Validation team production member

A validation team member from the Production department is responsible to participate in performing the validation steps during manufacturing processes and equipment qualification. This department should prepare the necessary SOPs for the new process or equipment and assist in the collection of validation data. 

A validation team member from Product Development Laboratories is responsible for defining the process (new product or process) to be validated and for providing technical assistance to the validation team by defining specifications, limits, and manufacturing methods. 

Prior to a site visit, assess the vendor remotely through product literature and submission of a preaudit questionnaire. When a vendor site audit becomes necessary, plan the audit s scope and focus and identify the audit team. Audit team members should include user group lead, information services groups (IT/IS/MIS), compliance, purchasing, and validation personnel. 

The team is designed to break down any barriers that may exist between production, maintenance, employees, and the leadership team. To close this potential gap, the team uses a peer-to-peer approach to ensure that the safety-related hazard and associated risk is assessed. The intent is to involve the employee, ensure that the work order is valid, and that the hazard and associated risk is vaUd and needs to be corrected. When the work order is completed, a member of the follow-up team discusses the issue/conditions with the employee who requested a hazardous issue be corrected. If the employee agrees with the correction, then the work order is signed off and closed. 

Step 1 begins with selecting the areas to improve — injury reductions, product improvement, inventory management, etc. A well-defined scope is established that will validate the business issues under review. The scope and objective can be established by a designated team, the process owner, and/ or a member of the leadership team. 

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