Parth Auditing of Production Department-1

M.Pharm.
QA (semester -2)
Subject : AUDIT AND REGULATORY
COMPLIANCE
Introduction and objectives to auditing

of production department
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
 Auditing is the on-site verification activity, such as inspection or

examination, of a process or quality system, to ensure compliance
to requirements. An audit can apply to an entire organization or
might be specific to a function, process, or production step.
 In production department generally three type of audit is conducted.
1. Internal audit:- by company own staff
2. External audit:-this is conducted by another company person and
team.
3. Third party audit:- they conducted by regulatory body and
government authorities.
auditing of production department
 Production process is defined as a process of making and fabricating by

converting the raw material (input) to finished good (output). An audit is the
examination, verification, evaluation, assessment, and check activities. Hence,
the production process audit can be defined as an activity to evaluate the process
of making and fabricating for its effectiveness and efficiency.
 Process audit, product audit and system audit are an integral part of auditing of
production department.
 All three are interrelated with each other . All are equally important but
viewpoint is different.
 System audit is focus on quality capability of quality management system.
 Process audit is generally focus on quality capability of products and their
process.
 Product audit is focus on quality characteristics of finished products.
Process audit
 Process Audit focuses on the product quality and the associated processes to
determine the quality capability of selected products and product groups and
their processes.
 The objective of process audit is to determine the production capability to
deliver products and services to satisfy the customer requirements in terms of
safety, quality, and quantity.
 The process audit is an examination to determine the process effectiveness
and efficiency using standard operating procedures(SOPs), control plan,
work instructions, process quality check sheet(PQCS), and customer-specific
required approaches and ensuring an output being achieved its intended
purpose.
Objective of process audit
 During the audit of the production process, study and analysis is carried
out with respect to seven attributes of the process namely:-
(i) effectiveness of the process technology for the desired product
(ii) process efficiency
(iii) process productivity
(iv) process availability
(v) process reliability
(vi) compliance with regulatory norms
(vii) safety and hazards related issues
 The audit is normally undertaken to verify whether the production
process is operating within the specified limits and achieving the
specified targets
 The audit of the production process examines the process from inputs to
the outputs and evaluates all the sequential process steps and the
interactions of these steps with each other and with the overall system.
Production audit
 Product audit focuses on checking product complies with specification by
assessing the quality characteristics of finished products or semi-finished
products.
 Product audit is an action to verify or validate the output of product
characteristics in each stage of manufacturing processes.
 It covers all the manufacturing stages starting from receiving raw material to
the final finished product including packaging and labeling. Any deviation
during product audit indicates the weakness in manufacturing processes.
 The quality documents like a process flow chart, control plan, quality plan or
quality inspection standard, etc. are used for conducting the audit.
 that the measuring instruments and gauges must be calibrated which are to be
used for checking the product characteristics like length, width, height, and,
diameter, etc.
PRODUCTION AUDIT PLAN AND PROCESS
 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
Check list of production audit

particulars Checked by remarks
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
5. The upkeep and maintenance of machine is done

on regular basis so as to increase their life and
proper track of the machine overhauling is
maintained in the prescribed format.
6. Separate machine log book is maintained and

updated
7. User manual/instruction kit of machines is
displayed through charts and hoardings at
various places of factory.
8. Machine maintenance chart is displayed and

updated for each machine near by the machine
itself.
9. Proper reporting of machine breakdown/shout
down is done by production in charge to unit
head with valid reasons
10. Shut down for more than 3 hours is reported to

Unit Head which further reports to higher
management
C Raw material
1. Need assessment is done by the Store-keeper and the

authorization is done by the Production Manager/In
charge.
2. Purchase of raw material is done as per the Purchase
Policy
3. The Quality Controller properly verifies the quality of
the raw material by taking samples and records the
same in prescribed format.
4. In case the quality of the raw material is not of good

quality, the reporting of the same is done to the Unit
Head and higher Management .The whole lot of raw
material is stored separately and Material Return Form
is filled by the Store keeper, duly verified by the
Quality Controller.
5. The raw material to the production is issued by the
storekeeper/store in-charge after signing the issue slip.
The production in-charge give its receiving through its
initials on the issue slip after properly weighing the
material issued.
6. The issue of raw material for production is on the basis

of production plan which is based on demand &
availability
D. PROCESS
- Method of production followed by Company
- Job Method
- Batch Method
- Flow/Process Method
- Uniform Method
E. Finished goods
1. The production Manager verifies the final product
according to the standard production plan and records the
same with deviations, if any in respect of quality and
quantity both.
a. Quantity Analysis is done by the Production Manager as
set out in master chart of the particular product.
b. Quality Analysis is done by the Quality Controller for the
finished goods. The Master Card for the quality check is
pasted at each such place where the production process is
carried on.
2. Samples taken for above purpose are recorded in the
quality check register. Verify the no. of samples taken per
lot of production.
3. The finished goods inventory is maintained as per the
Purchase and Inventory Policy of the Company
F. Wastage
1. Proper classification of wastage is done into
Normal & Abnormal.
2. Classification as abnormal is done if wastage

is occurred due to the following
- 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.
4. The monthly average wastage is properly

calculated and if the wastage exceeds the
standard wastage than necessary steps to
reduce the wastage are taken
Reference:-
 AUDIT AND REGULATORY BCOMPLIANCE By Dr . Prem Goel,
Pg No: 3.1 to 3.33
 AUDIT REPORT MANUFACTURING DEPARTMENT, OZONE
EXCELLENCE CONSULTING, page no: 5.
 Matson J.B., and McFarlane, D.C., (1999) “Assessing the
responsiveness of existing production operation”,
 International Journal of Operations and Production Management. Vol
19 No 8, pp. 765-784.

Parth Auditing of Production Department-1

Uploaded by

Copyright:

Available Formats

Parth Auditing of Production Department-1

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Parth Auditing of Production Department-1

Uploaded by

Copyright:

Available Formats

M.Pharm.

Introduction and objectives to auditing

 Auditing is the on-site verification activity, such as inspection or

 Production process is defined as a process of making and fabricating by

Check list of production audit

5. The upkeep and maintenance of machine is done

6. Separate machine log book is maintained and

8. Machine maintenance chart is displayed and

10. Shut down for more than 3 hours is reported to

1. Need assessment is done by the Store-keeper and the

4. In case the quality of the raw material is not of good

6. The issue of raw material for production is on the basis

2. Classification as abnormal is done if wastage

4. The monthly average wastage is properly

You might also like