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Commissioning
FDA SUBMISSION PACKAGE
Descriptive
Narrative
Basic Floor Plan
Waste/Personnel/Product Flow Diagrams
Air Pressurization Drawings
CMP/VMP
Definition:
ASHRAE Guideline 0, The Commissioning Process, defines commissioning
as "a quality-oriented process for achieving, verifying, and
documenting that the performance of facilities, systems, and
assemblies meets defined objectives and criteria". Commissioning is
therefore an "umbrella" process for all the planning, delivery,
verification, and managing risks to critical functions performed in,
or by, facilities. Commissioning uncovers deficiencies in design or
installation using peer review and field verification. Commissioning
also accomplishes higher energy efficiency, environmental health,
and occupant safety and improves indoor air quality. Commissioning
is a quality assurance-based process that delivers preventive and
predictive maintenance plans, tailored operating manuals, and
training procedures. Essentially, the commissioning process
formalizes review and integration of all project expectations during
planning, design, construction, and occupancy phases by inspection
and functional performance testing, and oversight of operator
training and record documentation.
Benefits:
Commissioning assists in the delivery of a project that provides a
safe and healthful facility; improves energy performance; optimize
energy use; reduces operating costs; ensures adequate O&M staff
orientation and training; and improves installed building systems
documentation.
Commissioning benefits owners' through improved energy efficiency,
improved workplace performance due to higher quality environments,
reduced risk from threats, and prevention of business losses.
Organizations that have researched commissioning claim that owners
can achieve savings in operations of $4 over the first five years of
occupancy as a direct result of every $1 invested in
commissioningan excellent return on investment. Meanwhile, the cost
of not commissioning is equal to the costs of correcting
deficiencies plus the costs of inefficient operations. For
mission-critical facilities, the cost of not commissioning can be
measured by the cost of downtime, which reaches an average of $26
thousand per hour for the package shipping industry, $89.5 thousand
per hour for airline reservation operations, and $6.45 million per
hour for brokerage operations, according to the research firm
Dataquest.
Commissioning Goals:
Commissioning is often misinterpreted to focus solely on testing
during the end of the construction phase. But commissioning is
actually a collaborative process for planning, delivering, and
operating buildings that work as intended. ASHRAE (The American
Society of Heating, Refrigeration and Air-Conditioning Engineers)
defines commissioning as "
the process of ensuring that systems are
designed, installed, functionally tested, and capable of being
operated and maintained to perform in conformity with the design
intent
Commissioning begins with planning and includes design,
construction, start-up, acceptance and training, and can be applied
throughout the life of the building." This definition accurately
depicts commissioning as a holistic process that spans from
pre-design planning to post-construction operation and can be
thought of as a checks-and-balances system. Accordingly, the goals
of commissioning are to:
1. Define and document requirements clearly at the outset of each
phase and update through the process.
2. Verify and document compliance at each completion level.
3. Establish and document commissioning process tasks for subsequent
phase delivery team members.
4. Deliver buildings and construction projects that meet the owner's
needs, at the time of completion.
5. Verify that operation and maintenance personnel and occupants are
properly trained.
6. Maintain facility performance across its life cycle.
Commissioning Principles:
Regardless of the extent of commissioning that is determined as
appropriate for a project (Number or complexity of systems
commissioned) and the approach utilized (Independent CA, A-E/CA,
CM/CA or Owner/CA), there are three overarching principles in the
Commissioning Process that begin at project inception and continue
through Occupancy and Operations.
Validation
VALIDATION MASTER PLAN (VMP)
The following is a proposed outline Validation Master Plan. The format,
order, and content are typically modified to accommodate details specific to
the project.
MASTER PLAN APPROVAL
OBJECTIVE
SCOPE
RESPONSIBILITIES
INTRODUCTION/BACKGROUND DISCUSSION - (PROJECT OVERVIEW)
DESCRIPTIONS
Company Background
Site(s) Description
Facility Description
Personnel and Material Flows
AHU Zoning/Room Pressurizations
Process Equipment
Process Support Systems/Equipment
Laboratory Equipment
Facility Systems & Utilities
APPROACH AND DEFINITIONS
Direct Impact System:
Indirect Impact System:
No Impact System
Critical Components
Non-Critical Components
Commissioning
Good Engineering Practice (GEP)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
SYSTEMS WITHIN SCOPE OF MASTER PLAN
Critical Facility and Utility Systems (Validated
Systems)
Process Equipment
Packaging Equipment
Control Systems
General Facility and Secondary Support Systems
(Commissioned Systems)
CLEANING VALIDATION
Spray Ball Pattern Verification
Nozzle and Spray Arm Coverage
Detergent Residue
Cycle Programming/Sequencing
COMPUTER/AUTOMATED SYSTEM VALIDATION
ACCEPTANCE CRITERIA
General Installation Qualification (IQ) Acceptance
Criteria
General Computer/Software/Control Qualification
Acceptance Criteria
General Operational Qualification (OQ) Acceptance
Criteria
General Performance Qualification (PQ) Acceptance
Criteria
Cleaning Validations
PROCEDURES AND FORMAT
Documentation Requirements
Validation Protocol Format
Validation Report Format (includes master plan
closeout report)
Validation Document Numbering and Filing System
Document Filing System
SUPPORT SYSTEMS
Environmental Monitoring
Preventive Maintenance
Change Control
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