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Safety Audit Procedure & Checklist

The Safety Audit Procedure and Checklist SOP is a comprehensive guide designed to ensure the systematic evaluation of safety practices within an organization. This document outlines the step-by-step process for conducting safety audits, including the preparation, execution, and follow-up phases. It features a detailed checklist covering critical safety aspects, enabling auditors to effectively identify potential hazards and compliance gaps. By implementing this SOP, organizations can enhance their safety management systems, promote a culture of safety, and ensure adherence to regulatory requirements.

Safety Audit Procedure & Checklists

1.0   Purpose

    • The objective of this Standard Operating Procedure (SOP) is;
    • To monitor the implementation and compliance of facility, system, and personnel under the Safety Policy and Safety Manual.
    • To monitor the effectiveness of corrective actions.

2.0   Scope

    • This SOP applies to all pharmaceutical drug manufacturing & API plants.

3.0   Responsibility
Safety Audit Procedure

    • The Audit team shall be responsible for;
    • Conducting the safety audit as per the given schedule.
    • Checking the compliance of observations made in the previous audit.
    • Preparation of internal safety audit report.
    • Quality Assurance (QA) shall be responsible for;
    • Preparation of annual calendar for internal safety audit.
    • Preserving internal safety audit reports and compliance reports.
    • Preparation of annual summary report for internal safety audit.
    • The Head – QA shall be responsible for;
    • Identifying the audit team.
    • Ensuring the effective implementation of the internal audit schedule.
    • Review of internal safety audit reports and compliance reports.
    • The Auditee shall be responsible for;
    • Conducting the audit as per schedule with the audit team.
    • Preparation of audit compliance report.

4.0   Procedure for Handling Safety Audit 

    • The annual schedule of internal safety audit shall be prepared and distributed by QA at the end of the current year for the forthcoming year. (Refer annexure – 2).

    • Constitution of audit team-

    • The safety audit team shall be formed based on qualification and working experience, (Refer to Annexure -1) the team shall have a lead auditor and members from different departments.
    • All the members of the audit team shall be trained in auditing skills; the lead auditor shall have a minimum working experience of 5 years.
    • Each department/section shall be inspected on half yearly basis. Apart from the safety aspects, the parameters to be covered shall include compliance with company EHS policy / Manual & SOPs, etc.
    • In preparation for the audit, the audit team shall review previous internal audits and external audits, to identify and collect the relevant documents and SOPs that define the work procedure of the area to be audited.
    • Before initiating the audit, the auditor(s) must notify the supervisor or in charge of the area to be audited 5 days in advance.
    • The audit shall consist of comparing written procedures versus actual practices and identifying any unsafe act or unsafe condition (which may or may not be part of system procedures), whether existing or extrapolated.
    • The safety audit team shall use the checklist to inspect the Department/Section, but not limited to. (Refer Format 1).

    • Online observations of audit/inspection are to be entered in a format no. 3.

    • When the audit is complete, the Non-Conformances (to manual / policy / SOP, etc.) shall immediately be reviewed with the area supervisor/manager.
    • The area supervisor, the department manager, and the lead auditor must attend the meeting.
    • An internal safety audit report shall be prepared based on factual evidence.
    • Non-conformance (NC) observed during the audit shall be categorized as critical, major, and minor.

    • Minor Observation

    • Any unsafe act or condition that immediately may not damage equipment, area, product, person, or environment site but has the potential to do so in the long run.

    • Major Observation

    •  Any unsafe act or unsafe condition, which has the potential to cause immediate damage to equipment, area, product, person, or environment on-site but not off-site.

    • Critical Observation

    • Any unsafe act or unsafe condition, which has the potential to cause immediate damage to equipment, area, product, person, or environment on-site as well as off-site.
    • Noncompliance points carried forward from the previous audit report.
    • Based on the observations of the internal safety audit, the auditor shall prepare the internal safety audit report in format no 2.

    • The numbering system for the report shall comprise fourteen (14) alphanumeric characters as;

ISA/YY/ZZ.

Where,  ISA: Internal safety audit, YY: Current year. ZZ: represents the internal safety audit sequence no. for the current year.

    • Lead Auditor shall evaluate, the classification of the NC observed and shall approve the audit report.
    • Internal safety audit report shall be prepared within 7 working days from the date of internal safety audit.
    • A copy of the internal safety audit report shall be submitted to Head QA.

    • Head QA shall review the internal safety audit report.

    • If any cost is involved or management approval is required to comply with the findings, the Head QA shall take up the matter with management.
    • All the compliance shall be based on corrective and preventive action (CAPA). Immediate corrective action shall be taken for NC observed, additional preventive actions shall be planned to avoid recurrences of the same.
    • The audited section shall prepare and send a compliance report to the Head–of QA, within 07 days of receipt of the audit report, with a target completion date (if applicable) for implementation.
    • Head QA shall evaluate the corrective action proposed and if required can recommend additional corrective actions for effective compliance of NC observed.
    • QA shall prepare an annual summary report for the entire NC reported and the compliances met. (Refer Annexure – 3).
    • A tentative date for closing the NC shall be given and if NC can’t comply then proper justification for the same shall be given.
    • A copy of the compliance report shall be forwarded to the audit team for the next year so that the audit team can refer to the NC and cover the same in consecutive audits.

5.0   Attachments – Safety Audit

Annexure – 1: List of Auditors

Annexure – 2: Internal Safety Audit Program

Annexure – 3: Annual Safety Audit Summary Report

Format – 01: Checklist for Internal Safety Audit

Format – 02: Audit Report and Compliance Report

Format – 03: Compliance from an internal safety audit

6.0   Reference

    • In-house

Annexure – 1: List of Auditors

Auditee Department

Name of Auditors

Lead Auditor
1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.
1.
2.
3.

