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4.0
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DETAILS OF PROCEDURE
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S.No.
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Action
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Responsibility
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4.1
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Stage 1 Audit
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4.1.1
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Attend the client's facilities
at the agreed time, with relevant audit forms for the visit.
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Auditor
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4.1.2
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The visit shall begin
with a meeting with senior management, or just the Management Representative. This
meeting must include a brief explanation of the assessment process and reporting,
as well as a clear statement of the purpose of the visit and how it will proceed.
During this meeting the QMS CS procedures should be presented and explained to the
client.
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Auditor
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4.1.3
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At
the end of the meeting, and before or after a brief tour, ask the client to give
an outline of the company and its Management System.
This will lead into an assessment of the Organisation and Responsibility
section of the standard and the client's Policy documents.
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Auditor
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4.1.4
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Audit
the client's management system documentation as per the checkpoints identified on
Page 2 of (F.16) ‘Stage 1 Audit Report'.
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Auditor
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4.1.5
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Evaluate
the client's location and site-specific conditions and to undertake discussions
with the client's personnel to determine the preparedness for the Stage 2 Audit.
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Auditor
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4.1.6
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The
above will be considered without regard for the actual practices of the client;
i.e. the assessor should not audit the implementation, except in the case of internal
document control. Any deficiencies
found should be discussed with the client to ensure validity and understanding and
then detailed on (F.16).
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Auditor
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4.1.7
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Review
the client's status and understanding regarding requirements of the standard, in
particular with respect to the identification of processes, their key performance
indicators and objectives.
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Auditor
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4.1.8
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Collect
and confirm necessary information about scope, location(s), no.of employees, no.
of shifts, product related statutory & regulatory requirements and their compliance,
exclusions, consultant, contact person, contact numbers, outsourced processes, key
production and service provision processes.
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Auditor
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4.1.9
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Review
the allocation of resources for Stage 2 Audit and agree with the clients on the
details of the Stage 2 Audit.
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Auditor
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4.1.10
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Gain
a sufficient understanding of the client's management system and site operations
with a view to develop an effective audit plan for Stage 2 Audit.
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Auditor
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4.1.11
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Check
whether internal audits and management review are being planned and performed and
adequate evidence available on the maturity of system implementation which support
client's readiness for the conduct of Stage 2 Audit.
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Auditor
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4.1.12
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Finalize
‘Stage 1 Audit Report' (F.16) identifying any areas of concern that could be classified
as nonconformity during Stage 2 Audit.
Take client's sign on Page 4 of (F.16) as a mark of their acceptance of audit report
contents.
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Auditor
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4.1.13
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Forward audit report
to Technical Manager – QMS CS.
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Auditor
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4.1.14
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Approve any changes (audit
man-days, location etc.) and arrange updation of database.
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Technical Manager
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4.2
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Stage 2 Audit / Triennial or Recertification Audit
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4.2.1
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Client to contact the Audit Team Leader or QMS CS indicating readiness for Stage
2 Audit.
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Client
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4.2.2
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Review file, including Stage 1 Audit Report. Ensure that responses to Stage 1 Audit
findings have been reviewed and accepted by Stage 1 Audit Team Leader. In the event
this has not been done and the Stage 1 Audit Team Leader is no longer in the company,
the newly appointed Audit Team Leader shall review the responses.
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Audit Team Leader
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4.2.3
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Select the entire assessment
team in consultation with Lead Assessor as per Sec.9.1 of Quality Manual. Ensure
that the interval between Stage 1 and the Stage 2 audits is sufficient to ensure
that any area of concern identified during Stage 1 audit can be resolved.
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TM
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4.2.4
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While finalizing audit plan in consultation with Technical Manager and audit team, ensure that each team member is assigned responsibility for auditing specific processes, functions, sites, areas or activities taking into account the need for competence, and the effective and efficient use of the audit team, as well as different roles and responsibilities of auditors, auditors-in-training and technical experts. Changes to the work assignments ‘Audit Plan’ may be made as the audit progresses to ensure achievement of the audit objectives.
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Audit Team Leader
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4.2.5
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Ensure that an audit
notice along with audit program is prepared and sent to the client for acceptance
and the assessors (as a formal appointment) for carrying out the assessment. The team leader shall also be sent Stage
1 Audit Report (F.16).
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OM
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4.2.6
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The Triennial assessment
planning shall include a review of the past performance of the client which shall
be taken into consideration in preparing the program.
The program must ensure that the assessment is comprehensive enough to verify:
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The effective interaction between all
elements of the system
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Overall effectiveness of the system
considering any changes
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Demonstrated commitment to maintain
the system's effectiveness and its contribution in achieving organization's policy
and objectives.
