Requirements
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Look
At
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Look
For
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�
INTRODUCTION
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0.1 General
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Has the organization made a
"strategic decision" (intent) to adopt the QMS?
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Adoption of the QMS
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Strategic
decision
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0.2� Process Approach
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a.� Has the organization promoted the "process
approach" to implement the QMS, improve its effectiveness, and enhance
customer satisfaction?
b.� Have the essential linked activities been
identified along with their inputs and outputs as shown in Figure 1 of page X
of the Standard?
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The Processes
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The QMS:
1.� Understanding and meeting of requirements
2.� Processes �adding value�
3.� Results of process performance and
effectiveness
4.� Continual Improvement based upon objective
measurement
5.� Application of� Plan-Do-Check-Act
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1�� Scope
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1.1�� General
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a.� Does the organization intend to strive to
consistently provide product that meets customer and regulatory requirements?
b.� Does the organization intend to strive for
continual improvement and enhance customer satisfaction through effective
application of the QMS?
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The
QMS
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1.� Product that consistently meets customer
and other applicable requirements.
2.� Enhances customer satisfaction:
���� a)�
Effective application of the QMS
���� b) � Conformity
to customer and other applicable requirements
���� c). Continual
improvement.
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1.2�� Application
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Does the organization limit
exclusions to inapplicable provisions which do not affect ability or
responsibility to provide product that meets customer and regulatory
requirements?
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Exclusions
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Justification of
exclusions.
Stated
exclusions do not contribute to the realization of product.
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4�� Quality Management System
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4.1� General Requirements
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1.� Has the organization established,
documented, implemented and maintained a quality management system in
accordance with the requirements of ISO 9001?
2.� Is the effectiveness of the quality
management system continually improved?
3.� Has the organization:
a)� Identified the processes needed for the
quality management system including their applications throughout the
organization?
b)� Determined the sequence and interaction of
these processes?
c)�� Determined the criteria and methods needed
to ensure that both the operation and control of these processes are
effective?
d)� Ensured the availability of resources and
information necessary to support the operation and monitoring of these
processes?
e)� Measured, monitored and analyzed these
processes?
f)�� Implemented actions needed to achieve
planned results and continual improvement of these process?
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a.� Identification of processes needed for the
application of the QMS throughout the organization
b.� Sequence and interaction of processes
c.� Criteria and methods needed to ensure that
the operation and control of the processes are effective.
d.� Availability of resources and information
e.� Monitoring and measurement of processes
f.� Actions to achieve planned results and
Continual improvement
g. Outsourcing
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a.� Clearly defined and understood processes.
Integration into the Business management System.
b.� Flowcharts, diagrams, tree or serial
process diagrams.
c.� Measurements, other criteria.
���� 1)�
Prediction of effectiveness from direct process measurements.
���� 2) � Prediction
from successful usage.
���� 3) � Prediction
from product conformance
���� 4) � Prediction
through the measurement of process capability.
d.� Availability:
� ��-
Resources
��� - Information systems
e. Measurements derived from the objectives.� Transparent methods of collecting evidence
and data.
f. � Positive effect upon the customer and other interested
parties.
g. Identification of outsourced processes.
����� Level of control over outsourcing.
����� Selection of outsourcing facilities.
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4.� Does the organization manage these
processes in accordance with the requirements of ISO 9001?
5.� Where processes that affect product
conformity with requirements are outsourced, are the controls for these
processes identified within the quality management system?
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4.2� Documentation Requirements
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4.2.1� General
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6.�� Does the quality management system
documentation include:
a)� Documented statement of a quality policy and
quality objectives?
b)� Quality Manual?
c)�� Documented procedures required by ISO 9001?
d)� Documents needed by the organization to
ensure the effective planning, operation and control of its processes?
e) Records
required by ISO 9001?
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Quality policy & Objectives
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Controlled and
approved documented quality policy & objective
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Documented Quality manual and
procedures
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Controlled and
approved documented quality manual and procedures
1.� Control of documents
2.� Control of records
3.� Internal audit
4.� Nonconforming product
5.� Corrective action
6.� Preventive action
The above
procedures are established, implemented and maintained.
