Individuals perceive topics related to quality and how to establish quality within an organization in various ways. Several misconceptions prevail regarding what constitutes “quality” and a “quality program.” When designing a quality program, one must distinguish between quality, quality system, and compliance. These terms are used pervasively throughout the clinical research arena, and they are often erroneously used interchangeably.
Quality, quality system, and compliance are considerably different from each other, and possess distinct and significant roles within a true quality program. Among the many misconceptions auditors face is the belief that written procedures are synonymous with possessing a quality program; such a belief could not be further from the truth. An organization might establish excellent written policies, but without a system to assure review, revision, and training pertaining to those procedures, the written standards provide no assurance of quality outcomes.
Digging Deeper into the Terminology
It bears repeating that many organizations operate under the belief that the establishment of written standard operating procedures (SOPs) is the equivalent of quality; however, without a complete quality system, an organization cannot assure that its products are of a particular quality standard. Hence, a key component of an effective quality program is an established quality system.
Many organizations establish impressive training programs pertaining to SOPs, but the training does not contain a means for assessment. Without an assessment mechanism, one cannot ensure employees comprehend a policy or procedure resultant from training. In addition, the establishment of auditing programs within an organization might assist with determining compliance to regulations and internal policies, but without trending, the stronger significance of the audit findings is frequently unexposed.
To truly establish an effective and efficient quality program, an organization must internally address the differences between quality, quality system, and compliance through defined functions and tasks.
A quality system incorporates not only written procedures, but also formalized training and assessment mechanisms to determine employees’ understanding of policies and how to properly execute procedures. Detailed SOP employee training records are also maintained as a function of a quality system, and SOPs are readily accessible to employees.
An effective quality system also contains an SOP review process to assure the maintenance of policies and procedures. Details of SOP revisions, the applicable employee training, and the effective dates pertaining to SOP revisions are also clearly communicated in a well-organized quality system.
But Wait, There’s More…
SOPs and training are only the tip of what is needed to establish a true quality program. In addition to policies, procedures, and training, an organization must demonstrate that its employees are compliant to its established procedures.
Compliance is the conformity to a procedure on a consistent basis. Simply put, compliance is the regular adherence to written procedures, which is often determined through incorporating a robust auditing function into a quality program. This function must remain independent from an organization’s operating group to avoid undue influence when assessing compliance to policies and procedures.
The auditing function regularly observes the execution of certain tasks and compares the execution to applicable SOPs (and regulations, when applicable), taking note of deviations. The deviations might be in the form of, but not limited to, erroneously recorded datum, missing documentation, unreported information, lack of communication, and/or nonadherence to a protocol or standard. These deviations indicate noncompliance, and can potentially alter the quality of a product or service.
Another common misconception is that if an audit results in no findings, then the operation observed during the audit is completely in compliance. This misunderstanding is often associated with results pertaining to inspections performed by regulatory agencies.
The essence of an audit is to sample different aspects of an operation; hence, an audit is a “snapshot” in time. The result of one audit is not indicative of the overall compliance of an organization or function, which is to say that audit findings only reflect the information that was observed during the audit. It is not uncommon for auditors to review particular documents and procedures and produce no audit findings, but an alternative set of documents and procedures within the same function not reviewed by the auditors at the time might later generate several audit observations.
If the purpose of an audit were to assure complete compliance of a function or organization, then every document, procedure, piece of datum, etc. would require review, which would be an arduous, virtually impossible, and most likely expensive task. Hence, to truly receive the greatest advantage from an audit, a quality program must also incorporate the trending of audit findings into its regular routine.
Trending is an examination of audit findings that might reveal a common issue or common noncompliance. Trending audit deviations helps to determine if there is an underlying root cause to an issue. Once a root cause is identified, an organization can determine how to remedy the problem and better assure quality is infused into its services and products.
Lastly, identifying issues and root causes through auditing is only effective if the information is properly communicated. A quality program should include a formal means for communicating quality observations, both good and bad, to individuals most affected by the findings. Most often, organizations request audit reports to document audit observations, but a system for receiving responses to audit findings should also be established. All documentation regarding the audits and audit responses also requires a formal means for retention.
Quality is not an easy attribute to establish. In the clinical research arena, just having auditors inspect principal investigator sites periodically across one study and produce audit reports is not a quality program in its entirety.
A quality program is also not truly effective unless audit reports across multiple functions, studies, and sites are trended and those trending data are used to improve quality standards. Likewise, a training program regarding written procedures and regulations can only be rendered effective if an assessment mechanism exists to gauge individuals’ true understanding of the material taught.
Hence, a highly effective quality program distinguishes between quality, quality system, and compliance by establishing quality through quality systems that include SOPs, a training program with an assessment mechanism, an auditing and trending function, and a means for effectively communicating quality issues and information.
Kris Walters-Herring, PhD, (email@example.com) is a faculty member, former director of research for the South East Area Health Education Center, and developer of the Master of Science in Clinical Research and Product Development program at the University of North Carolina Wilmington.