HVAC Installation Qualification

Protocol
Protocol No.

Installation Qualification Protocol

Title: HVAC
Company X

Effective Date
Revision #

APPROVAL PAGE
System

HVAC

Location Company X, Inc., Address

Protocol Prepared By:

Name/Title

Signature

Date

Signature

Date

Protocol Reviewed By:

Name/Title

Protocol Technical Reviewed By:

Name/Title

Signature

Date

Signature

Date

Protocol Approved By:

Name/Title

Table Of Contents
1.0 SYSTEM OVERVIEW
2.0 SYSTEM BOUNDARY
3.0 OBJECTIVE
4.0 SCOPE
5.0 QUALIFICATION STUDY OVERVIEW
6.0 RESPONSIBILITY
7.0 PREREQUSITES
8.0 ACRONYMS

9.0 DEFINITIONS
10.0 GENERAL DOCUMENTATION REQUIREMENTS
11.0 DATA COLLECTION AND DOCUMENTATION PROCEDURES
12.0 INSTALLATION QUALIFICATION TEST REQUIREMENTS
13.0 REFERENCES
Index Of Attachments
ATTACHMENT 1 Personnel Identification List
ATTACHMENT 2 Test Equipment Identification/Calibration
ATTACHMENT 3 Test Equipment Operation
ATTACHMENT 4 Equipment / Component Verification
ATTACHMENT 5 Utilities Verification
ATTACHMENT 6 Support Documentation - Equipment/System Specifications
ATTACHMENT 7 Support Documentation - Submittals
ATTACHMENT 8 Support Documentation Purchase Orders
ATTACHMENT 9 Support Documentation Equipment Manuals
ATTACHMENT 10 Support Documentation - Equipment/System Drawings
ATTACHMENT 11 Support Documentation - Equipment/System Standard
Operating Procedures
ATTACHMENT 12 Support Documentation - Equipment/System Calibration
Procedures
ATTACHMENT 13 Support Documentation - Equipment/System Calibration
Program
ATTACHMENT 14 Maintenance - Spare Parts List
ATTACHMENT 15 Maintenance - Lubricant Verification
1.0 SYSTEM OVERVIEW
History
The AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make
Up Air Unit (MAU-1). AHU-6 was purchased from York International in October 1994.
AHU-6 was designed and installed to supply recirculating air to rooms: 123125. MAU1 was purchased as part of the building and operated to supply make up air to the AHU6 and rooms 120-125, 111, 113, 114, 117, 118,and both service corridors.
Description
The major equipment / components of the AHU-6 and MAU-1 HVAC system include Air
Handler Unit AHU-6, Make Up Air Unit MAU-1, Humidifier H-1, twelve (12) reheat
coils RHC-1-RHC-9 and RHC-19 RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12,
and EF-15 - EF-17.
AHU6 is a recirculating air handling unit, which provides a constant volume of airflow
to rooms 123,124, and 125. It is equipped with a Pre Cooling coil, Preheat coil and 65%
efficiency air filters. AHU-6 provides airflow using outside air from MAU-1 mixed with
return air.

MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing
100% outside air. It is equipped with one (1) reheat coil and two (2) cooling coils. It has
35% efficiency pre-filters and 95% efficiency bag filters, it also utilizes eleven (11)
Variable Air Volume controllers VAV-A, B, C, D, E, F, G, H and VAV-j, K and L. one (1)
Steam Humidifier H-1 located in the supply air duct downstream from MAU-1 provides
humidification
The system is designed to provide personnel comfort. Performance criteria for the
system are:
Temperature: 70F 5F
Humidity: 20-80% R.H.
Rationale
This protocol will be performed utilizing 21 CFR 210 & 211, ICH Q-7A Good
Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001,.
Upon final approval of this IQ Protocol and Summary Report it will replace the previous
IQ study and render it obsolete. The system will also be placed under formal change
control in accordance with Company XChange Control Program summarized in
Standard Operating Procedure DNAP/QM/012 entitled Change Control System.
2.0 SYSTEM BOUNDARY
The system boundary is defined as the supply utility service first point of contact with
the system/equipment being installation qualified. In most cases this is interpreted as
the first inlet manual valve or motor control/electrical panel providing supply of said
utility.
Supplied Utilities

ID Number

Description

Compressed
Instrument Air

Inlet at
respective
valve

Supply air to all

applicable
pneumatic valves on
the AHU-6

Compressed
Instrument Air

Inlet at
respective
valve

Supply air to all

applicable
pneumatic valves on
the MAU-1.

