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TNI 2016 – Internal Audits

TNI 2016 – Internal Audits. BACWA Lab Committee ~ August 8, 2018. V1M2 3.1 - Definition.

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TNI 2016 – Internal Audits

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

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

  9. 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.

  10. 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.

  11. 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.

  12. 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

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