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Other company documentation
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1.�
Process planning
2.�
Process operation
3.�
Process control
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Required records
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* Management Review
* Education, training etc
* Evidence that product meets
requirements [7.1d]
* Review of product requirements
* Design input
* Design review
* Design verification
* Design validation
* Design changes
* Evaluation of suppliers
* Identification of product if
traceability is required
* Customer property
* Process validation
* Basis for calibration
* Validity of previous suspect
results [7.6]
* Results of calibration &
verification
* Audit results
Records
of conformity to acceptance criteria and authority for release of product
*�
� Records of nonconformity� and subsequent actions
* �� Results
of corrective action
* �� Results
of preventive action
* �� Other
records required to provide evidence of conformance to requirements (what?)
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4.2.2 Quality
manual
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7.� Has a quality manual been established and
maintained that includes:
a)� The scope of the quality management system,
including details of, and justification for any exclusions?
b)� Documented procedures established for the
quality management system, or reference to them?
c)�� Description of the interaction between the
processes of the quality management system?
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Documented
quality manual
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1.� Quality Manual is established and
maintained
2.� Includes the scope of qms
3.� Defines and justifies exclusions
4.� Includes or refers to the mandated
documented procedures
5.� Description of the interaction of the
processes making up the qms
6.� Adequacy to the ISO 9001.
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4.2.3��� Control
of Documents
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8.�� Are documents required for
the quality management system controlled?
9.��� Has a documented
procedure been established identifying the following controls needed?
a)��� Approval
of documents for adequacy prior to issue?
b)��� Review,
update as necessary and re-approval of documents?
c)���� Ensure
that changes and the current revision status of documents are identified?
d)��� Ensure
that relevant versions of applicable documents are available at points of
use?
e)��� Ensure
that documents remain legible and readily identifiable.
f)���� Ensure
that documents of external origin are identified and their distribution
controlled?
g)��� Preventing
the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained?
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The document
control process
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1.� A process to ensure that documents are
controlled.
2.� The documented procedure covering:
* Approval for
adequacy prior to release
* Review, update
and re-approval of documents
* Identification
of changes and current revision level
* Relevant
versions are available at point of use
* Document
legibility and identification
* External
documents:
� - Identified
� - distribution controlled
* Control of
obsolete documents
� - Identification as obsolete
� - Prevention of unintended use
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�� 4.2.4� Control of records
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10.� ������� Have
records been established and maintained to provide evidence of conformity to
requirements and of the effective operation of the quality management system?�����������������
11�� Has a documented procedure been established
to define the following controls needed?��
����� a)� Identification?�������������������������
����� b)� Storage?������������������
����� c)�� Retrieval?�����������������
����� d)� Protection?������������������������������
����� e)� Retention
time?����������������������
����� f)�� Disposition?
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Physical control
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1.� Legibility
2.� Identification
3.� Retrieval system
4.� Protection
5.� Retention
6.� Disposal
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Records as
evidence
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1.� Collection of evidence
2.� Use of evidence
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5��� Management Responsibility
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5.1 Management commitment
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1.�� Has top management provided evidence of its
commitment to the development and implementation of the quality management
system and for the continual improvement of its effectiveness by:
������� a)� Communicating
to the organization the importance of meeting customer as well as regulatory
and legal requirements?
������� b)� Establishing
the quality policy?
������� c)�� Ensuring
that quality objectives are established?
������� d)� Conducting
management reviews?
������� e)� Ensuring
the availability of resources?
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Management
commitment to the development, implementation and continual improvement of
the quality management system.
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* �� Definition in company of "top management".
* �� Involvement of top management.
* �� Understanding of top management.
* �� General communication of the importance of meeting
customer and other requirements.
* �� A quality policy and objectives based upon the 8 quality
principles [ISO 9000:2000: Section 0.2]
* �� Establishment and maintenance of quality objectives.
* �� Comparison of the results and targets set.
* �� Management Review process
* �� Determination and provision of resources.
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5.2� Customer focus
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2.�� Has top management ensured that customer
requirements are determined and met with the aim of enhancing customer
satisfaction?
