COMMISSIONING is a methodical, documented process to ensure that facilities, systems, and equipment meet established design requirements and stakeholder expectations. The commissioning process verifies the following: what was specified was installed; that it functions properly; and that it was successfully turned over to the user.

QUALIFICATION is a process that extends beyond commissioning because it is primarily concerned with verifying facility and system aspects that can affect product quality.

Facilities and System Qualification consists of three parts:

• Installation Qualification (IQ): Adheres to, and is installed, as per approved specifications.
• Operational Qualification (OQ): Operates as intended throughout all anticipated ranges.
• Performance Qualification (PQ): Performs as intended, meeting predetermined acceptance criteria over time.

The basic difference between commissioning and qualification is that the former is concerned with good engineering practice, whereas the latter primarily verifies facility and systems aspects that can affect product quality.

The commissioning and qualification process is commonly described by the “V” model. The left side of the V describes the user requirements (UR), functional requirements (FR), and design requirements (DR) against which the commissioning and qualification will be executed.

The right side of the V-model describes the steps in the commissioning and qualification process which will verify that the facility and system were installed and operate as intended and that they produce the desired results.

• Prefunctional checks/IQ: Is the system installed as specified?
• Functional checks/OQ: Does the system function as intended?
• Performance checks/PQ: Does the system perform in accordance with the user requirements?
  For newly constructed facilities and systems, the requirements on the left side of the V are clearly defined and documented during the design phase. For existing facilities and systems, these requirements may be vague. The reasons for this are:
• The facility has been in existence for some time and has evolved according to the needs of the business.
• While the systems have evolved over the years, documentation updates may have lagged behind. This may have resulted from the belief that existing documentation was sufficient to support the needs of the business.
• The facility and systems have been modified through numerous projects. As a result, facility and systems documentation has become organized by projects rather than by functions or systems. Persons accessing facility and systems information now have to trace facilities and systems documentation across project boundaries. These project boundaries frequently result in gaps and discontinuities in facility and systems documentation.
  As a result, existing facilities and systems documentation is often fragmented, inaccurate, inconsistent, or missing. Accurately defining and documenting facilities and systems requirements is the significant difference between commissioning and qualifying new installations and existing ones.
  The challenge with commissioning and qualifying an existing facility is to identify the following:
• What was specified? What were the user requirements at the time the system was installed?
• What are the current user requirements? Have they changed since the facility was initially designed or constructed?
• What is installed today? Is it accurately documented?
• How do the facility and systems function today? What are the impacts on product quality?
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A 10-Step Approach to Commissioning and Qualifying Existing Facilities

1) Define the Objectives
Commissioning and qualification of existing facilities and systems can be an overwhelming task. It is easy to become buried in innumerable details. Before beginning, we must define our objectives. A common reason for commissioning and qualifying an existing facility is to comply with Good Engineering, Manufacturing,Laboratory, or other Practices (GxP). Questions to ask are:

a) Why do we want to commission? Is qualification required?

b) What are the needs of the business? What is driving this effort?

c) What is our ultimate goal? Where do we want to end up?

2) Identify the Stakeholders
Commissioning and qualification will impact and involve many stakeholders including operations, engineering, maintenance, quality, compliance, and security personnel. It is critical to involve all of these parties in the program at the outset. Stakeholder feedback on the objectives needs and benefits of the program are very important. Stakeholder buy-in and commitment to the program is essential to its success.

3) Develop an Initial Plan
The stakeholders need to meet and clearly define:

a) Where are we today?
b) Where do we want to be?
c) What are the gaps?
d) What will it take to achieve our objectives? Cost, schedule, stakeholder commitments, resources required (internal and external), impacts on existing operations.
e) What are the key factors (i.e. success factors) that will make this program successful?

4) Refine the Program Scope
The program, as it is initially defined, may exceed available funding, schedule, and resources. The challenge is to refine the program scope so that it provides the maximum benefits and achieves the key objectives. A risk-based approach employs two tools that will help fit the program objectives and scope, to the budget.

a) Impact assessments: This is a process to help determine which elements have direct vs. indirect/no impact upon the key success factors of the program.

b) Risk assessments: This tool identifies the various risk scenarios that can occur. For each scenario, we define the likelihood that the risk will occur, the severity of impact if the risk does occur, and the probability that the risk will be detected. Based upon the outcome of the risk assessment, the risk scenarios can be prioritized in terms of impact on critical success factors.

5) Organize the Project Team
The project team may consist of members from the following groups:

a) Stakeholders from within the organization.

b) External consultants and contractors.

c) Additional project support: scheduling and coordination of project activities, especially concerning their impacts on existing operations, site support personnel for area access, escorts, information gathering, system accessibility, shutdowns, etc.

6) Project Kickoff

The program begins with a Project Kickoff Meeting. The purpose of this meeting is to:

a) Introduce the project team and the stakeholders.

b) Review the roles and responsibilities of all parties.

c) Establish channels of communication for the project.

d) Acquaint the project team with the facility operating, safety, and security requirements.

e) Review the program objectives.

f) Review the project plan and scope.

g) Review and confirm project team and stakeholder commitments.

7) Compile Existing Documentation
The project team begins the commissioning and qualification process by compiling existing facilities and systems documentation (i.e. “What do we have today?”). Documentation includes drawings and specifications, policies,standard operating procedures, manuals, and records.

8) Update Facility and Systems Documentation
Existing documentation is updated. Gaps are filled in. Methods for gathering facility and systems information include:

a) Stakeholder interviews: Key personnel have tremendous knowledge of the facility and the systems. The challenge is to collect this information from the “heads and desks” of these people and incorporate it into the overall documentation package.

b) Field surveys: Often, the only way to confirm what is actually installed is to conduct a field survey. Surveys may impact existing operations. Documenting facilities and systems may require shutdowns or access to critical areas. Measurement and testing may be required. Special permits may be required for cameras or recording equipment.

9) Execute Commissioning and Qualification
Having updated facility and systems documentation, the requirements on the right side of the V-model are clearly defined. The commissioning and qualification process is now ready to begin.

a) The initial Commissioning and Qualification Plan is revised, based upon updated documentation, in conjunction with the program objectives scope and critical success factors.

b) The execution of the commissioning and qualification process may have direct impact upon the facilities and its operations. Commissioning and qualification team access to facilities and systems may need to be coordinated so that they do not negatively impact ongoing operations.

10) Hand-Off to the Stakeholders
At the end of this program, commissioning and qualification of the facility and systems has been completed. Accurate facility and systems documentation is critical to remaining in compliance. As the project team disbands, facility and systems documentation must be transferred to the stakeholders. A process must be put in place so that documentation is maintained and updated so it represents current conditions. In regulated industries, a formal change control process will be implemented.

Summary
In this article we have described the challenges of commissioning and qualification of existing facilities and systems. This requires considerable effort, resources, and planning. However, with the use of this 10-step process, the goal of compliance can be successfully accomplished in a timely and cost-effective manner.

John Butterfield is Vice President & Engineering Manager at Hallam-ICS, 38 Eastwood Drive, Suite 100, So. Burlington, VT 05403. He can be reached at802-658-4891 or jbutterfield@hallam-ics.com.