Transcript 1. dia - u-szeged.hu

Quality Assurance in the
standardised field
(the ISO series)
1
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
• Product: result of an activity (production)
or of a service
• e.g. for this reason: no „Enterprise” but
Organisation we speak about
• Contract: 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
12
Requirements of an ISO quality
standard Main chapters
4. Technical planning
5. Documentation and data handling
–
–
–
–
general
regulating and registering doc’s
Quality Manual
document levels
6. Purchasing
7. Control of the production
8. Process control
9. Consumer services
10. 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 Management
B. 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
Director,
Production
Section Head
QA
Manager
Director,
QC
Section Head
Section Head
Deputy MG,
financial affairs
Director,
Support
Section Head
Director,
Bookkeeping
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”
employees:
A
B
C
D
E
red: supervisor in the given task black: subordinate
Domestic activity: A BCDE
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 predetermined 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
product
under
analysis
product
accepted
product
rejected
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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. Contracts
• 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 calculations
E.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 procedure
e.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
Quality Policy
O
R
D
E
R
I
N
G
level 1
level 2
level
3
REGISTERING
level 4
Quality Manual
Operating Procedures
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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ACT
PLAN
COMPARE
DO
CHECK
for continuous improvement
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Ishikawa gave the PDCA more
detail
Ishikawa:
A
Take
appropriate
action
Check the
effects of
implementation
C
Determine
goals and
targets
P
Determine
methods of
reaching goals
Engage in
education and
training
Implement
work
D
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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
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