4. ISO 9000:87
ISO 9000:94
ISO 9001:2000
BS5750 ISO 9001:2008
1979
AQAP1
(NATO)
1970’s
MIL-STD-9858
(1940’s)
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5. International Organization for Standardization
Develops standards do not certify companies
Around 140 countries members
Around 13000 standards produced
Technical Committees are formed to produce
standards
TC 176 for ISO 9000
International Organization for Standardization
Email: central@iso.ch
Web: http://www.iso.ch
http://www.bsi.org.uk/iso-tc176-sc2.
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6. 2 WHAT’S NEW IN ISO
9001:2008
Compared to ISO 9001:1994
7. Cancels and replaces second edition of 1994
revised title which no more uses the term QA,
instead just QMS (QA + Customer Satisfaction)
Released on 15 Dec 2000
up-graded in contents, effectiveness, and logical
implementation
9000- and 9004- series guidelines eliminated and
9004 to serve as a general purpose guidelines
Many guidelines available in the form of TR
(Technical Reports)
compatible with ISO 14001
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8. • Scope (modified):
• to demonstrate its ability to provide consistently, product
that meets customer and applicable regulatory
requirements, and
• to address customer satisfaction through the effective
application of the system, including processes for
continual improvement and the prevention of
nonconformity
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9. • ISO 9001, 9002, & 9003 merged into a single 9001:2008
• ISO 8402 and ISO 9000-1 merged into a new ISO
9001:2008
• ISO 10011 will be merged with ISO 14010 into a new ISO
19001 Quality & Environmental Auditing
• 3 years for co-existence
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10. 1. The Standard
2. The Structure
3. The Definitions
4. The Emphasis
5. The Requirements
6. The Flexibility
7. The Approach
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11. 1. New Standard
ISO 9002 and 9003 dropped
ISO 9001 modified
2. New Structure
• 20 clauses abandoned
• Now 5 sections
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12. 3. New Definitions
• Supplier: Vendors, subcontractors, etc.
• Organization: The company implementing QMS
• Product Realization: The interconnected processes
that are used to bring products into being. When you start
with an idea and end up with a product, you’ve gone through
the process of product realization
4. New Emphasis
Customer Focused
Continual Improvement
Integration of Processes with the QMS
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13. 5. New Requirements
1. Communication with customers
2. Identify customer needs and expectations
3. Meet customer needs and expectations
4. Measure and monitor customer needs and expectations
5. Meet legal and regulatory requirements
6. Internal Communication
7. Provide competent human resources
8. Provide necessary facilities and work environment
9. Evaluate the effectiveness of training
10. Measure and monitor realization processes
11. Evaluate the effectiveness and suitability of quality system
12. Identify QMS improvements
13 Improve QMS regularly Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
14. 6. New Flexibility
1. Permissible Exclusions from Section 7 if
a. it doesn’t apply
b. customer’s requirements make it reasonable to exclude
c. regulatory requirements make it reasonable to exclude
However, no part can be excluded, if doing so will undermine the
organization’s abilities or performance
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15. 7. New Approach
PROCESS APPROACH TO QMS
QMS can now be considered as a single large process with many sub-
processes. Each of these sub-processes uses inputs and outputs.
These are:
1. Resource Management 10. Internal Communication
2. Regulatory Research 11. Document Control
3. Market Research 12. Record Keeping
4. Product Design 13. Planning
5. Purchasing 14. Training
6. Service 15. Internal Audit
7. Product Protection 16. Management Review
8. Customer Needs Assessment 17. Measurement Processes
9. Customer Communication 18. Nonconformance Mgt
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19. Continual Improvement.
