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Chapter 13:

Quality audit
Dr. Shyamal Gomes
QUALITY AUDIT: A quality audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and suitable to achieve objectives - (ISO 8402) The Purpose of Audit, which pave the way to continuous Improvement, are to: 1. Establish the adequacy and suitability of the system 2. Determine the effectiveness of the system 3. Afford opportunities for system analysis 4. Aid Problem- solving 5. Facilitate decision making 6. Aid Employee involvement 7. Help in establishing the capability of process and equipment 8. Ensure meeting legal and statutory requirements 9. Aid communication and facilitate Training 10. Obtain a certification (clean and green Who is Auditor? Qualified individuals who have completed training in auditing principles and procedures do auditing. Training Programmes are available from ASQ (American Society for Quality), RAB (Registrar Accreditation Board), and CII (Confederation of Indian Industries). An auditor should be: 1. A good communicator, 2. A good listener 3. Able to focus on the task 4. Able to identify the vital facts from the ocean of data. 5. Honest and Impartial.

Auditing Techniques: Auditing is done by the following ways: 1. Examination of documents 2. Observation of activities 3. Interviews ( personal and group) Examining the documents is the easiest method. The Auditor examines the quality manual to determine that the policies meet the QMS standards. The control of document is also examined. Observation of activities requires a skill for fact-finding is the most difficult method of collecting evidences. The interview process can be made easier by the following procedures: 1. Make the auditee to feel comfortable by starting with an introduction and the purpose of the audit. 2. Listen more and talk less. Allow the auditee to speak about his/ her process. 3. If non conformance is identified, separate the trivial from the vital nonconforming items. 4. Always focus on the system, not on the auditee. 5. Understand that the audit is a fact-finding process and not a fault finding process. 6. Explain the auditee about the nonconformities in a simple language. Make sure that he/she understands what you have said. 7. Use appropriate question types to create an easy feeling and responsive environment. There are various types of questions for auditing which are very much situation and activity based: 1. Open Questions: For example: How often do you review the process? 2. Closed Questions: For example: Do you calibrate this instrument periodically? The answer to this type will be a YES or NO. If too many closed questions are used, the audit may look like an interrogation. 3. Clarifying Questions: For Example: What do you mean by DEAD zone of an Instrument? This type of question is used when more details are required. 4. Leading Questions: For Example, Dont you agree that the excessive scarp in this quarter is due to lack of calibration of the

instruments? Type of question should be definitely avoided, as it leads the auditee to answer in a particular way, which may be misleading and biased. 5. Aggressive Questions: For Example: Dont you think this is your responsibility? This type of question should be definitely avoided, as it is offensive and argumentative.

Audit Procedures: The lead auditor prepares an audit plan and checklist. The Audit plan should contain: 1. 2. 3. 4. 5. Department (s) to be audited Document details Regulatory requirements to be checked Details of the audit team An Audit Schedule

Apart from the audit plan, checklists should also be prepared. Checklist contains the list of questions and the sequence in which they should be asked. Questions are prepared based on the procedures, records, and work instructions to be audited. Basically the audit has three parts: 1. Pre-audit meeting: here the audit schedule is discussed and follow-up actions to be taken based on the previous audits are decided. 2. Audit: During the audit, the auditor checks the conformance of the implemented QMS to the standard. 3. Closing Meeting: At the closing meeting, the lead auditor presents a summary of the audit findings, and an audit report is prepared based on the nonconformance identified and corrective actions proposed.

Types of Quality Audit: There are three types of quality audits: First party (internal), Second party (external) and Third party (extrinsic) audits.

First Party Audit:

This is an audit carried out by a supplier on his / her own system to evaluate its performance. The organizations own personnel, drawn from functions independent of the one being audited conduct the audit. It can also be carried out by an outside agency on behalf of the supplier. Internal audit confirms that the quality management system is working effectively. Second Party Audit: The second party quality audit is performed by the purchasing organization upon the supplier organization. Important point is these audits can be performed by the trained personnel of the purchasing organization or an outside agency hired by them. Third Party Audit: This audit is performed by the certification bodies (ISO registered bodies) on the applicant organization seeking such certification. If these, auditors, after conducting the quality audit on the organization with respect to a standard, find the organization to be worthy enough, the certification is granted to the organization. Apart from the registered certification bodies, the third part audit may also be conducted by some government departments dealing with environment and pollution, health and safety, atomic energy etc.