Quality audit is one of the key management tools for achieving the objectives set out in order to verify that the individual elements within a quality system are implemented effectively and suitable in achieving stated quality objectives. The quality system audit also provides objective evidence concerning the need for the reduction, elimination and most importantly, prevention of non-conformities. The results of these audits can be used by management for improving the performance of the organisation. Quality ISO Audit As per ISO: 8402, Quality Audit is defined as - "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 are suitable to achieve the objectives". The quality audit can be carried out by: - (A) Companies own staff or outside consultant called the company, to give confidence to the management that the system is properly implemented. (B) Customers who are or wish to enter into business with company or their representatives and (C) Independent accredited body, for certification (called third party audit) Types of Internal ISO Audit:- System Audits are divided into three categories: (1) FIRST PARTY AUDIT:- This is an audit, which is undertaken by an organisation on its own quality system in order to assess if personnel are complying with the company procedures and maintaining the appropriate records. (2) SECOND PARTY AUDIT:- A second party audit is one, which is conducted on a company by the customer. This is usually against the criteria of the contract and any supporting quality system standards. These could be customer derived standards or international standards such as the ISO series. (3) THIRD PARTY AUDIT:- A third party audit is one that is carried out by an independent organisation i.e. they are not involved within the company or a representative of the customer. Third party audits are carried out by accredited certification bodies such as KPMG, BVQI, TUV, BSI, Lloyds Register of Quality Assurance, SGS, ICS, NQA, etc as part of the assessment of the quality management system of an organisation prior to registration. Many people are confused by the difference use of the terms 'audits' and 'assessment' although these activities appear to be identical. ISO 8402: 1986 Quality vocabulary - International Terms defines a 'quality audit' as: "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 are suitable to achieve objectives". The Term 'assessment' has no such formal definition within ISO 8402; although through industry custom and practice it is frequently used to describe the activities carried out by a Certification Body when verifying an organisation's compliance with a quality management system standard such as ISO 9000 prior to initial registration. Internal Quality Audit Process: - This is an audit carried out by a company on its own quality systems for the purpose of giving assurance to the management that its quality systems are effectively achieving the planned quality objectives. The internal quality audit also known as self-audit is a major component of the quality system. These audits can increase the confidence of management in its production system & demonstrate to its personnel that the company is committed to quality management. Internal quality audit can be carried out by the organisations own staff, provided they are independent of the systems being audited or by outside consultants. The steps involved in internal quality audit are: - (A) Audit Initiation. (B) Audit Preparation. (C) Audit Execution & Audit Report. Scope of Audit: - One should determine the scope of audit based on one's own needs & make the final decision as to which quality system elements, departments & organisational activities are to be audited & within what time frame. The particular department /section /activity to be audited should be functional & not shutdown/discontinued during the period the audit is to be carried out. To decide whether or not an audit of any activity, department etc. is required following points should be considered: - (A) Audits should preferably be carried out when they are most effective, such as, in the early or late stages of implementing the contract rather than in the mid stream. (B) Internal audits should be carried out also when there is a possibility of an external audit such as by a certifying body, or by a customer or his representative. (C) Audit of a particular area becomes necessary also when there is customer complaint Relevant to the work of that area. (D) Audit is needed also when the quality of product is not meeting the specified requirements. Frequency of Audit: - Factors to be considered for deciding audit frequency are: - (A) Implementation phases of the quality system. (B) The schedules as specified in the quality manual of the company. (C) Significant changes in management, organisation, policy,echniques or technologies that. could affect the operating of the quality system. (D) Changes to the system itself. (E) Results of recent previous audits. (F) Status and importance of the activity/department. Audit Plan:- The audit plan should be designed to be flexible in order to permit changes in emphasis (on the basis of information gathered during the audit) & to permit effective use of resources. The plan should answer the following. (A.) Which sections/departments of the companies are to be audited? (B.) What activities will be audited? (C.) Who is responsible for the audited activity? (D.) Who are the team members responsible for carrying out the audit? (E.) Date when the audit will be started? (F.) What is the expected time duration for each major audit activity? System Effectivenes:- The System Effectiveness is reported to convey informed judgement of the Lead Assessor in the Third Party Audit. As a minimum, the following need to be considered while reporting System Effectiveness. (A) To what extent has the documented Quality System addresses the requirements of the Standards. (B) To what extent has the documented system been put into practice? (C) To what extent is the system in practice effective. (D) Do the non-conformances raised indicate a particular areas(s) of the supplier's organisation Is (are) weak? (E) Do the non-conformances raised indicate a particular management system(s) Requirements(s) is (are) weak? (F) The area where greatest risk & least assurance lie in the Quality System implemented by the Supplier. (G) Kinds of failures found & there relative frequency. Check List for Guides:- (A) Have a final check of your area just before the Assessor's arrival. (B) Know your departmental procedures. (C) Know the Assessment Programme. (D) Know your Assessor. (E) Be punctual. (F) Be factual. (G) Do not argue with or hustle the Assessor. (H) Keep the Assessment Co-ordinator and line management fully briefed. Final Area Check:- (A) All absolute documents are removed. (B) All unidentified materials & components are disposed (C) Calibration status is maintained on all equipments. (D) Proper identification marks are present on intermediate & final products. (E) Record files are maintained up-to-date & are easily traceable. (F) Work instructions, quality samples, etc. are at proper places at all workstations. (G) Inspection status of the products are clearly identified (H) Make sure that objective evidence is readily available of compliance with standard Procedures. (I) Copy of assessment programme is received by him & he has identified the designated areas & time of escorting. (J) He should ensure that all the key members of the relevant department would be available During the audit, when required. (K) He is punctual during the audit for all appointments & the external auditor is introduced to The senior departmental personnel. (L) He should not supply non-compliances to the auditors. (M) If question asked by the auditor is not within employee's job knowledge, the auditor is Tactfully advised of the fact. Moreover, the guide should know the work of each employee of the department to whom he is escorting the auditor. He should answer the auditor's questions briefly, courteously & truthfully. He should not argue with the auditor or allow himself to be provoked. 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