Understanding The ISO/TS
16949:2002 Standard
5.6 Management Review
5.6.1
General
Top Management
shall:
Perform reviews of the QMS
Conduct these reviews at planned
intervals
Ensure that the QMS continues to be suitable, adequate and
effective
Assess opportunities to improve the QMS
Evaluate the need for any changes to QMS, quality policy and
objectives
Maintain records of management reviews
5.6.1.1
QMS performance – these
reviews shall include:
All requirements of the QMS & its performance trends as
an essential part of the continual improvement
process
Monitoring of quality objectives (see
8.4.1)
Regular reporting and evaluation of cost of poor quality
(see 8.5.1)
The above review
shall be recorded and provide, as a minimum, evidence of the
achievement of;
Quality objectives specified in the business
plan
Customer satisfaction with product
supplied
5.6.2 Review
Input
Management review input
shall 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 mgmt reviews
f)
Changes that could
affect the QMS
g)
Recommendations
for improvements
5.6.2.1
Review input -
Supplemental
Shall include an analysis of actual & potential field
failures and their impact on quality, safety or the
environment.
5.6.3 Review
Output
The output from
management review shall include any decisions and actions
related to:
a)
Improvement of effectiveness of the QMS and its
processes
b)
Improvement of product related to customer
requirements
c)
Resource needs
Key Explanation Points and
Tips:
Þ
The purpose of conducting management reviews of the QMS is to
gauge the health of the QMS. The review must determine QMS
suitability, adequacy and effectiveness. Are the QMS resources
and controls that were planned and implemented, suitable and
adequate for the QMS to be effective in achieving customer and
regulatory requirements; and in achieving quality objectives?
Are changes needed to improve product, processes and use of
resources?
Þ
A process to administer Clause 5.6 would be appropriate as it
has ISO 9001 standard specifies requirements for management
review inputs, value-adding review activities and outputs. The
process must address the frequency, schedule, quorum and agenda
for review meetings to be attended by top management.
Review specific requirements for management review at OEM
customer or IATF websites.
Þ
For the management review process itself to be effective, top
management must plan the review of all agenda items
with some regularity to gauge the health of the QMS and
take timely action to change or improve any part of it,
including the quality policy and objectives. To avoid problems
on frequency and scope of review, an effective way would be
incorporate QMS agenda items into regular monthly or quarterly
operational meetings. Some OEM’s require management review to
be held not less than once a year.
Þ
Clause 8 provides the majority of the agenda information for
management review. In addition to the items listed in 5.6.2;
5.6.1.1; 5.6.2.1, management review must also include – 7.3.4.1
summary of design and development measurements; 5.1.1 process
efficiency.
Þ
Under clause 5.6.1.1, all requirements of the QMS must be
reviewed. The review of QMS deployment and performance might be
measured through gap analysis for new systems and the results
of internal audits for established systems. Management review
must include the results of such analysis and
audits.
Þ
The agenda items in clause 5.6.2 will be discussed in detail
under various other TS 16949 clauses as they come up. For
example most of clause 5.6.2 agenda items come up in clause 8.
Field failures (clause 5.6.2.1) will be discussed under clause
7.5.1.7.
Þ
QMS objectives must flow from the business plan. The costs of
internal and external poor quality as well as process metrics
for all processes defined in clause 4.1.must be measured and
evaluated against business plan objectives and customer
satisfaction goals.
Þ
Management review input should preferably be in summary form,
showing QMS and operational performance measured against the
business and quality plans, customer and regulatory objectives
and goals. Appropriate actions must result from such reviews.
Þ
Review decisions and actions must relate to improving products
and processes or even creating new ones; providing more
resources or perhaps improving the efficiency of existing
resources; improving QMS controls; policies and objectives; and
improving overall QMS effectiveness and customer satisfaction.
Þ
Responsibilities and timelines should accompany these decisions
and actions. The performance of these actions must be followed
up at subsequent management review meetings.
Þ
Performance indicators to measure the effectiveness of the
management review process could include - achievement of
quality objectives and improvement in customer satisfaction
rating (see QMS objectives under clause 5.4.1
notes).
Þ
Clause 5.6 does not require a ‘documented’ procedure. However,
you must identify and document the management review process as
part of your QMS (see clause 4.1). You must also identify what
specific documents are needed
for effective planning, operation and control of this process
(see clause 4.2.1d). These documents may include – a
documented procedure; review schedule; agenda and action forms;
etc., combined with unwritten practices, procedures and
methods.
Þ
Management review records must include topics discussed;
decisions; responsibilities for corrective or improvement
actions and related timelines; provision of resources; and
follow-up actions from previous management
reviews.
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