Você está na página 1de 15

Compressed Air System

Equipment:

Protocol #: U-0018-2009-01

Date: 11/10/09

Location:
9000 Rockville Pike
Building 10 Penthouse
Bethesda, MD 20892

Revision: None

Compressed Air System

Facility:
National Institute of Health

Title:
Installation Qualification for Compressed Air.
Objective:
The objective of this protocol is to document the proper installation of the Compressed Air
System.
Written By: Narlin Beaty
Title: Consultant

Approved By: ______________________


Title: _____________________________

Signature:
Signature:
Date:
Date:

Approved By: ______________________

Approved By: ______________________

Title: _____________________________

Title: _____________________________

Signature:

Signature:

Date:

Date:
Qualification
Process
Solutions, Inc.

PROPRIETARY INFORMATION:
Unauthorized Duplication Is Prohibited

DOCUMENT NUMBER U-0018-2009-01


DATE: 10 Nov 2009
REVISION NUMBER None
Author: Narlin Beaty ______________________

PAGE: 1 of 24

Revision Date: None

Installation Qualification
EQUIPMENT NAME: Compressed Air

Equipment No: _______________

INSTALLATION QUALIFICATION
FOR THE
COMPRESSED AIR SYSTEM

INSTALLED
AT

NATIONAL INSTITUTES OF HEALTH


BUILDING 10
BETHESDA, MD 20892

QUALIFICATION PROCESS SOLUTIONS


13406 BLYTHENIA RD
PHOENIX, MD 21131
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 2 of 24

TABLE OF CONTENTS
1.0
Objective ....................................................................................................................
........................ 3
2.0
Scope ........................................................................................................................
.......................... 3
3.0
Equipment
Description...................................................................................................................
.... 3
4.0
Responsibilities .............................................................................................................
..................... 3
5.0
Reference
Documents ....................................................................................................................
.... 3
6.0
Definitions ..................................................................................................................
........................ 3
7.0
Test Function Number One: IQ Signature Verification List (Attachment #1) .................................. 3
8.0
Test Function Number Two: Specifications & Purchase List (Attachments #2) .............................. 4
9.0
Test Function Number Three: Test Equipment (Attachment
#3) ...................................................... 4
10.0
Test Function Number Four: Air Compressor System Specification (Attachment #4) ..................... 4
11.0
Test Function Number Five: System Documentation Verification (Attachment #5) ........................ 5
12.0
Test Function Number Six: Drawing Verification List (Attachment #6).......................................... 5
13.0
Test Function Number Seven: Instrumentation and Calibration Verification (Attachment #7) ........ 5
14.0
Test Function Number Eight: Supporting Utility Verification (Attachment #8) .............................. 5
15.0
Test Function Number Nine: Specific Installation Verification (Attachment #9) ............................ 6
16.0
Test Function Number Ten: Safety Review (Attachment
#10) .......................................................... 6
17.0
Deviation Reporting Log (Attachment
#11) ...................................................................................... 6
18.0
Installation Qualification Protocol Review (Attachment
#12) ........................................................... 7
19.0
Summary Report
Requirements ......................................................................................................... 7
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 3 of 24

1.0

Objective
The objective of this protocol is to verify that the Compressed Air System, described in Section 3.0,
has been assembled in accordance to manufacturers specification, and in accordance with Current
Good Manufacturing Practices (cGMPs).

2.0

Scope
This Installation Qualification pertains to the verification of the assembly of the equipment described
in Section 3.0 of this protocol, to be installed in the mechanical room at National Institutes of Health
(NIH), 10 Center Drive, Bethesda, MD 20892-1996. This protocol is specific to the Compressed Air
system and related instrumentation and equipment. This protocol is limited to the aseptic
manufacturing space and the compressed air utility therein.