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Customer needs
and
Customer satisfaction
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* �� Defined process for identifying customers, their needs and
expectation.
* �� Communication of needs throughout the organization.
* �� Key success factor or Key performance Indicator [KPI]
* �� Definition and responsibilities within organization.
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Principal
customer interfaces
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* Others:
� - Focus groups
� - Customer feedback
� - Industry surveys
� - Statutory and/or� regulatory requirements.
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5.3� Quality policy
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3��� Has top management ensured that the
quality policy:���������������������������
����� a)� Is
appropriate to the purpose of the organization?������������������������������
����� b)� Includes
a commitment to comply with requirements and to continually improve the
effectiveness of the quality management system?�������
����� c)�� Provides
a framework for establishing and reviewing quality objectives?�������������������
����� d)� Is
communicated and understood within the organization?������������������������������
����� e)� Is
reviewed for continuing suitability?
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Organizational
definition and documentation of quality policy by top management.
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�� Documented Quality Policy, which
reflects top management�s consciousness of organizational quality
requirements, objectives and goals.
Specifically:
� - Appropriateness to the purpose of the
organization
� - Commitment to comply to
requirements
� - Continually improve the
effectiveness of the qms
� - Establishes and reviews Quality
Objectives
� - How it is communicated and the depth of
understanding throughout the organization
� - Communication to new hires/temporary
workers
� - Is periodically reviewed for continuing
suitability.
*
�� Top management has signed the policy
or
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�� The policy is in the quality manual,
signed by TM or
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�� An authorization sheet is maintained
on file signed by TM.
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5.4� Planning
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5.4.1 Quality� objectives
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4��� Has top management ensured that quality
objectives are established at relevant functions and levels within the
organization?������������������
5��� Have quality objectives needed to meet the
requirements of the product been established?���� �����
6��� Are quality objectives measurable and
consistent with the quality policy?
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Quality
objectives
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* Defined
quality objectives
* Relevance to
all levels
* Derivation
from and supporting the quality policy
* Stated in
measurable terms
* Methodology
for communicating objectives
* Employees
translating the objectives into individual or group contributions.
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5.4.2� QMS�
planning
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7��� Has top management ensured that the
resources needed to achieve the quality objectives are identified and
planned?������������������������������
8��� Is the output of the planning
documented?� (e.g., quality manual,
procedures, work instructions, quality plans, etc.)������������������������
9��� Does top management ensure that the
integrity of the quality management system is maintained when changes are
planned and implemented?���� �����
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Top Management
planning to meet the quality objectives and requirements of 4.1
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Documentation,
including:
* Quality manual
* Operating
procedures
* Appropriate
work instructions
* Flow charts
* Process
routings
* Quality
[Control] plans
* Long range
plans
* Established
planning methodologies
* Use of
planning tools
* Skills,
knowledge and facilities needed
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Changes to the
QMS
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* Change control
process
* Authorities
and responsibilities
* Implementation
and project plans
* Management of
continual improvement
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Barrier Analysis
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5.5
Responsibility, authority and communi-cation
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5.5.1
Responsibility and authority
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10�� Has top management ensured that
responsibilities,� authorities are
defined and communicated within the organization?��������������� ���
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Method of
defining and communicating responsibilities and authorities
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�� Definition of inter-relationships
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�� Defined reporting structure.
*��� Individual understanding of their
defined scope, responsibility and authority of their functions.
*��� Individual understanding of designated "channels" to
take action.
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5.5.2�� Management Representative
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11�� Has top management appointed member(s) of
management who have responsibility and authority for:����������������
������� a)� Ensuring
that processes are established, implemented and maintained?���������
������� b)� Reporting
to top management on the performance of the quality management system,
including needs for improvement?
������� c)�� Promoting
awareness of customer requirements throughout the organization?
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MR appointment
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Documented
appointment, letter etc.
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Level of the MR
in the organization�s hierarchy
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Member
of management.
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MR
responsibilities
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*��� QMS processes are established, implemented &
maintained
*��� Reports to TM concerning the performance of the QMS and
the need for improvement
*��� Promotion of the customer requirements throughout the
organization
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Resources at the
disposal of the
MR
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Time
Money
Staff
Tools
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5.5.3�� Internal Communication
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12.� � Has
top management ensured that appropriate�
communication processes have been established within the organization?
