Document Name Process for Control of Non-Conforming Product Revision History # 1 2 3 4 5 6 7 Version 1.

0 Date 25-Mar-04 Rationale for change Initial Version

Doc. ID Version No Date

CN 1.0 25-Mar-04

Change Description -

Author Dinesh Kale

Reviewed and Approved By Vamsi Chelluri

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Document Name Process for Control of Non-Conforming Product

Doc. ID Version No Date

CN 1.0 25-Mar-04

Table Of Contents PROCESS SUMMARY.......................................................................................................................3 REFERENCES.....................................................................................................................................3 DEFINITIONS AND ACRONYMS...................................................................................................3 ORGANIZATION POLICY...............................................................................................................3 PROCESS INPUTS.............................................................................................................................4 ENTRY CRITERIA.............................................................................................................................5 PROCEDURE......................................................................................................................................5 VALIDATION CRITERIA.................................................................................................................8 QUALITY RECORDS........................................................................................................................8 PROCESS DELIVERABLES.............................................................................................................8 MEASUREMENT AND ANALYSIS.................................................................................................8 EXIT CRITERIA.................................................................................................................................8 ANNEXURE.........................................................................................................................................8

Author Dinesh Kale

Reviewed and Approved By Vamsi Chelluri

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Document Name Process for Control of Non-Conforming Product

Doc. ID Version No Date

CN 1.0 25-Mar-04

Process Summary The Control of NC Process applies to all the functions at SEAL, which includes projects, HR, purchase, system administration, Facilities, quality and management functions. The purpose of this process is to objectively review processes and work products against the respective procedures and standards and provide an objective insight to the management and project staff . Any deviation with respect to the project plan, customer specifications, and defined operational process of the projects and/or the defined QMS shall be treated as non-conformance and is applicable to all the processes. The Corrective action focuses on improving the processes established in the organization thereby improving the organization quality system as a whole. This process leads to analyze defects and problems relating to Quality, determine the root causes identified in the system/process/product and initiate Corrective action as well as monitor the effectiveness of corrective action. References CMMI ISO 9001:2000 Clause 8.3, 8.5.2 Process Area Process and Product Quality Assurance

Major Clause Name: Measurement, Analysis and Improvement Definitions and Acronyms MR PO QT QM FARG PIC TR Management Representative Process Owner Quality Team Quality Manager Functional Area Representative Process Improvement Committee Technical Review Team

Organization policy

Author Dinesh Kale

Reviewed and Approved By Vamsi Chelluri

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Document Name Process for Control of Non-Conforming Product Process Inputs 1. Review Results 2. Test Results 3. Incoming Goods Inspection Report 4. Audit reports 5. Customer Complaints

Doc. ID Version No Date

CN 1.0 25-Mar-04

Author Dinesh Kale

Reviewed and Approved By Vamsi Chelluri

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Document Name Process for Control of Non-Conforming Product

Doc. ID Version No Date

CN 1.0 25-Mar-04

Entry Criteria 1. Identified Defects/Bugs in the products/Items. 2. Customer Complaint Details. 3. Audit Non-Conformance Report. 1. PPQA review directed by the Head of Quality Management 2. PPQA activities as triggered by the project plan or PPQA Plan Procedure 1. 1.1 Plan for Process and Product Quality Assurance Based on the software development activities and the projects undertaken, scope out the PPQA program and its activities such as evaluation of processes, work products and services in the organization.(QH,PEG,SC) Define the roles & responsibilities required to perform the PPQA activities.(QH, QT ,SC) Identify the human resource required to perform the PPQA activities. This could consist of dedicated SQA or part-time SQA.(QH,PEG,SC) Assign PPQA responsibilities to the resources identified and provide training where required. (QH,SC) Establish the reporting relationship for individuals who perform the PPQA function in such way that it ensures required objectivity and independence. (QH, SC) Describe the interface between PPQA and QT.(QH,SC) Establish PPQA procedures, tools, methods for reviewing, reporting, escalating. (QH,QT,SC) Document the above arrangements in a PPQA plan.(QH, QT) Initiate Review of the PPQA Plan.(QH,QT) Perform PPQA Activities Plan and schedule the project-related PPQA activities in the project plan and execute it as per project plan.(PM,SQA) Objectively evaluate the designated processes, work products and services against the applicable processes, standards and procedures of the project as per the project plan and PPQA Plan.(SQA) Periodically report the outcome of PPQA reviews to the Quality Team and to the project manager.(SQA) Author Dinesh Kale Reviewed and Approved By Vamsi Chelluri Page 5 of 8

1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2. 2.1 2.2

2.3

Document Name Process for Control of Non-Conforming Product 1.