3.0

Equipment Description
The Air Compressor unit is a Quintaplex, air cooled, two stage, oil free, scroll compressor unit. Unit is
supplied with air receiver. Compressor unit is frame mounted. Unit is pre-piped and wired providing
single point connection for utilities and air piping.
Some of the unit components include:
Model WTR45-A Air Compressor (4 ea.)
Integral 30 diameter , 200 psi ASME coded air receiver
One set of twin tower desiccant dryers , ZEKS Model 160-200 ZPA heatless
One set of cartridge air filters, 5 micron primary and 1 micron final.
Quintaplex Controls
Pressure regulators

4.0

Responsibilities
4.1 Qualification Process Solutions, LLC.
4.1.1 It is the responsibility of QPS to write this protocol.
4.1.2 It is the responsibility of QPS to execute this protocol.
4.2 National Institutes of Health (SI)
4.2.1 Following the execution, NIH will approve the final report associated with this protocol,
indicating the executed protocol was completed correctly and all acceptance criteria were
met.

5.0

Reference Documents
WTR45-A Compressor Manual
Desiccant Dryer Manual

6.0

Definitions
6.1 Critical Instrumentation Critical instruments are defined as those whose performance will
affect the operation of the system and/or the quality attributes of the processed materials.
Critical instruments are calibrated and certified using standards that are traceable to NIST
(National Institutes of Standards and Testing).
6.2 Non-Critical Instrumentation Instrumentation provided for indication or convenience
purposes only.

7.0

Test Function Number One: IQ Signature Verification List (Attachment #1)

7.1
Objective
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 4 of 24
To identify all personnel involved in executing this protocol.

8.0

9.0

10.0

7.2

Procedure
Verify that each person who executes this protocol signs Attachment #1. On this attached form,
each person shall be identified by name, title, company, signature, initials and date.

7.3

Acceptance Criteria
Signatures from all personnel involved in execution of this protocol shall be present.

Test Function Number Two: Specifications & Purchase List (Attachments #2)
8.1

Objective
To verify that the system installed is the intended purchase.

8.2

Procedure
8.2.1 Verify that the attachment model and the installed equipment model are the same.
8.2.2 Complete the applicable attachment identifying the specific system.

8.3

Acceptance Criteria
The equipment was purchased for NIH by Gilbane construction. Verify that the model installed
is the model of the Attachment.

Test Function Number Three: Test Equipment (Attachment #3)


9.1

Objective
The objective of this test function is to verify and document all test equipment.

9.2

Procedure
9.2.1 Complete a list of all the instruments required for conducting IQ testing.
9.2.2 Verify that the test equipment/instruments are calibrated and the reference standards are
traceable to National Institute for Standards and Technology (NIST) or other approved
standard.
9.2.3 Complete the applicable attachment, indicating the equipment description, ID/serial
number, calibration date, re-calibration date.

9.3

Acceptance Criteria
All equipment required for execution shall be calibrated with copies of calibration records
attached.

Test Function Number Four: Air Compressor System Specification (Attachment #4)
10.1 Objective:
The objective of this section is to verify the primary equipment components of the compressor.
10.2 Test Method:
10.2.1 Review the as built system and compare it to the specifications on the attachment.

10.3 Acceptance Criteria:


The expected system specifications have been verified.
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 5 of 24

11.0

Test Function Number Five: System Documentation Verification (Attachment #5)


11.1 Objective:
The objective of this section is to verify and document that all required supporting
documentation for the system have been received and are filed in their respective reference
location.
11.2 Test Method:
11.2.1 Verify the system turnover documentation.
11.2.2 Attach a copy of each of these documents to this qualification protocol or reference their
location in the verification form.
11.3 Acceptance Criteria:
System documents are attached or their locations referenced.