at TCG {0336-2350594}
16. Generic QMS Model
Non prescriptive
Documentation culture
Implementation without training not
possible
Control of vendors
HRD
SPC
Not free of cost
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17. Main objective - image enhancing or market
compulsion - not quality improvement
Delegated to lower level of management - lack of
top management’s (CEO’s and dept’l heads
involvement
Insufficient training/understanding
Ineffective project management
Eagerness to achieve certification (rather than
Quality) as quickly as possible
dominated by the influence of non-believers
Insufficient writing strengths in management
Role of Consultants and Certification Agency
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at TCG {0336-2350594}
18. ISO does not certify itself
Hundreds of agencies available world wide
every company is free to choose
Selection criteria
Reputation
Accreditation (ISO Guide 62, scope of accreditation, IAF)
Quality of auditors with process know-how and experience
Cost
Availability and easy communication
Scope of Certification
Re-certification after every three years/surveillance
after 6-12 months
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20. About one year project
project team is formed (dept’l heads) and a Proj. Coord.
project team is trained
dept’l procedures are mapped/documented
ISO 9001 requirements are interpreted into each dept.
Solutions (quality processes) to fulfill the requirements are
identified
Solutions are run on trials
Solutions are added into prevalent dept’l procedures
Solutions are implemented
Internal Quality Auditing is started
Corrective Action Program is initiated
Selection of suitable certification agency
pre-audit/audit is carried out
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21. Project Coordinator - Quality Management
Representative (QMR)
Project members from each dept. (usually dept’l
heads)
Main Responsibilities
process mapping/documenting
project realization
project monitoring
system designing
validation of procedures
project control
owning the QMS at a company-wide level
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at TCG {0336-2350594}
22. Quality of the Quality Management System is
dependent on the Quality of Project Team
Training (ISO 9001, IQA, SQC, Process
Mapping, etc.)
Visits to good models of certified firms
Self study, interest, and initiatives
membership to professional organizations, e.g..
ASQ, IQA, etc.
Browsing internet
participating in discussions with professionals
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23. Excellent C
Good
Satisfactory
Acceptable B
A
3 6 9 12 18
Time (months)
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25. Organizations depend on their customers
and therefore should understand current and
future customer needs, meet customer
requirements and strive to exceed customer
expectations
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26. Leaders establish unity of purpose and
direction of the organization. They
should create and maintain the internal
environment in which people can
become fully involved in achieving the
organization’s objectives
Corporate
Goals
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27. People at all levels are the essence of an
organization and their full
involvement enables their abilities to
be used for the organization’s benefit
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28. A desired result is achieved more
efficiently when related resources and
activities are managed as a process
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29. Identifying, understanding and managing
a system of interrelated processes for a
given objective improves the
organization’s effectiveness and
efficiency
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30. Continual improvement should be a
permanent objective of the organization
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31. Effective decisions are based on the
analysis of data and information
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32. An organization and its suppliers are
interdependent, and a mutually beneficial
relationship enhances the ability of both to
create value
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at TCG {0336-2350594}
34. CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM
C R
e Management C S
a
U q
responsibility U
t
i
u
S i
S s
r Measurement, f
T e Resource
analysis and T a
c
O m management improvement
e O t
i
M n
t M o
Input n
E s Product Output
E
R realization Product
R
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35. 1 Scope 1.1 General
1.2 Application
2 Normative Reference
3 Terms and Definitions
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36. 4 Quality Management
System 4.1 General Requirements
4.2 Documentation Requirements
5 Management 5.1 Management Commitment
Responsibility 5.2 Customer focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management Review
6 Resource Management 6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 Product Realization 7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
