Originally Published IVD Technology October 2005
Biochemicals and chemical reagents
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| The quality of a biological chemical is exemplified not only by the product itself but through the vendor’s service and attention to detail. |
Any biological chemicals purchaser asked to name the most critical element in obtaining a good supply of biochemicals will almost certainly say reproducibility. Indeed, many would consider the association of the words biologicals and reproducibility to be paradoxical; yet there is no denying the fact that a good-quality in vitro diagnostic assay demands biological raw materials that are highly reproducible—that is, consistent. In evaluating a biological chemical’s consistency, it is important to consider three key areas: product quality, the associated service provided by the supplier, and, of course, price.
Evaluating Product Quality
To evaluate quality, it is vital to look not only at the quality of the product but also at the quality of the company that manufactures it. Quality is the ability to meet consistently all of the product specifications—nothing more, nothing less. A vendor’s decision to make a product improvement can be lethal to a diagnostic assay unless the change in the material has been proposed in advance to the buyer and properly validated.
The quality of the product can be suggested also by the strength of the vendor’s quality control/quality assurance (QC/QA) department. While it may be impossible to insert QC quality into a product that lacks inherent quality, a strong QC/QA department can be indicative of good product quality. A capable vendor QC department is also valuable to the many IVD manufacturers that are seeing advantage in pushing QC responsibility for incoming material back onto the supplier. Therefore, it is important to check whether the supplier has that capability.
It is sometimes possible for a good-quality product to be manufactured by a bad-quality company. A company’s quality can be accurately gauged from the answers given to such questions as where the company expects its focus to be in three years, whether the product will remain a core company product for some time, and what chance there is that the product line may be dropped owing to future acquisition, merger, or bankruptcy. Also, the vendor company must be able to handle the IVD manufacturer’s current and potential capacity. The level of process capability for the product in question should be measured, and determined to be adequate, up front.
Too often, a purchaser does not have a complete picture of the manufacturer’s forecasted needs and then suffers later when the vendor’s capacity cannot support the quantity demands of an assay whose sales have taken off. This can cause time-consuming scale-up validations or, worse, assay back orders.
Other questions are well worth asking a supplier. One is whether the company has a detailed disaster-recovery plan in place. Another involves how the company treats its employees; high turnover can lead to general lack of experience on the shop floor, which might affect product quality. Additional useful signifiers are the thoroughness of the supplier’s quality manual, the degree of support senior management gives the QC/QA department, and whether the company is ISO certified.
In short, the quality of a company and the quality of its product are directly related.
The Service Component of Product Supply
The second key area to consider when evaluating a chemical’s or reagent’s consistency is service. As the saying goes, one doesn’t just marry a spouse, one marries the family, too. So it is when purchasing a biological chemical for an IVD; the company that makes it is being purchased also.
Years ago, a major manufacturer learned this lesson the hard way. In an effort to keep its purchasing team from getting too friendly with the vendors—which executives feared might lead to softness—management rotated purchaser assignments every few months. This company soon realized that maintaining a close working relationship with key vendors is vital to developing the kind of partnership that creates and sustains consistent service.
Consistent service means consistency in the supply of a product, in communication, and in complaint resolution.
While it can be difficult to measure the level of something as time-related as supply consistency before actually having received several shipments of the product, it is nevertheless possible to get a preliminary idea of supply consistency by ascertaining the level of importance the vendor company places on shipping its products on time. The company’s on-time-shipment record is nice to know but perhaps not sufficient. Also good to know is how it is measured, whether by negotiated date or by reference to the customer’s initially desired ship date. The purchaser should find out whether the company communicates standard lead times to its customers and, importantly, whether these lead times are adhered to. If shipping delays are fed into the supplier’s corrective and preventive action (CAPA) program for ongoing improvement, then the firm has a clear commitment to reliability and consistency.
Good communication is essential to consistent service. The vendor communicates with its customers through a sales representative or customer service representative. While no buyer appreciates a pushy salesman, no one likes a silent one either. The representative should visit or call with reasonable frequency. He or she should possess expert product knowledge or, even better, have experience in manufacturing or using the product. Experience will help the rep to participate in vital problem-solving sessions.
How long the sales or customer service rep will be around is a factor to consider. It is not good to have to forge a new relationship often. It has been said that real trust in such a business relationship begins only after five years. The IVD manufacturer needs to know whether its account will be important enough to the vendor to be assigned a dedicated rep. Having a call directed to whichever rep happens to be available at the moment is something to be avoided.
