Process Validation Checklist

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 1. Overview.

• Definition. Process validation is a series of procedures and activities carried out to ensure that a given process creates consistent, high-quality and desirable results within a certain period of time.
• Purpose. The purpose is to guarantee that a given method for developing and manufacturing products is cost-effective and valid for meeting predetermined standards and requirements.
• Field of Use. Process validation is used in various areas and practices of management. Generally it is used in product development and manufacturing. It is also popular in project management, for example, when in some project there is a need to validate procedures for producing consistent deliverables according to stakeholder requirements and product scope statement.
• Implementation. Process validation can be implemented in three steps, such as Assemble Team, Plan Validation Activities and Perform Process Validation. Below we give descriptions of these steps.

2. Assemble Validation Team.

The first step requires you to acquire and assemble a group of people who have enough skills, knowledge and experience to work as a validation team and make joint efforts. A validation team takes responsibility for the implementation and results of the overall validation process. Such a team includes the following participants:

• The Steering Committee. It provides oversight and control. Its purpose is to ensure that the validation process is undertaken in strict accordance with requirements and rules stated in the validation protocol.
• Team leaders. They provide guidance, control and supervision to team members. Validation team leaders are responsible for ensuring that the team undertakes validation activities and procedures in line with the validation plan.
• Team members. They are engineers, developers, marketers, and other people involved in processes of producing, marketing and deploying a product.

3. Plan Validation Activities.

At this step you need to determine and record all the activities required for successful process validation. For this purpose you need to develop a validation plan that outlines details of each of the validating activities. Such a plan includes the following activities:

• Creating the validation protocol. It is a formal document that outlines rules, requirements and acceptance criteria for validating a process correctly. It is designed and used by the validation team, under supervision of the Steering Committee.
• Determine process implementation details. This activity is about developing specifications of validation deliverables used to state the desired outcome of your process.
• Perform qualification activities. This group of validation activities is intended for auditing process specifications, supply relationships, product design, installation processes, operational performance.
• Audit and control. These activities help you to check suitability of existing generic procedures applicable to the development of your process and to make regular reviews and audits in order to update the process, if necessary.
• Clarify process results. It’s about stating the desired outcome of your process and ensuring that validation deliverables have met acceptance criteria documented in the validation protocol.
• Conduct periodical reviews (revalidation). The final activity in your plan is intended for making regular reviews and checks of your process in order provide additional assurance of validation.

4. Perform Validation.

The final step in validating your process is to perform all the planned activities and make a report at successful completion. You can take the following actions to perform the validation:

• Involve your team in group discussions, interviews and meetings to develop the validation protocol and document general rules, requirements ...

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