Doc. ID Version No Date

CN 1.0 25-Mar-04

2. Identification and Control of NC 1.1 Any deviation with respect to the project plan, customer specificationsWork products, and defined operational process of the projects and/or the defined QMS shall be treated as non-conformance and is applicable to all the processes. 1.2 The identified Non-Conformance should be recorded in the PPQA review log respective records and necessary corrections to be taken. 3. Correction Actions for Non Conformance 2.1 The correction to be taken on Process / Product Non-Conformance can be one of the following: a) Continue using the non-conforming product after getting customer and management concurrence (authorization under concession by the Senior Management), which will be reflected through the management summary Report b) Rework b) Rejection 4. Re-verification/Testing after Correction 3.1 The Re-verification/Testing to be done after correction of deviations/defects/faults/issues in the respective process/product. 3.2 The result of re-verification/testing details should be logged in respective records. 3.3 The corrective actions would be initiated after correction of Non-Conformance in process/product in order to avoid re-occurrence of Non Conformance. 5. Corrective Action Corrective action is the action taken to eliminate the cause of non-conformities in order to prevent recurrence. 4.1 Investigating the root cause of non-conformities relating to the product, process and the quality system, and recording the results. 4.2 Determining the corrective action needed to eliminate the cause of the nonconformities. 4.3 Following-up to ensure that this corrective action is taken and that it is effective. 4.4 Update the PPQA review log for closure Details. 6. Initiation and Verification of corrective action: 5.1 All defects and problems identified in a product will be prioritized. While prioritizing, consideration may be given to the following: 1. Frequency of occurrence 2. Impact on quality, cost and schedule Author Dinesh Kale Reviewed and Approved By Vamsi Chelluri Page 6 of 8

Document Name Process for Control of Non-Conforming Product 3. Source of the defect or problem

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CN 1.0 25-Mar-04

5.2 Causes of high priority defects and problems will be investigated and recorded in the Root Cause Analysis Report. 5.3 High priority defects are those that are, in the opinion of the Project Management, repetitive in nature and have a significant impact on the project schedule, costs and product quality. 5.4 Causes may include one or more of the following: 1. Inadequate inputs from clients 2. Insufficient standards 3. Inadequate skill levels 4. Lack of training 5. Lack of documentation 6. Lack of communication 7. Inappropriate methodology or process 8. Inadequacy of using tools. 9. Poor Planning 10. Insufficient Time 5.5 The Root causes of problems can be analyzed with help of statistical tools such as Fishbone diagram, Histogram Chart, Pareto chart etc., 5.6 After analyzing the causes of problems, appropriate corrective action will be identified and recorded in the Corrective Action Plan. 5.7 The time period by which the corrective action is to be implemented will also be recorded. 5.8 The effectiveness of corrective action would be verified as per corrective action plan. This would lead to improve the system/process continually across the Organization.

Author Dinesh Kale

Reviewed and Approved By Vamsi Chelluri

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Document Name Process for Control of Non-Conforming Product

Doc. ID Version No Date

CN 1.0 25-Mar-04

Validation Criteria 1. Review of records on Re-Verification/Re-Testing of actions on the detected Non conformance. 2. 2. Verification of records on effectiveness of corrective action 1. Technical Review of the PPQA Plan Quality Records Root Cause Analysis Report Review record of PPQA Plan .

Process Deliverables 1. Closure of Non-Conformance Verification Report/Defect Report/PPQA review log.

Measurement and Analysis 1. No of times Re-Verification/Re-Testing carried out. Exit Criteria

2. Closure of PPQA issues identified in PPQA reviews Correction and Corrective action taken for all detected Non Conformance. Annexure 1. Template for Root Cause Analysis Report.

Author Dinesh Kale

Reviewed and Approved By Vamsi Chelluri

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