���������������������������
13.�� Does communication take place regarding
the effectiveness of the quality management system?
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The
communication system within the organization.�
Established and operative.
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Processes
to:
*
Communicate the quality policy and objectives
*
Customer requirements
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Accomplishments
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Typically:
�- Management-led communication in work areas
�- Notice boards, company newsletters,
magazines
�- Audio-visual and electronic media �
e-mail, web-sites.
�- Employee surveys and suggestion schemes
�- Procedures
�- All hands meetings to explain policy,
plans etc
�- Team briefings
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5.6�� Management Review
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5.6.1�� General
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14. Does the top management review the quality
management system, at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness?����������������������������
15. Are opportunities for improvement and the
need for changes to the quality management system, including quality policy
and objectives, reviewed during the review?���������������������
16. Are records of management reviews maintained
as quality records?
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The Management
Review for suitability of the system
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Controlled
changes in the scope of the system and the business
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The Management
Review for adequacy
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Compliance with
the standard and other requirements, business, legal and customer
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The Management
Review for effectiveness
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The system to
meet the measurements set out in the quality objectives and quality plans
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Review interval
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Schedule
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Review records
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Agenda, minutes,
action plans
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5.6.2�� Review Input
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17. Do the inputs to management review include
information on:���������������������������
������� a)� Results
of audits?�����������������
������� b)� Customer
feedback?���������������������������
������� c)�� Process
performance and product conformity?�����������������
������� d)� Status
of preventive and corrective actions?�� �
������� e)� Follow-up
actions from previous management reviews?�����������������
������� f)�� Planned
changes that could affect the quality management system?������������������������
������� g)� Recommendations
for improvement?�������������
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Review input and
considerations
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* Review of
Quality Policy and Objectives
* Measurements,
KPI�s
* Results of all
audits
* Review of
customer feedback
* Review of
process performance and product conformity
* Review of the
status of corrective and preventive actions
* Follow-up
actions from previous MR meetings
* Review of
changes that could affect the qms
* Assessment of
and recommendations for improvement
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5.6.3�� Review Output
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18. Do the outputs from the management review
include the decisions and actions related to:
������� a)� Improvement
of the effectiveness of the quality management system and its processes?�������
������� b)� Improvement
of the product related to customer requirements?��������������������
������� c)�� Resources
needed?
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Outputs from
Management Review
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* Minutes;
including attendance
* Decisions
regarding the improvement of the effectiveness of the qms
* Decisions regarding
the improvement of the� product related
to the customer requirements
* Allocation of
resources
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6�� Resources
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6.1� Provision of resources
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1.�� Have the resources been determined and
provided for:�����������������
����� a)� Implementing
and maintaining quality management system and continually improving its
effectiveness?�������������������
����� b)� Enhancing
customer satisfaction by meeting customer requirements?
