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Course Title : Total Quality Audit
Assignment Title : Action Learning Project - Individual Project
Name : Foong Liang Ming
Class : TQM ( C )
Name of Instructor : Mr. Tim Alcock
Hand In Date : 13th January 1996
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1.1) The purpose of the audit must be clarified and approved 1.2) The audit plan must be well prepared 1.3) The audit plan and final report must be documented 1.4) Appraisal against standards must be objectives and factual, Objective evidence must be obtained for any non-conformities 1.5) The audit should not unduly interfere with on-going operation 1.6) The frequency of audit should be done according to actual needs 1.7) Working paper and related documents should be kept in proper form and order 1.8) The auditor must follow up or re-audit remedial action 1.9) The auditor must be qualified or trained and independent of the to be audited area ( in the case of internal quality audit )
2) The BS 5750/ISO 9000 schemes was introduced to rationalize all the quality system assessment scheme as a third party audit scheme operated by an independent body which register companies as complying with the BS 5750/ISO 9000 standards. In addition, adopting ISO 9000 Quality Standards as an important role for the third party audit has the following benefits :- 2.1) ISO 9000 is an international recognized quality standards. 2.2) A company comply with ISO 9000 entitles the firm to use a special symbol in their company literature, packaging 2.4) Manufacturer can rely on the third party audit on the suppliers who are certified for ISO 9000 and need not conduct his own audit 2.5) Company saves time and money to audit their suppliers especially overseas suppliers. It is also not practical audit all suppliers by themselves.
3.1) Internal Quality Audit also called the First Party Audit is described as " an independent appraisal function established within an organization to examine and evaluate its activities as a service to the organization". 3.2) Since internal quality auditors are employee of the organization, they are the best person to know the "insight" of the operation of the and actual practice of the quality system. Therefore, they can pin-point the inefficient and weakness of the quality systems of an organization. 3.3) Internal Quality system is also used as an important program in the company to arose the awareness of the quality system during the preparation of the quality audit. It also can serve as a platform to educate employees on the importance of the quality system and its compliance. 3.4) From the result of the quality audit, any non- conformance of the quality system will be used to an organization to for further reinforcement and improvement of the quality system 3.5) Regular and effective Internal Quality Audit can help to achieve and maintain second or third party audit registration. 3.6) Internal quality audit can also help the auditors to understand an organization in a wider perspective and provide suggestion for improvement.
4) Some of the qualification criteria for assessing a potential candidates are :- ( Reference ISO 10011-2 Part 2 ) 4.1) Auditor should have completed at least secondary education 4.2) Candidate can demonstrate competence in clearly and fluently expressing concepts and ideas orally and in writing in their officially recognized language 4.3) Candidate should have undergone training to be competence in the skill and managing an audit. ( or otherwise training will be provided ) 4.4) Have knowledge and understanding of the standards 4.5) Candidate should have assessment techniques of examining questioning evaluating and reporting 4.6) Candidates should have some experience in quality auditing 4.7) Candidate should be open minded and mature 4.8) Candidate should posses sound judgment , analytical skill and tenacity 4.9) Candidate should be able to perceive situation in a realistic way
5.1) The objective of an external quality audit such as supplier audit , are :- 5.1.1) Internal QA Standards requirement 5.1.2) Improving quality of a supplier for the vendor development program 5.1.3) Selecting and evaluating new or existing suppliers 5.1.4) Increase quality awareness of suppliers 5.1.5) Help implementing quality system for suppliers 5.2) An external audit would comprise an overall audit program, individual company audit and element to be assessed during each audit is to ensure a systematic and consistency in each audit. It can be treated as a standards for an organization to be adopted to asses its suppliers to achieve the desired quality standards |
6) Audit Function Deployment to include typical functions according ISO 9001 : 1994 are illustrated in the table below :-
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Quality System | |||||
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Management |
Marketing |
Design |
Purchasing |
Production |
Quality |
- verification resources - management representative - management review |
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Development & Planning Organizational Technical interface Design Input Design Output Design Review Verification Validation Design Changes Document Control - Approval - Issue - Changes |
- corrective action |
- record - inspection status |
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7) Other purpose of the quality audit are :- 7.1) To determine the effectiveness of the implemented quality system in meeting specified quality objectives. 7.2) To provide the auditee an opportunity to identify weakness and improve the quality system ( in the case of internal quality audit ) 7.3) To report to the management the effectiveness of the quality system 7.4) To provide an opportunity to assess the suitability and effectiveness of a process in totality for strength and weakness for continuous process improvement ( in the case of process audit ) 7.5) To "benchmark" good practices in one department for other department to follow ( in the case of internal audit )
8.1) The Lead auditor is responsible for the preparation of the audit report. However, each auditor is responsible to provide an report of his audited area. 8.2) The audit report should faithfully reflect both the tone and content of the audit. It should be dated and signed by the lead auditor. It should contain the following elements as applicable :- 8.2.1) The scope and objective of the audit 8.2.2) details of the audit plan, the identification of the audit team members and auditee's representative, audit dates and identification of the specific organization audited 8.2.3) identification of the reference documents against the audit conducted ( quality system standards e.g. ISO 9000 , auditee's quality manual, procedures and work instructions etc 8.2.4) audit team's judgment of the extent of the auditee's compliance with the applicable quality system standard and related documentation 8.2.5) the system's ability to achieve defined quality objectives 8.2.6) the audit report distribution list 8.3) Audit report containing confidential or proprietary information shall be suitably safeguarded by the auditing organization. (Reference ISO 10011-1 Part 1 ) |