EMCO ELECTRONICS. DOC. TITLE : Procedure for Design and Development

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1 DOC. TITLE : Procedure for and Development Page. 1 of 8 Doc. Issue. 1.0 PURPOSE To ensure that the design and development of products including design changes, is controlled through planning, implementation, review, verification and validation. 2.0 SCOPE All products developed by EMCO ELECTRONICS for manufacturing.0 REFERENCES DD Format DD Format DD00-40 Format DD Format DD Format DD Format DC00-40 Format ITXX Format PD Procedure MK Procedure DC Procedure -" Plan" -" Change " -" Review Redord" -"Summary of Measures" -"Check list for Input Adequacy" -"List of Outputs" -"Masterlist of Documents (Internal)" -"Test Reports" -"Procedure for Production" -"Procedure for Contract Review" -"Procedure for Document and Data Control" 4.0 ANNEXURES : Annexure A - Process Maps & Flow-Charts Annexure B - s Table

2 DOC. TITLE : Procedure for and Development Page. 2 of 8 Doc. Issue. Annexure A - PROCESS MAPS & FLOW-CHARTS Process Owner : Head Process Controls : --- Process Performance Targets : Completion as per plan Actual cost not exceeding 5% of planned cost Process Inputs : Specific Customer requirement Customer Feedback Process Name : and Development Process Outputs : Plan Verification s Validation s Review s Change s Process Verification : Through Auditing and Process Performance Measures Process Resources (Means): Availability of softwares Process Measures (Metrics) : % Delay in implementation. (DD00-404) % Actual cost : Planned cost (DD00-404)

3 DOC. TITLE : Procedure for and Development Page. of 8 Doc. Issue. and Development Process: New product / n-standard product / change requirement from Marketing through Input Input change D input specification New product n-standard E Check list for Input Adequacy A1.1 Review of Input specification for adequacy as per Check list for input Adequacy DD Customer Drawings / Samples Information adequate? A1.2 Obtain necessary information through marketing Sales Engr. Input List of Outputs A1. Preparation of & Development Plan, indicating the following : & development stages Review, verification & validation as appropriate to each stage Defined responsibilities Review & updation of plan Plan DD DD Input A1.4 Preparation of appropriate & Development Outputs as per list of outputs Outputs Customer Drawings / Samples A

4 DOC. TITLE : Procedure for and Development Page. 4 of 8 Doc. Issue. Input A Plan DD Customer Drawings / Samples A1.5 Verification of Outputs at the stages defined in the & Development plan for confirming that the same have met the Input specification. Results of Verification are ed. Verification Outputs Output OK? A1.6 Correction of the design outputs, as required to ensure that the same meet the Input s Plan DD Outputs A1.7 Review of & Development Outputs with concerned functions, (namely marketing, purchase, production, QA, service as applicable), at the stages defined in the & development plan, for confirming that there are no concerns, issues relating to : 'marketability' 'procurability ' 'manufacturability' 'testability' 'servicaability' Review DD00-40 Any comments / changes required? B A1.8 Correction of the outputs as per the comments / changes required by the concerned functions

5 DOC. TITLE : Procedure for and Development Page. 5 of 8 Doc. Issue. B Customer approval required? A1.9 Forwarding of required drawings / documents to marketing for obtaining customer's approval A2.2 Manufacturing of prototype Drawings / Documents approved? F Functional Verification Checklist A2. Testing of prototype Test Report (Product) ITxx-402 Functional Verification OK Necessary changes/ modifications cariied out F A2.1 Modification of drawings / documents as per customer's comments and re-submission to customer for approval A2.4 Prototype send to customer where agreed for field test and feedback A2.5 Updating of Master-list for the final drawings / documents C Master List of Documents (Internal) DC00-40

6 DOC. TITLE : Procedure for and Development C Page. 6 of 8 Doc. Issue. A2.6 Manufacturing of Pilot Batch where necessary, as per manufacturing process Prod. sup Procedure for Production PD A2.7 Final Inspection and testing of Pilot Batch as per procedure for production, as validation of design Prod. sup Test Report ITxx-402 Test Results OK? Procedure for Document and Data Control DC A2.9 Release of drawings / Documents to production / QA / Stores as per procedure for Document and Data Control A2.8 Necessary modifications / changes carried out and drawings updated for the same D Change A.0 Changes are implemented as per requirement A.1 A.2 Changes are verified, revieved & validated as appropriate including effect of changes on existing design Results are recorded in Change Related Documents are revised & Change is updated Change DD Change DD00-402

7 DOC. TITLE : Procedure for and Development Page. 7 of 8 Doc. Issue. E Procedure for Contract Review MK A.4 Changes related to n-standard requirement from customer which has been reviewed & accepted as reffered in procedure for contract review are carried out as under : Changes are worked out & where required, the same are verified and reviewed to ensure that they meet the changed requirements and to identify any problems in implementing the changes. Necessary instructions for implementing such changes is given to various Departments through Memo for nstandard requirements including any changes required in the inspection and testing of the product wherever necessary. The changes are validated through inprocess final testing and recorded in the test report wherever practicable and applicable. Memo for n- Std Requirement Test Report ITXX-402

8 DOC. TITLE : Procedure for and Development Page. 8 of 8 Doc. Issue. RECORDS TABLE Sr.. FILE REFERENCE FILE DESCRIPTION LOCATION MAINTAINED BY RETENTION PERIOD 1. DD (Product) " File". - Plan (DD00-401) - Review (DD00-40) - Verification / Validation R & D Department R & D Head Years 2. DD " Change File". - Changes - Change (DD00-402) - Change Verification / Validation R & D Department R & D Head Years