12.0

Test Function Number Six: Drawing Verification List (Attachment #6)


12.1 Objective
To verify and document the equipment is constructed in accordance with the approved drawings
and/or specifications and the equipment has been properly tagged in accordance with the
drawing requirements.
12.2 Procedure
12.2.1 Verify the accuracy of the approved drawings, which represent the equipment as
installed.
12.2.2 Verify all major components of the equipment are properly tagged and identified.
12.2.3 Complete the applicable attachment with a list of applicable equipment drawings
associated with the equipment such as assembly drawings, loop diagrams, wiring
diagrams, and P&ID diagrams.
12.2.4 Attach copies or reference the reviewed drawing with the latest revision and if
applicable, redlined drawings.
12.3 Acceptance Criteria
All approved drawings shall either accurately represent the equipment as installed or be marked
to indicate differences.

13.0

Test Function Number Seven: Instrumentation and Calibration Verification (Attachment #7)
13.1 Objective
The objective of this test function is to verify that all system instruments are installed and, if
applicable, calibrated with a current calibration.
13.2 Procedure
13.2.1 Verify the information of each instrument associated with the system.
13.2.2 Locate and verify calibration data for calibrated instruments.

14.0

Test Function Number Eight: Supporting Utility Verification (Attachment #8)

14.1 Objective:
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 6 of 24
The objective of this section is to document that all supporting utilities have been certified by
others as having met the minimum specifications for operation of the system and are properly
connected in accordance with engineering design and/or vendor specifications.
14.2 Procedure:
Verify that the following support utility systems are properly connected to the system and are
within specifications:

Electricity

Chilled Water
14.3 Acceptance Criteria:
All supporting utilities meet the specified requirements for the operation of the system.
15.0

Test Function Number Nine: Specific Installation Verification (Attachment #9)


15.1 Objective:
The purpose of this section is to verify that vendor and engineering installation requirements
for the system are met.
15.2 Procedure:
15.2.1 Document the As-Found Condition as it relates to the listed requirements and compare
that condition to the requirement in the attachment.
15.3 Acceptance Criteria:

The field condition meets or exceeds the installation requirements as designated on the
attachment.

16.0

Test Function Number Ten: Safety Review (Attachment #10)


16.1 Objective:
The purpose of this section is to verify that the equipment has been inspected and any safety
concerns have been identified. The safety review pertains to the following system components:
Air Compressor
Desiccant Dryer
16.2 Procedure:
16.2.1 Complete the HAZOP data sheets in Section 10.10.4, Safety Review.
16.2.2 The safety review and either be completed as a walk through inspection of the equipment
or review of the equipment documentation. Identify how the review was completed.
16.2.3 Recommend personnel protection necessary to operate this equipment.
16.2.4 Submit review to owner safety personnel for approval.
16.3 Acceptance Criteria:
The attached safety review forms in Section 10.10.4 are completed and personnel protection
has been identified.

17.0

Deviation Reporting Log (Attachment #11)

17.1 Objective
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 7 of 24
To document any deviation to the stated test procedure or acceptance criteria, and to evaluate
the deviation relative to acceptability of the qualification study.
17.2 Procedure
17.2.1 Document all deviations found during execution using the Deviation Report Form that is
with the Deviation Reporting Log. Make copies of the form for each logged Deviation.
17.2.2 Deviations caused by Out of Specification (OOS) Conditions. If during the evaluation of
equipment parameters against specifications, the equipment fails to meet predetermined
acceptance criteria, a formal deviation report investigates the cause. In these cases, the
cause must be known prior to continuing the protocol execution since a true failure in
equipment performance is likely to affect the completion of the protocol. The protocol
deviation report determines 1) if the acceptance criteria are correct and current with user
requirements and manufacturer's ratings, or 2) if there is an immediate and obvious
explanation for the failure. If a true failure is documented, then appropriate root cause
analysis and corrective actions ensue and are agreed to between the protocol executors
and the department owners and QA. The protocol deviation report documents the
conclusion to this investigation and any appropriate retesting and an impact assessment
on the portions of the protocol executed prior to the documented failure.
17.2.3 Completed Deviation Report Forms are submitted to QA for signature acceptance.
18.0

Installation Qualification Protocol Review (Attachment #12)


18.1 Objective
To document that this protocol has been reviewed for completeness as per Qualification Process
Solutions, LLC Requirements.
18.2 Procedure
Complete attachment with name, title, signature and date.