Prepare by: Adnan Masood Manager QHSE 7.6 Control of monitoring and measuring devices
at TCG {0336-2350594}
37. 8 Measurement, Analysis
and Improvement 8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
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38. 1.1 General
Product consistently meets customer and
applicable regulatory requirements
to enhance customer satisfaction, including
continual improvement of the system and
assurance of conformity to customer and
applicable regulatory requirements
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at TCG {0336-2350594}
39. 1.2 Application
Generic requirements; applicable to all
organizations, regardless of type, size and
product provided
exclusion can be considered if certain
requirements not applicable
Exclusion allowed only from Clause 7
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40. ISO 9001:2008 Fundamentals and
vocabulary
Quality
(ISO 8402 is now obsolete)
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41. As given in ISO 9001
Product also means services
Supply Chain
Supplier Organization Customer
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at TCG {0336-2350594}
43. 4.1 Quality Management System
Examples
Quality • C/A with dept’l
ISO
9001:2000 procedures
Quality • Documentation with
Processes company administration
Management
• Training with HRD
System • Quality Objectives
with Corporate Review
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at TCG {0336-2350594}
44. 4.2.1 General
Documented statements of a quality policy and
quality objectives
a quality manual
documented procedures required by ISO
9001:2008
documents needed by the organization to ensure
the effective planning, operation and control of its
processes, and
quality records required by this standard
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at TCG {0336-2350594}
45. Documentation Requirements
• Documented Procedure means
– Established
– Documented
– Implemented
– Maintained
Appropriate documentation as per Nature
and size of the organization
Documentation can be in any form or
medium
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at TCG {0336-2350594}
46. 4.2.2 Quality Manual
Scope and justification for exclusion
procedures of the QMS or its reference
integration between QMS and Processes
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at TCG {0336-2350594}
47. How
What
Applicable Dept A Relevant
Clauses Procedures Records
QUALITY
Applicable Dept B
MANUAL Clauses Procedures
Relevant
(SUMMARY) Records
Applicable Dept C
Relevant
Clauses Procedures
Records
Applicable Dept D Relevant
Clauses Procedures Records
Applicable Dept E Relevant
Clauses Procedures Records
Supporting Documents
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e.g. standards, Manuals, GMP’s
48. 4.2.3 Control of documents
QMS documents shall be controlled Examples
appropriate review and approval
prior to issue • Quality Manual
• QMS Procedures
changes in revision are identified
• Dept’l Procedures
available at locations of use • Work Instructions
legible and identifiable • Drawings/standards
• Machine Manuals
external documents are included in
• Reference Manuals
control etc.
identification of obsolete
documents
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at TCG {0336-2350594}
49. 4.2.4 Control of Quality Records
Examples
Legible, readily identifiable
• Quality Reports
and retrievable • Audit Reports
• Output of Mgt
Reviews
clear procedure to define • Test Reports
the control, including • C/P Actions
retention and disposition • Customer Surveys
• Design Reviews,
validations etc.
• Customer
complaints, etc.
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50. Documented Procedures required
for:
Control of documents
Control of Quality records
Product non-conformance
Internal audits
Corrective actions
Preventive actions
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51. 5.1 Management Commitment
Examples
Evidence of top management
commitment for development, Visible involvement of
Implementation and continual CEO and dept’l heads
improvement of QMS by: in:
• forming quality policy
communication with the rest of the and objectives
organization on the importance of
meeting customer and regulatory • measuring and reviewing
requirements objectives and quality
• addressing resource
establishing the quality policy requirements
establishing quality objectives • addressing quality with
holding management reviews reporting team members
ensuring availability of resources regularly
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at TCG {0336-2350594}
52. 5.2 Customer Focus
Top management shall ensure Examples
that customer requirements are
determined and fulfilled with • Customer needs
identification
the aim of enhancing customer procedure?
satisfaction (7.2.1 and 8.2.1) (e.g. surveys, focus
groups, contracts)
• Top management
verification (through
1st, 2nd, 3rd party
assessment etc., that
such requirements are
fulfilled
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at TCG {0336-2350594}
53. 5.3 Quality Policy
Top management shall ensure that the What broad Quality aspects
quality policy: should be Covered in the
Quality Policy?
