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A.8b - Auditing Procedure

Authorised By:

Revision 00 Date 01 / 07 /2008

 Sanjay Kaushik
1.0 PURPOSE
   1.1 This procedure defines the conduct and reporting of:
a. Stage 1 Audits of Client's Quality Management System. The purpose of these visits is to ensure that the client has an assessable system, and to prepare a program for the initial Assessment (Stage 2 Audit).
b. Stage 2 Audit of Client's Quality Management System. The purpose of the Stage 2 audit is to evaluate the implementation, including effectiveness, of the client‘s management system.
c. Visits to the client's premises to examine corrective action applied to CARs graded as Major.
d. Surveillance Audits, so that the continuing validity of certifications may be verified, and any significant changes or additions to the Client's System are assessed for compliance with the assessment criteria.
2.0 SCOPE
   2.1 This procedure is applicable to :
a. Stage 1 Audits which must be carried out prior to all Initial Assessments Stage 2 Audit. An exception to this is for Clients who are transferring from another Certification Body. The Technical Manager may authorise other situations that may warrant the waiving of Stage 2 audit.
b. all Stage 2 audits and Triennial / Recertification Audits.
c. Corrective Action visits becomes necessary whenever CARs graded as Major are raised during an Assessment, a Surveillance Audit or are still outstanding after an earlier CA visit. This procedure also covers special visits to examine relevant parts of the system in the event of notification of significant changes or where a complaint or other source of information indicates that the Client's system may not be complying with the criteria.
d. All Surveillance Audits, held at least annually, but usually six monthly between assessments, including planning for triennial assessments.
3.0 DEFINITIONS & ABBREVIATIONS
   3.1 QMS CS QMS Certification Services
   3.2 TM Technical Manager
   3.3 OM Operations Manager
   3.4 CAR Corrective Action Request
   3.5 QMS Quality Management System
   3.6 CA Corrective Action
   3.7 SA Surveillance Audit
   3.8 Audit Team Leader The leader of an audit team.
   3.9 Audit plan Description of the activities and arrangements for an audit
   3.10 Non-conformity A failure to meet a requirement of the management system standard or the organization's documented management system.
   3.10.1 Major Non-conformity(i)
Is either:
i. Failure to fulfill one or more requirements of the management system standard. A number of minor non-conformities against a requirement can represent a total breakdown of the system for this is considered a major non-conformity, or
ii. A situation that raises significant doubt about the ability of the client management system to achieve its intended outputs, or
iii. Any non-compliance that would result in the probable shipment of a non-conforming product. Conditions that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
   3.10.2 Minor Non-conformity
A minor non-conformity is a non-compliance against the relevant standard that judgment and experience indicate is not likely to result in the failure of the management system or reduce its ability to assure controlled process or products. It may be either :
i. A single observed lapse in following one item of the organization's management system; or
ii. A failure of some part of the supplier's documented quality system relative to relevant standard.
4.0 DETAILS OF PROCEDURE
S.No Action Responsibility
 4.1 Stage 1 Audit
   4.1.1 Attend the client's facilities at the agreed time, with relevant audit forms for the visit. Auditor
   4.1.2 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. Auditor
   4.1.3 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. Auditor
   4.1.4 Audit the client's management system documentation as per the checkpoints identified on Page 2 of (F.16) ‘Stage 1 Audit Report'. Auditor
   4.1.5 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. Auditor
   4.1.6 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). Auditor
   4.1.7 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. Auditor
   4.1.8 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. Auditor
   4.1.9 Review the allocation of resources for Stage 2 Audit and agree with the clients on the details of the Stage 2 Audit. Auditor
   4.1.10 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. Auditor
   4.1.11 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. Auditor
   4.1.12 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. Auditor
   4.1.13 Forward audit report to Technical Manager – QMS CS. Auditor
   4.1.14 Approve any changes (audit man-days, location etc.) and arrange updation of database. Technical Manager
 4.2 Stage 2 Audit / Triennial or Recertification Audit
   4.2.1 Client to contact the Audit Team Leader or QMS CS indicating readiness for Stage 2 Audit. Client
   4.2.2 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. Audit Team Leader
   4.2.3 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. TM
   4.2.4 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). OM
   4.2.5
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:
- The effective interaction between all elements of the system
- Overall effectiveness of the system considering any changes
- Demonstrated commitment to maintain the system's effectiveness and its contribution in achieving organization's policy and objectives.
Audit Team Leader and QMS CS to ensure
   4.2.6 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. Audit Team Leader & Audit Team
   4.2.7
Conduct and Chair Opening Meeting, ensuring that the following points are covered:-
- Introductions, and roles of team members.
- Purpose of the assessment.
- Scope and Criteria.
- Review the Program; amend if necessary.
- Explain assessment method.
- Explain CAR system & define gradings.
- Outline format of Report and Closing Meeting
- Confirm Provision and role of Guides.
- Confirm provision of a private work area for the team.
- Safety, Security, Industrial Relations restrictions.
- Work and meal times.
- Confidentiality.
- Client's Questions.
Sign on Attendance Sheet, and circulate for signature of all client's personnel to record their presence during the Opening Meeting.
DO
   4.2.8 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. Audit Team Leader
   4.2.9 The assessment shall then proceed as per the program. Whenever a deficiency is found in the Client's System, discuss this with the client to ensure that they understands the problem and has opportunity to offer more evidence of compliance. 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. Auditor
   4.2.10
During these audits, auditor(s) shall:
- Examine and verify the structure, policies, processes, procedures, records and related documents of the client organization relevant to the management system;
- Determine that these meet all the requirements relevant to the intended scope of certification;
- Determine that the processes and procedures are established, implemented and maintained effectively, to provide a basis for confidence in the client's management system;
- Performance monitoring, measuring, reporting and reviewing against key performance objectives and targets;
- management responsibility for the client's policies, and
- 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.
Audit Team
   4.2.11
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 program is reviewed.
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.
Audit Team
   4.2.12 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. Audit Team
   4.2.13 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. Audit Team
   4.2.14 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. Audit Team
   4.2.15 Also ensure that the client's management system and performance are legally compliant. If non compliant issues are identified, raise these issues as CAR. Audit Team
   4.2.16 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). Request client to acknowledge the contents of Audit Report and Corrective Action Request (F.14). Audit Team
   4.2.17 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. Audit Team Leader
   4.2.18 A Surveillance Audit Plan shall be completed for all sites of a multi-site Client. Audit Team Leader
   4.2.19 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. Audit Team Leader
   4.2.20 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. Audit Team
   4.2.21
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:-
- Thank the Client for co-operation and hospitality.
- Presentation and signing of the CARs from the last day.
- Restate the Purpose, Scope, and Criteria.
- Summarise the findings, and state the Recommendation (Approval or Corrective Action Visit).
- 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:
- Advise that approval is subject to ratification by QMS staff not involved with the assessment.
- Explain the elements of the report.
- Explain the timing and nature of Surveillance Audit Visits.
- Offer to attend a certificate Presentation.
- Answer Questions.
- Arrange date for Surveillance Audit Visit.
- Close the meeting.
If approval is not recommended:
- Advise that a CA visit will be required.
- 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.
- 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).
- Explain the elements of the report.
- Answer Questions.
- Close the meeting.
Circulate Attendance list during the closing meeting.
Audit Team Leader
 4.3 Corrective Action Visits
   4.3.1 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. Auditor
   4.3.2 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. Auditor
   4.3.3 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. Auditor
   4.3.4 At the end of the visit present any new CARs for signing by the client and complete audit report F.19. Auditor
   4.3.5 Follow step 4.2.18 to 4.2.21. Auditor
 4.4 Surveillance Audits
   4.4.1 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. Technical Manager
   4.4.2 At least two weeks 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. Admin Manager and Operations Manager
   4.4.3
Arrange to send following original documents to the appointed auditor:
- All outstanding CARs F.14
- Surveillance Audit Programme
- Surveillance Audit Report F.19
- Assessor Notes F.23
- Attendance Sheet
Office Administrator
   4.4.4 Prepare working documents (checklists, audit sampling plans, etc.) as necessary for reference and for recording audit proceedings. Auditor
   4.4.5 Conduct Opening Meeting as per 4.2.7 above. Auditor
   4.4.6
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:-
- Changes
- 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).
- Other item on Surveillance Audit Programme
Office Administrator
   4.4.7 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. Auditor
   4.4.8 Raise CAR's as appropriate and complete ‘Surveillance Audit Report' (F.19). Auditor
   4.4.9 Follow step 4.2.18 to 4.2.21. Auditor
 4.5 Instructions for Technical Experts
   4.5.1 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. Technical Experts
 4.6 Monitor / Evaluate and submit report on performance of Technical Expert(s). Use ‘Technical Expert Performance Review Form’ F.3 for recording the performance. Audit Team Leader
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