19.0

Summary Report Requirements


19.1 Objective
To document data collected in support of the Installation Qualification Test of the equipment.

19.2 Procedure
19.2.1 Generate a Final Summary on completion of protocol execution.
19.2.2 Attach copies of the completed approved Deviation and Corrective Action Forms where
necessary.
19.2.3 Attach the completed executed protocol attachments to the Summary Report.
19.2.4 Compile a summary of the results obtained, and generate a conclusion, based on these
results, of the acceptability of the qualification results. The conclusion section will
contain a statement(s) of conformance to the specified acceptance criteria, evaluated in
conjunction with the approved Deviations/Variances and Corrective Actions taken, and a
determination of acceptability of the protocol, as executed.
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM

NATIONAL INSTITUTE OF HEALTH, BUILDING 10


BETHESDA, MD 20892
Page 8 of 24
LIST OF ATTACHMENTS
Attachment #1 IQ Signature Verification
List .............................................................................................. 9
Attachment #2 Specification and Purchase
List.......................................................................................... 10
Attachment #3 Test
Equipment ...................................................................................................................
11
Attachment #4 Air Compressor Systems
Specification .............................................................................. 12
Attachment #5 System
Documentation ....................................................................................................... 13
Attachment #6 Drawing Verification
List................................................................................................... 14
Attachment #7 Instrument
Calibration ........................................................................................................ 15
Attachment #8 Supporting Utility
Verification........................................................................................... 16
Attachment #9 Specific Installation
Requirements ..................................................................................... 17
Attachment #10 Safety
Review................................................................................................................... 18
Attachment #11 Deviation Reporting
Log .................................................................................................. 22
Attachment #12 Installation Qualification Protocol
Review ...................................................................... 24
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 9 of 24
Attachment #1 IQ Signature Verification List
This section identifies the personnel conducting the Installation Qualification Test. Each person
involved in executing this protocol shall complete an entry on the page.
Department/
Print Name

Title

Signature

Initials

Date

Company Name

Comments: ________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________

Acceptance Criteria: Signatures from all personnel involved in execution of this protocol shall be
present.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________
Date: ___________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 10 of 24
Attachment #2 Specification and Purchase List
List all applicable specifications, purchase orders and change orders. Note: Make additional copies of this
attachment as necessary. Existing documentation packages, where available, may be included as attachments.
Vendor

Equipment Specification

Initials/Date

Gardner Denver*

Model WTR45-A
User Requirement Specification
Gilbane Spec.
15360 Laboratory Compressed Air and
Gas Systems
*There is only one document for these two listing.

Comments: *Equipment was purchased through Gilbane as part of the PDS Atrium infill project.
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: The specification of model is as listed and the user requirements document is attached.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: __________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 11 of 24
Attachment #3 Test Equipment
This attachment identifies the instruments, equipment, and materials that are not part of the equipment or
system being qualified, but are used in this qualification.
Equipment
Manufacturer
Description
AC/DC True
RMS Clamp
Meter
Pressure
Calibrator

FLUKE

FLUKE

ID#
102526

ALID11
G23LAB
H4

Certified/

Cal.

Cal

Calibrated
Yes

Date
11 May
2009

Due Date
11 May
2010

Yes

26 Oct
2009

26 Oct
2010

Initials/

Serial #
92402293

9466060

Date

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: All test equipment required for execution shall be calibrated with copies of calibration
records attached.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: _____________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 12 of 24
Attachment #4 Air Compressor Systems Specification
Review the as built system and compare to the specifications on this attachment.
Verification Items
Manufacturer
Model Number
Serial Number
Quantity of Modules
Rating
Compressors
Mounting

Specified
Gardner Denver
WTR45-A
as found
1
48 CFM @ 175 psi
5-15 HP
Frame Mounted

Actual

Initial/Date

Electrical Service

460/60/3 21 amps (ea.)

