1.1 To lay down a standard procedure for Internal Audit (Self-inspection).
2.0 SCOPE
2.1 This SOP shall be applicable for the procedure to be followed for Internal Audit (Self-inspection) in the Department of Quality assurance (QAD) and Animal House Facility (AHF) where quality-related activities are carried out at the institution.
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Head- AHF
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Audit shall conduct by the audit team annually or if required for any reasons in between and the record shall maintain as per format no. F…………………. titled as Internal audit log.
5.2 Audit team contains one member of the QA department with a member of competent personnel of other departments.
5.3 Prepare the audit schedule in the ‘Annual Internal Audit Schedule’ as per format no. F……………… by marking ‘√’ for the scheduled months and circulate a controlled copy to concerned departments.
5.4 The auditors shall be suitably trained and shall be independent to conduct the audit.
5.5 The auditor can use a department-wise checklist to conduct the audit as per format no. F…………….. and format no. F……………………… respective to QAD and AHF.
5.6 The audit shall be planned any time of the month.
5.7 Auditee departments will be informed about the audit one week in advance by way of internal communication. The audit will be conducted to ensure compliance with the SOPs and GLP guidelines.
5.8 Before initiating the audit auditor shall make a formal meeting with the department head to discuss the intentions of conducting the audit and the department head shall depute a person to facilitate the auditor to conduct the audit.
5.9 At the end of the audit the auditor shall again make a formal meeting with the department head to discuss the issues observed during the audit. An action plan & compliance date to be assigned by the department head for the NCRs observed.
5.10 A conclusive report to be made and to be signed by the department head and the auditor.
5.11 Auditor shall provide a photocopy of the conclusive audit report to the department head for his further reference.
5.12 Verification of corrective action shall be done by the auditor during the next audit.
5.13 Numbering of Audit
5.13.1 All audits shall be numbered by QA personnel as per unique numbering system of 12 characters as below:
IA/XXX/YY/ZZ
Where 1st and 2nd characters are ‘IA’ which signify internal audit; 4th, 5th and 6th characters are ‘XXX’ which signify ‘Department Code’ to which audit belongs i.e. QAD for Quality Assurance and AHF for Animal House Facility; Character no. 8th and 9th are ‘YY’ which signify the last two digits of the year in which the audit shall be conducted; The 11th and 12th characters ‘01’ signifies the Sr. No. of audit conducted; Character No. 3rd, 7th and 10th are oblique marks ‘/’.
5.13.2 For example: First internal audit of AHF in 2015 : IA/AHF/15/01
5.14 Numbering of Nonconformance (NCR)
5.14.1 All Nonconformance (NCR) raised during audits shall be numbered as per unique numbering system of 13 characters as below:
NCR/XXX/YY/ZZ
Where first three characters are ‘NCR’ which signify Non-Conformance; 5th, 6th and 7th characters are ‘XXX’ which signify ‘Department Code’ to which Non-Conformance belongs i.e. QAD for Quality Assurance and AHF for Animal House Facility; Character no. 9th and 10th are ‘YY’ which signify the last two digits of the year in which the Non-Conformance shall be raised; The 12th and 13th characters are ‘01’ which signify the Sr. No. of Nonconformance; Character No. 4th, 8th, and 11th are oblique marks ‘/’.
5.14.2 For example First Nonconformance of AHF in 2015: NCR/AHF/15/01
5.15 Online audits can also be conducted by QA at any movement of time to ensure the online documentation and practices.
5.16 The report for online audits shall be given to the concerned department head as per format no. F…………………….
5.17 The department head shall make a compliance report as per format no. F……………….. on the same day at the earliest for non-compliance and shall handover it to the QA head.
5.18 QA shall verify the implementation of the same during an audit.
5.19 Department head/ Designee are Auditor & Auditee at the time of internal audit.
6.0 ENCLOSURES
6.1 Formats
|
Sr.
No. |
Format
Title |
Format
No. |
No.
of pages |
|
|
Annual
Internal Audit Schedule |
F…………………….. |
01 |
|
|
Internal audit checklist for QAD |
F…………………….. |
03 |
|
|
Internal audit checklist for AHF |
F…………………….. |
04 |
|
|
Internal audit observation sheet |
F……………………. |
01 |
|
|
Nonconformance report (NCR)/Compliance report |
F……………………. |
02 |
|
|
Internal audit log |
F……………………. |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 AHF- Animal House Facility
7.4 NCR- Nonconformance Report
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
7.4 NCR- Nonconformance Report
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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