Date:15th October 2014 Version: 5

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Standard Operating Procedure for

Internal Auditing of the Quality System
(NWORTH 1.03)

Approvals

Principal Author
Name: D. Skelhorn Signature: D. Skelhorn Date: 15/10/2014

Quality Assurance Officer

Name: p.p. J. Ryan Signature: J. Ryan Date: 15/10/2014

NWORTH Director
Name: R.T. Woods Signature: R.T. Woods Date:30/10/2014

Disclaimer: Printed SOP's are considered uncontrolled. To ensure you are working with
current version always refer to the pdf version on the NWORTH website.

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:15th October 2014 Version 5
SOP number: NWORTH 1.03 Page 2 of 10

DOCUMENT HISTORY
Version Effective Authorship Summary of changes
number date
1 N/A S. Westley, C. Bray, New
M. Jones
2 16/10/09 D. Skelhorn, New SOP numbering and layout, procedure completely
M. Williams rewritten.
3 23/10/10 D. Skelhorn, Appendix 3 Corrective action request form added and
M. Williams referenced in section 5
4 12/12/12 D. Skelhorn, ‘where possible’ added to section 5, SOP references
M. Williams updated, table of contents updated
5 31/10/14 D. Skelhorn, Minor. Flowchart updated schedule approval updated,
M. Williams reference to operational team added

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:15th October 2014 Version 5
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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. Adherence to 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:15th October 2014 Version 5
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5.1 Procedure Flow Chart

Audit schedule
prepared

Audit schedule circulated

Auditor(s) assigned

Audit preparation

Conduct audit

Report audit findings

Corrective Yes Corrective action(s)

action(s) agreed & audit report
identified? completed

No Follow up corrective action(s)

Audit report
completed
Corrective
action
completed? No
?

Yes

Corrective action
closed out

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Date:15th October 2014 Version 5
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5.2 The audit

5.2.1 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.
5.2.2 The auditor(s) will prepare an audit checklist based on the SOP to be audited
(see appendix 1).
5.2.3 Any findings from previous audits on that area will be reviewed to follow up
any observations and outstanding corrective actions.
5.2.4 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.
5.2.5 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.
5.2.6 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.
5.2.7 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.
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Date:15th October 2014 Version 5
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 Major Non-conformances which could potentially lead to a breach in

GCP or noncompliance with regulatory requirements, or could
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 the Trials Unit Manager and
escalated to the Operational Team and /or Executive team as appropriate

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 Operational Team.

6. Training plan for SOP implementation

Training will be carried out in accordance with NWORTH training SOP 2.01

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Date:15th October 2014 Version 5
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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.

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Date:15th October 2014 Version 5
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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:15th October 2014 Version 5
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Appendix 2: Example of audit report format

Date: Page x of x
Internal audit of xx

Present Representative:
Internal auditor:
Date of audit:
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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Appendix 3: Corrective Action Request

CLASSIFICATION: Critical Major Minor

Date: Corrective Action Request No: yy/ sequential number

Department / Area: …………………………………………………………………………….……….

Representative: …………………………………………………………………………………….…...
Auditors: ………………………………………………………………………………………………..
REP Repeat problem? Yes No If yes CAR reference number: ___________________________

1. NON-CONFORMANCE (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)

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