CLAUSE REQUIREMENT DOCUMENT

11.1 Self-inspection -Employee hygiene checklist

-Machine safety checklist
-Inventory checklist
-Hygiene Checklist

11.2 Internal audit -Internal audit form

- Supplier and contractor audit form
-Corrective Action Plan (CAP)
 STANDARD OPERATING PROCEDURE FOR INTERNAL INSPECTION

OBJECTIVE
To define a procedure for systemic examination of quality systems and processes to verify
compliance with applicable regulatory requirements.
SCOPE
This procedure is applicable to the internal quality audit carried out in the various
departments.
RESPONSIBILITIES
QA Executive/ QA Officer
ACCOUNTABILITY
QA Head/ QA Manager

PROCEDURE
1. Audit Plan: Initiate for the audit by filling up the audit plan form. A filled audit plan form
shall be circulated to auditors, auditee, and quality/Factory head. Mention the
details as explained below.
1.1 Audit Objective: Write audit objective in this column. Audits objective may be but not
limited to one or more of the following.
1.1.1 To determine the conformity or nonconformity of the quality system elements with
specified requirements.
1.1.2 To determine the effectiveness of the implemented quality system in meeting specified
quality objectives.
1.1.3 To meet regulatory requirements.
1.1.4 To evaluate an organization’s own system against GMP.
1.2 Audit Scope: Write the scope of the audit program. The scope and depth of the audit shall
be designed to meet the audit objective. The standards or documents with
which the auditee’s system is required to comply may be specified. The
scope may cover one or more of the following.
1.2.1 Quality system elements.
1.2.2 Organizational Activities.
1.2.3 Standard Operating Procedures.
1.2.4 Good manufacturing practices / Good Laboratory Practices.
1.2.5 Documentation.
1.3 Auditee:
1.3.1 Write the name of the department/ section which is to be audited.
1.4 Audit Team (Auditors):
1.4.1 Write the name and department of the auditors who shall conduct the audit.
1.4.2 The audits shall be conducted by, but not limited to a member of Quality Assurance.
1.4.3 The auditor or audit team shall prepare a checklist for the audit.
1.4.4 The auditors or audit team shall plan the audit, prepare working documents and
coordinate with other auditors of the audit team.
1.5 Audit Schedule:
1.5.1 Write the date, duration and place of the audit.
2. Executing the Audit:
2.1 While performing an audit, the auditor shall consider following.
2.1.1 Auditors shall report critical nonconformities to the auditee or audit team immediately.
2.1.2 Auditors shall exercise objectivity.
2.2 Collecting Evidence:
2.2.1 Evidence shall be collected through interviews, examination of documents, and
observation of activities and conditions in the areas of concern.
2.2.2 Information gathered through interviews may be tested by acquiring the same
information from other independent sources, such as physical observation, measurements
and records.
2.3 Audit Observations:
2.3.1 All observations shall be documented.
2.3.2 After all activities have been audited, the audit team shall review all of their
observations to determine which are to be reported as nonconformities. The audit team
shall then ensure that these are documented in a clear concise manner and are supported
by evidence.
2.3.3 Nonconformities shall be identified in terms of specific requirement of the standard or
related documents against which the audit has been conducted.

5.3 Audit Report:

3.1 The Audit report shall contain but not limited to the following items, as applicable.
3.1.1 The objective and scope of the audit.
3.1.2 Details of the audit team members, auditee’s representative, and audit dates.
3.1.3 Documents audited.
3.1.4 Observations of nonconformity mentioning the details of Product name batch no.,
reference document no., page no., line no., date, and the name of the person, whichever
is applicable.
3.1.5 The audit report distribution list.
3.2 Based on the observations the auditor shall prepare a report.
3.3 The audit report along with the observation shall be given to concerned department head
for response with a copy to Quality Head and Plant Head within 15 days after the audit.
3.4 The QA department may issue a corrective action request for the pending observation.
5.4. Corrective Action:
4.1 The auditee is responsible for determining and initiating corrective action needed to
correct the cause of non-conformity.
4.2 The auditee shall respond in writing to each observation, which shall include corrective
action taken within 15 days after receipt of the audit report.
4.3 Corrective action request may be given. The target date for closing of the corrective
action request shall be given in consultation with the auditee.
4.4 Follow up audit shall be done to confirm completion of pending corrective actions or to
check the effectiveness of completed corrective action at the discretion of QA Head.
4.5 After all the recommendations are implemented, the QA department shall close the audit
report.
5.5 Frequency: At least twice a year.

ABBREVIATIONS
1 SOP: Standard Operating Procedure
2 QA: Quality Assurance
3 GMP: Current Good Manufacturing Practices
HYGIENE CHECKLIST
Satisfactory Details of action
Yes No taken
Hygiene of rooms and equipment
Are food rooms and equipment in good
condition and well maintained?
Are food rooms clean and tidy and do
staff clean as they go including difficult
areas?
Is equipment easy to clean and kept in
clean condition?
Are all food and hand contact surfaces e.g
work surfaces, delivery areas, slicers,
blocks, fridge handles, food probes in
good condition and cleaned/disinfected
regularly?
Are suitable cleaning chemicals available
and stored correctly and are proper
cleaning methods used?
Are cleaning cloths and equipment
suitable for use and regularly cleaned and
disinfected and used properly?
Food Handling Practices
Are raw and ready-to-eat foods prepared
in separate or are the work surfaces
cleaned and disinfected between uses?
Is separate complex equipment (e.g.
vacuum packing machines, slicers,
mincers) used for raw and ready-to-eat
foods?
If colour coded equipment (e.g. chopping
boards) is provided, is it used properly?
Are frozen foods defrosted safely?
Are controls in place to prevent
contamination by chemicals/foreign
bodies e.g. cleaning chemicals, glass,
packaging materials, bolts, rust?
Are staff aware of food allergy hazards?
Are probe thermometers correctly used
and cleaned/disinfected before and after
use?
Personal Hygiene
Are staff fit to work, wearing clean,
suitable protective clothing and following
personal hygiene rules, particularly hand
washing?
 Are wash hand basins clean with warm
water, soap and hygienic hand drying
facilities?
Are wash hand basins used for hand
washing only and used regularly by staff?
Are staff handling food as little as
possible?
Are staff toilets and changing facilities
clean and tidy?

Name:……………………………… Position:…………………………………….Signed:
………………………………..Date:….
*Tick frequency checks carried out by manager or supervisor:
Weekly □ Fortnightly □ Monthly □