Document No.

: 2455
Revision No.: R1
Alachua, Florida Standard Operating Supercedes: R0
Procedure Effective Date: 10/03/02
Title: Performing an Installation Qualification

1. PURPOSE
The purpose of this procedure is to outline the steps involved in defining and verifying that a
facility, utility, or equipment is built and installed in accordance with approved specifications.
This procedure also defines the content and format of Installation Qualification (IQ) Protocols and
the process by which they are executed. In addition, this procedure specifies the responsibilities
for the writing, execution, and closeout of IQ Protocols.

2. SCOPE OR APPLICABILITY
2.1 This procedure governs all IQ Protocols used for validation of direct impact
systems/equipment utilized in the manufacture of products at Regeneration Technologies,
Inc.
2.2 This protocol does not define the requirements for the qualification of computerized
systems and associated software. IQ requirements for small systems can be documented
using this procedure as components of the system that is being controlled.

3. RESPONSIBILITIES
3.1 Quality Assurance Manager
3.1.1 Review and approve IQ protocols. This review and approval includes assessment
of testing methods and procedures and acceptance criteria.
Review and approve Nonconformance Reports in response to IQ protocol
deviations.
Provide technical assessment of product quality impact.
Review and approve raw data and IQ summary reports.
3.2 Validation/Engineering Team
3.2.1 Develop and approve IQ protocols including testing methods and procedures,
acceptance criteria, approval of forms and documentation.
Coordinate with the Project Manager to identify and schedule installation and
validation activities.
3.2.2 Coordinate the execution of IQ protocols.
3.2.3 Review and approve Deviation and Nonconformance Reports in response to IQ
protocol deviations.
3.2.4 Develop, review, and approve completed IQ summary reports.
3.2.5 Provide personnel and applicable technical support for scheduled validation
activities.
3.2.6 Provide technical input for equipment and process validation parameters.
3.3 Manufacturing Manager
3.3.1 Provide trained personnel and designated manufacturing equipment for support of
scheduled IQ activities.
3.3.2 Provide technical input for the design, operation, and validation parameters.

4. REFERENCES
4.1 SOP 1658
4.2 SOP D-606
4.3 Policy 47
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 Standard Operating Document No.: 2455
Revision No.: R1
Alachua, Florida Procedure
Title: Performing an Installation Qualification

5. DEFINITIONS
5.1 Deviation – any data or conditions that fall outside of the acceptance criteria as defined in
the approved protocol
5.2 Direct Impact – having a direct effect on the quality, safety, and/or efficacy of product
5.3 Installation Qualification – documented verification that all key aspects of process
equipment, including ancillary systems, meet specified requirements and are appropriately
designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning,
and use.
5.4 Nonconformance Report – documentation of the identification, evaluation, corrective action
and disposition of a nonconforming product.

6. MATERIALS AND EQUIPMENT

N/A

7. SAFETY REQUIREMENTS
Prior to the initial startup and operation of equipment and systems, all personnel involved in the
operation will receive a safety orientation and training on appropriate safety features and
procedures.
Only personnel who are properly trained in the operation and maintenance of the applicable
equipment and systems will operate the system/ equipment.

8. PROCEDURE
8.1 If so desired, the Installation Qualification and Operation Qualification protocols may be
combined into one document, an Installation, and Operation Qualification (IOQ) protocol.
8.1.1 In an IOQ protocol, the Purpose, System Description, Scope, and References
sections (see sections 8.3.4.2-8.3.4.5) will apply to both the IQ and OQ activities.
8.1.2 The prerequisites, procedures, and verifications (see sections 8.3.4.6-8.3.4.14) will
remain unique to either the IQ or OQ activities.
8.1.3 During execution of an IOQ protocol, IQ activities must be completed before
proceeding with OQ activities.
8.2 Documentation Required to Write an IQ Protocol:
8.2.1 The following documentation is typically required to write an IQ protocol:
8.2.2 Validation Master Plan
8.2.3 Engineering/Construction Specifications
8.2.4 Supplier Drawings and Specifications, including:
8.2.4.1 Purchase Orders and Contracts
8.2.4.2 Manufacturers Data Sheets
8.2.4.3 P & ID’s
8.2.4.4 Equipment List
8.2.4.5 System Hardware/Software Specifications
8.2.4.6 Instrument List
8.2.4.7 Tag List

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 Standard Operating Document No.: 2455
Revision No.: R1
Alachua, Florida Procedure
Title: Performing an Installation Qualification

