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Audit handling
- 1. 02-07-2019 1 HOW TO FACE AUDITS
- 3. TYPES OF AUDIT: 3 Internal Audits • Performed within an organization • Also known as Self Audits • Internal audit conducted by auditors who are employed by the organization being audited. 2nd party audits • External audit performed on a Vendor by a Customer • Second-party audits are subject to the boundaries of contract law such as defined scope, criteria, inclusions and exclusions. • Outcome of audit influences the Customer’s purchasing decision 3rd party audits • Performed by an audit organization independent of the Customer-Vendor relationship • Third-party audits may result in certification, registration, recognition, an award, license approval, a citation, a fine, or a penalty issued by the third- party organization or an interested party
- 4. TYPES OF AUDIT: 3RD PARTY AUDITS 4 Type 1 • Mutually acceptable to Customer and Vendor • E.g.: ISO certifications Type 2 • Driven by Organization for their own benefit • E.g.: Class A and EXCiPACT certifications
- 5. DIFFERENCE BETWEEN ASSESSMENT AND AUDIT Assessment Only done 1st time No rating is given after the assessment (pass/ fail criteria not present) When Customer wants to go for the business but not without assessing Vendor and providing direction for improvement Audit Performed routinely Rating is given to the Vendor after audit (A/ B/ C) Audit is to compare against a specific standard, and find specific gaps that should be corrected. 5
- 7. FLOW OF AUDIT PROCESS 7 Audit Planning and Scheduling Arrival of audit team on site Audit observations report sent Receive CAPA Close audit Follow Up
- 11. ROLES OF PERSONNEL IN AN AUDIT 11
- 12. 1. AUDIT COORDINATOR •Central Audit Coordinator: • Confirms audit date, agenda and scheduling (Divya – Global Quality Assurance) • Arranges for auditor details, auditor travel and stay (Sales Representative – Domestic/ Export) •Site Audit Coordinator • Interprets auditor needs • Informs the site on where the auditor is going next • Shadows the auditor • Admin team member 12
- 13. • The person who will be accompanying the auditor during the entire audit • Need not be more than 1 or 2 people • Admin personnel till the presentation room and then QA for the entire plant detail • If from QA, not plant QA head. Coz this represents the line of defense. 13 2. ESCORT
- 14. 3. SCRIBE 14 Records each and every detail asked by the auditor Interprets what might be asked next Informs to the Runner on the details and records asked by the auditor
- 15. 4. RUNNERS •Runner is responsible to take requests for documents from the Scribes to the respective persons 15
- 16. 02-07-2019 16 HOW TO HANDLE AUDITS
- 17. 1. LISTEN AND THEN RESPOND • Listen to their full question and do not interrupt. Wait till the question is completed. • Ask to repeat if the question is not understood • Answer only the question asked (and no more). • If you don’t know the answer, don’t guess. 17
- 18. 1. LISTEN AND THEN RESPOND 18 Do not irritate the auditor with irrelevant answers!
- 19. 19 WOCKHARDT 483 DR. REDDY’S 483 MISLEADING THE AUDITORS OR WASTING THE AUDITOR’S TIME IS A NON-CONFORMANCE IN ITSELF 1. LISTEN AND THEN RESPOND
- 20. 1. LISTEN AND THEN RESPOND 20 Answer only to the point
- 21. 2. CORRECT BODY LANGUAGE – BODY POSTURE 21
- 22. 2. CORRECT BODY LANGUAGE – BODY POSTURE 22
- 23. 2. CORRECT BODY LANGUAGE – EYE CONTACT 23 What do you think when you see this?
- 24. 24 What do you think when you see this? 2. CORRECT BODY LANGUAGE – EYE CONTACT
- 25. 25 What do you think when you see this? 2. CORRECT BODY LANGUAGE – EYE CONTACT
- 26. •Maintain eye contact •But avoid staring as you might make them uncomfortable •Maintaining low level of eye contact or wandering eyes indicates you are either lying or not confident 26 2. CORRECT BODY LANGUAGE – EYE CONTACT
- 27. 2. CORRECT BODY LANGUAGE – HEAD NOD 27 YES? NO?or
- 28. •Do not just nod your head. •Makes unclear communication about what is to be conveyed •It is best to keep all communication verbal and clear. 28 2. CORRECT BODY LANGUAGE – HEAD NOD
- 29. 3. LANGUAGE What do you think this means? 29
- 30. • Do not talk in a language that is not understood by the auditor • Do not whisper • Both these signify hiding of information • Do not have a group discussing the correct answer. Do not answer all at once. • If it is not your area, do not answer. Point out the correct person. Let the right person talk 30 3. LANGUAGE
- 31. •DO NOT FEAR. •BUT DO NOT HIDE THE TRUTH. •DO NOT LIE. 31 3. LANGUAGE
Editor's Notes
- Internal & external audits: first-, second-, and third-party audits A first-party audit is performed within an organization to measure its strengths and weaknesses against its own procedures or methods and/or against external standards adopted by (voluntary) or imposed on (mandatory) the organization. A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited. A second-party audit is an external audit performed on a Vendor by a Customer or by a contracted organization on behalf of a Customer. A contract is in place, and the goods or services are being, or will be, delivered. Second-party audits are subject to the rules of contract law, as they are providing contractual direction from the Customer to the Vendor. Second-party audits tend to be more formal than first-party audits because audit results could influence the Customer’s purchasing decisions. A third-party audit is performed by an audit organization independent of the Customer-Vendor relationship and is free of any conflict of interest. Independence of the audit organization is a key component of a third-party audit. Third-party audits may result in certification, registration, recognition, an award, license approval, a citation, a fine, or a penalty issued by the third-party organization or an interested party. 3 Types of audits Product audit – An examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards, and Customer requirements). Process audit – A verification that processes are working within established limits. It evaluates an operation or method against predetermined instructions or standards to measure conformance to these standards and the effectiveness of the instructions. Such an audit may: Check conformance to defined requirements such as time, accuracy, temperature, pressure, composition, responsiveness, amperage, and component mixture. Examine the resources (equipment, materials, people) applied to transform the inputs into outputs, the environment, the methods (procedures, instructions) followed, and the measures collected to determine process performance. Check the adequacy and effectiveness of the process controls established by procedures, work instructions, flowcharts, and training and process specifications. System audit – An audit conducted on a management system. It can be described as a documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the system are appropriate and effective and have been developed, documented, and implemented in accordance and in conjunction with specified requirements. A quality management system audit evaluates an existing quality program to determine its conformance to company policies, contract commitments, and regulatory requirements. Similarly, an environmental system audit examines an environmental management system, a food safety system audit examines a food safety management system, and safety system audits examine the safety management system.
