It`s only laundry…
But unraveling the mystery of cleanroom garment processing is more complex than simply washing clothes.
by Deborah Pikovsky
If you`ve ever been asked to evaluate your cleanroom garment program, you know such programs are complicated. But how can such a simple activity — laundry — become so complex when put in the context of aseptic processing and clean manufacturing environments?
The answer lies in the fact that cleanroom garment processing is not really about washing clothes. Cleanroom garment processing is, in reality, about information and asset management. It is about contamination control, standards, compliance and documentation. It is about capital allocation. It is about return on investment.
Let`s consider information. What kinds of information can a provider of cleanroom laundry services give you that will help you make better business decisions? One type is the data that will help you choose service providers. It is critical that you conduct a facility audit as part of your vendor qualification process.
Define requirements
The first step in choosing a cleanroom garment processing program is to define your requirements. Garment processors can be a valuable resource in defining a detailed scope of work. An assessment of your current garment program should be conducted. Specifications must be established to accomplish your contamination control requirements, and product and process recommendations should be made by the prospective service provider.
Verifiable information must give you assurance that the laundry provider has the validated process, controls and documentation of programs, procedures and results to meet or exceed your requirements. The facility, test protocols, validation results, environmental monitoring system, preventive maintenance records, employee training programs, standard operating procedures, internal auditing program and re-certification schedule must be evaluated as part of the auditing process. Standard operating procedures should be evaluated and compliance to these procedures should be verified. Preventive maintenance records should be reviewed. Are specifications for total particulate matter equivalent to room classifications? Is environmental data collected real-time and is there a personnel alert mechanism for out-of-control conditions? Are risk assessments conducted and is corrective action documented?
An understanding of the garment tracking system and the information it provides should be verified during the facility audit. Review reports to ensure that they present useful summary information rather than raw data. Ask how the tracking system accounts for individual garments from receipt through delivery to the customer. Find out if the system captures individual garment wash and repair history and how reconciliation of inventory is accomplished to ensure that deliveries are complete and all garments received are accounted for. The specified backup facility should also be audited to ensure that the process and controls are in place to produce identical results. All this information should be reflected in the laundry specification portion of your agreed upon Scope of Work.
Another type of information is fabric performance in tests. Cleanroom garment processors who have “closed loop” bar code or radio frequency (RF) chip tracking systems can give you performance data on cleanroom fabrics and even garment designs. Closed loop systems allow garment processors to capture repair information at the individual garment level and can guide your decisions regarding findings and features. Composite wash histories can yield information, which will aid in choosing cleanroom fabric by performance results based on in-use production application. An on-site audit of potential garment processing facilities will tell you whether the tracking system is capable of capturing data regarding garment performance over time.
Buy or lease?
Another decision to be made is whether you should purchase garments or lease them from the garment processor. It may be easier to think of these options in terms of car purchase vs. car lease. Cleanroom garments represent a substantial investment and should be viewed as capital assets. Like a car lease, capital allocation is made over the life of the service agreement on a straight-line depreciation basis with a residual value at the end of the contract. In auto leasing, you pay a monthly fee based on a predetermined usage, or miles driven. If you exceed the agreed upon usage, additional mileage charges are assessed. If the average depreciation schedule calls for 36 monthly lease payments with a residual value at the end of the 36-month period, and garments are turned in more frequently than agreed upon, they will wear out more quickly than intended. In addition to additional processing charges, the garment item is depreciated more quickly than originally scheduled. How do you know if your inventory is being utilized? You will determine the number of garment items placed in circulation for each wearer. This is called the inventory ratio. Safety stock plus circulating inventory combines to form total inventory investment. It is based on such things as number of wearers, change protocol, safety stock levels and service schedules.
Whether you decide to purchase garments or lease them from your garment processor, it is important that you have visibility to circulating inventory levels. This level can “creep” or grow over the life of the contract as new wearers enter the workforce and circulating inventory builds.
An example might be that two employees who wear size medium leave the company and are replaced by one medium and one large wearer. A large garment is purchased and added to inventory and there is an extra medium in the circulating inventory. Inventory has increased by 50 percent.
Keeping track
Companies experience turnover, but how do you keep track of the net effect of employment fluctuation and turnover on the size and composition of your garment inventory? The answer is, you don`t. The provider of your cleanroom garment processing must present reliable summary information, which keeps you informed of these key inventory utilization measures. In addition, the processing history of each garment must be captured if you are to effectively manage this garment investment. The provider can tell you the actual life vs. expectancy for your garments, the repair history for individual garments, how your performance data compares with historical data on similar garments in similar applications across a broad base, your inventory utilization by item and size, and whether your stock is being rotated and turned according to your change protocols. The summary information/processing history can also give you insight as to shelf life expiration dates and individual sterility assurance labels of sterile garments, whether sterile garments are being turned to ensure that shelf life expiration dates are not exceeded, whether you have the proper mix of garment items by size, and whether you know, at all times, the size and composition of your circulating inventory.
How can you determine whether the laundry is able to provide this type of reporting information on a continuing basis? It is imperative to audit the processing facility. Check to see if the laundry has bar code labels or RF tags, and determine what information is contained in each label. Are garments scanned into the process in soil scan? Are there other scanning points within the process flow to track disposition of garments into and out of repair? Are garments scanned out of the system so that reconciliation of pickup and return is possible? Find out what information is provided to you with each shipment. Are the contents of the barrel/tote clearly marked on the outside of the container? Ask to see reports which your cleanroom garment processor provides to ensure that there is a viable garment tracking and asset management program in place. Are these reports available upon request? Is there a program that will provide for systematic review of performance metrics?
Real-time feedback
Another aspect of the program should provide continuous real-time data on conditions within the cleanroom garment processing facility. Environmental monitoring systems have become standard in cleanroom garment processing environments. During your audit of the facility, ask how many points within the facility are monitored? What is the procedure for handling out-of-control situations?
Laundry is complex for many reasons. It is hard to get your arms around the program due to the sheer number of garment items inherent in garment programs. One way to manage this asset is to have reliable inventory information available to you on demand, formatted in a way that is meaningful to you.
Because of the capital investment necessary to support a cleanroom garment program, it is imperative that accurate performance metrics be established and performance indicators be reviewed on a regular basis. The value of this service depends on establishing accurate baseline information and benchmarking performance against this baseline. The ultimate service your cleanroom garment processor can offer is true continuous improvement in program quality and efficiencies, and new product development aimed at providing value-added product and services.
When you are comfortable that you have audited the processing facility and the backup facility, validated the process and test procedures, investigated the depth of the environmental monitoring systems and garment tracking system, and established clear expectations regarding your service in a scope of work, then you have begun to unravel the mystery of cleanroom garment processing. Cleanroom garment processing programs should take you out of the laundry business while giving you the assurance that this large asset is being managed properly.
Deborah Pikovsky is director of sales and marketing at G&K Services Cleanroom Division. G&K Services operates six Class 1 garment processing facilities with two facilities in development. She has over 11 years` experience in critical manufacturing environments.
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Keeping track of garment inventory is critical to proper asset management — a key component in cleanroom laundry services.