• is appropriate to the purpose of the
organization
1. Fulfillment of Customer needs
• includes a commitment to comply with
2. Fulfillment of applicable
the requirements and continually
national laws and regulations
improve the effectiveness of the QMS
3. Minimization of waste,errors
• provides a framework for establishing and nonconformance
and reviewing quality objectives 4. Continual improvement
• communicated and understood in the 5. Employees quality and
organization organizational culture
• is reviewed for continuing suitability
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at TCG {0336-2350594}
54. 5.4 Planning
• Quality Objectives: • What does Quality
– are established at relevant functions objectives for each
and levels, and are measurable and function means?
consistent with the quality policy
• What does Quality
• QMS Planning: objectives for each
– Each applicable process/dept. is level means?
addressed under the PDCA model;
– planning at changes is carried out
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at TCG {0336-2350594}
55. 5.5 Responsibility, Authority and Communication
• Responsibility and Authority: Examples
– defined and communicated within • Job Descriptions
the organization • QMR’s clear role
• Management Representative:
appoint a QMS Coordination role to a
management member
– ensure QMS is established,
implemented and maintained
– report the performance and the
need for improvement
– promote awareness
– liaison with external parties
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at TCG {0336-2350594}
56. • Internal Communication: Examples
ensure effective communication • Team briefing and
regarding the effectiveness of the meetings
QMS • notice boards
• newsletter
• intranet
• employees surveys
• Project presentations
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57. 5.6 Management Review
INPUTS
QUALITY
PROCESS OUTPUTS
QUALITY REPORT Improvements in QMS
covering Management Improvements in
•Audit results
Reviews
•Customer feedback Products/Processes
•process performance
•product conformity Resource Needs
•C/P Action
•follow-ups
•changes / follow-ups
•recommendations
for improvements Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
58. 5.6B Management Review
• Management reviews at planned
Intervals to ensure:
– Continuing suitability
– Adequacy
– Effectiveness
– Identifying opportunities for
improvement
– Assessment of needs for changes to
QMS
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at TCG {0336-2350594}
59. Break the group into smaller teams
Name your company and its business
Draft a quality policy and quality objectives for
approval by the Board of directors
Identify the major processes
Present in the plenary session
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at TCG {0336-2350594}
60. The organization shall
determine and provide the
resources needed to:
Implement and maintain
QMS and continually
improve its effectiveness
Enhance customer
satisfaction by meeting
requirement
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at TCG {0336-2350594}
61. 6.2.1 General
Right person for the right job
qualified managers?
Qualified /
qualified supervisors? Appropriate means
appropriate workers? 1. Education
2. Training
3. Skills
4. Experience
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62. 6.2.2 Competence, Awareness and Training
• Determine necessary Examples
competence of people • Performance
Evaluation
• provide training and other means
• Training Programs to
to satisfy these needs fulfil the gaps
• evaluate the training/other • Training evaluation
means to check effectiveness • Maintaining
• Provide awareness of the Resumes
relevance and importance of
their activities and its linkage to
Quality Objectives
• record of education, training,
skills, and experience Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
63. • Determine and maintain Examples
necessary infrastructure for the • suitable machines,
QMS program, e.g. workspaces,
software, hardware,
information
– building, workspace, utilities • Support services for
– process equipment (hardware/ logistics
software)
– supporting services, e.g. transport,
communication,
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64. • The organization shall determine Examples
and manage the work
environment needed to achieve • work space
conformity to product • heat, humidity, light
airflow,
requirements
• hygiene, cleanliness,
noise, vibration and
pollution, etc.
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at TCG {0336-2350594}
65. For the new organization you have just formed:
Draw an Organization Chart
Determine the infrastructure required
Determine the requirements for the work
environment
Present in the plenary session
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at TCG {0336-2350594}
66. 7.1
Planning 7.2
7.6
Monitoring & Customer
Measuring Related
Devices Processes
PRODUCT
REALIZATION
7.5 7.3
Production & Design &
Service Development
Provision 7.4
Purchasing
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at TCG {0336-2350594}
67. • Quality objectives and • Product Quality
requirements for the product Plans?