Low Pressure Steam

Inlet at
respective
valve

Supply to
appropriate inlets of
H-1

Compressed
Instrument Air

Inlet at
respective
valve

Supply air to all

applicable
pneumatic valves on
all VAV boxes: 19,19-21.

Chilled Water InAHU-6

CHWS-18

Supply to Cooling
Coil-

Chilled Water OutAHU-6

CHWR-19

Return from Cooling

Coil

Hot Water In-AHU-6

HWS-2

Supply to hot water

coil-

Hot Water Out-AHU-6 HWR-2

Return from hot

water coil

Low Pressure Steam

Out-MAU-1

To Be Field
Verified

Return from steam

reheat coil

Low Pressure Steam

In-MAU-1

To Be Field
Verified

Supply to steam
reheat coil-

Chilled Water OutMAU-1

To Be Field
Verified

Return from cooling

coil

Hot Water In-RHC-1

To Be Field
Verified

Supply to hot water

coil

Hot Water Out-RHC-1 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-2

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-2 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-3

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-3 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-4

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-4 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-5

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-5 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-6

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-6 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-7

To Be Field
Verified

Supply to hot water

coil

Hot Water Out-RHC-7 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-8

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-8 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-9

Supply to hot water

coil

To Be Field
Verified

Hot Water Out-RHC-9 To Be Field

Verified

Return from hot

water coil

Hot Water In-RHC-19 To Be Field

Verified

Supply to hot water

coil

Hot Water Out-RHC19

Return from hot

water coil

To Be Field
Verified

Hot Water In-RHC-20 To Be Field

Verified

Supply to hot water

coil

Hot Water Out-RHC20

Return from hot

water coil

To Be Field
Verified

Hot Water In-RHC-21 To Be Field

Verified

Supply to hot water

coil

Hot Water Out-RHC21

To Be Field
Verified

Return from hot

water coil

Chiller-1

To Be Field
Verified

Outlet to respective
Valve

Chiller-2

To Be Field
Verified

Outlet to respective
Valve

Chiller-3

To Be Field
Verified

Outlet to respective
Valve

Hot Water Boilers (7) To Be Field

Verified

Outlet to respective
Valves

Low pressure Steam

Boilers (10)

To Be Field
Verified

Outlet to respective
Valves

Electrical

AHU-6

Main Breaker
Supply to Unit

Electrical

MAU-1

Main Breaker
Supply to Unit

3.0 OBJECTIVE
The intent of this Installation Qualification (IQ) is to provide a complete inventory of
major equipment and/or components installed on the HVAC AHU-6 and MAU-1 system
and to ensure that:

Major components are those as specified in system manuals, contractors

submittals, original purchase orders or approved equivalents. These major components
will be verified during execution of this protocol.

All critical instruments are calibrated and placed within the calibration program
as defined in MF/SOP/178.

Operation manuals for the system or equipment are identified and available.

Required spare parts are identified

System or equipment maintenance requirements are clearly defined and

documented and are placed in the Preventative Maintenance Program as defined in
MF/SOP/179.

System or equipment cleaning procedures are established and current.

Lubricants will be identified and evaluated for acceptability during execution of

this protocol.

As-built drawings reflect the actual installation of the system or equipment

installed on (HVAC AHU-6 and MAU-1 system).
4.0 SCOPE
This protocol will be limited to the HVAC AHU-6 & MAU-1 System at Company X, Inc.,
Address
5.0 QUALIFICATION STUDY OVERVIEW
During the execution of this protocol, determination of the calibration frequencies and
formalized procedures will be provided to AAC Consulting Group, Inc. (AAC) by
Company X, Inc. Company X will calibrate all instrumentation requiring calibration
with traceability to NIST and certificates of calibration provided to AAC for inclusion in
the applicable section of this protocol.
The operation of AHU-6 and MAU-1 are controlled by Johnson Controls Metasys Air
Handling Unit Controllers with sensors monitoring air/water temperature, humidity
and air/water pressure. The operation is monitored through the use of the Metacomm
system as a Building Management System (BMS). Metasys VAV Controllers are
provided for the control of each VAV box. The BMS control system will be qualified in a
separate protocol, as part of the Computer System Validation (CSV).
The Operational Qualifcation of this system will be performed in accordance with
protocol # MF/VAL/OQ/013/PRO entitled Operational Qualification of HVAC AHU-6
and MAU-1 System.
6.0 RESPONSIBILITY
6.1 Validation Department:
6.1.1 Prepare and submit the protocol for approval in accordance with current industry
standards, regulatory requirements, and approved Standard Operating Procedures.

