Steps to Equipment Qualification Page 1 of 7

Steps to Equipment Qualification

 VALIDATION    

Jennifer Medlar , Nancy Cafmeyer | Jan 01, 2009

VALIDATION

Equipment qualification is a necessary and critical step in ensuring

that a product or service is provided accurately and consistently
with requirements aligned with medical device manufacturing and
testing. This is especially critical for the medical device industry
because the medical device manufactured by a company is
considered a piece of equipment and requires qualification, as
(click to enlarge )
much as other equipment and instruments involved in
This is an example
manufacturing. Verifying prerequisites before qualification ensures
of a table that would
a safe and smooth qualification process. A prerequisite in an
be included in a
equipment qualification is a documented verification intended to
qualification
demonstrate that everything is in order prior to initiating the
protocol in a
execution of the qualification section.
prerequisites test

For medical device companies, using prerequisites translates into section. An official

less time and money spent on avoidable delays. Because the copy of the protocol

requirements for a piece of equipment or a device can vary widely is printed and the

from company to company and even between pieces of the same tester fills in results

type of equipment, it is important to devise a universal set of of the procedure for

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21
Steps to Equipment Qualification Page 2 of 7

prerequisites that will address all potential trouble areas. Device the test section
OEMs and device-testing facilities need to understand how performed.
prerequisites fit into an equipment qualification, and need to know what should be
verified during prerequisite verifications in an equipment qualification. They should also
be able to outline a universal set of prerequisites.

Prerequisites in an Equipment Qualification Protocol

Setting up equipment in a medical device manufacturing facility includes ensuring that

the equipment will safely and consistently work as intended. To do this, it is necessary
to verify the following actions:

• That the equipment is installed according to the manufacturer's instructions.

• That the equipment is operated properly and consistently.
• That the equipment performs within the requirements determined by the facility.
To cover all of the necessary criteria, equipment qualifications are typically organized
by separating the protocol into three sections: installation qualification (IQ), operational
qualification (OQ), and performance qualification (PQ).

Because the IQ, OQ, and PQ are performed separately, each should have its own set
of prerequisite verifications. Because the equipment requirements at each of the
qualification stages are different, the prerequisite requirements at each of the
qualification stages should be different as well.

What to Verify during Prerequisite Testing

The general goal of prerequisite testing is to ensure that items that commonly cause
execution to be delayed or repeated are in order prior to starting the qualification.
Because of variations in equipment and differences in how facilities operate, using the
exact same prerequisite verifications may not always be the best approach.

For prerequisites to significantly help streamline the qualification process, they have to
be tailored to fit the specifics of both the equipment and the facility. As a whole, it is

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21
Steps to Equipment Qualification Page 3 of 7

easy to overlook potentially important prerequisites. Therefore, it is often helpful to

separate them into categories and address them one at a time. With a good
understanding of the categories, the process of tailoring the verifications to suit a
specific piece of equipment at a specific facility will be much smoother. Although it is
nearly impossible to cover all prerequisite verifications, some of the most common
prerequisite categories are presented and explained in the following paragraphs.

Procedure Prerequisites

Procedure verification includes any procedure that is required for operation or

maintenance of the equipment as well as any sampling or testing procedures required
to obtain and analyze the protocol samples. Each of these procedures has typical items
that need verification, such as the status of the procedure, the title, and the document
number. Specifications vary depending on the section of the protocol the verification is
being written for (i.e., IQ, OQ, or PQ). For example, during the IQ, it might be
acceptable for the procedures to still be in draft form. But by the time the PQ section is
going to be executed, the procedures must be approved documents.

Performing procedure verification could be cost-efficient for a company. For example, a

medical device facility brought in personnel to perform the time-consuming task of
collecting microbial samples for a qualification. When the samples arrived at the
laboratory, they realized that the testing procedure for the samples was still in
development. None of the samples taken were usable and the entire collection process
had to be repeated once the testing procedure was approved. Because of the delays,
the launch of the medical device into the market had to be postponed. The expense of
the wasted man-hours and supplies and the delay of the launch could have easily been
avoided by a procedure verification prerequisite.

Training Verification

The importance of verifying the training of operators and test

personnel is a universal prerequisite throughout the various types
of validations and qualifications. For equipment qualification, it's
(click to enlarge )
important to verify that the personnel operating the equipment (in

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21
Steps to Equipment Qualification Page 4 of 7

Procedure addition to the personnel executing the protocol) have the training
prerequisite required to successfully perform the necessary tasks according to
specifications in the currently acceptable method. Additionally, the personnel
equipment executing the protocol should be similarly trained.
qualification.
Picture executing a performance qualification of an autoclave for
which the operator doesn't know how to control the equipment, and the importance of
verifying operator training becomes clear. What may not seem as clear is why it is
important to verify the training of the qualification test personnel. A medical device
manufacturer learned the importance of test personnel training during the qualification
of a freezer. The freezer qualification included a 72-hour temperature mapping, which
required monitoring and recording the temperature in different quadrants of the freezer
at specified time intervals for a three-day period. During an audit, it was discovered that
the data were not collected for the full 72 hours. An investigation concluded that the
error was due to the fact that the testers who set up the mapping were trained on an
earlier revision of the protocol and didn't realize the time interval had changed. For this
company, the small amount of time that would have been needed to execute a
prerequisite seems well worth it after being set back three or more days because of the
need to investigate and repeat the test.

Utilities Verification

Although not actually a part of the equipment, utilities are essential to its operation.
Equipment cannot run without electricity, compressed air, gas, water, etc. Utilities that
should be verified include any utility that is required to execute the protocol and has the
possibility of not being available or not being available at the required level.

