CHECK LIST The purpose of any quality audit is to “To collect audit evidence, to permit an informed judgment about the status of the selected aspects of the QMS of the organisation”. Therefore by definition, audit is a sample check. The degree of confidence that can be placed on the findings of the quality audits, depends upon the quality of the samples drawn. To make the samples as representative as possible, auditors have to decide the salient elements of the system, which would be verified during the audit. They have also to decide the depth of verification of the selective elements. Checklist helps the auditor to take judicious decisions in this regard.
BENEFITS OF CHECKLISTS <ul><li>BENEFITS OF CHECKLISTS </li></ul><ul><li>Keeps the audit objective clear </li></ul><ul><li>It shows the professionalism of the auditor, by providing evidence </li></ul><ul><li>of planning </li></ul><ul><li>It helps the auditor maintain audit pace and continuity by </li></ul><ul><li>sequencing the areas / activities to be audit in a logical order and in </li></ul><ul><li>the defined timeframe </li></ul><ul><li>Although it is impossible to eliminate, but checklist helps to </li></ul><ul><li>reduce auditors bias, the tendency to dig- in and continue to audit </li></ul><ul><li>till deficiency is found </li></ul><ul><li>Reduces work load during audit. Auditor does not have to think what </li></ul><ul><li>to do next and where, and what notes to make </li></ul><ul><li>Record audit sample </li></ul>
ADEQUACY AUDIT An organisation implements a QMS to achieve it’s policy and objectives, as well as, to obtain certification to use it as a marketing tool. Therefore while preparing checklist for adequacy audit (documentation reviews) following two main purposes of adequacy audit should be kept in view: a. Does the documentation address every requirement in the standard, as to how it shall be achieved by the organisation? b. What is the likelihood of the QMS implementation achieving the policy and objectives of the organisation?
<ul><li>In addition to above a following issues also need to be considered </li></ul><ul><li> </li></ul><ul><li>Have all processes been identified and their interrelationships </li></ul><ul><li>established? </li></ul><ul><li> Have all the mandatory procedures as required by the standard being </li></ul><ul><li>documented in the manual, or reference has been made in to them? </li></ul><ul><li> Does the manual contain a list of mandatory records or make a </li></ul><ul><li>reference to them? </li></ul><ul><li> Are procedures in line with the stated policy and objectives? </li></ul><ul><li> Are the documents self exploratory giving a clear picture of the </li></ul><ul><li>activities to be performed if any abbreviation or terms are used </li></ul><ul><li>to which are not commonly understood, have definitions and </li></ul><ul><li>expanded meaning of terms given? </li></ul><ul><li> Have responsibility and authority of all persons whose work </li></ul><ul><li>affect product quality been adequately defined in the manual / </li></ul><ul><li>procedures / process maps / work instructions? </li></ul>
While carrying out adequacy audit of a procedure, try to find answer to the following questions, if they exist, the procedure or work instruction is a comprehensive one. Who is responsible for the process / procedure / activity? What is required to be done? activity properly defined? How activities should be performed? Work instructions reference, if required? When or by what time activities should be completed? Why the activity is being performed? Does it contribute to the achievement of the objective?
Check List PURCHASE ISO 9001 : 2000 S.N Audit Elements Clause Ref. Time Mints 1 2 3 Ask for overview of purchasing and supplier control process Responsibility / Authority clearly defined a. Interrelationship of process with other organisational process b. Adequacy and timely receipt of indent and other inputs c. Interface with goods receiving 7.4 5.5.1 4.1 b 35 4 5 How are these processes controlled e.g. procedures, specifications, contract requirement Is there any Quality Objective ? If so Achievement Vs Targets 4.1 c 5.4.1 / 8.1 25
6 7 How are process measured ? Compliance to procedures Review process and product monitoring results, check if requirements are being met 8.2.3 8.2.3 / 8.2.4 30 8 9 10 Sample purchase requisitions Have suppliers been evaluated ? check records Is purchasing information clear ? How is staff Trained ? evidence of Competency Evidence of continual improvement 7.4.1 7.4.2 6.2 8.5 30