6.1.2 Perform and coordinate the execution of the protocol and recording of all raw data.
6.1.3 Review deviations and support the preparation of all corrective action reports that
may be required to resolve discrepant situations.
6.1.4 Prepare and/or coordinate the preparation of a final test report analyzing and
summarizing the data and submit for review and approval.
6.2 AAC Consulting Group:
6.2.1 Provide technical input into the preparation of the test protocol in accordance with
cGMPs, industry, USFDA standards and guidelines, and Company Xapproved Standard
Operating Procedures. Provide expert review of the finished protocol and procedures.
6.2.2 Assist in the performance of the execution of the test protocol and
recording/analysis of the test results.
6.2.3 Assist in the preparation of deviation reports and recommend corrective actions to
resolve discrepant situations that may arise during execution of the test protocol.
6.2.4 Assist in the preparation of a final report and provide input as to the conclusions
summarizing the study and submit to Company Xmanagement for review and approval.
6.3 Manufacturing:
6.3.1 Review and approve the test protocol.
6.3.2 Provide qualified personnel to assist with the execution of the protocol and the
collection of samples.
6.3.3 Assist in preparation of deviation reports and recommend corrective action to
resolve discrepant situations that may arise during execution of the protocol.
6.3.4 Review and approve the final report.
6.4 Engineering and/or Facilities Department:
6.4.1 Review and approve the test protocol.
6.4.2 Provide documentation required for the generation and execution of the protocol.
6.4.3 Provide equipment that has been commissioned and functional as specified by Site
Acceptance Test Report.
6.4.4 Provide assistance in evaluating and resolving equipment malfunctions that may
be encountered during execution of the protocol.
6.5 Quality Assurance:

6.5.1 Review and approve the test protocol in accordance with the approved SOPs,
cGMPs, and current industry guidelines.
6.5.2 Review deviations and support preparation of corrective action reports that may
be required to resolve discrepant situations.
6.5.3 Review and approve the final report.
7.0 PREREQUSITES
All Standard Operating Procedures required for the execution of this IQ such as
maintenance and calibration of the equipment undergoing IQ must be approved before
the IQ Final Report can be approved.
8.0 ACRONYMS
AHU

Air Handling Unit

AL

Airlock

CGMP

current Good Manufacturing Practice

CPH

Changes per hour

CAV

Control Air Volume Boxes

EWT

Entering Water Temperature

GPM

Gallons Per Minute

HEPA

High Efficiency Particulate Air

HVAC

Heating, Ventilating, and Air Conditioning

IWG

Inches of Water Gage

LAT

Leaving Air Temperature

LWT

Leaving Water Temperature

MAU

Make-Up Air Unit

NEBB

National Environmental Balancing Bureau

NLT

Not Less Than

NMT

Not More Than

IQ

Installation Qualification

PSI

Pound per Square Inch

PM

Preventive Maintenance

P&ID

Piping and Instrumentation Diagram

RPM

Revolutions Per Minute

SOPs

Standard operating Procedures

RHC

Re Heat Coils

TAB

Testing, Adjusting, and Balancing

VAV

Variable Air Volume (Dampers or Boxes)

5.0 DEFINITIONS
Acceptance Criteria
The system specifications and accept/reject criteria that are necessary for making a
decision to accept or reject the system and/or component being qualified.

