TNI 2016 – Internal Audits BACWA Lab Committee ~ August 8, 2018

V1M2 3.1 - Definition Audit: A systematic and independent examination of facilities, equipment, personnel, training, procedures, record keeping, data validation, data management, and reporting aspects of a system to determine whether QA/QC and technical activities are being conducted as planned and whether these activities will effectively achieve quality objectives. Could almost group your audits up by the categories they specify here, facilities, equipment, etc.

V1M2 4.14 - Internal Audits The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and this standard. The internal audit program shall address all elements of the management system, including testing/calibration activities. It is the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management. Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited. Underlined items throughout presentation are Diane Lawver’s highlights. The takeaway here for me is that auditing must be scheduled and the schedule followed, all elements of the management system must be audited annually but not every technical procedure. Training and proof of qualifications must be provided for the auditor(s).

V1M2 4.14 - Internal Audits 4.14.2: When audit findings cast doubt on the effectiveness of operations or on the correctness or validity of lab’s results, the lab shall take timely corrective action and shall notify customers in writing if investigations show results may have been affected. Would an email suffice? The timing of the corrective action is noted by TNI assessors.

V1M2 4.14 - Internal Audits 4.14.3: Area of activity audited, audit findings, and corrective actions that arise shall be recorded. 4.14.4: Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken. Everything must be recorded, no surprise. So according to 4.14.3 and 4.14.4, you perform your audit, note findings and perform corrective actions, then perform follow-up audits that focus on the corrective actions?

V1M2 4.14 - Internal Audits 4.14.5: Additional Items The lab shall have a policy that specifies the time frame for notifying a client of events that cast doubt on the validity of the results. Lab management shall ensure that these actions happen w/in the agreed time frame. The internal audit schedule shall be completed annually. Again, email? Can we determine what an appropriate time frame is? A month? Regarding the last bullet, it looks like they are assuming you will split auditing up throughout the year, and that all QS items must be covered within a calendar year.

V1M2 4.1.7.1 The laboratory’s quality manager and/or designee(s) shall: Arrange for or conduct internal audits as per Section 4.14 annually. Diane: Internal audits can be delegated to qualified staff Set your “qualified” criteria so that most of your staff can perform audits. How about a training record of having reviewed the TNI Standard, CWEA certification, TNI webinars/seminars?

V1M2 4.2.8.4 p) The quality manual shall contain or reference: Procedure for audits and data review.

V1M2 4.10 The laboratory shall continually improve… through the use of… audit results. Diane: Assessors look for how a lab uses audit results to improve the management system. Audit-corrective action-audit-change to management system.

V1M2 4.11.5 Where the identification of nonconformities or departures casts doubts on the lab’s compliance with its own policies/procedures, or compliance with TNI, the lab shall ensure that the appropriate areas of activity are audited in accordance w/ 4.14 ASAP. Diane: Must record results of audit. Assessors look at timeframe. More about how corrective actions relate to audits, again note the reference to timeframe.

V1M2 4.11.5 - Continued Note: Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An additional audit should be necessary only when a serious issue or risk to the business is identified. Looks like there is some leeway granted.

Resources TNI Small Lab Handbook: Generally the same info covered here, some small clarifications. TNI Standard Interpretations: Only 1 for 4.14 - not every method needs to be audited annually. All aspects of the QS do. TNI Blank QS Checklist Virginia Audit Checklists We received the TNI checklist and Virginia checklists from Diane.