DOC. No.

: IF/QMS/07
PROCEDURE FOR INTERNAL AUDIT REV. No.& Date : 01&
(System, Process & Product Audit) 13.01.23
Efft. Date :-01.04.16

.
1. Purpose: To establish a Procedure for Internal Audit of Quality Management System
and to ensure whether the Quality Management System confirms –

 For Quality System Audit – Organization’s Processes and their related results comply with
planned arrangements and to ensure the effective implementation.
 For Manufacturing Process & Product Audit – Determination of effectiveness of
manufacturing process.
 Product Audit - to ensure conformity to product requirements at appropriate stages of
production and delivery to verify the conformity to all specified requirements, such as
dimensions, packaging, functionality and labeling.
 All customer specific requirements.

2. Scope: Applicable to all the following:

1. Organization Quality Management System.
2. Manufacturing Process Audit
3. Product Audit.

3. Responsibility: MR (Management Representative)

4. Procedure Steps:

Sl.
Activity Reference Responsibility
No.
System Audit:

1.Prepare a List of Internal Auditors based on List of Internal

their Qualification (Min. Graduate or Diploma) Quality System
MR
1 for the Audit of QMS, Knowledge & Experience. Auditors
(Minimum 2 years) with internal audit (IF/MR/F/06
certificate.
2.Minimum Audit conduct at least one audit each
cycle.

Annual Quality
Prepare Internal Audit Plan (frequency twice in
System Audit MR
2 a year), considering all QMS related processes &
Plan
activities as well as the results of previous audits.

Prepare Audit Schedule considering the status &

importance of processes & activities and the
Audit Schedule MR
3 number of shifts of operation. Ensure the
qualified and Approved auditors are used for
carrying out the Audit.
 DOC. No. : IF/QMS/07
PROCEDURE FOR INTERNAL AUDIT REV. No.& Date : 01&
(System, Process & Product Audit) 13.01.23
Efft. Date :-01.04.16

Audit Schedule is communicated to all the

auditors and auditees at least 7 days in advance.
Audit Check List is Prepared for each Process
ensuring that Audit Check List is Updated as per
QMS Standard and Customer Specific Audit Schedule
requirement. & Audit Check.
MR
4 Note: Audit schedule in both shift (A&B) List &
If both shifts running then – Observation
Production department, maintenance, quality, Sheet
store department
If production is not running in both shift then
twice audit in same shift otherwise audit
conducted both shift
All department audit observation report submitted
by the second day of last day of audit
Then inform to top management.

Communicate the non-conformances to

concerned auditees for taking appropriate actions
on the same. The corrective action on the
identified Non-conformance is initiated. For non
conformance, following action is initiated:
(a) Correction done immediately. Internal Quality
(b) Root cause is analyzed within one week System Audit
MR & Certified
Corrective action is implemented according to Non
5 Auditors
type of root cause. Conformance
After observation NC closer report review by top Report.
management
Audit observation signification as like that

O+ :-Positive Observation:- Major Non

conformity
O-:-Minor NC (Negative Observation) :-
Opportunity for improvement
Corrective Action
Target date for implementation are as following :-
(a) Close all observations within one month

Summarize the all Department Audit Finding Audit Summary MR

6
Results. Report
 DOC. No. : IF/QMS/07
PROCEDURE FOR INTERNAL AUDIT REV. No.& Date : 01&
(System, Process & Product Audit) 13.01.23
Efft. Date :-01.04.16

After Completed of each Audit Cycle:-

MR
a) Audit Result Summary is prepared and Audit
Results are Reviewed.
b) Audit Plan will be Reviewed and Revised
based on Audit Results (If Required)
c) When internal / External Nonconformities or Revised Annual
7 Customer Complaints occur, the audit frequency Audit Plan
shall be appropriately increased or decreased.

Effectiveness of corrective action is monitored

for 03 month and closed the NC if found
satisfactory for internal audit

Manufacturing Process /Product Audit:

Prepare a List of Internal Process and Product List of Process and

MR
8 Auditors based on their Qualification, Product Auditors
Knowledge and experience for the product and
process audit. (Criteria: Qualification Min
Diploma & Min 2 year experience )
Prepare an Annual Process and Product Audit
Plan, considering all processes and products.
Special Focus to be given on NG Areas of
Annual Process and
previous audit, customer compliant action MR
9 Product Audit Plan
taken history, action taken on customer visit
observations.
Process & product audit frequency once in a
year
Prepare Process and product Audit Schedule
considering the status & importance of
processes and product activities and the Process and Product MR
10
number of shifts of operation. Ensure the Audit Schedule
qualified and approved auditors are used for
carrying out the Process and product Audit.
11 11A:- Process and Product Audit Schedule is
communicated to all the auditors and auditees
at least 7 days in advance. Process and product
1:- Process and Product Audit Check List is Audit Schedule &
MR
prepared. Ensure that Process and Product Process and
Audit Check List is updated as per Product and product Audit Check
Process requirement if any. List
2:- Process / Product audit as per define
process and product control plan.
11B:-Process for written in process and product audit check sheet and control plan.
 During process audit, in process/Product audit check sheet written actual observation
with proper checking point as like document number and rev. No.& about about
 DOC. No. : IF/QMS/07
PROCEDURE FOR INTERNAL AUDIT REV. No.& Date : 01&
(System, Process & Product Audit) 13.01.23
Efft. Date :-01.04.16

document check point

 In control plan written product and process parameter as per physical observation
written in value or word as per requirement
 During Process/Product audit all process should be cover, if any process not cover then
take in next plan to cover all process.

