14 | September 2024 STANDARDS Quality Assurance Plans and Standard Operating Procedures: What? How? Why? Rebecca Turek, IEA Quality Assurance Manager Radon measurement professionals – currently certified or candidate - often ask some variation of the question “How do I write a QAP (Quality Assurance Plan)?” A QAP is important to a business because it helps to minimize errors in the delivery or manufacture of the product or service, improves efficiency and cost effectiveness, and promotes continuous improvement. In the radon industry, it keeps both professionals and their clients safer. As part of a Quality Management System, a QAP should be maintained in conjunction with a set of SOPs (Standard Operating Procedures), data tracking, and regular audits. The ANSI/AARST MS-QA 2023 Standard, which can be viewed for free online or purchased, offers a Sample QAP Manual template in the Companion Guidance, Section D at the end of the document. This is the first source measurement professionals should consult whether they are conducting a review of their current QAP or starting a radon measurement company and don’t know where to start. It is applicable regardless of the size of the organization. IEA’s audits of QAPs have found that the most common areas of noncompliance are QC (quality control) tracking, chain of custody (COC) documentation, and a lack of SOPs. The biggest problem observed, even if it’s a great QAP, is that some radon measurement professionals don’t do what they say they will do in their plan. Typically, this is evident in records that should be documenting QC activities. The professionals complete their spikes, duplicates, etc., successfully but they don’t track or document it. Section A in the MS-QA Companion Guidance breaks down a spreadsheet sample, including the calculation formulas for each cell which can make documentation much easier. There are a lot of ways a professional can manage the COC, whether software or a paper form. Spreadsheet records also work well once you get started. The purpose of a COC is to know where the data and devices were and who was responsible for them at all times. The benefit of a thorough COC is that, when it is necessary to address an error, bias, or other problem using a root cause analysis, issues can be more easily addressed if all of the relevant information is available. Even for a sole practitioner it is great to be able to provide this documentation should a test result ever be called into question. A SOP serves to standardize a process. Section 2.3.9 in the MS-QA QAP template states that “The onsite technician is to document the location and serial numbers of blank detectors placed in the field.” If a company has 10 technicians, it is highly likely that after 10 jobs there would be 10 very different documentation results if that was the only direction provided to employees. One could take a picture, one could make a note on their phone, one could scribble in a notebook, etc. None of these are necessarily wrong, but it is best practice to have uniformity. A good rule of thumb is if you won the lottery tomorrow, your SOP should be thorough enough that whoever takes over the next day can come in and complete the work based on the SOP. QAPs and SOPs can be living documents—if you want to change how something works at your company to make improvements outside of your internal audit schedule, go for it. As you make those improvements, it is best to update your documents to reflect those changes and supplement them with your CAPA (corrective and preventive actions) documentation. A popular QA mantra is “If you didn’t document it, it didn’t happen!”
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