INTRODUCTION
On Sunday and Monday, October 19 and 20, 169 quality assurance professionals achieved a milestone by taking the first examination for certification as Registered Quality Assurance Professionals in GLPs.

HISTORY
The quality assurance professional certification initiative began in 1993 as a result of information from the EPA which indicated improvements could be made in the activities of the Quality Assurance Unit. The SQA Board of Directors approved the creation of the Professional Certification Committee (PCC), and solicited volunteers from the entire SQA membership. The initial goal of the committee was to investigate the feasibility and utility of certification. The committee began by exploring the benefits and drawbacks to certification by gathering information on other certification programs in related regulatory and scientific fields. Next, the Committee solicited feedback, via a survey, from the SQA membership on their thoughts concerning certification for the quality assurance professional. As a result, an independent organization specializing in working with professionals in developing certification programs and administering examinations was selected. Applied Measurement Professionals (AMP) was contracted to conduct a job analysis to determine if the GLP quality assurance profession was amenable to certification. Next, AMP was hired to work with SQA in developing the certification program and with the administration of two examinations, one in 1997 and one in 1998. Responding to feedback from quality assurance professionals, the contract was amended to include the administration at multiple test sites for each year.

UPDATE
In addition to taking the examination, candidates were also asked to complete a survey which asked questions related to communication and the examination as well as their years of experience. Candidates were also given the opportunity to nominate themselves to write questions for future examinations.

Based on this survey, the examination was as expected for most candidates. The average score for recommending the examination to colleagues was slightly above neutral indicating that more candidates would recommend the examination than those who would not recommend it. Most candidates found the examination to be between average and moderately difficult and the majority had between 5-8 years of experience. The rating of the examination's difficulty does not appear to be a factor of years of experience nor does it appear to affect whether or not the examination would be recommended to colleagues.

In late November, but after the deadline for this article, a subset of the item (test question) and test form reviewers will meet via teleconference with AMP to discuss all items which are in question based on examination results. Items in question may include an item for which there was no single best answer or items for which there were apparently more than one best correct answer. It is likely that these questions will either be eliminated from the final examination score or will be accepted with multiple correct answers. The following day, the current and past SQA Presidents and the chair of the PCC will meet via teleconference with AMP to establish the final cut (passing) score. (The preliminary cut score was established in a prior meeting with the test form reviewers.) Finally, the score reports will be sent to candidates and will include the total score for the examination as well as the scores for the major and minor categories based on the content outline.

A registry of quality assurance professionals in GLPs will list those professionals who pass the examination. The registry will be maintained by SQA headquarters in the interim until an independent certification board is established. Individuals on the registry will be listed as Registered Quality Assurance Professionals in GLPs.

NEXT STEPS
The certification program will eventually be administered by a certification board which is independent of SQA. This decision was made early on in the process and is consistent with many professional certification programs. The Strategic Advisory Board (SAB) was asked to investigate how other professional certification boards operate. The results of the investigation were discussed in a recent meeting by the SAB and a report to SQA's Board of Directors is expected in the near future.

Re-certification will be required for all participants who wish to maintain their certification. Although the details of re-certification will be finalized by the certification board, the PCC developed preliminary recommendations based on their research of other organizations. As the re-certification program developed, the PCC decided it was important to keep the cost of re-certification to a minimum and it was important for individuals to demonstrate continued involvement in the profession of GLP quality assurance. Following is the rough draft of the program.

• Re-certification will occur every 3 years.
• A minimum amount of professional training and/or involvement will be required.
• For example, 12 units will need to be obtained over a 3 year period. Each half day course or professional meeting will be worth 1 unit. This means an individual could attend 3 one day SQA chapter meetings and 1 three day SQA annual meeting. An individual could also attend a 2 day course offered by a professional organization, a 2 day ISQA meeting, and a 2 day BARQA meeting. Additionally, units may be earned by completing course work towards a degree in regulatory quality assurance such as the program offered by Temple University.
• As mentioned above, the cost of re-certification will cover the administrative costs, only. The objective of certification is not to make money but to simply recover costs.
• Re-certification will not require re-examination unless one allows their certification to lapse before application for re-certification.

It is important to note that the above will simply be recommendations to the certification board and the final decisions on re-certification will be made once the Board has been established.

CONCLUSION
Professional certification is the single biggest and potentially most successful initiative within the GLP quality assurance profession to date. All contributors, including those who embraced the unknown by taking the first exam, deserve to be recognized for their commitment to the advancement of this profession. The challenge for each individual professional is to consider their role in this process and to embrace the opportunity to participate in the evolution of this initiative in whatever capacity that may be.

- Jillaine S. Griesemer
SQA Board of Directors
SQA Professional Certification Committee Chair
414.260.4954 jsgrises@scj.com