what is the product audit what is the procedutere of product audit
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 Audit –
Determination of effectiveness of manufacturing process audit.
·
For Product Audit – To ensure conformity
to product requirements at appropriate stages of production and delivery.
·
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. No.
|
Activity
|
Input
|
Output
|
Responsibility
|
|
1
|
System Audit:
Prepare a List of Internal Auditors based on their Qualification
(certified/ min. 3 years’ experience) for the Audit of QMS Knowledge &
Experience.
If any external agency/ auditors are used to carry out the System
Audit, ensure their qualification and experience to carry out an audit at SDU
end. For external auditors, he /she should be certified and have minimum 8
years of experience in the field of Quality Management System and
qualification certificate for carrying out an audit.
|
Certificates & Training records
|
List of Internal Quality System Auditors
L:MR:05
|
MR
|
|
2
|
Prepare an Annual Quality System Audit Plan, considering all QMS related
processes & activities as well as the results of previous audits.
- Special Focus to be given on NG Areas and Re – Planning of Audit
frequency to be revised for the same.
* Re
– Audit Criteria: - If any System/Process/Product has more than 3 NCs, Then
Re – Audit to be plan within next 2 months.
|
Manual, Procedure, Previous Quality System Audit Results (Audit
Summary sheet F:MR:07)
|
Annual Quality System Audit Plan
D:MR:01
|
MR
|
|
3
|
Prepare Audit Schedule considering the status & importance of
processes & activities and the number of shifts of operation. Ensure the
qualified and Approved auditors are used for carrying out the Audit.
|
Annual Quality System Audit Plan
D:MR:01
|
Audit Schedule
F:MR:04
|
MR
|
|
Sl. No.
|
Activity
|
Input
|
Output
|
Responsibility
|
|
4
|
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 requirement.
|
Audit Schedule & Customer Specific Requirement (D:MR:01)
|
Audit Schedule & Audit Check. List & Observation Sheet
F:MR:04
F:MR:06
|
MR
|
|
5
|
Conduct audit by the Certified auditors as per the audit schedules
& Refer audit check list or departmental procedures. Observations and Non-Conformance
are recorded in Audit Check List & Observation Sheet.
The selection of auditors and conduct of audits shall ensure
objectively and impartiality of the audit process. Auditors shall not audit
their own work.
|
Audit Schedule & Audit Check. List & Observation Sheet
F:MR:04
F:MR:06
|
Audit Check. List & Observation Sheet
F:MR:06
|
MR & Certified Auditors
|
|
6
|
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.
(b) Root cause is analyesd within 4 days
Corrective action is implemented according to type of root cause.
Corrective
Action
Target date for implementation are as following: -
(a) Action related to
documents revision & preparation within -3 days.
(b) Action related to impart in house/on job Training within 3 days.
(c) Action related to outside support within 7 days.
(d) Action Related to system Amendment within 07 days.
|
Audit Check. List & Observation Sheet
F:MR:06
|
Internal Quality System Audit Non-Conformance Report.
F:MR:05
|
MR & Certified Auditors
|
|
7
|
Summarize the all Department Audit Finding Results.
|
Internal Quality System Audit Non Conformance Report.
F:MR:05
|
Audit Summary Report
F:MR:07
|
MR
|
|
8
|
After Completed of each Audit Cycle:-
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 Customer Complaints
occur, the audit frequency shall be appropriately increased or decreased.
|
Audit Summary Report
F:MR:07,
Internal/External Non – Conformances or Customer Complaints
|
Revised Annual Audit Plan
D:MR:01
|
MR
|
|
9
|
After Re audit (if required) If any Department Found Repeated Ncs.
Inform to Management, identify and provide required resources (4M)
|
Audit Summary Report
F:MR:07
|
MRM D:MR:10
|
MR
|
|
Sl. No.
|
Activity
|
Input
|
Output
|
Responsibility
|
|
10
|
After Observe the Satisfactory Effectiveness of the Corrective
Action, non – Conformity Considered as Closed.
