Internal Audit SOP | Self Inspection Procedure

The purpose of this procedure is to provide an effective method for evaluating and controlling the company’s quality management system. 

This procedure defines the activities for planning and conducting internal audits, and inspections, in addition, to covering, correcting preventing, and documenting the audit deficiencies/ findings.

RESPONSIBILITY

1. The Management Representative is normally responsible for coordinating and overseeing the internal audit process including internal audit schedules are created and followed.

The Head of the Plant / Managing Director is responsible for appointing the internal audit team/auditors. He / She is also responsible for reviewing all internal audit results, NCRs, CAPA, and follow-up audits for desired results

2. Internal audits of each element of the quality system are conducted at least once a year. An audit schedule is established based on the workflow being audited. Internal quality audits may be conducted more frequently on a random basis as necessary based on past audit results and operational performance.

3. Auditors conducting internal audits will be qualified based on their knowledge of the area being audited, including those related to quality management system procedures and their knowledge of internal auditing skills. Training will be provided to all personnel involved in conducting internal audits personnel selected to conduct internal audits will be appointed by the Managing Director based upon their independence of the areas being audited. It means personnel responsible for the area should be excluded from auditing their own area.

5. Before each audit, an audit plan is established by the MR and documented on the internal audit plan for the year. The audit plan to include the following:

• Date of audit
• List of areas to be audited
• Checklist of the documents, records, and evidence to be audited
• Names of the auditors involved in the audit.

INTERNAL AUDIT REFERENCE NO. OF ISO 22716

The Procedure of Internal Audit

1. Assigned auditors conduct the audits as documented in the audit plan. Results are immediately reviewed by the in-charge responsible for that area and the non-conformities are agreed upon (sign off).

2. Audit findings are documented on the internal audit report form. This form has been shared beforehand with the in-charge responsible for that area.

3. If nonconformities are identified, the audit report is filed as open until corrective actions have been implemented and non-conformities are closed.

4. In charge of the area with non-conformance will develop a corrective action plan and take responsibility for implementing the corrective actions and closing the NCR. Corrective action plans to be monitored and discussed by MR during the Management Committee meetings,

5. Follow-up audits are scheduled based on the agreed-upon dates or during the regular routine audit depending on the criticality or urgency of the NCR and corrective action. If a major NCR is been raised a follow-up audit is a must.

6. When corrective actions are been implemented and the effectiveness of the same is measured and the findings are documented then the NCR and audit report can be closed and sealed.

7. Audit reports being retained for 3 years minimum.

INTERNAL AUDIT PLAN FOR 2014

Process/Procedures for audit (areas)

Jan

Feb

Mar

Apr

May

Jun

July

Aug

Sep

Oct

Nov

Dec

Production Area

Store Area

Maintenance

QMS

The frequency of audit can be decided by the following parameters:

• Critical areas/process
• Customer requirement
• HACCP requirement
• GMP requirement

Last audit points / NCR’s etc

List of auditors

SAMPLE AUDIT REPORT

Name of the Auditor					Name of the Auditee
Date of Audit					Area of audit
Documents / Reviewed
Standard Section Nos. (if any)
Review of previous audit	Area			Category of NCR			CAR?
Observations of the current Audit	Area/Section nos.			Category of NCR			Recommendations
1
2
3
4
5
6
7
8
9
10
Corrective Action Plan
Agreed Timeline for Closure
Review of Corrective Action Date
Review of Corrective Action Effectiveness

SIGNATURE OF THE AUDITOR                                  SIGNATURE OF AUDITEE

Classification of Non-Conformities

• Critical
• Major
• Minor
• Opportunity for improvement

SOP FOR ENTRY and EXIT OF PRODUCTION AREA

Audit Checklist and Guidelines | Audit rating System