an activity

(production) or of a service• e.g. for this reason: no „Enterprise”

but OrganisationOrganisation we speak about• ContractContract: accepted and delivered

requirements between the provider and the purchaser

• etc.

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Requirements of an ISO quality standard Main chapters

1. Personnel – Management and its task– Quality manager, – inspections

2. The Quality System – general part– SOPs– planning– Conformity Assessment

3. Contracts

continued

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Requirements of an ISO quality standard Main chapters

4. Technical planning5. Documentation and data handling

– general– regulating and registering doc’s– Quality Manual– document levels

6. Purchasing7. Control of the production8. Process control9. Consumer services10. Appendices

continued

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1. Personnel requirements in ISO

• Management: those managers who directly may influence the quality of the product/service

• Quality manager: responsible for the TQM, member of the management

• Tasks of the management: A. To develop its Quality Policy and

explain it to the personnel sometimes it is very difficult to convince the personnel…

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Quality Policy (document)

• Declares in writing that the Management is devoted to provide good quality (products and services)

• Employees should be informed and explained

• E.g. “we are devoted to quality, our customer is in the centre. To achieve this, ISO 9000 was introduced and its strict application required...”

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Tasks of the ManagementB. Organisational matters• Responsibilities, organogram: jobs,

connections (mainly between those who may identify defects, recommend solutions or control products/processes) his own boss? Matrix-organisation?

• Provision of resources (adequate number of staff for the given task) When audit it – irrationally high number of accepted responsibilities?

(cont’d)

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Organogram example

Managing Director

Deputy MG, general affairs

Deputy MG, financial affairs

Director, Production

QA Manager

Director, QC

Director, Support

Director, Bookkeeping

Section Head Section Head Section Head Section Head Section Head

Group leader

Group leader

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The Organisation itself may be wrong!

N.N. Director

N.N. Section Head

N.N. Director

X.Y. Section Head

N.N. Group leader

May be adequate („temporarily unified responsibilities”)

Inadequate! („his own boss?”)

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„Matrix Organisation”

A B C D E

employees:

Domestic activity: A BCDE

red: supervisor in the given task black: subordinate

Export activity: B ACDE

Import activity: C ABDE

Development: D ABCE

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Matrix organisation

• Pro: „everybody seems himself/herself a boss in a given field”

• Con: – one of the main task of a boss is setting

priorities– everybody may not set priorities at the same

time!– sooner or later the most respected person’s

priorities win: the matrix cees to exist

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Tasks of Management (cont’d)

• C. Quality manager, member of the Management (Should not have at the same time other „unimportant” responsibilities)

• D. Management inspection at pre-determined intervals: how the Organisation works? (avoid „people are learning from each other” – „self-movement of the Organisation…”)

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2. Quality system

• General part: a Qality system is operated to assure that defects are avoided

• Written Standard Operating Procedures for every important one

• Planning– to identify what can influence quality

• Operating the Conformity Assessment• timing of checks• acceptance limits

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Conformity assessment („quality control”) 1

• Does not improve the quality but helps identify and „filter” the defects

• 3 parts: - input quality (starting materials) - IPC (in-process control) - final product control

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Conformity control („quality control”) 2

• Important part is the quaranteen!• Colour codes (not completely the

same as in GMP!)

product

to be analysed: no label

under analysis

accepted rejected

productproduct

product

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Conformity control („quality control”) 3

Important: what happens if „in non-conformity” occurs?

• re-qualification, if it complies with another requirement?

• ad hoc authorisation (valid only for this batch)?

• reprocessing? (repetition of the purification step)• reworking? (introduction of a new purification

step)• wasting?

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3. ContractsContracts

• Checking the contract – covers all important issues? (e.g. melting point – but the value depends on the measuring method! – Do we know what has been contracted?)

• Modification of the contract – the procedure, approval, details should be archived… (which contract was valid when the given delivery was purchased?)

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4. Technical planning

• The planning must also be planned, in writing (to-day: change control)

• What are the relevant laws (e.g. environmental)

• What other possibilities do exist? Why this one was selected? (Planning = selection from different solutions – were other solutions taken into consideration? was it documented?)

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Technical planning (cont’d)

• Modification – what is the procedure

• Model calculationsE.g. change of the drug reimbursement system –

the model calculates as if the consumption structure remains the same. If not, the model calculations may be completely wrong...

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5. Documentation and data handling

• In general:• everything in writing• Who developed and who approved it• Identification code number• If modified: the same proceduree.g. handwritten changes – who, why, when?

What is in force?

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Document types

• Regulating documents– external, e.g. Foundation Document– internal, e.g. Rules of Operation and

Organisation

• Registering documents– e.g. purchasing documents, batch

manufacturing records…

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Quality Manual

• Description of conduct of all activities• Structure:

– either following that of the ISO standard, – or the life cycle of the product

(produced) (e.g. raw material purchasing, assembly, QC, packaging, selling)

• Approved by the Management, also its every modification

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Document levels

ORDERING

REGISTERING level 4

Quality Policy

level 1 Quality Manual

level 2 Operating Procedures

level 3

Plans, technological and maintenance orders and their modifications

Records, registers

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Level 3:

general name is process orders, their types

• quality• production-technological• supporting activities maintenance

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6. Purchasing

• Vendor rating Auditing on the spot. How to select the vendor, that can provide both quality and quantity

Old „socialist” system: ampoules produced by „the”íAmpoule Factory”…)

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Connections with the vendors

• Their selection (assessment)• Their support (e.g. providing a QA

system)• Activities after purchasing (e.g. help to

identify reasons of defects)

All these in a planned way!

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Purchasing (cont’d)

• Are the requirements unambiguous? (Melting point – see before, “former quality” - ?)

• QC of the product purchased – where and when? (HCl, tank car, underground tank)

• Identification and spotting of batches (used for which other batches)

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7. Control of the „production”

• Quality assessment– assessment of the steakholders’ satisfaction– assessment based on quality characteristics

(performance indicators)

• Regulation of „answering the customer needs” in 3 levels– Process regulation– Customer service– Annexes e.g. organograms, SOPs

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8. Process control

• Every process should be planned• Plan for maintenance• IPCs…

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9. „Customer service”

• Before selling: please the customer• Selling: conditions• After selling (spotting sold products,

adjustment, maintenance, complaints, product liability within and outside self-life, recall, buying and reprocessing of used products)

Planned before!

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Summary of the ISO quality management

PDCA

plan do check act

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PLAN

DO

ACT

CHECK

for continuous improvement

COMPARE

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Ishikawa gave the PDCA more detail

Ishikawa:

P

DC

A Determine goals and targets

Determine methods of reaching goalsEngage in education and training

Implement work

Check the effects of implementation

Take appropriate action

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Introduction of a Quality System

• As a rule: not mandatory, recommended!

• Middle size enterprise, outside experts: 10-12 months needed

• Small size company, in Hungary: at least 1-2 Million HUF without accreditation

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Introduction of QA system, a Questionnaire in Hungary

The prestige of the Firm, its marketing abilities, consumer trust, connections of internal procedures

Employee satisfaction, their better interest to improve working, cost decrease

More paperwork

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What will be in the exam topics?

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General characteristics of the ISO quality standard series

• What is ISO?• Why „series”?

How to select the standard adequate for you?

• Total Quality Management and Quality Assurance in ISO

• Compare ISO with the „Good Practices”

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Personnel requirements in the ISO

• Who is „the Management”, its main tasks

• The Quality Policy document• Quality Manual, its structure (2

possibilities!)• Documents and their „levels” in ISO