• establish processes, documents, • Guidance ISO 10005
and provide resources specific to • Process flowcharts
the product • Applicable industry
standards
• required verification, validation,
• Relevant Regulatory
monitoring, inspection and test Requests
activities specific to the product
and the criteria for product
acceptance
• identification of relevant records
to provide objective evidence the
realization process and resulting
product fulfill requirements Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
68. 7.2 Customer-related Processes
7.2.1 Determination of requirements related to the Product
• Determine: Examples
– customer’s requirements (including • contracts
delivery & past delivery) • customer surveys,
– unstated but necessary requirements focus groups
– statutory and regulatory product req’t • applicable national
– any additional requirement regulations
determined by the organization
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at TCG {0336-2350594}
69. 7.2 Customer-related Processes
7.2.2 Review of requirements related to the Product
Examples
• review contract before acceptance • Contract review
• review of results of
• ensure product reqts are defined surveys and focus
• resolve issues before acceptance groups, etc.
• confirm organization capability • Amendment
• maintain records
• ensure amendments understood,
recorded, and communicated to
relevant persons
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at TCG {0336-2350594}
70. 7.2 Customer-related Processes
7.2.3 Customer Communication
• Make effective arrangements for Examples
communicating with customers in • printing of product
relation to: information on
packaging
– product information
• internet
– inquiries, contracts or order handling,
including amendments, and • catalogs and service
manuals, etc.
– customer feedback, including
customer complaints
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at TCG {0336-2350594}
72. 7.3 Design and Development
7.3.1 D&D Planning
• Determine D&D stages • Development Review
Committee?
• plan the review, verification and
• Design &
validation for each stage Documentation
• responsibilities and authorities stages
• define interfaces
• planning documents (output) shall
be updated regularly
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at TCG {0336-2350594}
73. 7.3 Design and Development
7.3.2 D&D Inputs
• Determine functional and • What are some
performance requirements examples of design
inputs?
• applicable statutory and
regulatory requirements
• information from previous similar
designs
• clarity must be established in the
information
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74. 7.3 Design and Development
7.3.3 D&D Outputs
• D&D output shall: • Examples
° meet the input requirements • actual prototypes
° provide appropriate information for • specifications
purchasing, production and service • drawings
provision • tooling
° Contain or reference product • jigs/fixtures
acceptance criteria
° Supply the Characteristic of the
product for its safe & proper use.
• Systematic reviews at suitable
stages
• participation by relevant depts
• records of reviews Prepare by: Adnan Masood Manager QHSE
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75. 7.3 Design and Development
7.3.4 D&D Review
• At suitable stages Examples
• by appropriate persons • Review of outcomes
of experiments, trials,
• identify problems and their research, etc.
remedies
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at TCG {0336-2350594}
76. 7.3 Design and Development
7.3.5 D&D Verification
• To ensure that design output Examples
meets the design inputs • Output of design
reviews
• records
• tests
• 3rd party tests
• Comparative studies
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at TCG {0336-2350594}
77. 7.3 Design and Development
7.3.6 D&D Validation
• Ensure resulting product Examples
capability for intended use or • Simulations
application • Field Trials
• evidences/records • Environmental tests
• 3rd party tests
• Trial markets
evidences
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at TCG {0336-2350594}
78. 7.3 Design and Development
7.3.7 D&D Changes
• Changes shall be revised, Examples
verified, validated and approved • changes in all
before implementation drawings
/specifications,
• Ensure communication and including vendors’
records of changes
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at TCG {0336-2350594}
79. 7.4 Purchasing
PURCHASING
Verification of
Purchased Product
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80. 7.4 Purchasing
7.4.1 Purchasing Process
• Ensure that purchased product • Procurement of
conforms to specified Material
requirements • hiring of services, e.g.
Maintenance,
• type of control over suppliers calibration, consultants,
purchased product depend upon certification agencies,
their necessity etc.
