Document No.

: 2462
Revision No.: R0
Alachua, Florida Standard Operating Supercedes: NA
Procedure Effective Date: 09/20/02
Title: OPERATIONAL QUALIFICATION

1. PURPOSE
1.1 The purpose of this procedure is to define the process with which to establish, through
documented testing, that all critical components and direct impact systems are capable
of operating within established limits and tolerances. This procedure defines the content
and format of Operational Qualification (OQ) protocols and the process by which they
are developed and executed. This procedure also specifies the responsibilities for the
writing, execution, and closeout of OQ protocols.

2. SCOPE OR APPLICABILITY
2.1 This procedure governs all OQ Protocols used for qualification of direct impact
systems/equipment utilized in the manufacture of products at Regeneration
Technologies, Inc.
2.2 The OQ is performed on systems, which may consist of facilities, utilities, and/or process
equipment; and involves testing parameters that regulate the process or have an effect
on product quality.

3. RESPONSIBILITIES
3.1 Quality Assurance Manager
3.1.1 Review and approve OQ protocols. This review and approval includes
assessment of testing methods, procedures, and acceptance criteria.
3.1.2 Review and approve Nonconformance Reports in response to OQ protocol
deviations.
3.1.3 Provide technical assessment of product quality impact.
3.1.4 Review and approve test data, completed protocols, and summary reports.

3.2 Engineering/Validation Team

3.2.1 Develop and approve OQ protocols including testing methods and procedures,
acceptance criteria, approval of forms and documentation.
3.2.2 Coordinate with the Project Manager to identify and schedule OQ activities.
3.1.2 Provide personnel and applicable technical support for scheduled validation
activities and coordinate the execution of OQ protocols.
3.1.3 Review and approve Deviation and Nonconformance Reports in response to OQ
protocol deviations.
3.1.4 Develop, review, and approve OQ summary reports.
3.1.5 Provide technical input for equipment and process validation parameters.
3.1.6 Provide operator training, as required.
3.1.7 Provide technical input during design and qualification activities.
3.3 Manufacturing Manager
3.3.1 Provide trained personnel and designated manufacturing equipment for support
of scheduled OQ activities.
3.3.2 Provide technical input for the design, operation, and validation parameters.

4. REFERENCES
4.1 SOP D00389
4.2 SOP D-606
4.3 Policy P-13

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

5. DEFINITIONS
5.1 Deviation – any data or conditions which 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 Operational Qualification – documented verification that all key aspects of a system
perform as intended throughout the approved operating range; establishing, by objective
evidence, process control limits and action levels which result in product that meets all
predetermined requirements.
5.4 Nonconformance Report – documentation of the identification, evaluation, corrective action
and disposition of a nonconforming product.
5.5 Worst Case Conditions – a set of conditions encompassing upper and lower processing
limits and circumstances, which cause or create the greatest potential for process or
product failure.

6. MATERIALS AND EQUIPMENT

N/A

7. SAFETY REQUIREMENTS
7.1 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.
7.2 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 (IQ) and Operation Qualification (OQ)
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 8.3.5.2-8.3.5.5) will apply to both the IQ and OQ activities.
8.1.2 The prerequisites, procedures, and verifications (see sections 8.3.5.6-8.3.5.12)
will remain unique to either the IQ or OQ activity.
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 OQ Protocol:
8.2.1 The following documentation is typically required to write an OQ protocol:
8.2.1.1 Validation Master Plan
8.2.1.2 Functional Requirements Specifications
8.2.1.3 P & ID’s
8.2.1.4 Equipment Operations Manuals
8.2.1.5 Drawings and Specifications including:
8.2.1.6 Equipment Data Sheets
8.2.1.7 Equipment List
8.2.1.8 Instrument List
8.2.1.9 Alarm/Interlock Schedule
8.2.1.10 Operation Manuals
8.2.1.11 References for local, national and international codes and standards

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

8.3 Writing the Protocol:

8.3.1 The OQ protocol will identify and describe the system/equipment and its intended
usage, and provide an overview of the operation of the system/equipment.