Carrying out audit by the auditors as per the

audit schedule & Refer audit check list or
observations and non conformance are
recorded.
Verify the countermeasure and effectiveness Audit Check List & MR & Auditors
12 for Customer Complaint / Internal Problems Observation Sheet
& Previous Audit finding, Customer visit
observation).
Major NC:- Directly issue to customer
Minor NC:- Directly issue does not effect to
customer.
Communicate the non-conformances to
concerned auditees for taking appropriate
actions on the same. The corrective action on
the identified Non-conformance is initiated as
per following Action.
a) Correction done immediately.
b) Root cause is analyzed within 4 days
c) Corrective action is implemented
according to type of root cause. Internal Process and
Corrective Action :- Product Audit Non – MR & Auditors
13
Target date for implementation are as Conformances
following :- Report
(1) Action related to documents revision &
preparation within –one week.
(c) Action related to impart in house/on job
Training within fifteen days.
(d) Action related to outside support within
two week
Action Related to system Amendment within
fifteen days.

Summarize the all Department Audit Finding Audit Summary MR

14
Results. Report
 DOC. No. : IF/QMS/07
PROCEDURE FOR INTERNAL AUDIT REV. No.& Date : 01&
(System, Process & Product Audit) 13.01.23
Efft. Date :-01.04.16

After Completed of each Manufacturing Audit NC Report

Process and Product Audit Cycle:
A) NC to be raised to concerned department NC Summary
B) Process and Product Audit NC Summary Report
MR
15 report is prepared
Revised Annual
C) Process and product Audit Plan will be Process/Product
Reviewed based on Result Findings if Audit Plan
applicable

After Observe the Satisfactory Effectiveness of

the Corrective Action, Non- Conformity
Considered as Closed. Audit Summary MR, Respective
16
Effectiveness of corrective action is monitored Report Department Heads.
for 03 month and closed the NC if found
satisfactory.

AUDIT FREQUENCY
Once in a six month
if more than 5 NC in
Quality Management System (Internal Audit) Management
01 a dept audit, then
Representative
again re audit in next
one month
Once in a year if
more than 5 NC in a Management
02 Process Quality Audit
audit ,then again re Representative
audit in next 2 month
Once in a year if
more than 5 NC in a Management
03 Product Quality Audit
audit, then again re Representative
audit in next 2 month
Records

1. LIST OF INTERNAL AUDITOR Cum Competency Matrix :- IF/MR/10

2. Internal Audit Schedule. :- IF/MR/15
3. INTERNAL QUALITY SYSTEM AUDIT PLAN. :- IF/MR/09
4. Internal Audit Check sheet Cum Observation Report:- IF/MR/14
5. Audit Observation Sheet :- IF/MR/16
6. NON CONFORMANCE REVIEW :-IF/MR/17
7. Process & Product Audit Plan :- IF/MR/11
8. Process & Product Audit check sheet :- IF/MR/12
9. AUDIT NON–CONFORMANCE REPORT :- IF/MR/13
10. Organization structure :- IF/MR/01
11. Plant Layout :- IF/MR/02
12. List of Process & Product Auditor :- IF/MR/08
13. PROCESS/PRODUCT AUDIT AS PER CONTROL PLAN :- IF/MR/19
14. Audit Summary Report Sheet ( NC CLAUSE-WISE/DEPTWISE ANALYSIS REPORT ) IF/MR/25
 DOC. No. : IF/QMS/07
PROCEDURE FOR INTERNAL AUDIT REV. No.& Date : 01&
(System, Process & Product Audit) 13.01.23
Efft. Date :-01.04.16

02 20.01.2023 Non Conformance Report to be raised Mr. Jagmohan Mr. R. K Dubey

& NC Summary Report to be
prepared during product & process
audit
01 13/01/2022 Qualification (Min. Graduate or Mr. Manish Mr. R.K. Dubey
Diploma) for the Audit of QMS Sharma
Knowledge & Experience.
(Minimum 2 years) & both shift
audit point included & NC
Review 03 months
Rev No Rev Date Amendment detail Prepared By Approved By

PREPARED BY:- APPROVED BY:-

PREPARED BY:- APPROVED BY:-