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Resources
necessary to implement and improvement the QMS
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*
Management Resource plan or future plan
�� covering:
�- People
�- Suppliers
�- Information
�- Money
�- Availability of raw materials
�- Buildings
�- Production equipment
�- Other facilities
�- Transport
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Determination of
customer requirements
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Resources to:
�- Determine customer requirements
�- Measure customer satisfaction
�- Measure and resolve customer
dissatisfaction
�- Facilitate the use of customer feedback
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6.2� Human Resources
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6.2.1� General
2.�� � Is
competency for personnel who perform work affecting product quality based on
appropriate education, training, skills, and experience?����������
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Competency of
personnel
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* Demonstrated
ability to apply knowledge and skills
* Local
definition of competency based upon:
�- Education
�- Training
�- Skills
�- Experience
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6.2.2� Competence, Awareness, Training
3��� Has the organization:������������������
����� a)� Determined
the necessary competency for personnel performing work affecting product
quality?�������������������������
����� b)� Provided
training or take other actions to satisfy these needs?������������������������������
����� c)�� Evaluated
the effectiveness of the actions taken?���������������������������
����� d)� Ensured
that employees are aware of the relevance and importance of their activities
and how they contribute to the achievement of the quality objectives?���������������������
����� e)� Maintained
appropriate records of education, training, skills and experience
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a. Competency
needs for all personnel
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* �� Analysis of job tasks to determine the basic requirements
of education, skill, experience and training
* �� Annual assessments of the organization, taking into
account changes in technology and business objectives
* Individual
assessment
* Customer complaints
* Corrective
actions
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b. Provision of
training
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* Training plans
* Planned career
development
* Selection of
training providers
* New employee
training/induction
* Training of
temps/subcontract personnel
* Pre and post
training evaluation
* Success in
examinations
* Internal
auditing
* Monitoring of
performance
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c. Evaluating
the effectiveness of training
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* Knowledge of
the quality objectives
* Understanding
of the Customer requirements
* Knowledge of
the sequence and interaction of the
�� company processes
* Awareness of
internal customer and supplier
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d. Awareness of
employees of the importance of their activities and their contribution to the
achievement of the quality objectives
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Statements made
employees in response to interviews
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e. Training
records
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* OTJ training
records
* Signed
application form
* Resume/CV
* Copies of
training certificates
*
Diplomas/Degree certificates
* Training
attendance sheets
* Retention of
training records
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6.3� Infrastructure
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4.�� To achieve conformity of product, does the
organization identify, provide, and maintain the facilities including, as
applicable:�������������
����� a)� Buildings,
Workspace and associated utilities?���
����� b)� Process
Equipment, hardware and software?�
����� c)�� Supporting
services?�������������
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Requirements of
the organization�s products/customers
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* Plant
* Workspace
* Information
systems
* Tools and
equipment
* Support
services
* Communication,
transport facilities
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6.4�� Work Environment
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5.���� Has the environment needed to achieve
conformity of product requirements been determined and managed?�����
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The working
environment needed to achieve conformity to product requirements
Management�s
ability to manage the work environment
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* Housekeeping
� Straight
� Organized
� Clean
� Polished
Factors include:
* Proper
lighting
* Ambient
temperature
* Humidity
* Cleanliness
* Protection
against the elements
Other local
requirements: (Note)
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7�� Product Realization
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7.1� Planning of product realization
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1.�� Is planning of the organization's product
realization consistent with the requirements of the other processes of the
quality management system?���� �����
2.�� Are the following being determined when
planning the product realization:����������������
����� a)� Quality
objectives and requirements for the product?�������������������
������� b)��� The
need to establish processes, documents, and provide resources specific to the
product?���
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Planning for
product/service realization
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* Quality
objectives for the product/project/contract (5.4.1)
* Documentation:
�- Procedures/Work Instructions
(4.2.3)
�- Identification and communication of
significant features of the process
* The resources
necessary to the product (6.1)
* Acceptance
criteria for the product
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����� c)�� Required
verification, validation, monitoring, inspection and test activities specific
to the product and criteria for product acceptance?��� ���
����� d)� Records
needed to provide evidence that the realization processes and resulting
product fulfill requirements?������������������������������
3.�� Is the planning output in a form that is
suitable for the organization's method of operation?�
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* Methods of:
�- Verification
�- Validation
�- Monitoring
�- Inspection
�- Testing
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Appropriate
output of planning
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* �� Analysis, review and improvement of the
processes (7.5.2)
* �� Objective evidence/records that realization
processes and resulting product meet the stated requirements (4.2.4)
* Quality Plan/Control
Plan by product/ contract/ product family or process
* FMEA
* Reliability
predictions
* Other risk
analysis tools
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7.2�� Customer related processes
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7.2.1�� Requirements related to the product
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4.�� Has the organization determined:������������
����� a)� Requirements
specified by the customer, including the requirements for delivery and
post-delivery activities?�������������������������
����� b)� Requirements
not stated by the customer but necessary for specified or intended use, where
known?���������������������
����� c)�� Statutory
and regulatory requirements related to the product?����������������������������
����� d)� Any
additional requirements determined by the organization?����������
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Customer
requirements � specified
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* Quantity
* Delivery
* Post-delivery
* Performance
* Availability
* After sales
support
* Terms and
conditions
* Packing
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Customer requirements
� implied
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* Applicable
codes/standards
* Export requirements
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Statutory and
legal
requirements
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* Codes/standards
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Any organizational
requirements specified
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* Any company
requirements
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7.2.2� Review of requirements related to the
product
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5.�� Prior to the commitment� to the customer (e.g. submission of
tenders, acceptance of contracts or orders or acceptance of change orders)
are requirements reviewed to ensure that:����
����� a)� Product
requirements are defined?���
����� b)� Contract
or order requirements differing from those previously expressed are resolved?