Air Receiver
Dimensions
Pressure Regulators
Dessicant Dryers
Dimensions
Connections
Control Panel

1
30 X 84 , LOA 95.75
as found
1 twin tower
32x45x60 (LxWxH)
1 NPT
NEMA 4 Quintaplex

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: The actual specifications match the expected specification.


Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: _____________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 13 of 24
Attachment #5 System Documentation
Verify the documents listed below and their location.
Initial/
Document Titles

Description

Document Location
Date

Air Receiver
ASME
Certification

Certification Report

System Manual
WTR45-A
Maintenance Instructions
Compressor
Equipment Specification
System Manual
Desiccant Dryer
Maintenance Instructions
Sequence of Operations (or
Control Panel
Operating Manual)
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Acceptance Criteria: The documents have been located and are either attached here, or if too large to attach,
then their location elsewhere is clearly specified.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: __________________________________
Date: __________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 14 of 24
Attachment #6 Drawing Verification List
Obtain a copy of the current or approved revision for each drawing listed below. Record the revision number

and date of each drawing. Visually compare the drawings to the installed equipment/system.

Drawing

Rev. No./
Date

Location of
Initials / Date

Drawing Description

Number

Drawing

Air Compressor General


Arrangement
Air Compressor Bill of
Materials
Air Compressor Electrical
Wiring Diagram
Desiccant Dryer General
Arrangement
Desiccant Dryer Bill of
Materials
Desiccant Dryer Electrical
Wiring Diagram
Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: All drawings pertaining to the equipment are listed above and the information is
complete.
Meets Acceptance Criteria? ( ) Yes

( ) No

Reviewed by: ________________________________


Date: ______________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 15 of 24
Attachment #7 Instrument Calibration
Where these instruments carry calibration labels, indicate the calibration due date. Otherwise,
indicate not applicable (N/A).

Instrument

Description

Calibration
(Due Date or
N/A)

Initial / Date

Air Compressor
High Temp Switches 1-5

Panel Mounted

Low Pressure Switches 1-5

Panel Mounted

High Pressure Switches 1-5

Panel Mounted

Pressure relief valve

As Found

Interstage pressure relief valve

As Found

Desiccant Dryer
Tower Pressure Gage

Tower mount

Safety Relief Valve

Tower mount

N/A

Tank Mounted
Wall mounted
sensor.
Wall mounted
sensor.

N/A

Air Receiver
Safety Relief Valve
Differential Pressure Monitor
(DPM)
Remote Pressure Transmitter
(RPT)

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: Instruments listed above have been located and calibration status noted.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892

Date: ______________

Page 16 of 24
Attachment #8 Supporting Utility Verification
Measure/Verify the support utility parameters to assure that they match with system requirements.
Verification Items

Specified (nominal)

Electrical Power

460/3/60

Actual
Air Compressor

As-Found

Verification Method

Direct Measurement

Vendor Start-Up
Direct Measurement

Vendor Start-Up

Initial/Date

Chilled Water
(Temp/Flow)
Desiccant Dryers
Direct Measurement
Electrical Power

115/1/60
Vendor Start-Up

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: Actual support utility specifications have been recorded.


Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________

Date: ______________

DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 17 of 24
Attachment #9 Specific Installation Requirements

As Found Condition

Field Condition
Meets Requirement

Installation Requirement
Y/N
Equipment is properly leveled and
adequately secured in place.
Vibration isolators properly installed
and adjusted
Drain pans sloped. One outlet drain
per cooling section.
The filters are installed and are
orientated to match the flow direction.
Shipping braces removed
All piping is supported. (No visible
sag.)
Equipment has been cleaned prior to
start-up.
Adequate clearance provided to
equipment.
Drive belts aligned and tensioned.
Belt guards in place and secure.
Equipment appears to be clean and
not damaged.
125psi SS flex connectors are
installed at compressor inlet and
outlets. air piping provides supply air
Supply

Initials / Date

to all locations as specified on


drawings.

