Selecting a Sterile Gown Supplier Using a Team Approach
Using a team concept approach to determine requirements, solicit bids, and pick the best possible contract for your sterile gown needs is a critical part of cleanroom operations.
By Greg Jones
The combination of an uninformed user and a garment manufacturer without meaningful controls is a prescription for contamination disaster.1 A team concept approach will encompass all aspects of a diverse program. In addition to its own business needs, a company must know what is required from a compliance standpoint. When forming the team, consider that manufacturing operations are typically end users, and therefore should be given strong representation. Purchasing representatives should also be included, because their responsibilities in negotiating, supplying and contracting will be invaluable. The remainder of the team should be comprised of quality assurance personnel. Auditing and microenvironmental control representatives are certainly valuable contributors because of their specialized knowledge and experience. Financial validations, legal and accounting representatives should also be included or may be used for consulting. As consultants, they can provide valuable input, still allowing for a minimal, and manageable, overall team size. Once the team is established, it is easier to identify what specifics will be required from a potential contractor.
Internal Specifications
The first requirement should be to establish internal specifications. Compliance issues for pharmaceuticals can be referenced in Federal Standard 751A, “Stitches, Seams and Stitching,”2 and recommendations provided by the Institute of Environmental Sciences, “Garment Consideration for Cleanrooms and other Controlled Environments.”3 Once garment and processing criteria have been established, they should be documented and approved through appropriate in-house quality assurance validations and production management. The second requirement should be contractor serviceability. Once the company establishes its needs, ask if the potential contractor can provide the following:
Can the hood, gown and masks be packaged together or separately?
Can the garments be packaged in double- or triple-bags for sterile handling?
Can deliveries and pickups be made on certain days or more than once per week without extra charges?
Does the contractor have an individual garment-use tracking system?
Does it have a pilot program to test gowns and service?
What size garments are available?
What is required to change inventory two or three years into the contract?
How are repair and replacements handled–what costs are incurred and who pays?
What are the obligations at the end of the contract?
Establishing a Time Line
After the above issues have been reviewed, discussed and resolved, it is critical to establish a time line in order to meet the time frame you will be operating under. Renewing your current contract would require a shorter amount of time to renegotiate new requirements. If opening a new bid process, a minimum of 12 months is recommended to select, locate and contract a new vendor. This will allow adequate time to establish your in-house requirements, open communications with potential contractors, compare contractors, audit facilities, and reach an informed decision. (See “Establishing a Time Line.”)
Establishing the time line can be performed by taking the expected date for a new contract initiation and working backwards to today`s date. Allow enough time to:
Set up audits and follow-up responses from contractors.
Manufacture gowns. (For smaller orders, this could be a stock item. Larger orders might require 6-12 weeks for gowns to be manufactured).
Process gowns before the old contract expires (laundering, sterilization and delivery).
Should you be in a position where your present contract will expire before a renewal can be completed, consider contacting your current vendor for a month-to-month extension. This arrangement should be made as early as possible to inform them of a possible end to the current contract. Contact them in writing, citing issues that need attention. Inform them that you are soliciting bids from other contractors and would like to include them (the current vendor) if they are able to resolve these issues and meet your established criteria.
After notifying your current vendor, contact other potential contractors. Consider size, history and location of potential contractors. Are they large enough and capable of servicing your company and location? Do they meet your requirements? Can they provide recommendations from previous or current clientele? (See “Questions for References.”)
Establishing Compliance
A minimum of three possible vendors is recommended for evaluation to give a fair and competent comparison. Legal issues may need to be considered if you have an established contract award policy. During discussion of in-house requirements, establish a rating system to compare potential contractors equally. Establish categories of comparison that are significant to your operation, such as facility, systems, quality issues and customer satisfaction.
After selecting potential contractors, set up audits of their facilities. These audits should be two-fold. First, establish whether or not the company can meet your compliance requirements:
Do they have adequate facilities and equipment?
Are maintenance and training records documented and available for review?
Are procedures in place and are they followed?
Secondly, determine the kind of service the contractor can provide. Ask questions of management (and, if possible, the work force). Perform audits with team members, and review observations and issues from each of their perspectives. Use a rating system to evaluate and compare. (For example, see “Contractor rating system.”) Individual contractors should be informed of their ratings without including the ratings of other contractors.
You should inform each potential contractor of your audit findings and their respective rating so they can improve their own systems. Do not, however, review competitors` ratings with anyone else, because such ratings/rankings may be viewed as subjective.
Soliciting Bids and Picking a Contract
The next step in the process is to formally solicit bid contracts. Each potential contractor should specify the same quantities, sizes, gown types and delivery schedules. Don`t forget to address expected garment life and responsibility for replacement. Repair and replacement of garments can be a significant hidden cost. Another important issue is record keeping and traceability of individual garments. If the life expectancy of a gown is five years, or 50 uses, it is important to know how many times it has been processed. This tracking can be accomplished by barcoding each garment or a similar method. If a company is unable or unwilling to produce this technology, you may not want to consider them. Even “good faith” estimates can result in significant cost increases, which are usually paid by the customer.
Once quotations are received and rating systems are completed, it is time for the team to choose the best possible contract. To reinforce your cost comparison, it is recommended that you request your accounting department to review the contracts in terms of present and future values. Also at this time, you should prepare a presentation for upper management if their final approval is necessary.
After the decision is made, you may want to have your legal department review the proposal before awarding the contract. The remaining contractors should be notified that they were not selected. Discuss why they were not selected, but keep this dialogue professional, and do not discuss other vendors.
The final phase is implementing the contract. Issues that should have been resolved include: sizing (inventory), deliveries, documentation, stocking and follow-up on discrepancies. There should be a designated contact for both parties to discuss issues and a timetable to check service. Determine contingency backup plans, such as a processing plant shutdown or delivery shortages. A weekly check should be put in place for a period of two to four weeks to provide immediate positive and negative feedback. A formal follow-up meeting should take place at one month (monthly if needed) and six months to assure a smooth flow of service and communications.
Because processed garments are a critical part of cleanroom operations, it is important to be knowledgeable about the process. Any interruption in delivery can literally shut down your operation. It is in your best interests to know your requirements, know your supplier and establish open communications from the start. n
References
1. Berndt, C.W. “What You Should Demand From Your Cleanroom Garment Manufacturer.” CleanRooms, October 1994.
2. Federal Stan. 751A: “Stitches, Seams and Stitching.”
3. IES-RP-C003.2, IES 1993, Institute of Environmental Sciences, Mount Prospect, IL.
Greg Jones is director of manufacturing at GEN/Rx, Inc. (Fort Collins, CO). Jones has worked in sterile fill production for over 15 years. He began his career in the industry as a HEPA filtration technician and has been involved with facility startup approvals and second shift expansions. Jones has been responsible for compounding, component processing, filling and packaging. He has a business degree from Dallas Baptist University.
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Putting together a time line is critical for meeting your contract deadlines. Start a time line by taking the expected date for a new contract initiation and work backwards to today`s date.
Questions for references
What type of business?
What type of product or service does this contractor provide?
How long was the business relationship?
Did you realize any cost savings from the consultant/supplier?
Would you use this consultant/supplier again?
What problems were encountered? (Specifically: delivery, service, performance, billing, and quality)
Did the consultant/supplier offer cost savings ideas?
Were the personnel supporting your account competent and qualified?
How would you rate the contractor on a scale of 1 to 5?