• Vendor Evaluation
• suppliers evaluation and selection
Form
• criteria for selection, and • Criteria for approval
evaluation
• records of evaluation
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at TCG {0336-2350594}
81. 7.4 Purchasing
7.4.2 Purchasing Information
• Product approval requirements Examples
• requirements for qualification of Purchase Orders to
completely define:
personnel
• product specification
• QMS requirements • AQL
• Types of tests (where
applicable)
• Q.A. requirements, if
any
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at TCG {0336-2350594}
82. 7.4 Purchasing
7.4.3 Verification of Purchased Product
• Inspection and other activities to • Verification System
ensure quality purchases for the products
• verification system
• inspection at suppliers end should for services
be specified in purchasing
information
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at TCG {0336-2350594}
83. 7.5 Production and Service
Provision
7.5.1
Control of 7.5.4
Production & Customer
Service Property
Provision 7.5.3
Identification
and
Traceability 7.5.5
7.5.2 Preservation
Validation of of Product
Processes
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at TCG {0336-2350594}
84. 7.5 Production and Service
Provision
7.5.1 Control of Production and Service Provision
• Production to be carried out under Give examples of Service
controlled conditions Provision Depts in the
– product specs following Service
– correct methods to produce Organizations?
– suitable equipment
• Hotel?
– provision of monitoring and
measurement devices • University?
– monitoring and measurement • Hospitals?
programs
– effective release, delivery and post- • After sales service is also
delivery systems included, e.g. warrantees
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
85. 7.5 Production and Service
Provision
7.5.2 Validation of Processes for Production and Service Provision
• In the absence of any Examples
measurement program, that • Validation/qualification
process needs to be validated. of doctors and nurses
This should include: in hospitals, welders in
metal industry, cooks
– review and approval criteria
in hotels, etc.
– approval of eqpt and qualification of
• Validation of special
personnel
processes, e.g. types
– use of specific methods and of electrodes,
procedures machines, and
– records environment in a
– revalidation welding process.
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
86. 7.5 Production and Service Provision
7.5.3 Identification and traceability
• Identify the product by suitable All incoming and final
means throughout product products should be assured
both identification and
realization traceability, e.g.. Hardware
• identify product monitoring and (product marking, lot
measurement status numbers); software
(computer programs/files);
• if traceability is required, then services (transport, test
control and record unique reports), etc.
identification system
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
87. 7.5 Production and Service
Provision
7.5.4 Customer Property
• Take care of customer property Examples
• identify, verify, protect, and • Blood products,
tissues, babies,
safeguard customer property medications, personal
• if it is lost, damaged or found valuables, mobility
unsuitable, then it should be aids (walkers, chairs,
crutches) in hospital
reported to customer and records
• Customer cars in
maintained
hotels and companies
• Authors manuscripts in
publishing, etc.
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
88. Preserve conformity of
product during processing
and delivery to the
intended destination
Preservation includes
identification, handling,
packaging, storage and
protection.