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Acceptance Criteria: The field condition meets or exceeds the installation requirements as designated on the
attachment.
Meets Acceptance Criteria? ( ) Yes ( ) No
Reviewed by: ________________________________

Date: ______________

DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 18 of 24

Attachment #10 Safety Review


Hazop Review and Checklist
To be completed by Safety Personnel. Indicate which of the safety specifications listed below are applicable.
For those indicated, record the specific measures to take to verify their completion.
New Equipment Safety Review
Walk through conducted

[ ] YES [ ] NO [ ] N/A

HAZOP REVIEW [Hazard and operability analysis]


Conducted by: ________________________ Date: __________
Extreme Temperature:

Applicable

Location: ______________________

[ ] YES [ ] NO

All Hot Lines/Equipment Insulated:


Personnel Protection Available:
Heat Sources Shielded and Identified:
Signs Posted to Alert Operators that Surface is HOT:
Pressure Considerations:

Applicable

[
[
[
[

]
]
]
]

YES
YES
YES
YES

[
[
[
[

]
]
]
]

NO
NO
NO
NO

[
[
[
[

]
]
]
]

N/A
N/A
N/A
N/A

[ ] YES [ ] NO

All piping properly aligned


[ ]
Pressure rating of piping components is compatible with operating
Pressure relief devices provided where applicable
[ ]
Compressed AIR/GAS lines can be isolated and blend to zero energy
ASME stamps
[ ]
Location: ______________________________________________

YES [ ] NO
procedures
YES [ ] NO
state
YES [ ] NO

[
[
[
[
[

]
]
]
]
]

N/A
YES [ ] NO [ ] N/A
N/A
YES [ ] NO [ ] N/A
N/A

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Performed by: _______________________________

Date: _____________________

Reviewed by: _______________________________

Date: _____________________

Safety Specifications - Page 1 of 4


DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 19 of 24
Attachment #10 Safety Review
Hazop Review and Checklist (contd)
Hazardous Materials of Fluids:

Applicable

[ ] YES [ ] NO

If hazardous materials are applicable, attach Material Safety Data Sheet(s) to this report.
MSDS attached
[ ] YES [ ] NO [ ] N/A

If required, SOPs for safe handling written


Location: _________________________________
Spill retention provided
Toxic and Flammable Chemical Risks Controlled
Biohazards contained
Electrical Hazards:

Applicable

[ ] YES [ ] NO [ ] N/A
[ ] YES [ ] NO
[ ] YES [ ] NO
[ ] YES [ ] NO

[ ] YES [ ] NO

All wiring properly contained


[ ] YES [ ]
All systems properly grounded
[ ] YES [ ]
Lock outs available on all major equipment
[ ] YES [ ]
Specify types and locations: _______________________________________________________
Proper shielding provided
[ ] YES [ ]
Moving Parts:

Applicable

[ ] N/A
[ ] N/A
[ ] N/A

NO
NO
NO

[ ] N/A
[ ] N/A
[ ] N/A

NO

[ ] N/A

[ ] YES [ ] NO

Guards provided and in place at pinch points


Guards provided and in place over moving parts
Cut down lock nuts on shaft
Belt tension properly adjusted

[
[
[
[

]
]
]
]

YES
YES
YES
YES

[
[
[
[

]
]
]
]

NO
NO
NO
NO

[
[
[
[

]
]
]
]

N/A
N/A
N/A
N/A

Comments: _____________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Performed by: _______________________________

Date: _____________________

Reviewed by: _______________________________

Date: _____________________

Safety Specifications - Page 2 of 4


DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 20 of 24

Attachment #10 Safety Review


Hazop Review and Checklist (contd)
Physical Environmental:

Applicable

[ ] YES [ ] NO

Sharp edges removed or protected


Trip/fall hazards eliminated or protected against
Low clearance head space clearly indicated or eliminated
Equipment properly anchored
Eye hazards eliminated
Adequate lighting in area
Warning and precautionary signs where appropriate
Adequate Ventilation
Confined space eliminated or labeled
Dust Levels:

