One of the timeless principles of commerce is caveat emptor (Latin for, "let the buyer beware"). Under the principle of caveat emptor, the buyer takes the responsibility for the condition of the items or quality of the services that he or she purchases. Prior
to the current consumer protection laws, buyers had no warranties for the goods or services that they purchased. Today, most
states require goods to be of "merchantable or sellable quality." As this condition is often next to impossible to define
and enforce, buyers are advised to embrace the principle of caveat emptor prior to "signing on the dotted line."
While being conscious of the products and services purchased is good practice for consumers and most businesses, it is a regulatory
requirement for pharmaceutical and bio-pharmaceutical manufacturers. For these organizations, the decisions where to purchase
raw materials, components, manufacturing and testing equipment, and even consulting services, need to be well informed (and
documented). The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory
compliance, company profits, and even the reputation of the company.
Vendor qualification and quality systems
The qualification process is defined by the American Society for Quality Control (ASQC) as "the process of demonstrating whether
an entity is capable of fulfilling the specified requirement." Vendor qualification is the process by which a vendor is evaluated
to determine if it can provide the necessary goods or services to the standards that the purchasing company requires.
Before discussing the best approach to qualifying different types of vendors, it is important to first understand the concept
of quality systems. Quality systems are defined as "the processes, organizational structure, procedures and resources that
are used to control variables associated with producing a product of consistent quality and that meets predefined specifications."
In simpler words, an organization's entire operation is a measure of a product s quality and not simply the testing of its
This article employs the theme that vendor qualification is not solely an auditing process but rather a quality system in
itself for the pharmaceutical or biopharmaceutical organization.
In order to introduce the quality-systems approach to vendor qualification, consider the following simple analogy. Professional
football organizations do not sign on prospective athletes purely by the athlete's stated bench press or 40-yard dash statistics
(i.e., final test results). There are several factors that are taken into consideration. The team management first determines
what specifications the team requires for the open position, including, but not limited to, what the team is willing and able
to spend for the position to be filled.
Once these user requirements are defined, candidate athletes are identified. After identifying the top prospect (or prospects)
on paper, a selection is made. However, the process is far from over at this point. The selected individual (or individuals)
is then physically and mentally evaluated by team doctors to determine his readiness to play professional football for that
specific team. Only after successful fulfillment of the team's specific financial, physical, and mental requirements is the
player contracted. However, as many are aware, this one-time assessment does not guarantee consistent performance throughout
the player's contract. Therefore, the athlete's performance is regularly assessed to ensure continued ability to meets the
needs of the team. If the professional cannot meet the team's current requirements, the he is subjected to performance improvement
training and risks being traded or released.
Similar to the professional football candidate, a potential vendor should be thoroughly assessed against a company's requirements,
compared to other candidate vendors, physically evaluated once selected (and before a contract is signed), and reevaluated
as required and as defined on a regular basis. This article presents the Q.U.E.S.T. approach as a simple, effective, and compliant
approach to vendor qualification.