Compliance in a cleanroom relies on proving you have good engineering practices (commissioning), and verifying facility/systems aspects that affect product quality (qualification). Carrying out these verifications can be quite overwhelming. John R. Butterfield describes each process in cemag.us’ “Commissioning and Qualification of Existing Facilities.” He also offers advice on how to prepare your facility for each.
Here is a 10-step summary of how you can plan for commissioning and qualifying your cleanroom facility:
- Outline objectives. Before you begin, you want clearly defined objectives for the process. Why are you commissioning/qualifying? Are both required? What are your business’ needs? Why? What is the goal/where do you want to end up?
- Identify stakeholders. Your stakeholders need to be involved in your process. They should offer feedback on the objectives, and commit to the plan. Identify who they are across operations, engineering, maintenance, quality, compliance, and security.
- Create a plan draft. To develop an initial plan, ask your stakeholders where you are today, where you want to be, where the gaps are, what it will take to reach objectives, key factors for success, cost, schedule, and resources.
- Hone the scope of the program. Your first draft will need to be refined according to funding, schedules, and resources. Use impact assessments and risk assessments to determine how to refine your scope to still achieve key objectives and maximum benefits.
- Put together a project team. Use consultants, contractors, stakeholders, and anyone else who can coordinate project activities.
- Kickoff. You need to hold a project kickoff meeting to:
- Introduce the team and stakeholders
- Identify everyone’s roles/responsibilities
- Establish communication channels
- Explain facility operating, safety, and security requirements
- Go over program objectives
- Review the plan and scope
- Confirm team and stakeholder commitments
- Compile documentation. Collect the relevant existing documentation, like drawings/specs, policies, SOPs, manuals, and records.
- Update documentation. Update the information you have and fill in any gaps.
- Execute your commissioning and qualification. With your user requirements defined, functional specifications developed, and detail design docs created, you can now carry out pre-functional, functional, and performance testing.
- Follow-up. Maintain accurate/updated documentation, and transfer completed documentation to the stakeholders.
By taking the time to plan, gather resources, and execute testing, compliance is easier for you and your team. If you have questions about cleanrooms, validation, or certification, contact Gerbig Engineering Company at 888-628-0056 or info@gerbig.com. We’ve expertly handled cleanroom equipment and services since 1985.