Change control procedure
The purpose of procedure is to ensure that changes as required by customer or as required for product / process improvement is implemented effectively in manufacturing.
The procedure of change control is establish, maintain and update for conducting changes as per customer requirements or changes made to improvement, enhancement to improvement system, identification of mistakes in product / processes to improvements are implement and effectively deploy in the manufacturing. The change control procedure is unique process that directly concern with product or process that product quality is depends on the system are needs to improve, manage product / process enhancement, amendment or alteration to effective actions that improve product quality. The procedure covered effective changes in product drawing / specifications as received from customers, any changes through necessary for product or process improvement, the management should be actively involve to improve the product / process that concern drawing and specification of the product and its change implementation in current system.
Change control procedure is deployed in the system by management representative, and responsible for preparation of documentation, guidelines and instructions notes to concern departments, hence general manager is responsible for implementation of change controls at the places are identified for the implementation and amendment the process. Generally the change controls are established on the change request by change letter from customers, or inputs from internal department that change request or suggestions received form any person working in manufacturing processes.
The process is manage whenever any change letter or request is received by management, and it’s appropriateness shall be ensure that mean change is feasible to implement in terms of commercial and technically. When the change is feasible to implement that each function are being under the implementation should be identified, and the documents which needs to conduct, update and reviews should also identified for the implementation and statistically calculated. The general requirements for the analysis and requirements are stage inspection specifications documents, process failure mode effective analysis, work instructions, control plan etc., are major requirements for the change controls implementation. The effective verifications of the change should proper studies by process validation process will support initial process capability, and performance trends should be well monitored to ensure effectiveness of change process. To considering effectiveness verification to respective reason for change, and its permanent implementation for change should be initiated in the documentations that used to change control records, see picture below given as example format of change control sheet for education purpose:
Change control sheet is format that used for the recording information of change and its effective implementation in manufacturing processes, drawing and concern with product and process requirements. The team is conducting records from request and its requirements for the implementation and its relevant master records of documents should revised to indicate latest change should be effective; the records should be amended and indexed in line with change made during the change control process. The process validation indicate successful implementation of change, is results of the process are deployed in the system to implement changes and its effective controls in product or process as per customer / internal department person request.
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