By Avis D. Bullard, M.S., CSSBB (ASQ) and William Ellis, RPh, M.S.
The International Organization for Standardization (ISO) Standard 9001:2015 defines “quality” as the degree to which an object’s set of inherent characteristics fulfills requirements. Further quality assurance (QA) can be defined as “a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering solutions or services to customers”
In 2016, the National Commission for Certifying Agencies (NCCA) released revised Standards for the Accreditation of Certification Programs. Standard 23, a new standard from previous versions, focuses on quality assurance and states:
“The certification program must have a quality-assurance program that provides consistent application and periodic review of policies and procedures.”
Further, the Essential Elements of this standard include the following:
A. Mechanisms must be in place to promote delivery of program activities as intended, including such activities as application processing, examination preparation and publication, scoring, documentation, and financial management.
B. Processes must be in place to deal with errors found in program activities.
C. Certification organizations must have policies and procedures requiring the regular review of examinations and the results obtained from their use, including the management and correction of examination-related errors.
Quality assurance should be of importance to certifying agencies when one considers the definition “as preventing mistakes when delivering services or solutions to customers.” This is foundational because certifying agencies have a responsibility to the population they are certifying as well as the end users of a certificant’s products and services to be sure that the overall process is sound. Essentially the process of certification helps assure the health, welfare, and safety of the public. In addition, this is considered a sound business practice.
Quality has traditionally been measured in qualitative terms, not quantitative. In comparison to manufacturing, service organizations can find it difficult to define and measure quality. The quality of a product, like a car, can be defined by its features and performance, but how do you define the quality of a credentialing program? Based on the difficulty of measuring quality in a service organization, the approach to quality sometimes seems informal and unstructured, which can result in variability in the delivery of the service and product to the potential certificant. Therefore, quality improvements can't be made if the quality is not being measured.
Fortunately, there are quality assurance tools, techniques, and approaches that are available and applicable to all organizations. A certifying agency with a staff of almost any size can apply quality system methodology to learn more about the delivery of their products and services.
Below are five important quality assurance components to consider when developing a quality program:
1. Management commitment and leadership
The most important aspect of quality management is for organizational leadership to be excited about the quality and set an example because, without it, a quality program is going nowhere. Leadership must show visible enthusiasm and commitment and be ready to answer questions related to organizational quality goals and initiatives. Leadership must strategically manage quality in all business processes, products, and services.
J.M. Juran proposed his trilogy diagram for leading quality:
- Quality planning: Learning about customers and finding ways to satisfy them.
- Quality control: Comparing product/service performance to product/service goals and eliminating the gaps between them.
- Quality improvement: Establishing teams and providing the resources to make improvements in a planned way.
By developing this trilogy, Juran provided a method for leading improvement in an organization.
Measurements can be made on intangible things like customer satisfaction level or tangible things like incidences of misspelled names on certificates. These are examples of the most common types of measurements made in quality management systems (QMS): process-oriented and product-oriented. Process-oriented measurements are essential elements of quality management and include: the check step of the plan-do-check-act cycle, quality of service, financial measures, complaints and customer surveys. Product-oriented measurement can include audits, inspections and rework, all of which end up costing an organization time and money.
By providing the organization with key result measures of how progress is being made in meeting strategic goals, the framework for continuous process improvement is being built. For maximum effectiveness, these measures should follow the SMART model, i.e. Specific, Measurable, Achievable, Relevant and Time-bound.
3. Quality Tools
A variety of approaches, techniques, and tools are available for improving products, systems, processes, and activities. The toolbox for quality activities should contain improvement strategies that fit an organization’s resources and strategic goals. One of the best books on quality tools has been written by Nancy R. Tague, The Quality Toolbox, and describes in detail when to use each tool and the procedure for using them.
As a quick start, the most useful tools for understanding processes, determining the root cause of a problem or assessing how the organization is meeting standard requirements are as follows:
- Pareto chart: Identifies the most prevalent causes of an identified process problem
- Cause and effect diagram: Used to identify potential causes of an identified process problem
- Flowchart: Used to graphically depict a process
- Audits: Allows the organization to evaluate the effectiveness of the QMS, but also helps the organization in meeting its' strategic goals and objectives
4. Proper Documentation
The best way to ensure that business activities related to processes are performed correctly and consistently is to understand and develop appropriate procedures and train the appropriate personnel to follow them. NCCA Standard 23: Quality Assurance, Essential Element A and ISO 17024, clause 10.2.3 require the certifying body (CB) to have the appropriate documentation in place to support certification activities.
In terms of providing evidence to meet various certification standards, it is important to document that an activity took place, who was involved and what was done. For example, there should be some documentation of activities such as item writing workshops, role delineation studies, and passing standard meetings. If your process has specific inputs, hand-offs and outputs, and/or it generates a record, the entire process will need to be documented because a process cannot be left to the memories of those who have performed it.
Important quality documents include policy and procedures manual, work instructions, and records of completed activities.
5. Error Detection and Reporting
NCCA Standard 23.b and ISO Standard, clause 10.2.7 require a mechanism to document errors or nonconformities found in certification program activities. Errors, problems or nonconformances can occur with any product, service, process, vendor or in any system within an organization. Errors are most commonly identified from customer complaints, internal or external audits, or an inspection of a final product, e.g. a printed or digital certificate.
Once an error is identified it must be addressed by some form of action, e.g. investigating customer complaints, or by discussing audits and establishing a plan of preventative or corrective action. In both instances, the error and associated corrective action(s) must be documented. Detailed records of the corrective action(s) provide evidence that the problem was identified, corrected, and that the proper controls were implemented to ensure that the problem does not occur again.
In summary, implementing an effective quality program requires leadership commitment and communication throughout the organization, focused goals, and a trained team to execute organizational policies and procedures.
International Organization for Standardization (ISO), ISO 9001:2015- Quality management systems—requirements, clause 3.
 https://en.wikipedia.org/wiki/Quality_assurance (Accessed January 14, 2019)
 Institute for Credentialing Excellence. (2014). National Commission for Certifying Agencies Standards for the Accreditation of Certification Programs (2016 revision).
 Institute for Credentialing Excellence. (2009). Certification: The ICE handbook. Washington, DC: National Organization for Competency Assurance.
 Philip B. Crosby (1979), Quality is Free, New York: New American Library.
 Joseph M. Juran (1989), Juran on Leadership for Quality, Free Press.
 Wheeler, Donald J. and Lyday, Richard W., Evaluating the Measurement Process, 2nd Ed., Addison-Wesley,1990
 https://en.wikipedia.org/wiki/SMART_criteria (Accessed January 24, 2019)
 Tague, Nancy R. (1995), The Quality Toolbox. Wisconsin: ASQ Quality Press.