Your boss announces that you are in charge of selecting and implementing a new cleaning system. Recently, we described steps to take1 in terms of analytical tests that you or prospective equipment/chemical vendors can run to determine which systems can perform effectively. Now it is time to actually make a selection.
Kick the tires
When it comes to the outlay of a large sum of money, go beyond the flashy brochures, published case studies, and the performance claims made by sales associates. Ask for a list of references, people who have purchased the same system. And then, actually call them.
Is the type of cleaning equipment pertinent to what you need? It is unlikely that you will find an exact process match. More often than we would like to see, we have called references only to find that the cleaning equipment was of a very different type than what we were concerned with on the current project. A good evaluation of a vapor degreaser is not necessarily useful if you want to purchase an in-line aqueous cleaner.
Ask them about their total experience. Not just, “Does the system do the job?” but inquire about the purchasing, installation, and follow-up customer support. Were there issues of cost creep, delivery delays, or installation glitches? Was the vendor prompt and thorough at answering questions? Is the vendor still there for support or did they disappear into the woodwork once the equipment was purchased?
If possible, arrange for a site visit, so you can view the cleaning process in its native habitat. Does the equipment hold up with continued use? Is it corroded? Are the technicians muttering curse words under their breath every time they come near the cleaning system? If you can, ask the techs how they like the system.
It’s a selection, not an election
Hopefully, you will have a number of equipment vendors to select from. However, look rationally at your reasons. It is more than looking at which one has the most items in the “pro” column and fewest in the “con” column. Are you selecting purely on capital cost? Are you considering total cost of ownership? Have you factored in the value of vendor support? If you or your boss tends to add up the pros and cons, try the approach of listing the selection factors and then assign a number related to importance of each factor.
It might be O.K. to go with your gut, but figure out why your gut is saying that. Are you most attracted to the one that matches the color of your facility? Yes, we have actually seen upper management purchase the second or third equipment choice because it matched the décor. Ask the equipment vendors about color choices before you talk to your boss.
Discerning bidding
Bidding is not a global contest. Speaking of cost, be selective in the number of bids you request. It takes the bidder time and money to put together a bid and it takes you time and money to analyze it. We have frequently found it most productive to start with a large list of “possibles,” but down-select to a few “probables” to request full quotes from. Among the criteria for down select are ROMs for cost and delivery, degree of vendor support during the pre-selection process, and, of course, performance of the system for your application.
When it comes time to request meaningful quotes, be as detailed as possible in the request specification. The more detailed you are, the less guessing you will need to do to interpret the bids. For example, if you do not specify stainless steel tanks, a vendor may base a bid on a carbon steel tank to save on capital cost and keep the bid price down, but that tank may not last as long and wind up costing you more money in the long run. Equipment suppliers are running a business, so keep the door open for future projects. For example, our policy is to not share bids among competitors.
When the final selection is not final
Medical device manufacturers talk of IQ-OQ-PQ validation for equipment.2 Installation qualification (IQ) says that the equipment is properly installed (e.g. plugged into the correct socket). Operational qualification (OQ) means that it operates as described in the manual. Performance qualification (PQ) means that not only is it hooked up right and operates, but successfully performs the task that is needed. It is not enough that your product was successfully cleaned in equipment at the vendor’s test lab; it needs to perform in your plant. It is a good idea to put a “PQ provision” into the contract for a system; make sure that the system is successfully cleaning your product in your plant before final payment is made. Think of it as “lemon” insurance. It is more than just a warranty that the equipment works—it works for the application for which it was chosen.
It might cost extra to have the vendor’s technical people come out to help with the installation and employee training. However, frequently that can be a good investment and relatively inexpensive insurance. The experienced technician who has installed this equipment before can be a lot more effective than reading a user manual.
Select before it breaks
Sometimes a sudden unforeseen process malfunction forces a quick decision. Some people, perhaps subconsciously, wait for a complete breakdown of the cleaning equipment, because it takes the responsibility of choosing a new cleaning system away from their control. They “have” to choose whatever cleaning system is available for immediate delivery; they “have” to mimic a decision made by another facility.
More often than not, there are enough signs of an upcoming need to change, that a systematic selection process can be made. Perhaps performance requirements have tightened and the existing system won’t cut it. Maybe that large order you were hoping for materializes and the increased throughput requires a new system.
If you allow time to vet the selection in a relatively relaxed manner, you increase the probability that the new cleaning system will not only do the job but will actually add to the bottom line.
References
1. B. Kanegsberg and E. Kanegsberg, “The Applications Laboratory, Parts 1 and 2,” Controlled Environments Magazine, May and June 2014.
2. B. Kanegsberg and E. Kanegsberg, “Contamination Control and cGMP,” Controlled Environments Magazine, Feb. 2008.
Barbara Kanegsberg and Ed Kanegsberg (the Cleaning Lady and the Rocket Scientist) are experienced consultants and educators in critical and precision cleaning, surface preparation, and contamination control. Their diverse projects include medical device manufacturing, microelectronics, optics, and aerospace. Contact: info@bfksolutions.com
This article appeared in the September 2014 issue of Controlled Environments.
