Internal Audits

1. Internal Audits Mohammed Amin, Ph.D. Management Supervisor/QAO Ohio Department of Agriculture 8995 East Main St. Reynoldsburg, OH Tel. (614) 728-2619 amin@agri.ohio.gov

2. Internal Audits - Definition The organization’s own process for monitoring the correct implementation of its own Quality system

3. Organization Ohio Department of Agriculture ADDL CAL Bacteriology Pathology Serology Virology General Chemistry Microbiology Pesticides

4. Quality System All of the elements that contribute to the production of quality goods or services, e.g., • Policies • Procedures • Work Instructions • Training

5. ADDL & CAL Quality System • Tier I – Quality Manual • Tier II – SOPs referenced in Tier I • Tier III – Lab SOPs • Tier IV – Program Specific Quality Manuals • Tier V – Forms and Worksheets • Tier VI – External Documents

6. ADDL/CAL Internal Audits INTERNAL AUDIT SOP • Types of Internal Audits • Selection of Auditors • Planning of Audits • Conducting Audits • Preparing Audit Reports • Non-conformances & Corrective Actions • Audit Responses • Audit Closeout

7. ADDL/CAL Internal Audits • System Audit • Method (SOP) Audit

8. CAL/ADDL Internal Audits System Audit • This includes the audit of the essential requirements of ISO 17025 and AAVLD described in Tier I. • This audit also covers the Tier V and VI documents that are associated with Tier I. • This audit uses ADDL/CAL Form 022

9. CAL/ADDL Internal Audits(ADDL/CAL Form 022)

10. CAL/ADDL Internal Audits Method (SOP) Audit • This includes the audit of critical and unique steps described in Tier II and Tier III documents. • This audit also covers the Tier V and VI documents that are associated with Tier II and Tier III documents. • The QAO and the Supervisor select the SOP(s) to be audited. • During the audit, the auditor checks whether the SOP is followed as described. • The auditor uses ADDL/CAL Form 023 in conjunction with the SOP that is audited.

11. CAL/ADDL Internal Audits

12. Selection of Auditors • The QAO selects the auditor(s)except for the audit of his/her own QS activities • The QAO works with the Lab Director and Supervisor for the selection • The lab Director selects the auditor for auditing QAO’s QS activities

13. Auditor Selection Criteria • The person has laboratory working experience but is not part of the activities that are being audited. • The person has successfully completed ADDL/CAL Quality System training. • The person has training and experience in internal auditing. If the person does not have such training and experience, the QAO trains him/her according to authorized ADDL/CAL training SOP. • The person is available for the audit.

14. Planning the Audit • Audits are scheduled in such a way that each section of ADDL and CAL is audited at least annually for both System and Method audits. • There are four sections in ADDL and three sections in CAL. Management and QA office are to be included in the schedule. • During the 4th quarter of a year, the QAO prepares a schedule for the following year’s audits and distributes it to the Supervisors and Lab Director before the end of the year.

15. Planning the Audit (contd) • Each audit is planned ahead of the scheduled date and copies of the plan are given to appropriate personnel. The plan shall have the following components (ADDL/CAL Form 014): 1) Audit Date(s) 2) Audit Number 3) Name(s) of Auditor(s) 4) Audit Purpose and Scope 5) Audit Participants 6) Audit Documents and Records 7) Technical Expert, if needed 8) Audit Report Distribution List 9) Report issue Date 10) Signatures and Dates

16. OHIO DEPARTMENT OF AGRICULTUREANIMAL DISEASE DIAGNOSTIC LABORATORY & CONSUMER ANALYTICAL LABORATORYINTERNAL AUDIT PLAN Laboratory Section: _____________Audit Date(s): ______________Audit Number: _____________ Type of Audit______________________________________________________________________ (System Audit or SOP Performance Audit) Auditors: __________________________________________________________________________ Lead Auditor:______________________ __________________________________________________________________________________ Note: Use extra pages, if needed. If extra pages are used, make sure to include the reference of the item. See also the “Planning the Audit” section of SOP: ADDL/CAL-QP-008. 1) Audit Purpose: (See “Audit Planning” in SOP: ADDL/CAL-QP-008 for details) 2) Audit Scope: (See “Audit Planning” in SOP: ADDL/CAL-QP-008 for details) 3) Audit Participant(s): (List the names of personnel participating in the audit) 4) Audit Documents and Records: (List the documents and record required during the audit) 5) Technical Experts: (List name(s) of any technical experts, if needed during the audit) 6) Audit Report Distribution List: (List names of personnel that will be receiving the audit report) 7) Audit Issue Date: (Expected issue date of the report) ______________________________________ ____________________ QAO, ADDL/CAL Date ______________________________________ ____________________ Section Supervisor Date