Summary of Results
A written summary of the qualification policies, procedures, and results that may
include graphs and tables to support conclusions and final acceptance. Also included in
this summary would be documentation of deviations, their investigation, and final
corrective action implemented to provide final closure.
System
The term system as used in this protocol refers to the series of components, measuring
or control devices and/or equipment, that when working together perform a function
considered critical to the manufacturing of a product intended for medicinal use. Within
the scope of this procedure, the term system equally applies to computerized systems,
process control systems, utilities, services, and equipment set-ups (e.g., a reactorcondenser-motor-agitator set-up).
10.0 GENERAL DOCUMENTATION REQUIREMENTS
10.1 Personnel Identification List
10.1.1 All personnel involved in the execution of the protocol must review and complete
Attachment 1.
10.1.2 Curriculum Vitae for all contract personnel have been submitted to the Validation
Department, documented in the Approved Personnel List maintained by the Document
Control Department at Company X, Inc.
10.2 Test Equipment Identification/Calibration
10.2.1 Document on Attachment 2 the test equipment that is used during execution of
this protocol.
10.2.2 All test equipment descriptions have been submitted to the Validation
Department, documented in the approved Test Instrument List maintained by the
Document Control Department at Company X, Inc.
10.2.3 All test equipment must be calibrated against standards that are NIST traceable.
Copies of all calibration certificates for the test equipment must be included in this
attachment.
10.3 Test Equipment Operation
10.3.1 Document on Attachment 3 the SOPs and/or Operation Manuals that are
required for the test equipment used in the execution of this protocol.
10.4 Protocol Corrections
10.4.1 Protocol corrections must be documented by the issuance of a protocol
amendment providing the correct information.

10.5 Raw Data Corrections

10.5.1 Corrections to the raw data must be performed using a single line cross out and
explanation with the persons initials and date.
10.6 Protocol Deviations
10.6.1 A protocol deviation indicates the discovery of discrepant results, methods,
information, or procedures resulting from the execution of this protocol.
10.6.2 A discrepancy indicates the discovery of discrepant results.
10.6.3 All protocol deviations, discrepancies, and incidents must be documented in
accordance with the current Company X Standard Operating Procedure # MF/SOP/097,
entitled SOP for the Reporting and Investigation of Investigation on Incidents,
Discrepancies and Deviations.
10.7 Worksheets
10.7.1 Data, other than laboratory data, must be documented on one of the following
types of worksheets during the execution of the protocol:
10.7.2 Protocol specific data worksheets, provided in the attachments, are to be used to
record data as required.
10.7.3 The General Data Worksheet provided in the attachments, may be customized for
additional data collection or clarification.
10.7.4 Copies of raw data from notebook pages or laboratory test results may be
attached to this summary package.
11. DATA COLLECTION AND DOCUMENTATION PROCEDURES
11.1 Installation Qualification Worksheets
11.1.1 Each IQ worksheet must be completed as directed on the individual worksheet.
11.1.2 The executed IQ worksheet raw data should be compared against the acceptance
criteria, evaluated, and initialed/dated. In the event the acceptance criteria are not met,
a deviation report must be prepared, reviewed and approved, and recorded on the
deviation report log for each occurrence.
11.1.3 All data and results are to be recorded on approved copies of IQ worksheets.
11.1.4 Initial and date each entry and sign and date each worksheet.
11.1.5 Each page of any attachments to the protocol must reference the protocol #,
section and page #, and must be initialed and dated.

11.1.6 A summary of results reflecting conclusions for all verifications should be

prepared and this document inserted at the beginning of the data package.
11.1.7 The acceptance criteria as indicated for each IQ worksheet must be met.
11.1.8 All specified data available at the time of protocol generation should be entered on
each worksheet prior to approval of the protocol. The source of each specified value
entered should be referenced in the comment section of each IQ worksheet. All specified
data that cannot be determined at the time of protocol generation will be recorded as
Not specified and the actual value from field verification will be recorded. In the event
a specified cannot be field verified a reason should be entered in the comment section of
the form.
12. INSTALLATION QUALIFICATION TEST REQUIREMENTS
12.1 Objective
11.1.1 To verify that the HVAC system and its components have been installed in
accordance with the requirements as indicated in the engineering specifications and
system drawings.
12.2 Acceptance Criteria
11.2.1 The acceptance criteria as indicated on each protocol attachment must be met or
written explanation providing resolution must be documented.
12.3 Procedure
12.3.1 Complete each protocol attachment as directed on the individual attachment
making sure all required data is properly recorded, initialed, and dated.
12.4 Methods of Data Analysis
12.4.1 Review all completed attachments and compare against the acceptance criteria to
assure that all criteria have been met.
13. REFERENCES
13.1 ISO-14644-1, Cleanrooms and Associated Controlled Environments, Part 1:
Classification of Air Cleanliness, First Edition, 1999-05-01.
13.2 ISO-14644-2, Cleanrooms and Associated Controlled Environments, Part 2:
Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1, First
Edition, 2000-09-15.
13.3 ISO-14644-4, Cleanrooms and Associated Controlled Environments, Part 4: Design,
Construction, and Start-up , First Edition, 2000-04-01.