- Internal & external audits: first-, second-, and third-party audits A first-party audit is performed within an organization to measure its strengths and weaknesses against its own procedures or methods and/or against external standards adopted by (voluntary) or imposed on (mandatory) the organization. A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited. A second-party audit is an external audit performed on a Vendor by a Customer or by a contracted organization on behalf of a Customer. A contract is in place, and the goods or services are being, or will be, delivered. Second-party audits are subject to the rules of contract law, as they are providing contractual direction from the Customer to the Vendor. Second-party audits tend to be more formal than first-party audits because audit results could influence the Customer’s purchasing decisions. A third-party audit is performed by an audit organization independent of the Customer-Vendor relationship and is free of any conflict of interest. Independence of the audit organization is a key component of a third-party audit. Third-party audits may result in certification, registration, recognition, an award, license approval, a citation, a fine, or a penalty issued by the third-party organization or an interested party. 3 Types of audits Product audit – An examination of a particular product or service (hardware, processed material, software) to evaluate whether it conforms to requirements (that is, specifications, performance standards, and Customer requirements). Process audit – A verification that processes are working within established limits. It evaluates an operation or method against predetermined instructions or standards to measure conformance to these standards and the effectiveness of the instructions. Such an audit may: Check conformance to defined requirements such as time, accuracy, temperature, pressure, composition, responsiveness, amperage, and component mixture. Examine the resources (equipment, materials, people) applied to transform the inputs into outputs, the environment, the methods (procedures, instructions) followed, and the measures collected to determine process performance. Check the adequacy and effectiveness of the process controls established by procedures, work instructions, flowcharts, and training and process specifications. System audit – An audit conducted on a management system. It can be described as a documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the system are appropriate and effective and have been developed, documented, and implemented in accordance and in conjunction with specified requirements. A quality management system audit evaluates an existing quality program to determine its conformance to company policies, contract commitments, and regulatory requirements. Similarly, an environmental system audit examines an environmental management system, a food safety system audit examines a food safety management system, and safety system audits examine the safety management system.
- Assessment Eg: If you want to buy a plant somewhere, you cannot fail it. So you assess it to understand the level of the plant and get it to your standards.
- These kinds of roles and responsibilities are used for successful regulatory audits Every organization is different and hence might have a different approach towards handling audits Today, everyone would be doing this, but not acknowledging it We don’t want to distract/ disturb what’s going on. What we can do it, look at it and see if this is useful and if we can improve or not. If everything is already equipped, then great; If not, we got you. :P
- The site audit coordinator shall convene an opening meeting with the Inspector to discuss the purpose and scope of the Inspection and shall introduce the head of departments and the Inspection support team to the Inspector(s) after welcoming the Inspector. The site audit coordinator may then either make a presentation or present hard copies of documents giving a short description of the site as per details given in Section 6.1.7 The site audit coordinator may brief the Inspector about the company policies regarding shift timings, area restrictions (if any), cafeteria facilities, general restrictions (if any), etc. so that he may plan his Inspection itinerary accordingly
- Scribes’ must make notes of the inspection proceedings including (but not limited to) the Inspector’s questions, responses given to the Inspector’s questions, documents presented to the Inspector, participant details, etc. These may be noted in notebooks or formats. They must also make a list of the documents requested by the Inspector. These document requests are to be handed over to the ‘runner’.
- Auditors understand when anyone tries to take them for a round. It can also be considered as an NC if you give irrelevant answers. It indicates that you to do not know your topic.
- Senior managent – Email are subject to audit (regulators) – diaries/ drawers etc. Dustbin/ drawers should be cleam. People need to answer. Not their managers.
- Auditors are trained to learn the local language.
- Treat all auditors same. Treat auditors very well and with respect. This includes internal auditors. More points – more chances at improvement. Just because auditor is saying, don’t accept point blank. It is important to defend your systems. If the auditor still persists, take the point and explain it in justifications. If there are grey areas that you know is a problem, show that there is an action