17. Conducting the Audit Opening Meeting • Gather all the major participants and record attendance • Discuss audit scope and objectives • Review the audit plan and schedule • Discuss the audit procedures and techniques used to conduct the audit • Date and time for the closing meeting • Discuss the audit reporting mechanism • Discuss how deficiencies will be handled • Questions/comments from the participants • Meeting adjourns and audit starts

18. Conducting the Audit (contd.) Gathering Information • Use checklist, “ADDL/CAL Form 022” for System Audit • Use checklist, “ADDL/CAL Form 023” along with selected SOPs for Method Performance audits

19. Conducting the Audit (contd.) Gathering Information • Asking Questions • Observing Activities • Examining Facilities • Examining Documents • Examining Records

20. Conducting the Audit (contd.) Closing Meeting • Gather participants – everyone if possible • Review the compliance areas • Review the non-compliance areas • Complete any records • Thank people for their assistance and time

21. Non-conformances # 1 Rule of Auditing If you can not express the non-conformance in the words of the Quality System (policies, procedures, work instructions etc), THEN YOU DO NOT HAVE A NON-CONFORMANCE

22. Non-conformances – contd. Non-conformances shall be written • Clear • Concise • Non-confrontational • Non-blaming • Non-personal

23. Audit Report Audit report format: • Audit Identification 1) An Audit Number 2) Audit Date 3) Lab Section or Program that is audited 4) Name(s) of Auditor(s) 5) Audit Participants • Purpose and Scope • Audit Summary • Previous Audit(s) • Non-conformances • Suggestions (Optional)

24. Audit Report(ADDL/CAL Form 004) OHIO DEPARTMENT OF AGRICULTURE ANIMAL DISEASE DIAGNOSTIC LABORATORY & CONSUMER ANALYTICAL LABORATORY INTERNAL AUDIT REPORT Laboratory Section: ________________Audit Date(s): _______________Audit Number: _____________ Auditors: _________________________________________________________________________________ Type of Audit______________________________________________________________________________ (System Audit or SOP Performance Audit) Lead Auditor: ______________________________ Audit Participant(s): _______________________________________________________________________ _________________________________________________________________________________________ __________________________________________________________________________________________ NOTE: Use extra pages wherever needed. If extra pages are used, make sure to include the reference of the item. See also the “Preparing the Audit Report” section of SOP: ADDL/CAL-QP-008. 1) Audit Purpose and Scope: (see the “Internal Audit Plan”) 2) Audit Summary: (Write a summary of audit performance in different areas covered by the checklist(s)) 3) Non-conformances (Write non-conformances along with the corresponding item numbers from audit Checklists and SOP section numbers, whichever applies.) 4) RFAs: (Write a short summary describing the status of corrective actions for RFAs written since the last audit of this laboratory section. Include RFA numbers.) 5) Previous Audits: (Write a short summary describing the status of corrective actions for non-conformances (if any) since the last audit of this laboratory section. Include audit identifications.) 6) Signature: ______________________________________ Date: ___________ QAO

25. Audit Response From the Lab • Use the appropriate form (ADDL/CAL Form 007) to respond to non-conformances • Write the reason/explanation for non-conformance and provide a plan for corrective action(s) • Follow the appropriate SOP for corrective action(s) (ADDL/CAL-QP-002)

26. Audit Response From the Lab(ADDL/CAL Form 007) OHIO DEPARTMENT OF AGRICULTURE ANIMAL DISEASE DIAGNOSTIC LABORATORY & CONSUMER ANALYTICAL LABORATORY NTERNAL AUDIT REPORT RESPONSE Laboratory Section: ________________Audit Date(s): _______________Audit Number: ___________ Auditors: _____________________________________________________________________________ Type of Audit___________________________________________________________________________ (System Audit or SOP Performance Audit) ______________________________________________________________________________________ NOTE: Use extra pages wherever needed. If extra pages are used, make sure to include the reference of the item. See also the “Audit Follow-up” section of the SOP: ADDL/CAL-QP-008 for details.) Responses to non-conformances: (Write down the checklist item number cited in the Audit Report and then write the reason/explanation for the non-conformance and provide a plan for corrective action with specific deadlines for the corresponding item). 3) Signature _____________________________________________ ___________________ (Type name and designation here) Date

27. Corrective Actions • Conduct root cause investigations for non- conformances • Identify potential corrective actions • Determine the significance and resources • Evaluate possible effects on other elements of the Quality System • Establish a time frame for implementation • Monitor the results of corrective actions • Verify that proposed corrective actions have been effective • Conduct additional audits if the lab is still out of compliance

28. Audit Closeout When all corrective actions are complete, the QAO provides a closeout memorandum to the Lab Director and the Supervisor stating that no further follow-up is required.