13.4 ISO-14644-7, Cleanrooms and Associated Controlled Environments, Part 7:

Separative Enclosures (Clean Air Hoods, Gloveboxes, Isolators, Mini-Environments,
Draft.
13.5 Title 21, Code of Federal Regulations, Parts 210 and 211
13.6 ICH, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients, August 2001.
13.7 Standard Operating Procedures for Reporting and Investigation of Deviations,
Metrology Services, Preventive Maintenance, Change Control System.
General Data Worksheet
Attachment #__
Use this worksheet for additional data gathering or data clarification. Include in
applicable section of summary package. NOTE: Make copies of this worksheet as
necessary.

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:
ATTACHMENT #1 Personnel Identification List

Each person who will be executing the protocol must complete an entry on this page.
Signatures signify that they have been trained in the protocol and understand the
protocol requirements. NOTE: Make copies of this attachment as necessary.
Name

Title

Signatures

Initials

Date

Reviewed
by:

Date
:

QA
Approval:

Date
:

ATTACHMENT 2 Test Equipment Identification/Calibration

Document test equipment not installed on the equipment/system being qualified that
are required for execution of this protocol. NOTE: Make copies of this
attachment as necessary.
Test Equipment Calibration

Description

Model
Serial # Tag #
#

Last Cal
Initials
Cal Due
Date
Date Date

Criteria Met? Initials

(Yes/No/NA) Date

Acceptance Criteria

The test equipment is calibrated and

the calibration is current.
The calibration standards are
traceable to NIST.
A copy of the calibration
certification(s) for the test equipment
used is attached.

Comments:

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:
ATTACHMENT 3 Test Equipment Operation

Document SOPs and/or Operation Manuals that are required for operation of the test
equipment used in the execution of this protocol and verify they are current. NOTE:
Make copies of this attachment as necessary.

Documen
t#

Title

Current and
Effectiv Documented Initial/Dat
e Date
?
e
(Yes/No)

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:
ATTACHMENT 4 Equipment / Component Verification

(one per each main component including instrumentation/Controls)

Description

AIR HANDLING UNIT AHU-6

Specified1

Type

A-Series

Location

Mezzanine above
Room 124

ID #

AHU-6

Manufacture
York International
r

Model #

AP80FSFCV12X1
2

Serial #

CADM-005952

Capacity
Rating

3400 CFM

Actual

Initial/Dat
e

Dimensions
126x 53x 43
(L*W*H)

Acceptance Criteria

Criteria Met? Initial/

(Yes/No/NA) Date

Actual values conform to specified

values.
Justifications are provided for actual
values that cannot be field verified.

Specified values taken from Dwg # H-04-rev 2,

Comments PO # 30563-05, York International I/O/M
Manual, 100.09-nom1.
1

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:
ATTACHMENT 5 Utilities Verification

Document Hot Water requirements for the applicable equipment/system undergoing

IQ. Also document specific connections to the facility steam supply. List sources for any
specified information recorded on this page in comments. All information recorded as
actual is from field verification unless recorded as otherwise in comments. NOTE:
Actual information, such as pressure, should be measured where possible.
Description /
Type ( X ) Plant ( ) Clean
Purpose
Item
Source

Specified1
Boiler (7)
HydroTherm-

Actual

Initial/Date

MultiTemp
Regulated
Pressure

18 PSI

Temp

173 F

Method of
Joining

To be field
verified

Acceptance Criteria

Actual values conform to specified

values.
Justifications are provided for actual
values that cannot be field verified.
Dielectric Unions are present between
piping of dissimilar metals.