����� c)�� The
organization has the ability to meet defined requirements?
6.�� Are results of reviews and actions arising
from these reviews recorded and maintained as records?���������
7.�� Where the customer has not provided a
documented statement of requirements, are customer requirements confirmed by
the organization before acceptance? ������������
8.�� Where product requirements are changed,
does the organization ensure that relevant documentation is amended and
relevant personnel are made aware of the changed requirements?
|
Reviews for
ability to meet the requirements before the commitment to the customer
|
a. Full
definition of product requirements
b. Evidence of
resolution of any differences
�� previously expressed
c. A decision
that the company can meet all the requirements:
�- Documented review with signature
�- Review signature on P.O.
�- Entry into the company manufacturing and
control
�� system
* Order log
* Records
* Documented
verbal orders
* Control and
coordination of changes
|
|
7.2.3� Customer communication
|
|
|
|
9.�� Has the organization determined and
implemented effective arrangements for communicating with customers relating
to:
����� a)� Product
information?�����������������������������
����� b)� Inquiries,
contracts, amendments or order handling?�����������������
����� c)�� Customer
feedback, including customer complaints?
|
Methods for
communicating to customers with regard to:
1.�� Product information (before sale)
|
* Product
catalogues
* Product
specifications
* Exhibition
arrangements
|
|
2.� Enquiries, contracts, contract changes
|
* RFQ
logs/computer system
* SOP computer
system
* EDI
|
|
3. Customer
feedback; including complaints (after sale)
|
* Complaints
escalation process
* Competitor
analysis
* Benchmarking
* Reports from
sales team
* Reports from
service team
* Surveys
* Focus groups
* Networking
|
|
7.3 Design and
development
|
|
|
|
7.3.1 Design and
development planning
10. Are product
design and development activities planned and controlled?���������������������������
11. During
design and development planning has the organization determined:�������������������������
����� a)� Stages
of design and development?�
����� b)� Review,
verification and validation that are appropriate to each design and
development stage?�����������������������
����� c)�� Responsibilities
and authorities for design and development?�������������������������
12.� Are interfaces between different groups
involved in design and development managed to ensure effective communication
and clear assignment of responsibilities?�������������������������
13 Is planning output updated as the design and
development progresses?�����������������������
|
1. Planning and
controlling design and development
|
a. Project plans
�� * Milestones
�� * Gateway points
�� * Defined stages in design
b.� Appropriate review, verification and
validation points
c. Defined
responsibilities and resources
��� * Authority for release to the next stage
|
|
2. Interface
between the different groups/ departments involved in design and development
|
* Effective
communication system
* Clear
assignment of responsibility in the different
�� functions
|
|
3. Output
|
* Project plan
* Updated
project plan
* Project file
|
|
7.3.2� Design and development input
14.� Are inputs relating to product requirements
defined, documented and maintained as a record?�������������������������
15.� Does design and development input include:
����� a)� Functional
and performance requirements?
����� b)� Applicable
statutory and regulatory� requirements?
����� c)�� Applicable
information derived from previous similar designs?�������������������
����� d)� Other
requirements essential for designs and development?�����������������������
16 Are design and development inputs reviewed
for adequacy?�������������������
17 Are incomplete, unambiguous or conflicting
requirements resolved?������������
|
Unambiguous� definition of the product design required
|
a. Functional
and performance requirements
* Physical
parameters and environment concerns
*
Customer/marketplace needs and expectations
* Contractual
requirements
b. Statutory and
regulatory requirements
* Industry or
other applicable codes of practice
c. Know data
from:
�- Earlier designs
�- Similar products
d. Resolution of
conflicts in design requirements
�- Consistent information
�-�
Consistent requirements
e. Resolution of
safe and proper usage requirements
* Arrangements
for disposal after useful life
|
|
7.3.3�� Design and development outputs
18.� Are outputs of the design and development
provided in a form that enables verification against the design and
development inputs?