8.3 Writing the Protocol

8.3.1 The IQ protocol will identify and describe the system/equipment, intended use of the
system/equipment, and the major components (filters, pumps, fans, gauges, valves,
etc.)
8.3.2 The IQ protocol will include IQ checkout sheets (defined as worksheets or
attachments) to document that the installed equipment adheres to design criteria,
and meets equipment specific installation requirements, such as pressure tests,
cleaning and passivation, motor checkout, and safety requirements.
8.3.3 In the IQ protocol, the acceptance criteria must be clearly defined. This will be the
criteria that must be met in order to successfully complete the installation
qualification.
8.3.4 Installation Qualification Protocols should include the following sections:
8.3.4.1 Table of contents
8.3.4.2 Purpose – defines the reason for performing the qualification on the
equipment/system with an indication of the expected outcome of the
qualification.
8.3.4.3 System Description - briefly describes the system/ equipment, including
major components and controls; and identifies the usage and location of
the piece of equipment, system, or process. Note that the location of the
equipment during the IQ should be the same as the intended location
during manufacturing.
8.3.4.4 Scope - details the boundaries that the testing encompasses.
8.3.4.5 References - Indicates the name and applicable document number of any
support information used in the creation of the IQ. This list may include
validation SOPs, engineering specifications, design drawings and
specifications, vendor manuals or other appropriate drawings.
8.3.4.6 Prerequisites – identifies actions that must be performed prior to protocol
execution.
8.3.4.7 Procedure – describes the procedure or methods to be used to conduct
the inspections; includes instructions for completing the IQ checkout
sheets, documentation requirements, and an execution signature log.
8.3.4.8 Material Certifications – identifies required material certifications for
product contact surfaces within the system and acceptance criteria.
8.3.4.9 Installation Verification – identifies supporting services and all major
components of the equipment/system to be inspected, and acceptance
criteria; verifies that the system is installed according to specifications,
reviews quality of workmanship, materials of construction, etc.
8.3.4.10 Utilities Verification – identifies supporting utilities and acceptance criteria;
verifies that utilities are installed according to specifications, appropriately
supplied and labeled
8.3.4.11 Equipment Drawings- identifies equipment/system drawings including
Piping and Instrumentation Diagrams (P&IDs), Isometric Drawings (where
pipe slopes are critical), Control Panel Layouts, Wiring Diagrams, and any
vendor drawings; verifies that field conditions and drawings match.

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 Standard Operating Document No.: 2455
Revision No.: R1
Alachua, Florida Procedure
Title: Performing an Installation Qualification

8.3.4.12 Other fabrication or installation features that have direct product quality
impact – contains any additional inspection attributes and acceptance
criteria that were not covered by the material certifications, equipment
installation verification, or equipment drawings sections.
8.3.4.13 Instrumentation Verification – contains a list of instruments to be
calibrated and/or loop checked, and verifies that those activities have
been completed and documented. This section also documents any
control system hardware as installed.
8.3.4.14 Installation Qualification Completion – verifies that installation
qualification support documentation is complete and available, identifies
documentation location.
8.3.5 A Deviation Report Form should be included as an attachment to the protocol. The
form should provide space to document and explain each deviation, the resolution
and required action; and a means to identify the deviation as critical or non-critical.
8.3.6 The IQ protocol must be reviewed and approved prior to the initiation of any testing.
At a minimum, the protocol must be approved by Validation and Quality Assurance.
8.4 Documentation Required to Execute an IQ Protocol
8.4.1 The following is a list of documentation that is typically required to execute an IQ
protocol:
8.4.1.1 Operation and Maintenance Manuals
8.4.1.2 P&IDs
8.4.1.3 Wiring diagrams
8.4.1.4 Other vendor drawings
8.4.1.5 Instrument list
8.4.1.6 Equipment list
8.4.1.7 Material certifications
8.4.1.8 Instrument calibration certificates

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DOCUMENT>>
Printed 07/12/21

IPS Classification: General

 Standard Operating Document No.: 2455
Revision No.: R1
Alachua, Florida Procedure
Title: Performing an Installation Qualification

8.5 Executing the Protocol

8.5.1 The execution of the Installation Qualification Protocol involves comparison of the
installed system with the approved Installation Qualification Protocol acceptance
criteria and approved design documents.
8.5.2 Whenever possible, verifications shall be performed in the field to verify “as
installed” conditions unless specifically exempted in the protocol. If field verification
is impractical or not possible, verifications may be performed using vendor or
contractor supplied documentation. In this case, an entry will be made in the
comments section of the protocol to identify the method of verification.
8.5.3 The Installation Qualification Protocol shall be kept on location during execution.
Data, including initials and dates, shall be entered in the Installation Qualification
Protocol as it is executed. All data must be entered in accordance with
Regeneration Technologies, Inc. Policy No. 47.

8.5.4 Each page of the executed portion of the protocol shall be signed by the person
responsible for conducting the inspection/ test, reviewed and signed by a second
person, and verified and signed by a QA representative.