Applicable

[
[
[
[
[
[
[
[
[

]
]
]
]
]
]
]
]
]

YES
YES
YES
YES
YES
YES
YES
YES
YES

[
[
[
[
[
[
[
[
[

]
]
]
]
]
]
]
]
]

NO
NO
NO
NO
NO
NO
NO
NO
NO

[
[
[
[
[
[
[
[
[

]
]
]
]
]
]
]
]
]

N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A

[ ] YES [ ] NO

Particulate matter concentration results

[ ] YES [ ] NO [ ] N/A

Location: ____________________________________________________
Respiratory equipment/device in place, if required
Noise Levels:

Applicable

[ ] YES [ ] NO [ ] N/A

[ ] YES [ ] NO

Noise level is ________________dB


Noise reduction equipment/device in place, if required.

[ ] YES [ ] NO [ ] N/A

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________

Performed by: _______________________________

Date: _____________________

Reviewed by: _______________________________

Date: _____________________

Safety Specifications - Page 3 of 4

DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 21 of 24
Attachment #10 Safety Review
Hazop Review and Checklist
Ergonomic Design:

Applicable

[ ] YES [ ] NO

Ergonomic risks evaluated, operators can access all areas of machine [ ] YES [ ] NO [ ] N/A
Adequate operator visibility

[ ] YES [ ] NO [ ] N/A

Emergency stop buttons visible, accessible, labeled, and operational [ ] YES [ ] NO [ ] N/A
Warning bells and lights visible and functional

[ ] YES [ ] NO [ ] N/A

Belt/conveyor/table width not operational without safety guard

[ ] YES [ ] NO [ ] N/A

Hazardous equipment not operational without safety guard

[ ] YES [ ] NO [ ] N/A

Excessive reaching, body bending, weight pushing and pulling eliminated or minimized
[ ] YES [ ] NO [ ] N/A
Personnel protective equipment to be worn while operating is indicated. Include requirements.
[ ] YES [ ] NO [ ] N/A

Requirements location: __________________________

This equipment can be safely operated if it is maintained properly and appropriate procedures are followed.
Safety Personnel Signature: _________________________

Comments: ______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Performed by: _______________________________

Date: _____________________

Reviewed by: _______________________________

Date: _____________________

Safety Specifications - Page 4 of 4


DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 22 of 24
Attachment #11 Deviation Reporting Log
Document all deviations found during execution. Note: Make additional copies of this attachment as
necessary.
DEVIATION LOG
Deviation
Description

Resolved (Y/N)

Number

Yes / No

Yes / No

Initials & Date

Yes / No

Comments: _______________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________
Acceptance Criteria: A list of deviations resulting from the execution of this protocol shall be recorded.

Meets Acceptance Criteria? ( ) Yes ( ) No

Reviewed by: __________________________


Date: ____________
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 23 of 24
Protocol Deviation Report (Template)
Protocol #

Protocol Section

Date Encountered:

Page

Executor/Discovered By

Step

Description of Deviation

Investigation / Findings

Statement of Impact

Resolution

Approvals
Role
Executor

Name (Print)

Signature

Date

Reviewer
NIH QA Officer
DOC. # U-0018-2009-01
INSTALLATION QUALIFICATION PROTOCOL
COMPRESSED AIR SYSTEM
NATIONAL INSTITUTE OF HEALTH, BUILDING 10
BETHESDA, MD 20892
Page 24 of 24
Attachment #12 Installation Qualification Protocol Review
I attest that this document has been reviewed and found satisfactory.

Name (print):____________________________________________________________________

Company (Print): _________________________________________________________________

Title: ________________________________

Signature: ____________________________________________

Date: ___________________

NIH Document Review Approvals:

Approved By: ______________________

Approved By: ______________________

Title: _____________________________

Title: _____________________________

Signature:

Signature:

Date:

Date: