Regulatory Compliance: How to avoid some common pitfalls and maximize success
Jul 09, 2019
Is your lab currently accredited? Are you looking for accreditation or certification? Perhaps, you are just looking at getting better at maintaining your accreditation or certification? Indisputably, meeting all the requirements for regulatory compliance is difficult. Balancing the focus on quality, research, and manufacturing is also challenging, especially if there are limited resources in the lab. Some common pitfalls in many laboratory procedures can add to compliance strain, especially when trying to meet demanding production goals. In this article we dive in and look at some of these challenging issues and explore ideas on how labs can overcome them.
Mastering compliance doesn’t have to be tricky. Let’s find out how!
1. Uncertain about measurement uncertainty? Let’s talk about how to define it:
Measurement uncertainty is an area that most laboratories struggle with. The first step is to clarify how it should be applied. The uncertainty measurement (usually a range) should be applied to the process, and not a specific piece of equipment. Essentially you assess how far the experimental quantity could be from the “true value” that was read/measured due to process variation. Setting a measurement uncertainty can be difficult as it will be unique to your laboratory space. Some things to keep in mind when evaluating a measurement uncertainty are environmental factors that may impact equipment functionality. For example, altitude, barometric pressure, and humidity can have effects on liquid handling. If your lab is in a dry climate your balances may be affected by static electricity. Also, if you are using various pieces of equipment (ex. microplate readers) or different operators to conduct measurements, you may want to gather some statistics on their average functionality (mean, range, median, etc.) All of which should be considered when setting a measurement uncertainty for your process. At the end of the day, setting something that is realistic for your process and lab environment will be key. You want to be able to meet and adhere to the criteria you set.
2. Here’s how you can avoid the process and equipment traceability trap:
If using measurement devices or external vendors for calibration or verification services, ensuring their traceability is critical. Basically, it’s proving the instrument or service has accurate methodology and that the measurement uncertainty can be verified/trusted from your vendor or your tool. For example, let’s say you need to check a thermometer in your lab. Your process could include taking several measurements from the thermometer you are testing; along with taking measurements from another thermometer that is placed in the same area as the one you are testing. To assure testing validity, it would be important to show that the thermometer you are measuring your thermometer in question against has documentation accounting for its accuracy (ex. NIST traceable). Otherwise, you have no way of tracing the validity of your measurement basis. If you are outsourcing equipment for calibration or maintenance, then you want to ensure you are getting a calibration/maintenance certificate that has appropriate credentials from the vendor, especially if they themselves hold accreditation status. Another consideration is moving the calibration/maintenance procedure in house, if resources allow for this. If you are purchasing new measurement equipment, getting the traceability documentation from the manufacturer will be important to have on file. The documentation should also list when that initial traceability expires. Marking this date on your calendar (with some flex time) will help remind you to work on renewal of the traceability before it expires.
3. Could your Standard Operating Procedures (SOPs) be creating variation instead of standardization? Let’s look at how:
SOPs (Standard Operating Procedures) can be hard to manage in today’s fast paced and ever-changing lab space. It can be challenging to keep up with the pace, let alone the documentation. However, this can be a hot button area during compliance audits so it’s worth some elbow grease getting the documentation in shape. SOPs are typically reviewed by assessors, and that may also include observing individuals perform the procedure in front of the auditor. Here are a few examples where SOPs can go awry…if steps are performed out of order, not at all, the SOP references outdated equipment or reagents, or if a frequency of process completion is stated and not adhered too, you will fall out of compliance. A simple rule of thumb to think of with SOPs is that you are completing the steps as written in the SOP. If your process does have flexibility, then it is critical to add some verbiage into the document that addresses that. For example, you could make a simple statement like, “The following steps aren’t required to be performed in order” or use phrases like “recommended” instead of “required.” Regarding frequency, it might be a good idea to review your protocols to see if you are performing any steps in excess. A good place to start would be to check the manufacturer’s recommendation for calibrating and/or verifying the instrument. Another tricky issue with SOPs is having outdated versions lurking around the lab. SOPs are handy, especially as we are training or renewing our proficiency testing but having antiquated print outs or short cuts on computers in the lab will certainly lead to discussions with your accrediting body regarding version control. If documents must be printed out, go through your QA department to ensure appropriate measures are taken. If accessing electronically consider using a centralized repository for the documents so that they are easy to locate and control.
4. Are your operators qualified to perform processes or train other operators? Documentation is key…here are a few considerations:
As we have already discussed, it can be hard to keep up with the fast pace of the lab, let alone document control. Operator training and proficiency records are critical and need the same attention as SOPs. Accurate training and operator competency records are also worth the investment to keep up to date. Creating a folder or binder for each employee is a great start in getting organized. A recommended first place to start would be on the SOP in your lab that discusses training and operator competency. Make sure the system you put in place meets the SOP. From there you could setup standardized templates, calendar reminders, or get help from your lab team setting up a system where everyone can support one another in completing proficiency tasks. Another helpful tip is to ensure your language is standardized between your proficiency templates. It can bring up confusion during your audit if you are using different or inappropriate terminology. An example of this would be verification vs. calibration. If the operator is only proficient to perform verification checks on an instrument, it is critical not confuse that with calibration.
5. If you don’t have a record of it occurring….it will be interpreted as it never happened. Here’s a few ideas regarding document storage:
Secured storage for laboratory data and records is another area where labs struggle. Having backups of validation documents, procedures, and training are critical when meeting regulatory compliance standards. Investing in secure servers, fireproof safes/cabinets, and quality fire suppression systems can not only help you with meeting regulatory compliance needs but can also save the painstaking task of re-doing work if records are lost. For your electronic records, it’s also a good idea to look at the types of documents you are storing. Keep in mind some data files could become corrupted or can be easily modified (ex. Word or Excel). Consider converting documents to a secured file type (ex. Pdf) before archiving.
Meeting compliance standards doesn’t have to be a difficult task, or a last-minute dash preparing for an audit. As we reviewed above there are a few ideas on how to incorporate solutions more easily into day to day procedures. Involving your team and level-loading the required tasks can also be helpful. The more eyes you have, the more likely you are to catch other potential pitfalls allowing you to become more proactive instead of reactive. With some preparation work and tools at your fingertips, your lab can be regulatory compliance superstars.
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About the Author
Breeann Bryan is a dedicated laboratory professional with a LEAN Six Sigma Black Belt. Her background ranges from the bench to operational administration and project management. She is proud to share her knowledge and empower others to tackle their process improvement challenges, whether it’s troubleshooting data quality issues, finding out how to maximize efficiency in the lab, or keeping teams on task. She firmly believes that everyone deserves to have the right tools needed for the job.