What you should know about cleanroom laundries/garment processors
By Susan English-Seaton
Whether selecting or just auditing a cleanroom laundry, education and accountability are key to a successful partnering
In separate interviews with CleanRooms Associate Editor Susan English-Seaton, Bob Spector, group manager at Prudential Cleanroom Services (Round Rock, TX), and Chuck Berndt, principal at C. W. Berndt Associates (Highland Park, IL), share their expertise with end-users of the cleanroom laundry/ garment processing industry.
Q: What`s the most important aspect of selecting a cleanroom laundry or garment processor?
A:Bob: When looking to develop a garment program, the key, in our opinion, is auditing the supplier. That`s not something that people don`t do when they make other major purchases or large investments for their operation. They need to compare what they are being sold vs. what they really see happening at the supplier`s operation. This is very much a “buyer beware” arrangement.
Don`t be afraid to ask questions. Do some research before you go on a site visit or audit. Everybody in the cleanroom industry has a network of associates or peers they`ve interfaced with at some point. Talk to them: Find out what they look for. Find out what they have found to be a problem. If you`re not familiar with garment programs, don`t be afraid to retain a consultant to help you learn. Utilize the conferences and programs that exist out there and learn what it is you`re going to be spending your money on. And learn it to a level where you feel comfortable asking questions.
Chuck: The first thing a user`s got to do is familiarize himself with what a laundry is all about. What`s the first thing that happens? How do you record that a shipment has arrived? Does it get a unique identification, such as a badge or lot number? How do you isolate my garments from the next guy`s? How do I know there`s no cross-contamination? Show me your procedures. Show me all related record keeping. How do you train your people? Do you train your people? How often? Who does the training? How do they demonstrate competence?
Q:What should a laundry be asking the user?
A: Bob: What do people expect from their garment supplier? Do they expect them to walk in the door and tell them exactly what it is that they need in their facility? Unfortunately, that does happen quite a bit. The problem is that while most garment service suppliers know what the capabilities and/or limitations of different fabrics are, they can`t necessarily know the limitations or sensitivities of the product that`s being manufactured. So don`t feel put out when the supplier starts asking a lot of questions concerning your product. This will help them narrow down the options that exist so they can provide you with better service. Partnering is very important.
Chuck: What a laundry should be asking you, the user, is, what kind of contamination control concerns do you have? What kind of controls do you need? The laundry should be asking informed questions about you, the user, because only then can it intelligently apply the right fabrics, the right garment configuration, the right processing for your particular needs. Otherwise, you`re going to wind up overpaying or underpaying, overengineering or underengineering.
The laundry should also be asking, are you using any hazardous chemicals? If so, it should request Material Safety Data Sheets. When clothing comes into the laundry with residues, it`s a safety issue for the people who work in the laundry, number one; number two, if it`s a heavy metal or an insoluble material — if I don`t know what it is, how can I intelligently and effectively remove the soil and clean it to a particular standard? This also sets the stage for the audit, because it`s telling the laundry: `These people know what they`re talking about. They`re asking questions.`
Q:What about traceability?
A:Bob: In a lot of ways, it`s very similar to a lot traveler in a semiconductor fab. Are there travelers in place to document the flow of the product through the facility, so there is traceability in the event of a problem? Is there something physically wrong with the garments or with the process? You want to look at their history and at their wash logs. Find out what kind of information they keep track of. Do they monitor and record water temperatures? If the user does not prohibit mixing of their garments with somebody else`s, is there a way to determine whether somebody else`s garments were washed with yours? You will hear claims about different types of tracking systems. See the system: see it work. Get copies of reports.
Chuck: Ask the laundry, when you count garments, do you do it when they come in or when they leave as clean or both? How do you account for and track garments if something has to be repaired? What if something gets shunted off for repair and the rest of the load goes out, but it`s short x-number of garments. How do you keep track of that?
Q:What questions should be asked about process control?
A:Bob: You want to be sure they`re not washing show covers or footwear of any type with what I`ll call “body covering” — hoods, bouffants, coveralls, frocks, etc. Is that controlled? You should expect to see a controlled process whether they`re in pursuit of ISO or not. A garment program should be invisible to the user; it should be something that when they walk in every day, the garments are there, ready and waiting for them, and it should not have any adverse effects on their facility. That should be provable, based on the audit of the facility, where you can say, “Okay, yes, they have consistently laundered with this type of wash process. Any deterioration we see on our garments may very well be due to the age and/or where the garment has been utilized or how the garment has been utilized.” Then it`s obviously incumbent on the user to determine what their garments are being used for or how they`re being used.
Chuck: Do you have process controls? Do you have SPCs? Do you have control charts? Ask to see them. If control charts are all pretty and perfect and on a computer screen, if I were the auditor, I`d say, “You guys don`t understand.” The best control chart I`ve ever seen is hand-drawn and stapled onto a wall somewhere, with coffee and doughnut stains on it — that`s a good control chart.
There are, of course, the obvious things: What kind of machines do you have? What kind of water do you use? Can we see test data on your water quality? What kind of filters do you use? How often do you change them? Are dryers steam or gas-driven? (If they`re gas driven, I would really start worrying about this laundry because of the explosion hazard.) Are they HEPA-retrofitted? Do you have a formal preventive maintenance program in place? Can I see the documentation for that? How do I know the wash chemicals are added at the right time and in the right mix? How do you test for that? Where are your records for that — for temperature, humidity, particle counts during the course of operation, and at what locations?
For example, do you count particles in the exhaust of your dryer? That would be a good thing to do because most particle removal occurs there. You should be able to see a kind of curve over your drying time that (a) validates the fact that drying time is long enough — and that`s just to dry the garments within a particular percentage of moisture content — but also (b) that the particles have leveled off, rather than just mindlessly saying, “Twenty minutes are up. Pull it out, put it in the cart, fold it up, let`s get it out of here.”
