Ref. No: SFM/QP/9.

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SFM PROCEDURE FOR QUALITY

INTERNAL AUDIT

REVIEWED BY:
APPROVED BY:
EFFECTIVE DATE
COPY NUMBER
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CONTENTS

1.Scope 4
2. Purpose 4
3. Definitions/Terms/Abbreviations 4
4. Pocedure 4
4.1 Audit planning 4
4.2 Carrying out an audit 5
4.3 Corrective action review 5

AMMENDMENT HISTORY

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Section Amendment summary Issue Date

All Initial issue 1.0 dd/mm/yy

1 Scope

This procedure specifies how internal quality audits in SFM are planned, conducted, reported and
corrective actions on observed non conformities implemented. The procedure contains the following
sections:

4.1 Audit planning

4.2 Carrying out an audit
4.3 Corrective action review

2 Purpose

The purpose of this procedure is to provide a planned and documented method for carrying out
internal audits of the Quality Management System (QMS).

Internal quality auditing verifies whether quality activities comply with planned arrangements and the
effectiveness of the QMS. If any non-conformities are found, corrective actions will be
implemented based on the results of these audits.

3 Definition/ Terms/ Abbreviations

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AS - Audit Schedule
MR - Management Representative
QMS - Quality Management System
NC - Nonconformity
OBS - Observations
QA - Quality Auditor

4 Procedure

The Management Representative (MR) is to ensure the implementation of this procedure and is
responsible for maintaining the audit schedules and audit reports.

The MR and trained Quality Auditors (QA) are responsible for conducting internal quality audits.
Records are maintained in accordance with Control of Retained Information Procedure.

4.1 Audit planning

Audits are planned using the Audit Schedule (AS) so that all sections of the management system are
audited at least once per year. More important activities or areas with identified problems are audited
as often as required to correct deficiencies and to give confidence of correct operation.

The Audit Schedule has a key for completion and this is updated following an audit to show the status
of the audit and to provide information for future planning.

Quality Auditors are trained and are appointed to audit areas that they do not generally work in. This
is to provide an independent check as far as possible with the number of staff available.

The Quality Auditors will make arrangements with the relevant personnel prior to the planned audit to
confirm the day of the audit and availability. Auditees are notified at least one week prior to audit
conduct date.

4.2 Carrying out an audit

The audit is carried out using the Audit Report SFM/PR/002, which consists of an audit finding report
and a corrective action report. The report forms are specifically prepared for each process / section of
the QMS.

After selecting the area to be audited, a copy of the previous completed report is reviewed for any
areas of concern noted at that time. The audit is then conducted, recording clearly all the audit
findings and observations on the report.

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Audit findings must include process description, file/job or record numbers and people interviewed.
The findings should be clear and unambiguous to anyone reading the report.

The status of the findings are recorded beside each entry and will be one of the following:

OBS - The findings are not incorrect but give cause for concern or could be improved;

NC - The findings indicate a procedure has not been followed or the procedure does not meet the
requirements of the QMS;

 - The findings and answers are satisfactory and comply with the procedure.

The auditee should be made aware of the findings and observations, good and bad.

The appropriate section of the report is signed by the auditee and auditor to confirm agreement of the
content of the report. Where more than one auditee is audited they should be told the findings at the
time of audit and the department head will be asked to sign the report.

4.3 Corrective action review

The completed audit reports are reviewed by the MR and the schedule updated.

Satisfactory reports are signed and filed in the completed audit section of the quality file. Audit
reports that are not fully completed are discussed with the auditor as part of the ongoing audit training.

Reports requiring action are discussed with the relevant persons and actions are agreed and
documented. Recorded actions will clearly detail what is to be done, who is responsible and the times
scale for completion to ensure that the issues are resolved and the recurrence of a similar problem is
prevented. Significant or longer timescale issues may be recorded on a Quality Report EAL/PR/003, to
assist with the tracking and closure of corrective action.

The MR and QA will monitor the actions and review completion on the agreed dates. Once satisfied
that the actions have been effectively implemented the report is signed off and filed.

The audit results are reviewed at the Management Review meeting and, if considered necessary,
additional preventive actions are implemented.

5 Related documents

 Audit report form SFML/IA//001,

 Control of records procedure SFM/PR/DI.
 Audit schedule.
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 Quality report form SFMPR/002.

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Appendix 1 – Summary flow chart

Internal auditing requirements Audit schedule

planned and audit schedule
produced

Auditor appointed to carry out

next audit on schedule (taking
into account auditor
independence)

Date / time for audit

confirmed with auditee and Audit report
audit checklist generated/ SFM/PR/003,
reviewed

Previous audit reviewed.

Previous audit audit conducted and
report (A/R) findings recorded on audit
report

Findings categorised as
Audit report
compliant (), observation
SFML/PR/003,
(Obs) or non-conformity
(NC)

Record List QP02

Corrective actions agreed Quality report

with process owner / SFM /PR/003,
auditee, timescales set and
audit findings signed off

Completed audit report form

passed to MR and audit Updated audit
schedule updated schedule

Corrective actions reviewed at due Completed audit

date. Completed audit report signed report
off and filed by MR
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Appendix ii
SFM , AUDIT FINDINGS RECORDS
Sheet No:
Audit Date: Identification:

Organization
Name:
Section:
Activity/
Aspect Audited:
Who was present

Reference Details of activities, documents, methods, procedures, records, results, and reports
examined during audit.

Reference Non-compliance record (nil report required). ISO Major or

Exact Observation of the facts: Where it was found. What 9001: Minor
was found. Why it is non-compliance. 2015 ref:

Auditor(s):

Name: Date: Signature:

Comments of person in charge (Corrective action, Time scale, etc).

Responsible for section:

Name: Date: Signature:

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