Installation Qualification

Updated: Sep 28

Ticking-off as a necessary evil or to build a strong foundation?




Do you think IQ is the least important part of process validation? Do you think this is just a monotonous ticking-off boxes exercise with no value? In fact, the installation qualification builds a strong foundation for the manufacturer to prevent future issues [1].


This post talks about:

· Why perform an IQ

· What an IQ is

· What information to put in an IQ

· Calibration records


Why perform an IQ

The ISO 13485:2016, 7.5.6 b) requires that the organization shall document procedures for equipment qualification. There we have it; IQ is a requirement per ISO 13485, but the U.S. FDA has a similar requirement under 21 CFR 820.70(g) and other regulatory bodies too.

Even though performing an IQ is required by regulation, it should not be the only reason we perform it, but more on that later.


What is an IQ

The GHTF (Global Harmonization Task Force) defines installation qualification as “establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.” [2]


Some manufacturers divide the installation qualification into two separate entities: a factory acceptance test (FAT) and a site acceptance test (SAT). FAT activities are conducted at the equipment supplier's site before shipment. These documents can then be used to supplement the installation qualification at the final place of operation. However, it is most likely insufficient to only the equipment supplier's documents. Whether a piece of equipment is suitable for the manufacture of a medical device is ultimately the responsibility of the manufacturer of the medical device.


What information to put in an IQ

GHTF mentions typical IQ considerations:

· Equipment design features (i.e., materials of construction cleanability, etc.)

· Installation conditions (wiring, utilities, functionality, etc.)

· Calibration, preventative maintenance, cleaning schedules

· Safety features

· Supplier documentation, prints, drawings, and manuals

· Software documentation

· Spare parts list

· Environmental conditions (such as clean room requirements, temperature, humidity)


The ISO 11607-2:2019 adds in 5.2.1 the following IQ considerations:

· Equipment operating within the stated design parameters

· Software and/or Firmware validation

· Environmental conditions such as cleanliness, lighting

· Documented operator training

· Operating manual or procedure


Other considerations may be:

· Health

· Ergonomics

· Interfaces

· Functional Testing


Along with technical considerations, many quality management requirements can be observed. Calibration and preventive maintenance are examples of measures that should be triggered by the quality management system. Therefore, it must be verified that the equipment has been integrated into the appropriate systems to ensure regular tasks.


Calibration records

Calibration was mentioned as an IQ consideration. Unfortunately, we have seen far too many misuses of the word calibration and the content of a record. Thus, we want to summarize what a calibration record must contain according to the U.S. FDA under TITLE 21 CFR 820.72(2):


“The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. “ [5]


Not to forget that these records shall at least be readily available and traceable to national or international standards.



Are you concerned about the increased requirements due to MDR (Medical Device Regulation; 2017/745) and already behind schedule? Contact us today, and we'll take the burden off your shoulders and help you make your supply chain compliant.



References


[1] http://www.quality-on-site.com/get.php?fileid=139

[2] http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

[3] ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

[4] ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

[5] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart

=820&showFR=1


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