How To Develop a Regulatory Compliant QA/QC Program For Your CMS – Part 3
Posted: February 5th, 2026
Authors: Corey W.
Looking back and moving forward
In the previous parts of this 4 The Record series, we explored the specific quality assurance (QA) and quality control (QC) activities necessary to implement a QC Program for continuous monitoring systems (CMS) along with a discussion about what makes implementation of a QC Program successful. Those previous articles are located here:
The overall theme of this article series is about upping our game; to move from simply having a QA/QC Plan to the implementation of a QC Program. All QC Programs for CMS have a QA/QC Plan, but just because you have a QA/QC Plan does not mean you have a good QC Program. Part 3 of this series covers the nuances in the development of a QC Program. ALL4 has been focusing on 40 CFR Part 60, Appendix F, Procedure 1 (P1) in this series even though you can find similar requirements in other applicable regulations that require monitoring (i.e., 40 CFR Part 63, 40 CFR Part 75, etc.). Appendix F P1 specifies that facilities subject to this procedure “must develop and implement a QC Program” and that “each QC program must include written procedures which should describe in detail, complete, step-by-step procedures and operations” for specified QA and QC activities. Part 3 addresses what is meant by “detail”, “complete”, and “step-by-step”. Part 3 also addresses how the training of facility personnel ties into the upkeep of the QC Program.
How detailed is detailed enough?
As previously discussed, simply having a QA/QC Plan does not satisfy QC Program requirements specified in Appendix F. The QC Program must be developed and implemented, and detailed, complete, step-by-step procedures and operations must be included in “written procedures” (i.e., a QA/QC Plan). What is meant by “detailed”, “complete”, and “step-by-step”? These subtleties and nuances are not specifically addressed and may be up for interpretation. How detailed do the procedures in the QA/QC Plan need to be for completing activities associated with CMS? The regulatory requirement is to “describe in detail, complete, step-by-step procedures and operations”. Does that mean that anyone “off-the-street” would be able to complete the QA and QC activities by following the procedures? Of course not, there is a presumption of minimum level of applicable competency. As an extreme example, the procedures are required to be written such that the user must have a minimum competency to read and understand the procedures. The level of competency directly relates to the training associated with implementing the procedures associated with the CMS.
So far, we have a requirement to implement a QC Program for our CMS and to write procedures with a certain level of detail to be included in our QA/QC Plan. The next step is training for those that implement the QA/QC Plan to establish baseline competency. The better the training, the higher the baseline competency, and the less “step-by-step” the procedures must be. At a minimum, the QA/QC Plan should at least be detailed and complete enough that it can be used as a resource for training facility personnel (discussed in further detail in the next section) and to address questions that arise regarding performance of QA or QC activities. For example, if a daily calibration drift test fails, can the Instrumentation Technician (or whoever is responsible for addressing this) use the QA/QC Plan to determine the procedure for resolving the issue and bring the CMS back into control to provide quality-assured data? Is the QA/QC Plan organized enough for the Instrumentation Technician to quickly find these procedures? If the answer to either of these questions is “no”, then it may be time to consider updating your QA/QC Plan.
Do I have enough training to properly implement a QC Program?
Some regulations require training specific to the operation of the CMS (e.g., 40 CFR Part 63, Subpart EEE) based on the role and responsibility of the employee completing the required activity. Other regulations imply training through establishing a minimum level of competency. Can a successful QC program be implemented with specific training conducted at a routine frequency? The training should not just be a refresher for existing employees, but for new facility personnel to ensure facility personnel are able to implement QA and QC activities and react to issues with the CMS in a timely manner. For example, if an Instrument Technician resigns or retires, can the QA/QC Plan be used to train their replacement? Again, if the answer to this question is “no”, then it may be time to consider updating your QA/QC Plan and adding additional training.
Another indication that it is time to update your QC Program and QA/QC Plan is if the CMS knowledge communicated during the training of facility personnel is not also well documented. The QA/QC Plan should be both detailed and complete enough that it can be a source of CMS knowledge at the facility, and so this knowledge does not reside with a particular person/people. This level of detail will contribute to the longevity of a robust QC Program and help good practices regarding QA and QC activities continue when facility personnel retire or change companies over time.
Conclusion
In conclusion, it is important that your QA/QC Plan contains enough detail to support the level of competence of those who implement it. The QA/QC Plan should also serve as a resource to both train facility personnel and be able to answer questions that may arise regarding QA and QC activities quickly and efficiently. Part 4 will conclude the series and contain other topics important to consider while developing and implementing a QC Program. ALL4 has a team of experts dedicated to helping our clients comply with CMS requirements and implement robust programs. If you have any CMS-related questions, need help assessing or updating a CMS QA/QC Program, or want to suggest additional topics, please email Eric Swisher (eswisher@all4inc.com) or Corey Weiss (cweiss@all4inc.com).
