Unclear about the difference between qualification and certification? If so, you aren’t alone. Though many companies make a distinction between the two when they describe employees who have received training for a specific job, they don’t always agree on what that distinction is, or even what each of the terms means. Here are some definitions taken from a small survey of trainers:

“Qualification is done for a specific task; certification is done for a series of tasks.”

“Qualification equals field training; certification equals classroom training.”

“Qualification is done through internal trainers; certification is done through an outside body.”

“Qualification is an ongoing process; certification happens once.”

“Qualification equals on the job training plus experience and education, which allows individuals to produce desired results consistently. Certification equals documented evidence through pre-established programs that desired results are consistently obtained.”

What’s the Answer?

With such diverse opinions about qualification vs. certification, let’s turn to the Merriam-Webster Dictionary for definitions of these two terms.
Qualification: “to fit by training, skill or ability for a special purpose. To declare competent or adequate; synonym; certify; meet the required standard.”

Certification: “to attest authoritatively, to attest as being true or as represented or as meeting a standard. Usually applies to a written statement, especially one carrying a signature.”

From these definitions we might say the words are almost identical in meaning, at least according to the dictionary. The only difference is that some type of written document may be associated with certification. So if the definitions are similar, why the concern?

One problem lies in the connotations associated with the terms, especially with regard to the perceived status conferred by the word “certification.” Some organizations are reluctant to offer an official—sounding ‘‘certification’’ to employees for a variety of reasons. “If we certify some employees, what about the others?’ asked one training manager. “Are certified employees better than the rest?” A lead operator in a manufacturing organization wondered whether creating a group of “certified” employees would suggest that other, “uncertified” workers were somehow less capable than those holding certifications.

“At our organization the word ‘qualified’ is more acceptable than ‘certified,’” said one trainer. “What exactly do we mean by ‘certification?’ It sounds like it might have some legal status. On the other hand, I’ve run into a difference of opinion as to what ‘qualification’ means, too. I’d say the whole area is somewhat nebulous.”

Still other organizations seem to be unconcerned about making fine distinctions. “We call all our employees who have been through first-level training ‘certified,’” said one training professional. “I don’t think anyone’s ever questioned it. It’s not a problem for us.”

What’s Really Important?

How important are the differences between certification and qualification? In fact, do any real distinctions exist between the two? The answers lie in organizational attitudes toward certification vs. qualification and sometimes in legal considerations about which term to use. But whether employees are considered certified or qualified, drug and devicemakers share the same underlying need: to establish that their employees are competent to perform their jobs.

Regardless of what we call these employees, they all must he capable of helping the organization reach its goals. These include:

• ensuring quality outcomes,
  
• maximizing productivity,
  
• containing costs,
  
• eliminating turnover,
  
• minimizing injuries, and
  
• complying with federal regulations.

Meeting these goals calls for a workforce competent in performing its assigned tasks. And ensuring that employees are competent—regardless of whether we consider them qualified or certified—relies on providing the kind of training and performance evaluations that will ensure employees possess the skill and knowledge to do their jobs. As most drug and devicemakers now recognize, this means developing competency-based training for their workforces.

The Case for Competency-Based Training

The FDA has not published a guidance establishing acceptable procedures for personnel training. Neither has the agency specified strict training requirements. In the absence of firm guidelines for training, many in the industry have interpreted FDA commentary and audits to promote a competency-based approach to training, with valid and reliable training programs that produce measurable performance outcomes.

A competency-based approach to training employees begins with identifying the skills and knowledge (competencies) required to do a job by conducting a task analysis. Once job competencies are identified, training is developed around the competencies. This usually involves designing classroom instruction or on-the-job training aimed at conveying knowledge and developing hands-on training to convey skills. Written tests and performance evaluations are designed to measure the acquisition of skills and knowledge. All evaluations should include evidence that employees are capable of following applicable SOPs and batch records to produce a quality outcome.

Although we may never resolve the issue of certified vs. qualified, most training managers are justifiably more concerned with achieving excellent performance than they are about terminology. If your goal is to encourage excellence—and ensure that the training department plays a key role in contributing to your organization’s bottom line—your focus should be on competency-based training as a means of providing the best-trained workers for your organization.

Contact Information:

Dave Gallup
GMPTraining.com, Inc.
18585 Coastal Highway
Unit 10, #149
Rehoboth, DE  19971
215-870-5665
dagallup@gmptraining.com
www.gmptraining.com