Pro Sys 05
Pro Sys 05
Pro Sys 05
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Procedure for Rev.No/ Issue Date 0 / 01-05-2023
Internal Audit
Procedure for Internal Audit
1.0 Purpose
The purpose of this procedure is to establish procedure and responsibilities for carrying out
internal quality and product safety audit of all operations and activities. It is also used to check
whether the quality and product safety system is as effective and efficient as it should be and
whether any changes are needed.
2.0 Scope
This procedure applies to auditing of all activities described and covered in the BRC Product
Safety Manual and supporting procedures and documents to verify effective implementation of
the system.
3.0 Responsibility
3.1 Management Representative is responsible for the planning and implementation of the audit.
The auditors, who are selected normally from within the organization, however assist him. Such
a person has to be one who has been trained in the particular area but is not working in the
same area, which is to be audited. If need arises, outside auditors can also be employed at the
discretion of Management Representative.
3.2 Internal Auditors are responsible to execute audit as per plan and verify the effectiveness of
implementation of Product Safety Management System.
3.3 Top Management, Functional Heads and concerned persons of the department are
responsible for providing cooperation during audit and taking corrective action in their area
expeditiously and also for maintaining audit records.
4.0 Description of Activity
4.1 Audit Schedule
4.1.1 The Management Representative prepares audit plan, considering the months when last audit
was done, the month in which audit is planned and the next month of audit. The audit plan
covers all aspects of quality and product safety system. Audits are scheduled on the basis of the
status and importance of the activity and previous year’s audit findings.
4.1.2 Audits are performed at least once in Six Months.
4.1.3 Unscheduled audits may be carried out at the discretion of the Top Management or Management
Representative.
4.2 Planning and Scheduling of Audits
Audit plan is prepared with the details of name of activity, scope of audit – full / part of the
activity, date and time and name of auditor. After that, Audit Plan is circulated to concerned
person / informed verbally to Auditor / Auditee. After execution of audit, actual audit program is
also recorded in the audit plan. Management Representative ensures that auditor is independent
of the area being audited by him.
4.3 Frequency
Prepared And Approved By Signature Page
Management Representative 1 OF 4
PRO_SYS_05
Doc.Ref.No:
Procedure for Rev.No/ Issue Date 0 / 01-05-2023
Internal Audit
Internal quality & product safety audit is scheduled on the basis of the status and importance of
the activity to be audited.
Normally, the frequency of internal quality & product safety audit is at least once in Six Months
for each function / element. However, it could be done more frequently in the beginning when the
system is to be firmly established, and later on also when it is noticed that:
(a) Product safety results are not achieved in specific areas / activities as per requirements.
(b) Previous reports (i.e. IANCRs) are not closed or,
(c) There are significant changes in the key personnel / process / techniques / technology etc.
4.4 Audit plan for different functional areas can be staggered to suit availability of competent and
trained auditors or for any other reason. An auditor communicates any change in audit plan to
the auditee, if any.
4.5 Selection of Auditors
The following are the criteria for selection of auditors.
4.5.1 He should have undergone training in auditing.
4.5.2 He is not working in the same section / area of which audit is being carried out.
4.6 Working Documents
The following documents are made available to the audit team:
1. "Controlled" copy of the Product Safety Manual.
2. “Controlled” copy of Product Safety Procedures / Process Approaches related to the
activities to be audited.
3. Previous Internal Quality & Product Safety Audit Reports.
4. Forms for IQANCR Reports.
5. Clause Wise – Document Wise Audit Review Report.
4.7 Audit Execution
4.7.1 The audit criteria, scope and method is defined. The auditor for each function should familiarize
himself with the relevant procedures and operating instructions applicable in the work area being
audited. Then as per audit review of pre-determined questions and document-related questions,
audit is carried out to verify implementation of the system.
4.7.2 All the concerned persons (auditee) ensure that the auditors are given full cooperation in
conducting audit, their questions are answered courteously and truthfully and they are given
access to all facilities and documents as required.
4.7.3 The auditors do auditing with the help of working documents within the audit scope. They collect
and analyze relevant evidences, and perform objective evaluation of working practices, resourc-
es, accuracy of work, documents and records, etc. They act in an ethical manner and keep
findings confidential. The audit report is prepared by pointing out non-conformance observed
and recorded as "Internal Quality & Product Safety Audit Non-Conformity Report".
4.7.4 If non-conformance observed is too serious in the opinion of the auditor, the activity is stopped
immediately and the required corrective action or disposition is agreed and implemented with the
concurrence of all persons concerned.
Internal Audit
4.7.5 Evaluation of individual verification results
During internal audits, the product safety team evaluates that the planned verification are
achieved. Also, necessary actions are taken through following:
Review of existing procedures and communication channels
The conclusion of the hazard analysis, the established operational PRPs and the HACCP
plan
The PRPs
Review of the effectiveness of human resources and training activities.
4.8 Audit Report and Follow-up
4.8.1 On completion of the audit, auditor discusses with the auditee to review findings and obtain
clarifications, if required. Auditor prepares audit IQANCR report.
4.8.2 Appropriate corrective measures are also discussed, including assignment of responsibility for
the corrective action and expected time for implementation. These are then incorporated in the
report, which is signed by the auditor as well as the concerned person. Considering the
complexity of IQANCR, sometimes audit suggestions are also written in IQANCR form to close
NCR. The recorded audit findings are used as the main formal means of resolving problems and
deficiencies detected in the product safety system.
4.8.3 Functional Head takes necessary corrective actions to close the IQANCR. The Management
Representative does the follow-up for the review of corrective action and also arranges for it to
be reviewed by the auditor. Their decision about whether the NCR is "closed" or still "open" is
recorded in the same IQANCR.
4.8.4 NCR may be closed out by Management Representative / Auditor based on the evidence
submitted by the auditee, or they may be closed out subject to verification during next audit.
4.8.5 Management Representative prepares and reviews the Clause wise-Procedure wise Audit
Review report based on audit findings and provides it to the Top Management for their ready
reference.
4.8.6 The Audit Report Distribution
The audit report is initially given to auditee to take action and after closing the NCR copies are
distributed as per details given below:
(a) Audited person is given a photocopy of IQANCR for reference.
(b) Original copy is kept in audit records file of MR for follow-up and future reference.
4.8.7 The results of audit reports are compiled by MR and discussed in management review meeting
to see effectiveness of the system.
4.8.8 During next audit / as per the plan for checking effectiveness of action taken, implementation
and effectiveness of the action taken on NCRs is reviewed and recorded in the original copy of
NCRs. If similar type of nonconformity is found again then repeat NCR is given to the concerned
person.
Internal Audit
4.9 For third party / external audit and follow-up after audit, the same procedure described above is
followed. In such cases only auditors are outsider and they carry out audit in their own way and
forms are used as per their suggestions. The audit plan as well as NCR report is prepared by
them and necessary follow-up is done as per procedure described above.
4.10 For any serious and repeated type of NCR identified by MR, preventive actions are taken to
prevent future recurrence.
4.11 Audit reports are retained by all the functional heads and kept in a file marked "BRC Product
Safety Management System Record” or QMS Record. Management Representative keeps all
audit records in audit file.
5.0 Reference
5.2 BRC Global Standards for Packaging Material, Issue 8, August 2019.