Effectiveness of corrective action is monitored on monthly basis till
three months and closed the NC if found satisfactory.
Make a graph monthly basis.
|
Audit Summary Report
F:MR:07
|
Audit Summary Report F:MR:07,
MRM D:MR:10
|
MR, Respective Department Heads.
|
|
11
|
Manufacturing Process Audit:
Prepare a List of Internal Process Auditors based on their
Qualification (certified/ min. 3 years’ experience) for the Audit of Process
Knowledge & Experience.
|
Experience Certificate Training Records
|
List of Process Auditors L:MR:05A
|
MR
|
|
|
12
|
Prepare an Annual Process Audit Plan, considering all processes.
Special Focus to be given on NG Areas and Re – Planning Audit for that end.
|
Manual, Procedures Previous Internal Process Audit Results (Audit
Summary Sheet F:MR:07A)
|
Annual Process Audit Plan
D:MR:01A
|
MR
|
|
|
13
|
Prepare Process Audit Schedule considering the status &
importance of processes & activities and the number of shifts of
operation. Ensure the qualified and approved auditors are used for carrying
out the Process Audit.
|
Annual Process Audit Plan
D:MR:01A
|
Process Audit Schedule F:MR:04A
|
MR
|
|
|
14
|
Process Audit Schedule is communicated to all the auditors and
auditees at at least 7 days in advance.
Process Audit Check List is Prepared for each Process. Ensure that
Process Audit Check List is Updated as per Process Requirement.
|
Process Audit Schedule & Customer Specific Requirements
D:MR:01A)
|
Process Audit Schedule & Process Audit Check List F:MR:06A F:MR:04A
|
MR
|
|
|
15
|
Carrying out audit by the auditors as per the audit schedules &
Refer audit check list or observations and non-conformance are recorded.
Verify the countermeasure and effectiveness for
Customer Complaint / Internal Problems & Previous Audit findings.
|
Process Audit Schedule & Process Audit Check List F:MR:06A F:MR:04A
|
Audit Check List & Observation Sheet F:MR:06A
|
MR & Auditors
|
|
|
Sl. No.
|
Activity
|
Input
|
Output
|
Responsibility
|
|
|
16
|
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.
Corrective
Action :-
Target date for implementation are as following :-
(1) Action related to
documents revision & preparation within -3 days.
(c) Action related
to impart in house/on job Training within 3 days.
(d) Action related
to outside support within 7 days.
Action Related to system Amendment within 07 days.
|
Audit Check List & Observation Sheet F:MR:06A
|
Internal Process Audit Non – Conformances Report F:MR:05A
|
MR & Auditors
|
|
|
17
|
Summarize the all Department Audit Finding Results.
|
Internal Process Audit Non – Conformances Report F:MR:05A
|
Audit Summary Report F:MR:07A
|
MR
|
|
|
18
|
After Completed of each Manufacturing Process Audit Cycle:-
a) Process Audit Result Summary is prepared and Audit Results are
Reviewed.
b) Process Audit Plan will be Reviewed based on Result Findings.
|
Audit Summary Report F:MR:07A
Internal / External Non – Conformance or Customer Complaint
|
Revised Annual Process Audit Plan
D:MR:01A
|
MR
|
|
|
19
|
After Re – Audit If any Process Found Repeated Ncs. Inform to
Management, identify and provide required resources (4M)
|
Audit Summary Report F:MR:07A
|
MRM F:MR:10
|
MR
|
|
|
20
|
After Observe the Satisfactory Effectiveness of the Corrective
Action, non – Conformity Considered as Closed.
Effectiveness of corrective action is monitored for 15 days and
closed the NC if found satisfactory
Make a Graph monthly basis.
|
Audit Summary Report F:MR:07A &
MRM F:MR:10
|
Audit Summary Report
F:MR:07A
Graph
G:MR:01A
|
MR, Respective Department Heads.
|
|
 |
|||||
|
Sl. No.
|
Activity
|
Input
|
Output
|
Responsibility
|
|
|
21
|
Product Audit:
Prepare a List of Internal Product Auditors based on their
Qualification (certified/ min. 3 years’ experience) for the Audit of Product
Knowledge & Experience.
|
Work Experience Training Records
|
List of Product Auditors
L:MR:05B
|
MR
|
|
|
22
|
Prepare an Annual Product Audit Plan, considering all products.