Applies to the constitute
parts of product
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
89. 7.6 Control of Monitoring and
Measuring Devices
• Identification of correct need to monitor
and measure product
• correct use of monitor and measuring • Correct
devices • correct point of
measure
• calibration, at defined intervals, with • correct selection of
authentic/traceable sources measuring equipment
• correct use of adjustments • correct accuracy and
precision of measure
• safeguarding adjustments
• proper handling, maintenance & storage
• C/A when devices found out of
calibration
• confirmation of software
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
90. Draw a process of product/service
realization of your new company
Present in the plenary session
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
91. 8.1
General
8.3
Control of
non-conforming
product
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
92. 8 Measurement, Analysis and
Improvement
8.1 General
• Plan and implement the process • This section is about
for monitoring, measurement, Quality Control (QC)
analysis and input to: • Conformity to customer
needs, contracts, and
– Ensure conformity of the product national regulation must
– ensure conformity of the QMS be ensured before
– ensure effectiveness and continually product is dispatched
improving the QMS • Validation of measuring
procedures
• Regularly up-grade
accuracy and
effectiveness of QMS
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
93. 8 Measurement, Analysis and
Improvement
8.2 Monitoring and Measurement Examples of CS:
• Direct interfaces
8.2.1 Customer Satisfaction
• focus groups
– device a method to measure and
monitor customer satisfaction from • surveys
customer perception point of view • sector and industry
– Method for obtaining and using the studies
information shall be determined. Examples of IA:
• Main objective is to
check the correctness
and performance of
functions and
processes; not
documentation of
processes
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
94. 8.2 Monitoring and
Measurement
8.2.2 Internal Audit
Regularly carryout internal
audit to check conformity and
effectiveness of the QMS
design an effective audit
program and plan, criteria
competent auditors
audit results and records
follow-ups and timely C/A
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
95. 8 Measurement, Analysis and
Improvement
8.2 Monitoring and Measurement
Examples
8.2.3 Processes • use of SPC,
– apply suitable monitoring of especially control
processes where required charts
– C/A when deviation occurs • monitoring and
supervision of
process parameters
8.2.4 Products • daily morning reviews
– measure product characteristics to of quality by workers
confirm fulfillment of quality and their supervisors
– at appropriate stages in accordance • Appropriate product
with the quality plans quality plan
– define acceptance criteria
– authorize release and records
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
96. 8 Measurement, Analysis and
Improvement
8.3 Control of nonconforming product
• Ensure nonconforming product is Identification and taking
identified and controlled corrective actions on:
• wrong purchases
• define responsibilities and
• wrong deliveries
authorities in this procedure
• defective products
• clear action: C/A, concession, re- produced
grade with customers’ consent • wrong packing
and evidence • wrong storage
• re-verification • wrong dispatches
• if detected in use, then take • wrong invoices
appropriate action of recall or • etc.
compensation
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
97. 8 Measurement, Analysis and
Improvement
8.4 Analysis of Data
• Determine, collect and analyze • Analysis is not
appropriate data from compiling of data
measurement sources to check • Analysis is after
compiling of quality
conformance and analysis for data
improvement in: • Analysis is part of
– customer satisfaction Quality Report
– product conformance • Sources of data?
– process
– suppliers
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
98. 8 Measurement, Analysis and
Improvement
8.5 Improvement
8.5.1 Continual Improvement • Clear evidence of
– identify opportunities of improvement improvement
from quality policy, objectives, audit processes
results, analysis of data, C/P actions, • Clear evidence of
and management reviews improvements
– mobilize improvement programs
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
99. 8 Measurement, Analysis and
Improvement
8.5 Improvement
8.5.2 Corrective Action • What is the
– take timely action to eliminate the difference between
cause of nonconformities. Correction,
Corrective Action
– Review nonconformities and Preventive
– determine causes Action?
– evaluate • Corrective Action
– determine and implement action Form
– records of results • Control of Corrective
– review and confirm results Actions
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
100. 8 Measurement, Analysis and
Improvement
8.5 Improvement
8.5.3 Preventive Action • Outputs of
– determine potential nonconformities management
current mistakes and future planning reviews or corrective
actions
– determine their causes
– device actions
– implement actions
– record results
– review action taken
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
101. – What would be some of the
performance indicators of the
processes/products of your
new company?
– How would you measure and
analyze them and at what
frequency?
– Present in the plenary session.
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
102. Systems are not what documents say what they are;
they are the habits of people which they practice .
Most failures are not because of documents or systems;
but because of people who do not change their
prevalent habits (systems).
Therefore, Systems usually do not fail, people do.
Prepare by: Adnan Masood Manager QHSE
at TCG {0336-2350594}
103. Adnan Masood
Manager QHSE
The Chishtian Goods Transport
Company