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Audit Team Leader and QMS CS to ensure
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4.2.7
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Prepare work documents
(checklists, audit sampling plans etc.) as necessary for reference and for recording
audit proceedings. Conduct audit team meeting, review audit plan and make changes
if necessary.
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Audit Team Leader & Audit Team
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4.2.8
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Conduct and Chair Opening
Meeting, ensuring that the following points are covered:-
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Introductions, and roles of team members.
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Purpose of the assessment.
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Scope and Criteria.
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Review the Program; amend if necessary.
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Explain assessment method.
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Explain CAR system & define gradings.
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Outline format of Report and Closing
Meeting
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Confirm Provision and role of Guides.
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Confirm provision of a private work
area for the team.
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Confirm formal communication channels between the audit team and the client.
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Inform conditions under which the audit may be prematurely terminated like total breakdown of system, presence of an immediate and significant risk, non-cooperative auditee etc.
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Confirm status of findings of the previous review or audit, if applicale..
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Confirm language to be used during the audit.
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Confirm that client will be kept informed of audit progress and any concerns as the audit progresses.
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Safety, Security, Industrial Relations
restrictions.
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Work and meal times.
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Confidentiality.
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Client's Questions.
Sign on Attendance Sheet,
and circulate for signature of all client's personnel to record their presence during
the Opening Meeting.
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Do
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4.2.9
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A
brief tour of the facility may be appropriate at the end of the meeting, as well
as a brief private team meeting to instruct the other team members regarding the
Style of the audit and peculiarities of the Client's System. Where the audit of
a particular activity on site requires specific competence, the team leader assigns
the audit team member personnel accordingly.
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Audit Team Leader
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4.2.10
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The assessment shall
then proceed as per the program. Audit findings summarizing conformity and detailimg nonconformity and its supporting audit evidence shall be recorded in Assessor Notes and/or Corrective Action Request. Discuss nonconformity with the client to ensure
that they understand the problem and have opportunity to offer more evidence of compliance. A CAR shall be recorded against a specific requirement of the audit criteria and should be worded adequately, identifying in detail the objective evidence on which the nonconformity is based At the end of discussions
with a particular person all deficiencies shall be recapped, so that they (and the
guide) will know what to expect as CARs the next morning
or the Audit Closing meeting, whichever is appropriate??
Do not give prescriptive advice or consultancy while explaining the audit
findings and / or clarifying the requirements of ISO 9001 standard. Gradings should
not be discussed, unless it is definitely a Major. 'Opportunities for improvement or Observations' may be identified and recorded in Assessor Notes, however, ensure that nonconformities are not recorded as 'Opportunities for improvement or Observations'.
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Auditor
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4.2.11
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During these audits,
auditor(s) conduct interviews, observes processes and activities and review documentations & records to:
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examine and verify the structure, policies, processes, procedures,
records and related documents of the client organization relevant to the management
system;
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determine that these meet all the requirements relevant to the
intended scope of certification;
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determine that the processes and procedures are established,
implemented and maintained effectively, to provide a basis for confidence in the
client's management system;
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performance monitoring, measuring, reporting and reviewing against
key performance objectives and targets;
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management responsibility for the client's policies, and
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identify to the organisation for its action any inconsistencies
between the organisation's policy, objectives and targets and its processes or the
result of their application.
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Audit Team
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4.2.12
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During the audit, periodically assess audit progress and exchange information. Audit Team Leader shall reassign work as needed between the audit team members. A meeting shall be held
at the beginning of each day by the team to discuss findings of the previous day
and for the team leader to countersign all CARs raised.
Then a meeting is held with the client at which the CARs are presented for
signing, and the plan is reviewed. Resolve any diverging opinions between the audit team and the client concerning audit evidences or findings, and record unresolved points.
Note:
If CARs have been worded adequately, there will rarely be any need for explanation
after reading out, as they should be self-explanatory.
If this is not the case, time will be wasted and the client may become confused
when trying to formulate corrective actions.
All assessors should be aware of this, and strive for the clearest wording in their
own and others' work.
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Audit Team & Audit Team Leader
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4.2.13
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As the assessment progresses,
consider CARs outstanding from previous SA visits and process them as appropriate. Areas of concerns identified during
the Stage 1 shall either be noted as closed, or detailed on CARs by the assessors. The team leader shall ensure that all
Stage 1 concerns are considered in this manner prior to preparing the report.
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Audit Team
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4.2.14
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Record details of audit evidence in ‘Assessor Notes' (F.23). Notes should include:
(i) area audited (ii) client representative (iii) procedures referred to (iv) management
system standard requirements (clause number) and (v) details of samples selected. Submit these ‘Assessor Notes' to the
Audit Team Leader.