8.3.2 The OQ protocol will describe the operational tests, measurements, and control
tolerances of the parameters that are critical to proper operation of the system.
Test objectives, methodologies and acceptance criteria will be outlined in each
protocol.
8.3.3 The OQ protocol should include challenges to the system to demonstrate
acceptable performance under worst case conditions.
8.3.4 In the OQ protocol, the acceptance criteria must be clearly defined. This will be
the criteria that must be met in order to successfully complete the operational
qualification.
8.3.5 Operational Qualification protocols should include the following sections:
8.3.5.1 Table of contents.
8.3.5.2 Purpose – defines the reason for performing the qualification on the
equipment/system with an indication of the expected outcome of the
qualification.
8.3.5.3 System Description – briefly describes the system/ equipment; identifies
the usage and location of the system, including how the system is
controlled. Note that the location of equipment during the OQ should be
the same as the intended location during manufacturing.
8.3.5.4 Scope - details the boundaries that the testing encompasses.
8.3.5.5 References - indicates the name and applicable document number of
any support information used in the creation of the OQ. This list may
include validation SOPs, engineering specifications, design drawings
and specifications, vendor manuals or other appropriate drawings.
8.3.5.6 Pre-requisites – identifies actions that must be performed prior to OQ
protocol execution.
8.3.5.7 Procedure – describes the procedure or methods to be used to conduct
the testing; includes instructions for completing the OQ test data sheets
and an execution signature log.
8.3.5.8 Functional tests – identifies and describes testing of each function,
alarm, interlock, or other operational features. In some cases, factory
acceptance testing, site acceptance testing, or commissioning testing,
may be referenced to demonstrate the specific function operates as
required. Each test case should contain detailed procedures and
specify acceptance criteria.
8.3.5.9 Operational performance tests – identifies and describes testing of
certain operational performance requirements (temperature uniformity,
pressure control, etc.), including appropriate challenges. Some of these
types of tests may be performed during the Performance Qualification
(PQ) instead. Each test case should contain detailed procedures and
specify acceptance criteria.

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

8.3.6.0 Test equipment/instruments list – identifies and lists all critical

measuring
and monitoring devices such as timers pressure indicators and
temperature sensors used during the qualification.
8.3.6.1 Calibration and Preventive Maintenance (PM) Program Verification –
verifies that a PM program has been established for the system, and all
critical instruments have been entered into a calibration program;
verifies the PM and calibration activities have appropriate, associated
work instructions.
8.3.6.2 SOP Verification - verifies that final drafts of SOPs have been created
based on OQ execution information, and that the drafts have been
submitted for approval.
8.3.6.3 Training Documentation – verifies that operator training has been
completed, and includes the location of training documentation.

8.3.7 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.
8.3.8 The OQ 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 OQ Protocol

8.4.1 The following is a list of documentation typically required to execute an OQ
protocol:
8.4.1.1 P&IDs
8.4.1.2 Instrument list
8.4.1.3 Equipment list
8.4.1.4 Instrument calibration certificates
8.4.1.5 Approved IQ protocol

8.5 Executing the Protocol

8.5.1 Prior to beginning OQ protocol execution, the IQ should be completed, reviewed,
and approved, and all deviations corrected. OQ protocol execution may
commence prior to closeout of the IQ if incomplete items or open discrepancies
have been verified by Engineering, Validation, and Quality Assurance not to
impact the outcome of the OQ.
8.5.2 Prior to execution of the OQ protocol, computer IQ and OQ activities should be
complete and all deviations corrected or verified not to impact operational
qualification.
8.5.3 Prior to execution of the OQ protocol, all critical instruments should be calibrated.
8.5.4 OQ execution involves extensive operation and testing of systems, utilities,
and/or equipment. Only personnel trained in equipment/system operation and
safety features should perform operations.

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

8.5.5 During OQ execution, if a situation arises where the system/equipment responds

in an unexpected manner or if the testing creates a situation where a question of
safety arises, immediately cease all testing and return the system/equipment to a
‘safe’ condition. Consult with the Project Manager prior to proceeding with
protocol execution.
8.5.6 The OQ protocol shall be kept on location during execution. Data, including
initials and dates, shall be entered in the OQ Protocol as it is executed. All data
must be entered in accordance with Regeneration Technologies, Inc. Policy No.
P-13.
8.5.7 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/Discrepancies
8.6.1 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.
8.6.2 Record and explain the deviation, resolution, and required corrective action on
the deviation report form supplied in the protocol.
8.6.3 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.
8.6.4 Minor changes to a system required to meet acceptance criteria that do not
require a change to the design of the system may be documented in the
applicable comments section of the Operational Qualification protocol.
Document the scope of the change and the justification for the change. Once the
change is complete, testing may continue.
8.6.5 A critical deviation that may impact product quality must be resolved prior to
proceeding with the Performance Qualification (PQ).
8.6.6 A non-critical deviation (errors in the protocol, missing documentation, etc.) may
be resolved after commencement of the PQ.
8.6.7 All deviations must be addressed and resolved.
8.6.8 When the corrective action has been completed, the failed portion of the OQ
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.
8.6.9 During retrospective qualification, if deviations occur and a change in the system
design or a change to the protocol acceptance criteria or test procedure is
required that could potentially adversely impact product, complete a
Nonconformance Report in accordance with SOP D00389.

