Parth Auditing of Production Department-1
Parth Auditing of Production Department-1
Parth Auditing of Production Department-1
QA (semester -2)
Subject : AUDIT AND REGULATORY
COMPLIANCE
PATEL PARTH U.
M.pharm. QA, sem-2
Shree s.k.patel collage of pharmaceutical education & research
GANPAT UNIVERSITY
content
Introduction
auditing of production department
Process audit
Objective of process audit
Production audit
What’s Included in a Manufacturing Audit?
Cheak list of production audit
references
Introduction
STEP-1:- planning
STEP-2:- notification
STEP-3:- opening meeting
STEP-4:- Fieldwork
STEP-5:- report drafting
STEP-6:- management response
STEP-7:- closing meeting
STEP-8:- final audit report distribution
STEP-9:- follow up
What’s Included in a Manufacturing Audit?
There are many aspects of an audit that can tell you a lot about a
factory and supplier.
The following are….
Manufacturer’s background
Manpower
Production capability Machine facilities & equipment
Manufacturing process & production line
in-house quality system such as testing & inspection
Management system & capability
Environment
A General
1. Proper reporting is done by assistants to
respective division in charge & further reporting
by in charge to immediate boss
2. Proper listing of products with their respective
codes and brand names
3. The record for no. of labour required to work at
each machine for standard production is
maintained as per given format
4. Calculation of idle time is done on percentage
basis and in case the idle time exceeds 25% the
reporting of the same to the higher
management on daily/weekly basis with proper
reasons
5. Calculation of overtime and recording of the
same is done by the Production Manger and he
further reports it monthly to the Unit head and
the HR coordinator of the unit.
6. The total area covered by the production floor
with its utility including storage for raw and
finished goods is recorded in prescribed format.
B Machinery
1. Fixed Assets Register is maintained & updated in the
prescribed format
2. Proper coding for each capital asset
3. New Machinery
a. The requirement of new machines can arise due to
following reasons:
- Increase in demand
- Change in technology
- Change in product line
- Increase in production
b. Proper assessment is done by Production Manager/In
charge approved by the Unit Head
c. Requisition to the purchase department is sent for
further processing as per purchase and inventory
policy of the Company based on Quotation Analysis.
d. The new machines is properly installed in supervision
of the Technical person and the Unit Head and the
reporting of the same is done to the higher
management after installation.
4. Capacity Analysis of machines is done in the
prescribed format
- Error in machine
- Raw material quality issues
- Power cut with prior information
·
- Labour mistake
- All other wastage which is not normal
3. The wastage is properly recorded in the
wastage register/sheet on daily basis along
with proper reasons and it is shown in the
production MIS in the prescribed format.