Annexure – 2: Internal Safety Audit Program

Name of Department

 Duration Jan 1 Feb 2 Mar 3 Apr 4 May 5 Jun 6 Jul 7 Aug 8 Sep 9 Oct 10 Nov 11

Dec 12

Annexure – 3: Annual Safety Audit Summary Report

Department NON CONFORMANCE Remark
Critical  (Nos.) Major (Nos.) Minor (Nos.)
Observed Complied Observed Complied Observed Complied
                 
               
               

Department:                                                   Auditor:

Format – 01: Checklist for Internal Safety Audit

Check Points Observation Remark
Yes No

PERSONAL PROTECTIVE EQUIPMENT (PPE)
1 Appropriate eye/face protection is available and used if a hazard present
2 Appropriate hand protection is available and used if a hazard is present.
3 Appropriate hearing and foot protection is available and used if hazards are present.
4 Protective clothing – coveralls, aprons, gowns, etc. available & used if needed
5 Approved respirators are available and used if needed.
6 PPE is properly stored, clean, and in good condition
7 Appropriate helmet head protection is available.
8 Appropriate hearing and foot protection is available and used if hazards present
9 Personal protective equipment issue record.
10 Are approved safety glasses, face shields, gloves, palm guards, aprons, clothing, and hearing protection used in the required area?

WORKING PLACE SAFETY

1 Are all emergency stops, safety guards, and safety devices located on equipment and tools working and adjusted properly?
2 Permit to Work System
3 First Aid box with content
4 First Aid SOP & Records
5 The work area is properly ventilated for the type of equipment or chemicals in use.
6 General housekeeping of the facilities –SOP and records.
7 Accident and incident report
8 Ventilation system and preventive Maintenance records
9 Areas with high noise levels and hearing protection are required to be used.
10 Work areas are clean, sanitary, and orderly. (Garbage disposed properly, etc.)
11 Used oil collected and recycled properly.
12 Are electrical plugs, outlets, and cords in good condition and are not missing covers, taped, or broken?
13 Are floor surfaces clean, dry, level, not slippery, or sticky, and in good condition?
14 Ceiling tiles are not damaged, loose, or missing.
15 Are hazardous waste containers properly identified and labeled with the words, “HAZARDOUS WASTE.”
16 Are all controls and emergency stops clearly defined and within reach of the operator?
17 Are non-slip surfaces in good condition on steps and platforms?
18 Are emergency lights properly operated?
19 Do not employees have proper ID badges?
20 General Housekeeping of the facilities – SOP & Records.
21 On-Site Emergency Plan & training records.
22 Periodic training of security personnel.
23 Emergency light
24 Motor Vehicle Safety. (Internal and Third Party)
25 Cleaning of drinking water cooler and records.
26 Water consumption.
27 Environmental Monitoring.
28 Tag and Colour code system.
29 Diesel Storage and Handling Procedure.
30 Stacker Preventive maintenance record.
31 Lifting cage condition.
32 External Trainer Training Arrangement.

ELECTRICAL SAFETY
1 Extension cords are not used as permanent wiring.
2 Extension cords and power strips are not daisy-chained one to another
3 Electrical cords not be under carpets/rugs, through doorways, or in high-traffic areas.
4 Power cords are in good condition with no splices or broken insulation.
5 Circuit breaker panels and emergency shut-offs are unobstructed and labeled.
6 Energized parts, circuits, and equipment guarded against accidental contact.
7 Are electrical plugs, outlets, and cords in good condition and are not missing covers, taped, or broken?
8 Do circuit breakers indicate whether they are in the “ON” or “OFF” position and are switch panels marked?
9 Are electrical outlets or cords not overloaded? Only allowable number of connections (i.e,.4-way outlet only  has 4 pieces of equipment connected and not loaded with additional extension cords) NOT:-Isolated Power Not Included

CHEMICAL STORAGE & ENVIRONMENT SAFETY
1 Chemical containers are properly labeled, stored, & closed when not in use.
2 Chemicals are segregated and stored by compatibility.
3 Vacuum equipment trapped and/or filtered.
4 Refrigerators/Freezers properly labeled.
5 Fume hoods and/or biosafety cabinets are not used for general storage.
6 Are SOP s display each activity’s
7 Protective clothing – coveralls, aprons, gowns, etc. available & used if needed.
8 Fire extinguishers are properly mounted, located, and identified.
9 Flammable storage cabinets labeled “Flammable – Keep Fire Away.”
10 Safety shower. QC & RO Plant ( if required )
11 Are flammables and combustibles stored properly?
12 Are hazardous materials properly stored?

OTHER IF ANY

1  
2  
3  
4  
5  

 Sign of Auditee:                                        Sign of Auditor: 

Format – 02: Audit Report and Compliance Report

Department   Date of Audit:
Address  
Auditor Auditee
Name Designation Name Designation

 

Category Detail of Non-Conformance Corrective Action Preventive Action Time Scale
Critical Carried forward from the previous inspection
Critical New  in this inspection
Major Carried forward from the previous inspection
Major New in this inspection
Minor Carried forward from the previous inspection
Minor New in this inspection

 

Comments (Auditor) :

 Name/Sign./Date:
Comments (Auditee) :

 

Name/Sign./Date:
Conclusion (Auditor)

 Name/Sign./Date:
Comments (QA) : Conclusion:

 Name/Sign./Date:
Comments (CQ) (If required): Conclusion:

 Name/Sign./Date:

Format – 03: Compliance from an internal safety audit

Sr. No. Observation Action to be taken Remarks 
Sign of Auditee : Verified By :

 

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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