Standard Operating Procedure for Internal Auditing of the Quality ...

Date: 09th October 2012

Version: 4 Page 1 of 10

Standard Operating Procedure for Internal Auditing of the Quality System (NWORTH 1.03)

Approvals Principal Author Name: D. Skelhorn

Signature: D. Skelhorn

Date:09-Oct-2012

Quality Assurance Officer Name: p.p. T.H. Roberts

Signature: T.H. Roberts

Date:11-Oct-2012

NWORTH Director Name: R.T. Woods

Signature: R.T. Woods

Date: 11-Dec-2012

North Wales Organisation for Randomised Trials in Health (& Social Care) (NWORTH) Institute of Medical & Social Care Research (IMSCaR) Y Wern, Holyhead Road, Bangor University, Bangor, Gwynedd, LL57 2PZ Telephone: 01248 388095

Email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

Version 4 Page 2 of 10

DOCUMENT HISTORY Version Effective Authorship number date

Summary of changes

1

N/A

New

2

16/10/09

3

23/10/10

4

12/12/12

S. Westley, C. Bray, M. Jones D. Skelhorn, M. Williams D. Skelhorn, M. Williams D. Skelhorn, M. Williams

New SOP numbering and layout, procedure completely rewritten. Appendix 3 Corrective action request form added and referenced in section 5 ‘where possible’ added to section 5, SOP references updated, table of contents updated

1. Table of Contents 1. Table of Contents ................................................................................................................. 2 2. Purpose................................................................................................................................. 3 3. Scope .................................................................................................................................... 3 4. Responsibilities .................................................................................................................... 3 5. Procedure ............................................................................................................................. 3 5.1 Procedure Flow Chart ........................................................................................................ 4 5.2 The audit ............................................................................................................................ 5 5.3 Corrective action ................................................................................................................ 5 5.4 Corrective action review/ follow up................................................................................... 6 6. Training plan for SOP implementation ................................................................................ 6 7. Glossary of Terms ................................................................................................................ 7 8. References ............................................................................................................................ 7 9. Referenced SOPs ................................................................................................................. 7 10. Appendices ......................................................................................................................... 7 Appendix 1: Audit checklist ................................................................................................... 8 Appendix 2: Example of audit report...................................................................................... 9 Appendix 3: Corrective Action Request .............................................................................. 10

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

Version 4 Page 3 of 10

2. Purpose This SOP describes the internal audit process for the quality system, which takes place on a planned basis over the course of a year.

3. Scope The internal audits will inspect actual practice against the requirements of the SOPs. Each auditor or audit team will prepare an audit checklist of the area to be covered. Corrective actions may be raised following an internal or regulatory audit where non-conformances have been observed. This SOP does not cover monitoring of clinical trials (for monitoring see NWORTH 3.07)

4. Responsibilities Quality Assurance officer is responsible for:  Organising internal quality audits. He / she will appoint a person or team to carry out each audit. The lead auditor will be independent of the area being audited.  Ensuring that corrective actions are closed out in a timely fashion, within determined close-out dates whenever possible, this is a joint responsibility with the representative of the area being audited. Auditor/audit team is responsible for:  Arranging a suitable time for the audit with the representative.  Reviewing the SOP and from this developing an audit checklist.  Completing the audit and audit report. Representative is responsible for:  Cooperating with the internal auditor.  Progress corrective actions to completeness. NWORTH team is responsible where required to cooperate with the internal auditor. NWORTH Trials Unit Manager has the responsibility of acting as facilitator, if the appropriate corrective action cannot be agreed between the auditor and the auditees’ representative.

5. Procedure The Quality Assurance officer will prepare and circulate the audit timetable for the forthcoming year to NWORTH staff. The timetable will be approved at the NWORTH meeting. Adherence to all SOP requirements will be subject to audit at least once during a 12 month period where possible.

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

5.1

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Procedure Flow Chart Audit timetable developed Auditor(s) assigned Audit preparation Conduct audit Report audit findings

Corrective action(s) identified?

Yes

No

Corrective action(s) agreed & audit report completed Follow up corrective action(s)

Audit report completed Corrective action completed?

No

?

Yes Corrective action closed out

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

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5.2 The audit 5.2.1

5.2.2 5.2.3 5.2.4 5.2.5

5.2.6

5.2.7

The auditor or audit teams, appointed by the Quality Assurance officer, are responsible for making arrangements with the appropriate auditees’ representative in the area to be audited. The auditor(s) will prepare an audit checklist based on the SOP to be audited (see appendix 1). Any findings from previous audits on that area will be reviewed to follow up any observations and outstanding corrective actions. Findings, positive and negative are recorded by the auditors during the audit, on the audit checklist, which is dated to ensure traceability to the audit. The audit findings will be discussed with the representative at the end of the audit to ensure the auditor and representative are in agreement with the auditors findings. At the conclusion of the audit, an audit report (example layout appendix 2) will be completed and will include corrective action raised during the audit and corrective actions followed up from previous audits, as well as any observations noted. A non-conformance should be categorised as one of the following: critical, major or minor. The audit report and the corrective action request should be completed and returned to QA within 1 month of the audit. It will be circulated to the auditees’ representative and the Trial Unit Manager. If any of the findings are related to a clinical trial(s) the relevant CI will receive a copy of the report.