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Audit Team
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4.2.15
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Where the available audit evidence indicates that the audit objectives are unattainable or suggests the presence of an immediate and significant risk (e.g.safety), immediately report this to the client and, if possible, to QMS CS to determine appropriate action. Such action may include reconfirmation or modification of the audit plan, changes to the audit objectives or audit scope, or termination of the audit. Report the outcome of the action taken to QMS CS..
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Audit Team Leader
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4.2.16
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Review with the client any need for changes to the audit scope which becomes apparent as on-site auditing activities progress and report this to QMS CS.
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Audit Team Leader
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4.2.17
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Put great emphasis in determining the maturity of internal auditing and management
review processes as these are absolutely mandatory for achieving desired results
out of implemented management system.
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Audit Team
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4.2.18
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Also ensure that the
client's management system and performance are legally compliant.
If non compliant issues are identified, raise these issues as CAR.
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Audit Team
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4.2.19
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When all items on the
Program have been assessed, the team shall come together to raise CARs from the
last day, and to complete ‘Stage 2 Audit Report ‘ (F.17). In finalizing the audit conclusions, kindly consider: -
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the audit findings, and any other appropriate information collected during the audit, against the audit objectives;
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the uncertainty inherent in the audit process;
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requirements of any necessary follow-up actions;
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the appropriateness of the audit programme or identify any modification required (e.g. scope, audit time or dates, surveillance frequency, competence).
Request client to acknowledge the contents of Audit Report and Corrective Action
Request (F.14).
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Audit Team
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4.2.20
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The Audit
Report shall clearly state the recommendation for approval or otherwise and
point out that it is subject to review by QMS CS management.
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Audit Team Leader
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4.2.21
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A Surveillance Audit
Plan shall be completed for all sites of a multi-site Client.
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Audit Team Leader
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4.2.22
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Decide
to hold a special visit in three months time to clear up significant numbers of
CARs, or if some element such as Internal Audit is not considered terribly reliable,
and needs closer scrutiny. The reasons
for such a visit shall be clearly explained to the client.
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Audit Team Leader
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4.2.23
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Generally Minor CAR's
must be closed out before the next surveillance audit or they will escalate to a
Major CAR. In the case of recertification, all CARs must be closed out prior to
the expiration of the current certificate.
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Audit Team
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4.2.24
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The Closing Meeting shall
be held with the client's staff and chaired by the lead assessor who ensures that
the following items are covered:-
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Thank the Client for
co-operation and hospitality.
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Presentation and signing
of the CARs from the last day.
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Restate the Purpose,
Scope, and Criteria.
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Summarise the findings and their grading, and state the Recommendation (Approval or Corrective Action Visit). Agree the timeframe with the client to present a plan for correction and corrective action action for any nonconformities identified during the audit. Point out that the sampling nature of the assessment means that their exists an element of uncertainty and although no CARs have been raised in a particular area of the system, it does not mean that no problems exist.
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Point out that the Sampling
nature of the assessment means that, although no CARs have been raised in a particular
area of the System, it does not follow that no problems exist.
If approval is recommended:
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Advise that approval
is subject to ratification by QMS staff not involved with the assessment.
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Explain the elements
of the report.
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Explain the timing and
nature of Surveillance Audit Visits.
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Offer to attend a certificate
Presentation.
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Answer Questions.
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Arrange date for Surveillance
Audit Visit.
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Close the meeting.
If approval is not recommended:
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Advise that a CA visit
will be required.
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Explain the nature of
CA visits including that Major CARs must be downgraded to Minor or closed within
three months or else whole elements (including at least Management Review, Internal
Audit and Corrective Action) will be re-examined at the CA visit.
If Major CARs are not closed or downgraded within six months, a full assessment
will be required.
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Give them an estimate
of when you would expect the CA visit, and ask them to contact the team leader with
a firm date. (or if appropriate, inform
the Client that it may be held by correspondence).
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Explain the elements
of the report.
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Answer Questions.
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Close the meeting.
Circulate Attendance
list during the closing meeting.
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Audit Team Leader
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4.3
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Corrective Action Visits
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4.3.1
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Conducting large, formal
Opening Meeting is not necessary, unless the client requests one.
However the visit shall begin with a discussion with at least the client's
MR, to review the CARs and to construct an informal program for the visit.
Any entire elements of the system which have been set for re-assessment should
be programmed first. Issues relating
to the reason for a special visit shall be treated as CARs or areas requiring re-assessment.
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Auditor
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4.3.2
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Examine objective evidence
relating to each CAR to establish whether the CAR can be downgraded or closed, record
the verification results on ‘Corrective Action Plan' (F.15).
