Prior to starting commissioning and qualification activities, a plan should be developed. The plan may be commonly referred to as a Commissioning Plan, Commissioning and Qualification Plan, Qualification Plan or Validation Plan. The name changes based on the overall intent of the activity, but the documents all serve the same purpose – to help guide your team through the execution of the commissioning or qualification activities. It is written at the start of the project and defines the project’s scope and goals.
Although unique, each Plan document typically contains the following basic elements:
- Defines the facilities, system , or equipment to be included in the project
- Defines the goals of the project
- A high-level overview of a system and its components within the scope of the project.
- Provides a process description that speaks to the mechanical and automated functions of the systems and equipment.
- A limit drawn around the system(s) to logically define what is and is not included in the system. The boundaries clearly define what elements (e.g. process equipment, facilities, instrumentation, utilities, etc.) makeup the system. Predetermined system boundaries help to define the scope of C&Q activities
- For larger projects, this section may identify a methodology that would be used to identify the boundaries of direct and indirect systems with a goal of ensuring that critical components are only associated with direct impact systems.
- For smaller projects, this section may include the actual boundary output (e.g. the marked up project drawings identifying the system boundaries).
Roles and Responsibilities
- A RACI (responsible, accountable, consulted and informed) chart or diagram is a matrix of all deliverables/activities on the project and the corresponding action or responsibility of each person/role on the project. This chart or diagram provides an organizational structure for the team members of the project, helps to reduce overlapping of responsibilities, and optimizes resource usage.
- The Plan should provide a listing of all of the documents to be generated in order to fully commission or qualify the system or equipment This may include:
- User Requirements
- Risk Management (e.g. FMEA, System/Component Classification)
- Design Review/Qualification
- Commissioning (Installation Verification and Functional Testing)
- Qualification (Installation Qualification, Operational Qualification, and Process Performance Qualification)
- Summaries/Final Reports
- Traceability Matrices
- A schedule should be included, listing activities such as system turnover and document development and execution for each system and/or major piece of equipment.
- The schedule may consist of a high-level milestone schedule and reference a project schedule created and maintained outside of the plan document.
- Alternatively, the detailed schedule may be held within the planning document. With the understanding that every change would require review/and approval of the planning document.
Approval and Changes
The Plan should be approved prior to commencing subordinate tasks. Approvers may include client representatives from Design, Construction, Engineering, Quality, Validation, and End-User management. Changes to the plan should be reviewed by the original approvers and a revision history maintained.
Have a question about commissioning, qualification, and/or validation planning. Please use our Contact us form to ask your questions or to inquire as to how Performance Validation may assist you with your project needs.