An example of the benefit of performing utility verifications was seen during the
qualification of equipment designed to weld the seam of a medical device. For the
equipment to produce a successful weld, it was critical that the laser power supply
meet very specific electrical requirements. During the qualification, multiple
unsuccessful welds were observed. After a lengthy investigation, it was discovered that
the problems were caused by a variation in the electricity feeding the laser. Although
the problem was identified, the time needed to correct the problem and rerun the test

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21
Steps to Equipment Qualification Page 5 of 7

was costly and could have been avoided had the utility qualification of the electrical
system been performed prior to starting the testing.

Test Instrument Prerequisites

Instituting test instrument prerequisites is a simple way to eliminate costly delays and
misunderstandings. The items that should be tested in this section include any
instrument or piece of equipment that is required during the execution of the protocol.
Some examples of instruments or equipment that are typically verified in test
instrument verification include voltage meters, particle counters, and scales. Testing
and sampling instruments and equipment are often used by many people and often
require calibration. Typical items that benefit from prerequisite testing include the
availability or location of the instrument or equipment and its calibration status for the
expected duration of the qualification execution. Just imagine the headache it would
cause, if, when it came time to start a qualification, you realized that your scale was out
of calibration or the particle counter you ordered a month ago never arrived. Making
arrangements for calibration or tracking down an order often involves time-consuming
activities (e.g. getting approvals, contacting customer service representatives, and
tedious paperwork). Such tasks are time-consuming in general, so don't add to the
burden by waiting to do them until it's too late to resolve the issue without holding up
the qualification. Performing prerequisites allows you to address the items before they
start causing delays.

An incident during a qualification of an incubator at a contract testing laboratory shows

how test instrument verification can make a difference in a timeline. Temperature
mapping was included as part of the qualification. After completion of the qualification,
it was discovered that some of the data loggers used during the mapping were out of
calibration. The calibrations were scheduled and performed, but the mapping had to be
repeated once the data loggers were received back from calibration. The hassle of
additional scheduling and the delays incurred could have been avoided had the
contract testing laboratory performed a test instrument verification that included the
data loggers.

Equipment Status Prerequisite

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21
Steps to Equipment Qualification Page 6 of 7

The purpose of equipment status prerequisite testing is to

ensure that the equipment being qualified is installed and
ready for qualification. As with procedure verification,
different requirements or specifications are typically desired Learn more about
for different sections of the qualification. For example, it prerequisites:
might be necessary for the equipment to be set up, Process Validation
calibrated, and ready to run during a PQ. However, for the Prerequisites 101
IQ, it's only necessary for the equipment to be installed.
Another possible inclusion in equipment status verification is the availability of the
equipment for use. Unlike process validation, which cannot begin until a process has
been developed, equipment qualification protocols are sometimes written before the
equipment is even received. As a result, a protocol can be ready for execution long
before the equipment has arrived and been installed.

Recently, the qualification of a building management system at a medical device facility

was scheduled to begin, and consultants were hired to execute the protocol. When the
consultants arrived at the facility to begin the qualification, they found out that an
ancillary electrical panel had not been installed because it was on back order. If the
equipment status had been verified prior to the qualification, the cost and time of the
additional on-site visit by the consultants in order to reassemble the team could have
been avoided.

Additional Benefits of Prerequisites

Documentation of prerequisites creates a system that actively tracks future problems,

not just problems that have already occurred. When combined with the existing
methods of identifying trouble areas of the quality system, prerequisites provide a little
extra help in meeting the overall goal of preventing problems rather than just reacting to
them.

Adding prerequisites to a validation or qualification program also helps OEMs prepare

before an audit. By performing these simultaneous “spot checks” or verifications of the
quality system, it is possible to generate trends in the quality system. The additional
method of locating such holes and inconsistencies helps a company understand the

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21
Steps to Equipment Qualification Page 7 of 7

areas to focus efforts prior to an audit instead of after an auditor has found the
problems.

Conclusion

Incorporating prerequisites into an equipment qualification ensures that equipment is

ready to run consistently and reliably. Moreover, it ensures that the equipment can
pass the testing outlined in the protocol with fewer failures, investigations, or retesting.
The ability of prerequisites to streamline the execution of a qualification, with the added
bonus of the ways that they benefit a quality system, demonstrates the value of
incorporating prerequisites into an equipment qualification. Having a clear
understanding of the benefits and being able to apply them to your facility can ensure
smooth, cost-effective qualification efforts.

Jennifer Medlar is a consultant for Advanced Biomedical Consulting LLC (ABC; St.
Petersburg, FL), and Nancy Cafmeyer is a project manager at the company. Contact
them at jmedlar@advancedbiomedicalconsulting.com and
cafmeyer@advancedbiomedicalconsulting.com .

Bibliography

“Current Good Manufacturing Practice for Finished Pharmaceuticals,” Code of Federal

Regulations, Part 211, Title 21, Rev. April 2006.

Food and Drug Administration (FDA), “Guideline on General Principles of Process

Validation,” Rockville, MD, 1987.

N Cafmeyer and JM Lewis, “Process Validation Prerequisites 101,” Medical Device &
Diagnostic Industry, March 2008.

Copyright ©2009 Medical Device & Diagnostic Industry

Source URL: https://www.mddionline.com/equipment/steps-equipment-qualification

file:///C:/Users/User/AppData/Local/Temp/Low/PGABXXAD.htm 08-May-21