Comments

Criteria Met? Initial/

(Yes/No/NA) Date

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

ATTACHMENT 6 Support Documentation - Equipment/System

Specifications
Document associated equipment/system specifications including, manufacturing
specifications, vendor audits, Factory Acceptance Testing, and inspection reports for the
equipment/system undergoing IQ. Also, document the equipment/system logbook
established for the equipment/system undergoing IQ. NOTE: Make copies of this
attachment as necessary.
NOTE: For computer related systems, document associated specifications including
computer system validation plan, process description (user requirements), functional
requirements, design specification, software description and change control history.

Type

Title/Description

Doc.
Location Initial/Date
#

Acceptance Criteria

Copies of the manufacturing

specifications for the
equipment/system are attached.
Installed conditions have been verified
to reflect functional specifications.
Equipment/system logbook
established.
Filter specifications and manufacturing
validation guides are available.
HEPA filter specifications are
available.
Computer related systems have
specifications available.

Criteria Met?
(Yes/No/NA)

Initial
/
Date

Comments

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:
ATTACHMENT 7 Support Documentation - Submittals

List the approved submittals as supplied by the contractor or manufacturer supporting

the system and system components. Include a copy of each submittal with this protocol.

Description:

Initials
Date

Acceptance Criteria

The submittals have been

verified to accurately describe
and document the system
being qualified.
Copies of the approved
submittals for the system and
components are attached.

Criteria Met?
(Yes/No/NA)

Initials
Date

Comments

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

ATTACHMENT 8 Support Documentation - Purchase Orders

List the purchase orders supporting the system and system components. Include a copy
of each purchase order with this protocol.

Description

Purchase
Order
Number

Initials
Date

Air Handler AHU-6

30563-05

Variable Air Volume Box

30563-12

Heating/Cooling Coils

30563-05

Exhaust Fans

30563-12

Humidifier H-1

30563-07

Acceptance Criteria

The system being qualified

conforms to the PO requirements.
Copies of the purchase orders for the
system and system components are
attached.

Comments

Criteria Met? Initials

(Yes/No/NA) Date

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

ATTACHMENT 9 Support Documentation - Equipment Manuals

Verify that pertinent equipment documentation exists and reference the location where
the document is kept.
Title

Location

Initials/Date

Acceptance Criteria

The manufacturers equipment

manuals are described above
and the location of each manual
is documented.

Comments

Criteria Met?
Initials/Date
(Yes/No/NA)

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

ATTACHMENT 10 Support Documentation - Equipment/System Drawings

Document associated process flow drawings, P&IDs, layout drawings, shop drawings,
and any other pertinent drawings, including all associated equipment, facility, and
utility drawings for the equipment/system undergoing IQ. Verify that the drawings are
accurate and sufficient to characterize the equipment/system. Verify that components
are physically labeled in accordance with drawings. Highlight the verified portions of
the drawings and redline changes as necessary. All drawings must be verified, signed,
and dated. Submit any redlined drawings to the Document Control Group for revision.
Include copies of the highlighted, verified drawings, redlined copies, and applicable
Document Control Forms with this summary package. NOTE: Make copies of this
attachment as necessary.
NOTE: Controller diagrams and wiring diagrams will be documented on separate
attachments.
Drawing
#

Title

Rev.

Rev.
Initial/Date
Date

Acceptance Criteria

Drawing list includes associated

equipment, facility, and utility
drawings.
Drawings, with redlines if applicable,
are sufficient to characterize
equipment/system.
Equipment/system installation
corresponds to drawings, with redlines
if applicable.
Components including equipment,
valves, and instruments are physically
labeled and labels correspond to
drawings, with redlines if applicable.
Copies of verified drawings and
redline copies are included with this
summary package.
Drawings have been verified, signed,
and dated.
Redlined drawings submitted for

Criteria Met? Initial/

(Yes/No/NA) Date

revision to the Document Control

Group and copy of Document Control
form included with this summary
package.
The Document Control Group controls
original drawing files.

