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 List of Internal Quality System Auditors                                    :                        L:MR:05 List of Internal Process Auditors                                                 :                       L:MR:05A List of Internal Product Auditors                                                 :                       L:MR:05B Annual Internal Quality System Audit Plan                                 :                       D:MR:01 Annual Internal Process Audit Plan                                              :                       D:MR:01A Annual Internal Product Audit Plan                                               :                       D:MR:01B Internal Quality System Audit Schedule                                     :                        F:MR:04 Internal Process Audit Schedule                                                  :                     F:MR:04A Internal Product Audit Schedule                                                 :                     F:MR:04B                                                    Internal Quality System Audit Non Conformance Report         :                  F:MR:05 Internal Process Audit Non Conformance Report                       :                      F:MR:05A Internal Product Audit Non Conformance Report                       :                      F:MR:05B Internal Quality System Audit Check Sheet                                :                      F:MR:06 Internal Process Audit Check Sheet                                             :                      F:MR:06A Internal Product Audit Check Sheet                                             :                      F:MR:06B Internal Quality System Audit Summary Report                         :                     F:MR:07 Internal Process Audit Summary Sheet                                        :                     F:MR: 07A Internal Product Audit Summary Sheet                                        :                     F:MR:07B Graph of Monthly Basis (System Audit)                                      :                    G:MR:01 Graph of Monthly Basis (Process Audit)                                      :                   G:MR:01A Graph of Monthly Basis (Product Audit)                                      :                   G:MR:01B Management Review Meeting                                                       :                   F:MR:10