8.6 Deviations
If a deviation is encountered during protocol execution (i.e. acceptance criteria is not met),
contact the Project Manager and evaluate the exceptional condition and its potential impact
on product safety and/or quality.
8.6.1 Record and explain the deviation, resolution, and required corrective action on the
deviation report form supplied in the protocol.
8.6.2 Number each deviation as follows: protocol section number where the deviation
occurred followed by a sequential number for each deviation observed, e.g., 8.1-1,
8.1-2, etc.
8.6.3 A critical deviation that may impact product quality must be resolved prior to
proceeding with the Operational Qualification (OQ).
8.6.4 non-critical deviation (errors in the protocol, missing documentation, missing
equipment tags, etc.) may be resolved after commencement of the OQ.
8.6.5 All deviations must be addressed and resolved.
8.6.6 When the corrective action has been completed, the failed portion of the Installation
Qualification protocol may be re-executed. If a change in the test procedure or a new
procedure is required, a protocol addendum will be required, and must be approved
by all persons responsible for initial approval of the protocol.
8.6.7 During retrospective qualification, if critical deviations occur that could potentially
adversely impact product, complete a Nonconformance Report in accordance with
SOP 1658.

8.7 Completion of the Installation Qualification

The Installation Qualification is considered complete when all test cases have been
executed and verified and Quality Assurance and Validation have approved all deviation
resolutions.

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 Standard Operating Document No.: 2455
Revision No.: R1
Alachua, Florida Procedure
Title: Performing an Installation Qualification

8.8 IQ Summary Report

8.8.1 Upon completion of the installation phase of a system/equipment, an IQ summary
report may be prepared.
8.8.2 Alternatively, a report may be prepared after completion of the Operational
Qualification (OQ), combining the results from the IQ and OQ.
8.8.3 The IQ Summary Report should include the following sections:
8.8.3.1 Purpose – defines the reason for performing the qualification.
8.8.3.2 System/equipment description – briefly describes the system/equipment,
including major components and controls; identifies the usage and
location of the piece of equipment or system.
8.8.3.3 Scope – details the boundaries of the qualification
8.8.3.4 Responsibilities – outlines the responsibilities of the departments involved
in completion of the IQ
8.8.3.5 Definitions – defines significant terms and/or abbreviations
8.8.3.6 Equipment/System Location – identifies the location of the equipment;
include room number, building number, and address as applicable
8.8.3.7 Documentation Requirements – lists the documentation that was required
to complete the IQ and the location of the documentation
8.8.3.8 Qualification Results – describes the steps taken during execution of the
IQ Protocol (e.g. verified that pipes met specification, field conditions
matched P&IDs, etc.); includes an evaluation of the results; identifies
deviations, resolutions, corrective actions, and recommendations (if any).
8.8.3.9 Acceptance Criteria – describes the general acceptance criteria; includes
a statement of adherence to the acceptance criteria
8.8.4.0 Summary – briefly summarizes the qualification; identifies the
status/condition of the system/equipment
8.8.4.1 Re-qualification Requirements – identifies the requirements and schedule
for re-qualification
8.8.4.2 Completed Checkout Sheets – attach the completed sheets
8.8.4.3 Deviations and Resolutions – attach the completed and approved
Deviation Report Forms.
8.8.4.4 Final Approval - includes spaces for signatures and dates of each of the
original document approvers; these signatures verify that the protocol
execution has been successfully completed and that all acceptance
criteria have been met.

8.9 Commencement of the Operational Qualification

8.9.1 When possible, the IQ should be completed and approved prior to commencement of
the OQ.
8.9.2 Prior to completion of IQ, OQ protocol execution may begin provided an engineering
assessment of the state of IQ is performed to verify that any incomplete items or open
discrepancies will not affect the outcome of OQ testing. This assessment shall be
documented via signature either at the end of the IQ protocol or as a pre-requisite
listed in the OQ protocol and must be approved by Quality Assurance.

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 Standard Operating Document No.: 2455
Revision No.: R1
Alachua, Florida Procedure
Title: Performing an Installation Qualification

9. RECORD KEEPING REQUIREMENTS

9.1 Protocols will be processed in accordance with SOP D-606.
9.2 Upon approval, a working copy of the protocol may be printed and utilized during the
execution portion of the process.
9.3 The original protocol, recorded data, and final report should be kept in Document
Control or another controlled location for the amount of time specified in RTI Policy
No. 47.

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 Installation Qualification Flow

START Assess System

Identify Commissioning
1. Identify components Is system required; Formal
System/ No
2. Determine impact - critical? qualification not
Utility/
Equipment direct, indirect, or no impact required

Yes

Is all relevant
documentation on Is Schedule re-
Has an IQ Yes
No Yes Yes Re-qualification
file? been done? qualification
due?

Update Files Yes

No No
Include original protocol,
recorded data, and
summary report Is all relevant
Perform an OQ - Perform an IQ, documentation on No action
refer to SOP No. refer to SOP No. Yes
file? required
D-691 D-692

No

Update Files

Did deviations Include original IQ

Yes protocol, recorded data,
occur?
and IQ summary report

Halt testing; Are deviations

consult with QA resolved & corrective
No No
and Regulatory actions completed?
Compliance

Update Files
Yes Include original IQ
protocol, recorded data,
and IQ summary report
IQ successfully completed;
Refer to SOP No. D-691 to
perform an OQ

Attachment A Page 1 of 1 2455 R1 10/03/02 Page 8 of 8