Procedure for Evaluating the Effectiveness of Company Quality System are as follows:
1. Purpose:
The purpose of this procedure is to ensure that a system for evaluating the effectiveness, suitability and the degree of implementation of Company Quality System is initiated and maintained.
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2. Scope and Responsibility:
ADVERTISEMENTS:
This procedure applies to all Internal Quality Audits performed in the Company. It shall be the responsibility of the Managing Director to approve this document. It shall be the responsibility of the Engineering Manger (MR) to issue, update and maintain this document.
3. Definitions:
Audit – A systematic and independent examination to determine whether quality activities and their related results comply with the requirements of the Quality System.
Interned Audit – An audit carried out internally by the Company’s personnel to evaluate the company’s performance.
External Audit – An audit carried out by a customer or third party to evaluate the activities of the Company.
4. Procedure:
ADVERTISEMENTS:
General:
The Engineering Manager (MR) is responsible/oral Internal Audits. He is responsible/or submitting to management an Annual Schedule of Audits for review and approval.
Audits can be carried out on a departmental basis or by procedure but the MR is responsible for ensuring that all areas of the quality system are audited at least once every twelve months.
Internal Audits shall be performed by qualified Internal Auditors independent of the function being audited.
ADVERTISEMENTS:
Arranging the Audit:
The MR shall appoint a Lead Auditor, and where necessary a team of assistants, responsible for performing an audit. The Lead Auditor is responsible/or informing the Head of the Department to be audited, by way of Audit Notification letter, at least five days prior to the audit commencement.
He shall ensure that the date and time is convenient and shall identify the audit scope, agenda and the names of all auditors involved
The Lead Auditor shall prepare a checklist relating to the scope of the audit, this shall be used during the performance of the audit. He shall register the audit in the Audit Register held by the MR and review the previous two audits of the area under scrutiny (if applicable).
The Entry Meeting:
On arrival at the audit venue the lead auditor shall convene a brief meeting with the audited. The purpose of this Pre-audit meeting is to:
(i) Introduce the audit team and audited
(ii) Confirm the purpose and scope of the audit Review the audit timetable and agenda
(iii) Summaries the methods and procedures to be used
(iv) Agree a completion time and closing meeting with senior management of the audited. The names of those present shall be recorded on the Audit Attendance Record.
The Audit:
Using the prepared checklist as a guide the auditors shall collect objective evidence to determine compliance with the specified requirements, and determine the effectiveness of the implementation of the quality system.
All details shall be recorded on the checklist and any information gained at the pre-audit meeting should be corroborated by acquiring the same information from alternative sources.
The documented procedures and work instructions/or the area being audited shall be used as checklist by auditor. The auditor shall prepare himself for audit by making notes against these procedures and underlining those clauses that call/or attention.
In completing this audit checklist, auditor shall have a compliance column ticked icier ‘X’. The comments / remarks column shall be used to expand on an activity or to reference other objective evidence and non-conformances.
Evaluation of Results:
On completion of the audit the audit team should meet to consider and evaluate the evidence generated during the audit. Objective evidence of any departure from approved procedures, documented requirements and / or other applicable documents should be considered as valid audit findings.
All such audit findings should be recorded on a Corrective Action Report (CAR). The CAR should be completed by the Lead Auditor to show only the nature of the non-conformance and its level of importance i.e. Major or minor non-conformance or observation.
Once all CAR’s are completed the Lead Auditor shall convene the Exit Meeting.
The Exit Meeting:
The exit meeting should be attended by the auditors, the MR and the audited management. The names of those present shall be recorded on the Audit Attendance Record.
During the meeting the Lead Auditor shall present an overview of the audit results and provide the findings. The audited shall review the CAR’s raised and shall sign to signify his understanding of the non-conformance and present a copy of each CAR to the audited. The auditor shall inform the audited when the formal audit report shall be issued.
The audited shall be given a set period of time (to be agreed between auditor and audited) to respond to the CAR’s and propose the corrective actions required to rectify the deficiency. He shall also indicate the date by which this action shall be implemented. The Engineering Manager (MR) is responsible for updating the. CAR Logbook
The Audit Report:
The audit report shall be prepared by, or under the direction of, the Lead Auditor who is responsible for its accuracy and completeness.
The report should contain the following information, as applicable:
(i) Area of Audit
(ii) Scope and objectives of the audit
(iii) Details of the audit itinerary or timetable
(iv) Identification of the audit team members
(v) Identification of the audile’s representatives
(vi) The audit Criteria i.e. quality system standard, quality manual, procedures or work instructions
(vii) Record of non-conformances
(viii) The result of the audit
(ix) Audit distribution list ‘
The Audit Report shall be presented in a uniform manner comprising the following:
(i) Covering Letter
(ii) Cover Sheet (Summary Sheet)
(iii) Report Sheets
(iv) CAR’s
The report sheets shall be presented in a uniform manner comprising the following:
(i) The Entry Meeting
(ii) The Audit
(iii) The Exit Meeting
(iv) Follow-Up
The Follow-Up Audit:
The audited is responsible for determining and initiating the necessary Corrective Actions to rectify a deficiency and to rectify the cause of the deficiency.
Corrective Action shall be completed within an agreed timescale and the Lead Auditor and the audited shall agree a time-scale for the follow-up audit to verify the completion of the action.
If satisfied that the deficiency has been corrected the Lead Auditor can close out the CAR. If the deficiency has not been resolved this shall be stated in the follow up section of the CAR and a new CAR shall be issued to address the problem.