CARs relating to re-assessed areas shall be closed or downgraded (if appropriate)
before leaving the area. Raise new
CARs if and when appropriate.
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Auditor
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4.3.3
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If time runs short before
examining all CARs, elect to postpone examination of some Minor CARs until the next
Surveillance Audit. However, all Major
CARs must be reviewed during the visit.
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Auditor
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4.3.4
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At the end of the visit
present any new CARs for signing by the client and complete audit report F.19.
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Auditor
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4.3.5
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Follow step 4.2.18 to
4.2.21.
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Auditor
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4.4
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Surveillance Audits
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4.4.1
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The frequency of Surveillance
Audits is defined in the contract, and usually occurs six monthly (plus or minus
one month), but must be held no more than twelve months between visits (no tolerance). If this is exceeded without suspension
or withdrawal, the Technical Manager – QMS must explain and record the reasons why
the approval has not been suspended or withdrawn.
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Technical Manager
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4.4.2
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At least one week prior
to the visit, contact the client and the assessor to verbally confirm or adjust
the visit date and time. Once these
have been agreed they shall be sent in writing (mail or fax) to both the client
and assessor along with Audit Plan.
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Admin Manager and Operations Manager
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4.4.3
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Arrange to send following
original documents to the appointed auditor:
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All outstanding CARs
F.14
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Surveillance Audit Programme
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Surveillance Audit Report
F.19
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Assessor Notes
F.23
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Attendance Sheet
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Office Administrator
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4.4.4
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Prepare working documents
(checklists, audit sampling plans, etc.) as necessary for reference and for recording
audit proceedings.
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Auditor
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4.4.5
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Conduct Opening Meeting
as per 4.2.7 above.
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Auditor
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4.4.6
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If there are any significant
changes to the system (eg. Purchasing now computerised), those areas shall be assessed prior to
auditing the areas identified on the SA Plan.
If time becomes restrictive, the following priority order shall apply:-
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Changes
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Mandatory Items marked 'slash' 'I' on Surveillance Audit Programme (Internal Audits, Management Review, Action on previous CARs, Action on complaints, Acievement of objectives, Continual improvement and Use of Marks).
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Other item on Surveillance
Audit Programme
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Auditor
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4.4.7
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During audit, evaluate
effectiveness of the management system: a) with regard to achieving the objectives
established by the concerned client and b) in fulfilling requirements between recertification
audits.
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Auditor
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4.4.8
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Raise CAR's as appropriate
and complete ‘Surveillance Audit Report' (F.19).
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Auditor
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4.4.9
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Follow step 4.2.18 to
4.2.21.
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Auditor
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4.5
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Audit Reports
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4.5.1
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Following audit report formats are used for different type of audits in addition to Audit Plan (F.12), Corrective Action Request (F.14) & Corrective Action Plan (F.15):
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Stage 1 Audit Report
F.16
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Stage 2 Audit Report
style="mso-tab-count: 2" class="text">
F.17
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Surveillance Audit Report
F.19
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Recertification Audit Report
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These audit reports have QMS CS Logo (for identifying certification body), name and address of the client and client’s management representative, type of audit (stage 1, stage 2 etc.), audit criteria, audit objectives (in F.12 audit plan), name of audit team leader, audit team members and any accompanying persons, dates and places where the audit activities (on site or offsite) were conducted, audit findings (in F.14 corrective action request and F.23 assessor notes), audit conclusions and any unresolved issues, if identified.
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4.6
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Instructions for Technical Experts
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4.6.1
4.6
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Provide technical advice
to auditors including advice on sector specific terminology, technical characteristics
of processes and products and sector-specific processes and practices. Work in close
co-operation with competent auditor, but shall not perform an independent auditing
function.
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Technical Experts
Monitor / Evaluate and submit report on performance of TEchnical Expert(s). Use 'Technical Expert Performance Review Form' (F.3) for recording the performance.
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4.8
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Observers and guides
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4.8.1
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Ensure that observers, if any, do not influence or interfere in the audit process or outcome of the audit.:
Audit Team
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4.8.2
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Ensure that each auditor is accompanied by a guide, unless otherwise agreed with the client.:
Audit Team Leader
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4.8.3
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Ensure that guides, do not influence in the audit process or outcome of the audit. Responsibilities of a guide can include: -
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Establishing contacts and timing for interviews;
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the uncertainty inherent in the audit process;
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Arranging visits to specific parts of the site or organization;
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Ensuring that rules concerning site safety and security procedures are known and respected by the audit team members;
Request client to acknowledge the contents of Audit Report and Corrective Action
Request (F.14).
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Audit Team
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