5.3 Corrective action 5.3.1 If non-conformances have been noted and agreed during an internal audit, the auditor will reference them in the audit report, the auditor will raise a Corrective Action Request (Appendix 3) and complete section 1 of the form for each non-conformance, after requesting a Corrective Action Request number from the Quality Assurance Function. Section 2 will be completed by the representative (auditee). The agreed action date should take into account the severity of the non-conformance and the time needed to complete the corrective action. The auditor must assign a date to follow up the corrective action. The corrective action request is signed by the auditor and the auditee 5.3.2 The auditor should assign a date to follow up the corrective action. 5.3.3 The non-conformances are categorised as:

Critical

Non-conformances which constitute a breach in GCP or noncompliance with regulatory requirements or are a combination of major non-conformances which indicates a critical system failure. This type of deficiency must be corrected as the highest priority.



Major

Non-conformances which could potentially lead to a breach in GCP or noncompliance with regulatory requirements, or could

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

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be indicative of poor control, could be considered major deviations; or a combination of minor non-conformances which indicate a major system failure, or a number of repetitive minor non-conformances. Requires corrective action to be agreed as a priority. 

Minor

A deficiency which cannot be classified as critical or major. Requires corrective action to be agreed, but is not a high priority.

5.3.4 Progress of internal audits will be reported to NWORTH management, and a summary of progress provided at the NWORTH team meeting

5.4 Corrective action review/ follow up 5.4.1 The auditor or Quality Assurance officer will return to the audit area as soon as possible to the agreed follow up date and assess the effectiveness of the action taken. Findings will be noted on section 3 of the Corrective Action Request(CAR) Appendix 3, and if satisfactory, the CAR will be closed out 5.4.2 In the event of the actions being incomplete, a new date is agreed and the reason for incomplete actions noted on the CAR. If there is a persistent problem, this will be reported to NWORTH management. 5.4.3 The corrective action is closed only when the auditor is satisfied with his / her findings. 5.4.4 The corrective actions are tracked using the corrective action register. This is reviewed on a regular basis by the Quality Assurance officer.

5.5

Re- audit

A re-audit can be organised by the Quality Assurance officer to determine if the corrective actions have been effective. If the corrective actions have not been effective, it is the responsibility of the Quality Assurance officer to initiate further corrective actions, and to make NWORTH Management aware of any problem preventing satisfactory corrective action being taken. These issues may be formally raised at the NWORTH meeting.

6. Training plan for SOP implementation Training will be carried out in accordance with NWORTH training SOP 2.01

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

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7. Glossary of Terms CI Chief Investigator The investigator with overall responsibility for the research. Corrective Action The action taken to eliminate the cause of a detected non-conformance. Corrective action is taken to prevent recurrence. CAR Corrective Action Request Form used to document non-conformance, the resulting corrective action and follow-up to determine if the corrective action has been completed in a satisfactory manner Internal Audit A systematic and independent examination to determine the effectiveness of the quality management system ensuring adherence to SOPs, Good Clinical Practice (GCP), and the applicable regulatory requirement(s). GCP Good Clinical Practice A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Non-conformance Failure to adhere to the Quality System, required standards, policies, procedures, regulations etc. NWORTH

North Wales Organisation for Randomised Trials in Health (and social care)

SOP Standard Operating Procedure The written instructions and records of procedures agreed and adopted as standard.

8. References ICH E6 (R1) Guide for Good Clinical Practice

9. Referenced SOPs NWORTH Training SOP 2.01 NWORTH Monitoring SOP 3.07

10. Appendices Appendix 1: Audit checklist Appendix 2: Audit report Appendix 3: Corrective Action Request.

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth

Date: 09th October 2012 SOP number: NWORTH 1.03

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Appendix 1: Audit checklist Area:.................................................... Date: ......................... Page .......... of .......... Auditor: .............................................................. Representative:..................................... Question / audit point. Findings / comments Compliant Y/N

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Date: 09th October 2012 SOP number: NWORTH 1.03

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Appendix 2: Example of audit report format Date:

Page x of x

Internal audit of xx Present Representative: Internal auditor:

Summary of findings Include positive and negative observations

Audit report Audit checklist and findings Question / audit point.

Findings / comments

Complies with SOP Y/N

Recommendation(s)

Corrective Action(s) (note if the non-conformance(s) are critical, major or minor)

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Date: 09th October 2012 SOP number: NWORTH 1.03

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Appendix 3: Corrective Action Request CLASSIFICATION:

Critical

Date:

Major

Minor

Corrective Action Request No: yy/ sequential number

Department / Area: …………………………………………………………………………….………. Representative: …………………………………………………………………………………….…... Auditors: ……………………………………………………………………………………………….. REP Repeat problem? Yes 1. NON-CONFORMANCE

No

If yes CAR reference number: ___________________________

(To be completed by Auditor):

Signed: ……………………………………………… (Auditor) 2. CORRECTIVE ACTION (To be completed by Representative) AND ACTION TO PREVENT RECURRENCE (if applicable):

Date For Completion Of Corrective Action: ……………………………………………… Signed: …………………….……………. (Representative) …………………….…………………… (Auditor) Date: …………/…………/…………….. 3. FOLLOW-UP AND CLOSE OUT

(To be completed by Auditor):

Proposed Follow-Up Date: ……………………………………………………………………….. Follow-Up Details:

C.A.R. Close Out Date: ………/…………/.……… Signed: …………………..………………… (Auditor)

NWORTH: Telephone: 01248 388095 email [email protected]

http://www.bangor.ac.uk/imscar/nworth