8.7 Summary Report

8.7.1 Upon completion of the operational qualification of a system/equipment, an OQ
summary report may be prepared.
8.7.2 Alternatively, a report may be prepared combining the results from the IQ and
OQ.
8.7.3 The OQ Summary Report should include the following sections:

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

8.7.3.1 Purpose – defines the reason for performing the qualification.

8.7.3.2 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; briefly
describes the system operation.
8.7.3.3 Scope – details the boundaries of the qualification.
8.7.3.4 Responsibilities – outlines the responsibilities of the departments
involved in completion of the OQ.
8.7.3.5 Definitions – defines significant terms and/or abbreviations.
8.7.3.6 Equipment/System Location – identifies the location of the equipment;
include room number, building number, and address as applicable.
8.7.3.7 Functional Requirements – lists the functional requirements of the
equipment and/or process.
8.7.3.8 Documentation Requirements – lists the documentation that was
required to complete the OQ and the location of the documentation.
8.7.3.9 Qualification Results – describe the steps taken during execution of the
OQ Protocol (e.g. alarms and interlocks function properly, regulators
accurately regulate pressure, etc.); includes an evaluation of the results;
identifies deviations, resolutions, corrective actions, and
recommendations (if any).
8.7.3.10 Acceptance Criteria – describes the general acceptance criteria;
includes a statement of adherence to the acceptance criteria.
8.7.3.11 Summary – briefly summarizes the qualification; identifies the
status/condition of the system/equipment.
8.7.3.12 Re-qualification Requirements – identifies the requirements and
schedule for re-qualification.
8.7.3.13 Completed Test Data Sheets – attach the completed sheets.
8.7.3.14 Deviations and Resolutions – attach the completed and approved
Deviation Report Forms.
8.7.3.15 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.

8.8 Completion of the Operational Qualification

8.8.1 The Operational Qualification is considered complete when all test cases have
been executed and verified; Quality Assurance and Validation have approved all
deviation resolutions; and a Summary Report has been written and approved by
the original signing departments.
8.9 Commencement of PQ:
8.9.1 When possible, the OQ should be completed and approved prior to
commencement of the PQ.

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 Standard Operating Document No.: 2462
Revision No.: R 0
Alachua, Florida Procedure
Title: OPERATIONAL QUALIFICATION

8.9.2 Prior to completion of OQ, PQ protocol execution may begin provided a

documented engineering assessment of the state of OQ is performed to verify
any incomplete items or open discrepancies will not affect the outcome of PQ
testing. This assessment shall be documented via signature either at the end of
the OQ protocol or as a pre-requisite listed in the PQ protocol, and must be
approved by Validation and Quality Assurance.

9. RECORDKEEPING REQUIREMENTS
9.1 Protocols will be processed in accordance to 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 Upon completion of the OQ, a final report should be written and approved.
9.4 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. P-13."

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 Operational Qualification Decision Algorithm

START Assess System

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

Yes

Perform an IQ,
Has an IQ been
refer to SOP No. No
done?
D-692
Yes

Yes
Update Files
Update Files Is all relevant
Is all relevant Is Include original IQ
documentation on
documentation on Re-qualification No No and OQ protocols,
Include original protocol, No file?
file? due? recorded data, and
recorded data, and
summary report summary report(s)

Yes Yes
Yes
Yes

Has an OQ No action
Schedule re-
been done? required
qualification

No

Perform an OQ,
refer to SOP No.
D-691

Halt testing;
Are deviations
consult with QA Did deviations
No resolved & corrective Yes
and Regulatory occur?
actions completed?
Compliance

No

Update Files
OQ successfully completed;
Yes Include original OQ Refer to SOP No. D-693 to
protocol, recorded data, perform an PQ
and OQ summary report

Attachment A Page 1 of 1 2462 R0 09/20/02 Page 8 of 10