19.� Are design outputs approved prior to
release?���� ���
20.� Does the design and development output:
����� a)� Meet
the design and development input requirements?����������������������
����� b)� Provide
appropriate information for purchasing, production and for service provision?�������������� �
����� c)�� Contain
or reference product acceptance criteria?������������������
����� d)� Specify
the product characteristics that are essential to its safe and proper use?���������������
|
Output in a form
that enables verification against input requirements
|
* Approval
before release
* Product
acceptance criteria
* Meeting the
input requirements
* Adequate
information for other concerned departments:
�- Purchasing
�- Production
�- Marketing
�- Service
* Specification
for safe and proper use
|
|
7.3.4�� Design and development review
21.� Are systematic reviews performed in
accordance with planned arrangements at suitable stages of the design and
development?�����������������
22.� Do design and development reviews:���
����� a)� Evaluate
the ability of the results of design and development to meet requirements?
����� b)� Identify
problems and propose necessary actions?������������������
23.� Do review participants include
representatives of functions concerned with the design and development
stage(s) being reviewed?
24.� Are results of reviews and any actions
necessary maintained as records?������������
|
Systematic
reviews at planned stages
|
* Records of
reviews
* Participation
of functions involved
* An evaluation
in the review of the ability of the design to meet requirements
* Identification
of problems or resource issues
|
|
7.3.5�� Design verification
25 Is design and development verification
performed in accordance with planned arrangements to ensure that the design
outputs have met the design and development input requirements?� �� ���
26 Are results of the verification and actions
maintained as records?����������������������������
|
The planned (process
by the org.)� that verifies that
the design outputs have met the input requirements
|
* Identification
of responsibilities and authorities for verification
* Methods of
verification including:
�- Alternative calculations
�- Comparison with a proven design
�- Tests or simulations
|
|
Confirmation that
all application customer and regulatory requirements have been met and any
issues found have been resolved.
|
* Records,
duly authorized, of design verification
* Action items,
recorded, when necessary
|
|
7.3.6�� Design validation
27.� Is design and development validation
performed in accordance with planned arrangements?�������� ���
28.� Is design and development validation
performed to confirm that the product is capable of meeting the requirements
for the specified application or intended use, where known?�������������������
29.� Is validation completed prior to delivery or
implementation of the product wherever applicable? �����������������
30.� Are results of the validation and actions
maintained as records?
|
Confirmation (with
the customer) that the resulting product is capable of meeting the requirements
for the specified application or intended use.
|
* Proof that the
product (incl. S/W and firmware) actually performs as
�� planned under specified operating
conditions:
�- Validation records
�- Validation completed before prior to
delivery and/or installation.
* Validation may
include:
�- Prototype testing
�- Field testing
�- Pilot plant
�- Reliability test data
�- Simulation
|
|
Results of
validation.
|
* Validation
records, authorized by responsible person.
* Details of any
necessary actions.
|
|
7.3.7� Design changes
31.� Are design and/or development changes
identified and recorded?��������������������������
32.� Do reviews of design and development changes
include evaluation of the effect of the changes on constituent parts and
product already delivered? ���
33.� Are design and development changes reviewed,
verified, validated as appropriate and approved before implementation?���������������������������
34 Are results of the review of changes and
necessary actions maintained as records?��������������
|
The method of
identifying and recording design changes.
|
* ECO system
with records
|
|
The system to
review, verify, validate and approve design changes before implementation
|
* Authorities
for review etc
|
|
How ECOs effect
constituent parts and product already delivered
|
* Classification
of changes.� Typically:
�- Urgent, safety, FFF
�- Value engineering not affecting FFF
�- Cosmetic
* Scheduling
provisions
|
|
7.4 Purchasing
|
|
|
|
7.4.1 Purchasing
process
|
|
|
|
35.� Are the purchasing processes controlled to
ensure purchased product (or service) conforms to requirements?����������������������������
36.� Is the type and extent of control applied to
the supplier and purchased product dependent upon the effect of the purchased
product on subsequent product realization or the final product?����������������
37.� Are suppliers selected and evaluated based
on their ability to supply product in accordance with the organization's
requirements?���������������������������
38.� Has the organization established criteria
for selection, evaluation & re-evaluation of suppliers?���
39.� Are results of the evaluations and any
necessary actions maintained as records?
|
Purchased
product conforms to specified requirements
|
* Effects of
different products on subsequent product realization.
