Quality Audits, and How to Survive them

Types of Audits First Party Internal audits of the Quality Management System and Processes, performed by trained Internal Auditors Second Party External or Extrinsic Audits performed between Customers and Suppliers. Usually performed by trained Auditors from the Organisation Third Party Extrinsic Audits performed on the Company’s Quality System and Processes by independent bodies, eg. Notified Body Audits for ISO 13485, performed by Independent Auditors

First Party Audits Purpose Investigate the effectiveness of the Company’s Quality Management System and it’s processes Identify opportunities for improvement Evaluate training needs Ensure compliance with standards and regulations Auditor? Trained Internal Auditor, independent of process being audited

First Party Audits What will be audited? Procedures and activities related to the process being audited eg. purchasing, Goods-In Inspection. Audit Report / Outcome A written report detailing positive findings, non-conformances, observations and the audit score, together with an Action Plan. - Non-conformances are issues that breach the associated standard, and are split into major and minor. - Observations are issues that could lead to a non-conformance, or serve as recommendations for improvement

Second Party Audits Purpose Investigate the effectiveness of Supplier’s Quality Management Systems to establish suitability for supply of components or services, and ensure ongoing assessment of existing Suppliers Auditor? Usually a Trained Internal Auditor

Second Party Audits What will be audited? The Organisations Quality Management System for compliance with specified standards and regulations, or specific areas of interest. Audit Report / Outcome A written report detailing positive findings, non-conformances, observations and the audit score.

Third Party Audits Purpose Internal audit of the Quality Management System and all associated processes to ensure ongoing effectiveness and compliance with specified standards. Auditor? An independent Trained Auditor

Third Party Audits What will be audited? The Organisations Quality Management System for compliance with specified standards and regulations. Audit Report / Outcome A written report detailing positive findings, non-conformances and observations. Recommendation for certification to selected quality standard (hopefully!) Continued certification to specified quality standard/s and regulations (double hopefully!)

How are Audits arranged and performed? Audits are performed to an audit schedule: First Party Audits – Every process to be audited within a 12 month period Second Party Audits – To be performed on all critical component Suppliers Third Party Audits – Once certified, surveillance audits every 6 months

What do the Auditors look for? Are processes documented? Are processes implemented? - Do relevant persons know and understand their process? Do you comply with process requirements? Are the processes effective? Are the processes continually improving?

What is expected of the Employees? Know you processes and product requirements Know exactly what to do and how Understand your role in the QMS Help correct process and product problems? Help improve the processes and the QMS Know and understand the Quality Policy and Objectives Ask, if you’re not sure……….

Auditor Requirements Ethical Professional Fair and patient Assertive but not aggressive Enquiring but not gullible Co-operative but not compromising Persuasive, not abrasive Thick skinned and resilient

Auditee Requirements Guidance for Auditees When being audited: - Be honest, open and cooperative Ask the auditor to explain if you’re not sure what they require. Only answer the questions being asked - name, rank and number! Don’t draw attention to problems - but don’t try to hide them Don’t blame others Be truthful - once credibility is in doubt . . . Prepare in advance - check your documentation, etc. If you don’t know, say so - but add that you will find out If you disagree with the Auditors findings, ask for clarification

Auditor Questions What do you do when you start a new job? How do you check your work, and how often? Do you record the inspection results? Where is this process written down and Can you show me? What do you do when you find something is wrong? Can you explain your company’s quality policy? Do you know the objectives for your process? Are these objectives measured? Can you show me? How do you know that your measuring tool is calibrated? What happens if you’re not here, who is your deputy? Are you involved with correcting problems? etc…..

How to answer the Auditors Questions Be polite and honest. Answer only the questions that are asked. Do not volunteer information. Never lie!! Answer directly and with confidence. It’s OK to ask for clarification. It’s OK to say: “I don’t know.” It’s OK to say: “That’s not my responsibility” but be prepared to say who is. Remember, the Auditors are not out “to get you.” They are only TESTING the quality system and its processes. You help the Auditor understand how your process works. That’s all!

How not to answer the Auditors Questions DO NOT! Bluff your way out of trouble Lie, you are allowed to not know the answer Waffle, answer only the question asked Argue with the Auditor Provoke the Auditor Bribe the Auditor Sidetrack the Auditor, they almost always remember to go back to things missed and stay on track.

How do you prepare for the audit? Know and follow all your process and product requirements Be able to show the appropriate documents that apply to your job Check your processes and work area - Clean, well-organized, all product identified, calibrations up-to-date, all checks/inspections completed, all “paperwork” correctly filled-out Anything you don’t know? ASK!!!! Be prepared to answer the Auditor’s questions

Audit Process FOUR PHASES an opening meeting / discussion the audit itself completion of an audit report/audit documentation a closing meeting.

Audit Report Details what was seen, and includes reference to documents reviewed. Highlights Non-conformances and Observations, together with proposed actions Should include positive comments relating to the Processes audited. For third party audits will be presented at the Closing Meeting For first and second party audits, will be presented within a fortnight of completion.

Audit Follow-up The reports become the property of the Quality Manager and will be held in the Open Audit file until all actions have been addressed. When all actions have been addressed, the Lead Auditor will verify them, and if acceptable close the audit and place it into the Closed Audit file. If verification shows that the actions have not been effective, new actions will be proposed. Any queries should be directed to the lead auditor.

Are you ready for Quality Audits?