Comments

Completed
by:
Reviewed
by:

Date:
Date:

QA
Approval:

Date:

ATTACHMENT 11 Support Documentation - Equipment/System Standard

Operating Procedures
Document operating SOPs (e.g. operation, maintenance, cleaning and sanitization)
associated with the equipment/system, including controls, undergoing IQ. NOTE:
Make copies of this attachment as necessary.
NOTE: For computer related systems, SOPs should include failure/backup/recovery,
security, system monitoring and maintenance.
Document
#

Title

Acceptance Criteria

Rev.

Rev.
Initial/Date
Date

Criteria Met? Initial/

(Yes/No/NA) Date

List above includes operation,

maintenance, cleaning, and
sanitization procedures as applicable
that are approved and current.

Comments

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

ATTACHMENT 12 Support Documentation - Equipment/System

Calibration Procedures
Page ______ of _______
Document the calibration SOPs associated with the critical instruments on
equipment/system, including controls, undergoing IQ. NOTE: Make copies of this
attachment as necessary.
Document
#

Title

Rev.

Rev.
Initial/Date
Date

Acceptance Criteria

All calibration procedures associated

with the critical instruments on the
equipment/system undergoing are
approved and current.

Comments

Criteria Met? Initial/

(Yes/No/NA) Date

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

ATTACHMENT 13 Support Documentation - Equipment/System

Calibration Program
Page ______ of _______
Document the equipment/system components (e.g., instruments,
controlling/monitoring switches) undergoing IQ that require calibration. Verify that
these components are entered into calibration program by reviewing copies of the
calibration reports obtained from the Metrology Department. Ensure that all
components requiring calibration have been calibrated and are traceable to National
Institute of Standards and Technology (NIST), the American Society of Testing and
Materials (ASTM), or other applicable standard. Additionally, verify that all calibrated
instruments have a calibration tag. Include copies of the calibration reports with this
summary package. NOTE: Make copies of this attachment as necessary.
NOTE: Instrument verification, process instrument materials of construction
verification, and digital sensors and controlling/monitoring switches list will be
documented on separate attachments.
Compone
Las
Associat Associat
Re
nt Asset #
Cal
t Initia
ed Cal
ed Cal Re v.
and
Frequen Cal l/
Procedur Procedur v. Dat
Descripti
cy
Dat Date
e#
e Title
e
on
e

Acceptance Criteria

Components that require calibration are

entered into the calibration program.
Components are traceable to applicable
standard.
Components have a tag indicating last
cal date and cal due date.
Components are calibrated by the
conclusion of protocol execution.
Copies of the calibration reports are
included with this summary package.

Comments

Criteria Met?
(Yes/No/NA)

Initial
/
Date

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:
ATTACHMENT 14 Maintenance - Spare Parts List
Page ______ of _______

Document spare parts lists for the applicable equipment/system and associated controls
undergoing IQ. Document the location of the manufacturers recommended list (e.g.,
installation manual). NOTE: Make copies of this attachment as necessary.
Equipment/
System Name

Spare Parts List Location

AHU-6

Form 100.09-MOM1 York

International O/M Manual

MAU-1

4/5/95 Mammoth O/M Manual

Initial/
Date

Acceptance Criteria

Criteria Met? Initial/

(Yes/No/NA) Date

Locations of manufacturers
recommended spare parts lists are
documented.

Comments

Completed
by:
Reviewed
by:

Date:
Date:

QA
Approval:

Date:
ATTACHMENT 15 Maintenance - Lubricant Verification
Page ______ of _______

Document lubricants, used with equipment/system undergoing IQ. Using information

obtained from the Quality Assurance or Maintenance Departments, the manufacturer,
and/or the supplier, verify the lubricants are acceptable for their intended use. Include
documentation supporting the acceptability of the lubricants with this summary
package. List sources for any information recorded on this page in comments. NOTE:
Make copies of this attachment as necessary.
Lubricant Type
and Manufacturer

Purpose

Acceptance Criteria

Acceptable? Initial/
(Yes/No)
Date

Criteria Met? Initial/

(Yes/No/NA) Date

All lubricants are acceptable for

intended use.
Documentation supporting the
acceptability of the lubricants is
included with this summary package.

Comments

Completed
by:
Reviewed
by:
QA
Approval:

Date:
Date:
Date:

Download the accompanying presentation, "Effective Qualification of Critical Utilities,"

presented at IVT's Validation