- Critical
components
�- Utilities etc
|
|
Supplier control
and selection
|
* Criteria for
supplier selection (incl. cal. labs, carriers, temp agencies)
* Evaluation of
methods and results
|
|
Records
|
1) Evaluations,
2) planned re-evaluations, 3) actions resulting from evaluations
|
|
7.4.2 Purchasing
information
|
|
|
|
40.� Does purchasing information describe the
product to be purchased?�����������������������
����� Including where appropriate:���������������������
����� a)� Requirements
for approval of product, procedures, processes and equipment?���������
����� b)� Requirements
for qualification of personnel?�� �
����� c)�� Quality
management system requirements?
41.� Is the adequacy of specified purchased
requirements ensured prior to their communication to the supplier?��������������
|
Adequacy of
purchasing information prior to release to supplier
|
* Full
description of the product to be purchased, including:
�- Requirements for approval of product,
process, equipment, procedures
�- Requirements of qualified personnel
�- Quality Management System requirements
* PO review before issue
|
|
7.4.3� Verification of purchased product
|
|
|
|
42.� Have the inspection or other activities
necessary for ensuring that purchased product meets specified purchase
requirements been established and implemented?������������������������������
43.� Are verification arrangements and method of
product release specified in the purchasing information where the
organization or its customer intends to perform verification at the
supplier's premises?
|
Verification
methods
|
*
Incoming/source inspection/test (incl. In PO
with requirement for supplier I/T Report
* Degree of
control over the supplier
|
|
Verification on
supplier�s premises by organization or customer
|
* Verification
requirements arrangements stated in the P.O.
* Method of
product release stated in the P.O.
|
|
7.5�� Production and service provision
|
|
|
|
7.5.1� Control of�
Production and Service provision
|
|
|
|
44.� Are the production and service provision
planned and carried out under controlled conditions including:���������������������
����� a)� Availability
of information that describes the product characteristics?����������������������
����� b)� Availability
of work instructions, as necessary?�����������������
����� c)�� Use
of suitable equipment?
����� d)� Availability
and use of monitoring and measuring devices?����������������������������
����� e)� Implementation
of monitoring and measurement?���������������������
����� f)�� Implementation
of release, delivery and� post-delivery
activities?
|
Realization
carried out under controlled conditions
|
a. Product
characteristics information available to production
b. Work
instructions if necessary
c. Suitable
equipment
� - Maintenance
* Control of NC
programs and other software
d. Available
monitoring and measuring devices and instructions:
�- Process sheets
�- Inspection instructions
�- Shop travelers
�- Test procedures
�- Standard operating sheets
e.
Implementation of monitoring and measurements
f. Release,
delivery and post-delivery activities.
|
|
7.5.2� Validation of processes for production and
service provision
|
|
|
|
45.� Have processes where deficiencies may become
apparent only after the product is in use or the service has been delivered
been validated?��������
46.� Do the results of validation demonstrate the
ability of the processes to achieve planned results?
47.� Where applicable, have the arrangements been
established for:���������������������������
����� a)� Defining
criteria for review and approval of processes?����������������������������
����� b)� Approval
of equipment and qualification of personnel?����������������������������
����� c)�� Use
of specific methods and procedures?
����� d)� Requirements
for records?������������������
����� e)� Re-validation?�������������������������
|
The validation
methods used to ensure that the processes can achieve planned results.� [Including "Special" processes]
|
* Process
documentation and records
- Use� of run charts
�- Capability [Process Capability Analysis]
* Criteria for
review and approval of processes
* Approval of
equipment
|