Installation Qualification: Step One in Ensuring Reliable, Predictable Operation of Your SPD Equipment
“Wherever you go, well, there you are.”—Confucius (or Buckaroo Banzai)
“How did I get here?”—David Byrne of Talking Heads
In my previous article for NewSplash, “The Nuts and Bolts of a Quality System,” I wrote about the three aspects of equipment qualification: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This article is a deeper dive into the first of these, Installation Qualification. IQ is the first step to make certain that the equipment purchased is, in fact, what you think it and is compatible with the utilities you can supply to it. To know where you are, you have to know how you got there, so answer David Byrne’s question.
In the previous article, I gave a simple definition for IQ: “It arrives. It survived shipping without damage. It’s what you ordered. All controls and safety equipment are present and functional. It turns on. The utilities are suitable. It doesn’t blow up (electrical, pneumatic, or water issues).”
This article will explore each of these in some detail and provide a basic template for IQ execution.
This is what you have been waiting for, but the journey to use of the equipment has just begun.
It survived shipping without damage
The equipment is not dented or otherwise damaged. All parts are present.
It’s what you ordered
The purchase requisition, purchase order, and the equipment documentation from the manufacturer all show the same thing. When you examine the equipment itself, all features specified are present. For example, if you ordered a cabinet or sterilizer with the door hinged at the left, it is not hinged at the right. If you ordered a device with a sliding door, it isn’t hinged. If you ordered a sterilizer with a vacuum pump, it has a vacuum pump, not an eductor/ejector. And so on.
All controls and safety equipment are present and functional
For all of the questions in this subpart of an IQ, the questions to ask are, “Is the item there? Is it connected correctly? Does it work?”
For a temperature controller, this means that the temperature should be controlled within the specification that the manufacturer has supplied. The same is true for any other controller.
Some adjustments may need to be made to ensure in-spec operations. Among these can be calibration. If this is needed, it should be stated by the manufacturer in the installation instructions. It should be noted that in a laboratory or industrial context, for devices that can be calibrated, calibration is always required after a device is moved to a new location. You don’t want to do less than they do.
Safety equipment can be something as simple as an arc-flash warning label on a high-voltage electrical box. Or an electrical safety stamp from a nationally recognized testing lab (UL, CSA, ETL, etc.). Or correctly sized fuses/circuit breakers per the electrical drawings. Or overpressure safety relief valves on a pressure vessel (e.g., sterilizer) of a pressure setpoint lower than the pressure vessel’s rating. These should all be checked before the equipment is placed into service.
The utilities are suitable
- Is there steam of the required pressure, quality, and quantity (and have you tested it)?
- Is the electrical service the right voltage, amperage rating, and number of phases?
- If the floor drain large enough?
- Is there an air break at the floor drain?
- Is/are the water supply(ies) of adequate purity, quantity, temperature, and pressure?
- Is critical water needed?
- For washers, if there is a central detergent station, does it interface with the washer and deliver the correct dosage?
- Is the connection to the IT network configured correctly and does it connect?
- Does the device integrate with tracking software (if you ordered that capability)?
All of these, and more, must be seen to for correct operation. Any omissions you accept will probably cause trouble later. Once all of the utility questions have been answered, you may proceed to the next step.
In some cases, it is a good idea to trace out the plumbing and electrical wiring to confirm that the device was built to the drawings supplied with it. You should receive a piping schematic and electrical drawings. You paid for the device and, when it is out of warranty and service contract, someone is going to have to troubleshoot it and fix it. You should also receive a component list for nongeneric parts, even if the parts are only defined by the manufacturer’s part number and not the original supplier’s name and part number.
It turns on
No arcs, no sparks, no blown fuses/circuit breakers, and any internal tests for the adequacy of utilities are met.
It doesn’t blow up (electrical, pneumatic, or water issues)
No leaks. No smell of burning wire. No flying air hoses. No dousing of the personnel with water.
Okay, it’s done and documented. The next step, OQ, will be described in the next article in this series.
Basic template for an IQ protocol and report
- General inspection
- The device arrived intact and is still intact after installation
- Device identifier
- Purchase order number
- Manufacturer’s internal build tracking order
- Serial number
- Verification of build to order
- Size, if applicable
- Configuration (wall mount, free standing)
- Door configuration, if any
- Built-in utilities, if any, and their sizing
- Machine-specific items correctly supplied
- Installation instructions
- Operator manual
- Service manual
- Spare parts listing
- Electrical schematics
- Piping schematic (P&ID)
- Bill of materials (for nongeneric items)
- Certifications (pressure vessel, electrical safety, etc.)
- Safety equipment documentation
- Document the presence of any required safety equipment and their sizing being correct per the supplied drawings
- Verification of component presence and compliance with specification
- Verify component presence per the electrical and piping schematics
- Ensure that the component installed has the specifications listed in the documentation
- If it is on the drawings, it should be verified
- Document calibration, if needed
- This includes transducers and timers if there is a requirement in applicable standards
- Check supplied electrical voltage, amperage, and phase for supplied electricity
- Check that a three-phase motor turns in the right direction
- Check that adequate water supplies of the right purity, quantity, and pressure are connected to the device, if any
- Check that adequate compressed air of the right purity, quantity, and pressure are connected to the device, if any
- Check that the drain is large enough, has an air break, and that effluent is cooled to a level where it will not damage the drain
That’s a lot of work! But if you get it right the first time, it will help you maintain the device in good working order for its design life and, hopefully, longer.
Dr. Jonathan Wilder has worked with all thermal and chemical sterilization methods, as well as cleaning and disinfection methodologies, bringing his background in physical chemistry and surface physics to bear upon difficult problems in the field. He has been an active participant in U.S. and international standards development since 1998 through AAMI. As of January 2018, he is the cochair of the U.S. standards-making committee for hospital steam sterilizers.
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