Another key factor in determining service consistency is the manner in which the vendor handles product complaints. Complaints are inevitable in the biological chemical industry. How a vendor handles them is highly indicative of its approach to service and its service capability. A company that provides consistent service will not ignore or dread product complaints, but will handle them thoroughly and efficiently, recognizing in each new complaint another opportunity for operational improvement. It will assign every new complaint a tracking number immediately upon receipt, and will create a CAPA file for it. The vendor will collect details of the complaint and conduct an investigation as quickly as possible while keeping the customer informed of the investigation’s progress. The overall goal should be to resolve the complaint within 30 days. Complaints should also be tracked, by category and by product type, for evidence of trends.
Price and Total Cost
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| Scantibodies Laboratory Inc. (Santee, CA) manufactures monoclonal, polyclonal, and highly specific antibodies; blockers; controls; calibrators; raw materials (antigens); human and animal sera; and finished test kits. |
Price is the third consideration to keep in mind when evaluating consistency in biological chemical supply. While a simple price quote is one of the easiest things on which to base a decision regarding whether or not to purchase a product, it can also be one of the most deceiving. This is because a product’s price involves so much more than the unit cost displayed on the quote. To compute a product’s total price, the purchaser should take into account additional terms and the vendor’s willingness to enter into a supply agreement, as well as available cost-reduction initiatives. The rubric “additional terms” can include cost of shipping, payment terms, and call-off schedules (that is, how long the vendor is willing to hold finished-goods inventory without charge). These terms can potentially affect the total cost of the material significantly.
A supply agreement is a very useful tool for purchasing biological chemicals because it guarantees prices over a set period of time. This precludes a sneaky vendor offering a low price to secure a customer’s business and then increasing it sharply later. Also, some biological chemicals have active properties that can vary from lot to lot. A shrewd purchaser will negotiate a supply agreement in which the price of each lot may vary with the lot’s activity. The supply agreement is also a good place for buyer and seller to settle on and stipulate detailed product specifications.
The final element of price definition is the vendor’s willingness to participate in regular cost-reduction initiatives. During this exercise, the vendor and buyer typically meet to brainstorm and identify aspects of the vendor’s production process that add cost but are not critical to quality from the buyer’s perspective. Both parties need to be very careful that the removal of a non-value-added step does not affect the product’s quality adversely. Often, the removal of such an element will require validation to be performed by both parties—process validation on the part of the vendor and assay validation for the buyer. A cooperative vendor will be willing to split the resultant cost savings. The manufacturer might perform a risk assessment to weigh the benefits of such a change against the cost of a potential product failure not being picked up until the final QC step.
Exercises such as these require a high level of trust and close communication, but they can be extremely rewarding. Another good question for the purchaser to ask is whether the biological chemicals supplier has initiated any lean manufacturing practices. An affirmative answer would show that the company is working toward continual process improvement, which plays an important role in cost-reduction efforts.
The Sourcing Decision
It is important to confirm all of the matrices just discussed before validating a sample. Sadly, too many purchasers are compelled to buy raw materials from a shady company because the assay development scientist has already validated the sample. This is one reason why many purchasers prefer to buy new materials from an existing qualified vendor. They know also that every new vendor added to the stable represents an additional cost to be managed.
Also worth pointing out is the buyer’s temptation to keep alive multiple sources for a raw material instead of initially investing some time in order to find the right source. Though single-sourcing can involve risk, one should never qualify multiple sources simply in order to avoid the work necessary to make a proper selection up front.
Another tempting shortcut to substitute for performing thorough up-front vendor appraisal and selection is to purchase a one-time 10-year supply of the chemical. The buyer may grimace all the way through the transaction, but satisfaction comes in knowing that this vendor will not have to be seen again for a long, long time.
However, such a plan is generally not cost-effective, owing to 10 years of inventory carrying costs. And it carries the potential for loss of stability with longer-term storage. Finally, it has the unfortunate effect of creating a large problem for the IVD manufacturer’s next buyer 10 years down the road.
Conclusion
Product quality, service, and price are all factors that have a bearing on a company’s level of performance consistency, or reproducibility, if you will, which is a vital consideration also in selecting biological chemicals to purchase for use in IVD assays. The best strategy to employ in selecting a supplier of biological chemicals is to perform a careful and thorough vendor qualification, which should reveal whether or not the vendor’s product is likely to exhibit the desired consistency.
David Cantor, Scantibodies Laboratory Inc. (Santee, CA)
Copyright ©2005 IVD Technology