Special Focus to be given on NG Products and Re – Planning Audit for that
product audit plan is prepared by considering the status & importance of
products. Ensure the Product Knowledge auditors are used for carrying out the
Product Audit.
|
Manual, Procedures Previous Product Audit Results (Audit Summary
Sheet F:MR:07B)
|
Annual Product Audit Plan
D:MR:01B
|
MR
|
|
|
23
|
Samples for product audit is picked randomly basis from the finished
product stage. Product audit is carried as per defined control plan.
|
Annual Product Audit Plan
D:MR:01B Control Plan & SOP
|
Product Audit Schedule F:MR:04B
|
Auditors
|
|
|
24
|
Carrying out audit by the auditors as per the audit schedules &
Refer audit check list or departmental procedures and quality issues occurs at
Customer end and internally. Also Check its countermeasure, action &
effectiveness during Audit.
Observations are recorded in Audit Observation Sheet.
|
Product Audit Schedule & Customer Specific Requirements
(D:MR:01B)
|
Product Audit Schedule & Product Audit Check List & Observation
Sheet F:MR:04B F:MR:06B
|
Auditors
|
|
|
25
|
Correction and Corrective Action is Initiated for the identified Non
– Conformity. Correction is Associated as Following Steps: -
Correction: -
a) Identify the Suspected Quantity & Traceability and Hold the
Material.
B) Immediate Inform to Dispatch & QA In charge.
C) Segregate the Entire Quantity and Disposition Accordingly.
Corrective Action: -
Corrective Action is Associated Following Steps: -
a) Corrective action is implemented according to type of root cause.
Target date for implementation are as following: -
b) Action related to documents revision & preparation within -3
days.
c) Action related to impart in-house/on job Training within 3 days.
d) Action related to outside support within 7 days.
Action Related to system Amendment within 07 days.
|
Audit Check List & Observation Sheet F:MR:06B
|
Action on Non – Conformances F:MR:05B
|
MR & auditors’
|
|
|
Sl. No.
|
Activity
|
Input
|
Output
|
Responsibility
|
|
|
26
|
Summarize the all Product Audit Finding Results
|
Audit Non – Conformance Report
F :MR :05B
|
Audit Summary Report F:MR:07B
|
MR
|
|
|
27
|
After Completed of each Product Audit Cycle: -
a) Product Audit Result Summary is prepared and Audit Results are
Reviewed.
b) Product Audit Plan will be Reviewed based on Result Findings.
|
Audit Summary Report F:MR:07B Internal & External Non –
Conformities or Customer Complaints
|
Revised Annual Product Audit Plan D:MR:01B
|
MR
|
|
|
28
|
After Re – Audit If any Product Found Repeated Ncs. Inform to
Management, identify and provide the required resources. (4M)
|
Audit Summary Report F:MR:07B
|
MRM D:MR:10
|
MR
|
|
|
29
|
After Observe the Satisfactory Effectiveness of the Corrective
Action, non – Conformity Considered as Closed.
Effectiveness of corrective action is monitored for 15 days and
closed the NC if found satisfactory.
Make a graph monthly basis.
|
Audit Summary Report MR:07B & MRM
F:MR:10
|
Audit Summary Report
F:MR:07B
Graph
G:MR:01B
|
Respective Dept. Head /in charge
|
|
 |
|||||
|
30
|
Top Management Audit:
-
It is an audit
conducted by the president or Managing Director and / or C.E.O. of the
company.
It could be once or twice in a year.
|
Suggestions by Top Management
|
Improvement Points / Gaps
|
Top Management
|
|
|
|
|
|
|
|
|
5. Document
Reference
|
|||||
Comments
Post a Comment