Other questions you should be asking: Do you have instruments? Do you calibrate them? How often? Can I see your calibration records? How do you keep your records? Are they just loose pieces of paper with coffee stains on them or are they properly bound in a book written — not in pencil, but in ink — and countersigned? Are they easily accessible? We`re not talking ISO here — just common sense.
Q:What about quality control?
A:Bob: What is the level of quality control within the organization you`re looking to audit? Do they maintain a distinct and separate quality control group? Are they managed properly? Does the plant`s quality control person report directly to the management of the plant, or is there separate reporting, so there`s no fear of retribution in the event quality control has to do something adverse to the plant? If the particle counts in a piece of equipment or in the room fail, is the QC technician afraid to shut down the equipment or the room because they`re afraid the general manager — who`s their boss — will hold it over their head come next review time and not allow them to meet their production schedules? Or do they have a separate line of reporting for accuracy on such things as particle counts? Is there a dotted line to a general manager for day-to-day functions? A lot of companies don`t have that. Be sure you know where QC reports.
How well equipped is the QC technician? Is this just random testing? Do they have separate laboratories? Can they show you documentation on all the different tests they claim to perform? Do they have specs in place for the performance of those tests? Will they be happy to show you those? You need to have physical documentation to support any claim that`s being made. If you come into the facility and can`t be handed a book to review, then there`s something wrong. Are the entries — whether printed or on a computer — up to date, or are they lagging behind two, three, or four weeks? If they are, that`s a problem! Because then, how is the operation being monitored?
Chuck: Do you have a quality control program? What is it? Do you have a sampling plan? Show me your sampling plan. What is the rationale behind your sampling plan? Once you`ve sampled your garments — besides how often you sample them — how many replicates are there? What do you do with them then? What kind of tests do you do? What instruments do you use? Do you calibrate these instruments? How often? Can I see the certifications for the calibrations? When you do your testing, do you do it in the same room where you`re folding your garments and inspecting them? Or do you have a separate so-called controlled laboratory environment? How do you decide when something needs repairing? What are your criteria for replacing a garment vs. repairing it?
Do you have a formal provender of maintenance program based on the machinery manufacturer`s specifications, recommendations, and operating manuals? Are these things recorded? Do you have a regular schedule of PM with signoff? It should include boilers, holding tanks for water, DI/RO tanks. Here`s an example: if you have a deionizer or RO water sitting in a tank, if it sits long enough, you`re going to have a microbial problem for obvious reasons. Do you have a regular program whereby you have a recirculation pump in that tank to keep the water moving? Do you ozonate or do you chlorinate? If you chlorinate, we have a problem with the disk drive and semiconductor manufacturers. Look at the piping system. What are the pipes made of, stainless steel or PVC? What about dead legs? How often is your boiler serviced? Your boiler can cause contamination in your system, even though it`s a closed loop. Boiler chemicals can cross-contaminate.
Q:What about environmental controls?
A:Bob: Let`s look at the environment in the room. How is the room designed? The user coming into a cleanroom laundry facility should see the environment as comparable to what they have or better. The environment should not be an issue that has to play into their decision. The ability to control the flow of the garments and the cleanliness levels of the process are the key aspects of the laundry. A user should be so comfortable with what he sees in the form of a clean environment, it really shouldn`t raise issues or concerns.
Chuck: Do you certify your cleanrooms? Obviously, who doesn`t! Where are the reports? How often is it done? Is it done by an independent certified contractor? What about ionics? How do you control that? What kind of cleanroom do you have? What kind of flow? What is your production flow?
Q:What about SOPs?
A:Bob: Not only do you need to audit the operation, you need to look at the standard operating procedures in place for the facility. I wouldn`t take it to the degree you might see it in a microelectronics facility, where somebody will physically audit every action of an individual to make sure they`re following the spec exactly. This is not necessarily a spec process, but you need to make sure that the activities being performed are documented. Are personnel handling the garments properly clothed? Are they in a position to contribute to the particle levels of the dirty garments? Are the garments moving through the facility in a documented, traceable path? In other words, when garments are completed, if there`s a problem, can they go back and trace who may have been involved with the sorting operation? Which washer the garment actually moved through? Which dryer the garments went into and came out of? Who did what? When did it happen?
Chuck: Now we`re talking about an SOP manual. Where are your SOPs for repair? Who controls it? Is there a master manual, and are copies of that manual specifically signed out to specific people, numbered and controlled? When there is a change in an SOP, are replacement pages sent to the holder of the manual, and are the old pages sent back, and is there a signoff?
Getting back to one of the points Bob made: a QC supervisor should be reporting to no dotted line — he should be reporting to the general manager period. If my production manager is nervous about my QC person running around pointing out things and trying to make things better, I`ve got the wrong production manager! It should work as a team.
Q:What about education and training?
A:Bob: Is the laundry itself staying up to date as to what is available as far as the cleanroom industry is concerned?
Chuck: For everyone from your washing machine guy to your folder, there should be training and understanding of your customer base`s needs. In terms of the service you`re rendering — is it effective in terms of the needs of the market you`re servicing? Your markets could be diverse. The needs of the critical assembly or aerospace/defense industry are different from disk drive, which are different from semiconductor, which is different within semiconductor, which is different from biotech, which is different from pharmaceutical or aseptic fill — it goes on!
There`s a lot more, because the laundry should also be tested in terms of their understanding of the service they provide. Can customer service people answer questions intelligently?
The major message is: Don`t just blindly contract a laundry. You`re dealing with very, very complex and sensitive issues. Take the time to familiarize yourself. Get out there! You don`t have to ask all the questions I`ve mentioned. But do something! CR