On the Path to ISO 17025 Accreditation What We Wish We d Known Before We Started And Some Definitions: Language of ISO 17025 Version: 2013-08-29 1
Susan Humphries, QA Officer Bureau of Food Laboratories, Division of Food Safety Florida Department of Agriculture and Consumer Services Gail Parker, Quality Manager Bureau of Chemical Residue Laboratories, Division of Food Safety Florida Department of Agriculture and Consumer Services Version: 2013-08-29 2
The Bureaus of Food Laboratories and Chemical Residue Laboratories gained accreditation to ISO 17025, for the specific tests listed in A2LA certificates 2534.01, 2534.02, and 2534.03 on March 31, 2007. Accreditation has been continuously maintained, with the current renewal valid to March 31, 2015. However, our path started five years before that! Version: 2013-08-29 3
More auditing and outside auditing can be hard on everyone There are some ways to help reduce the stress on staff: Use internal audits as practice for external audits Explain that the audits are to help us improve, not to catch us doing something wrong. The auditors are here for our benefit. Emphasize that it s perfectly ok not to know the answer but you should know how to find the answer (ask your supervisor, or look it up) Thank people for pointing out things that need to be fixed! Version: 2013-08-29 4
Corrective action (investigations) should never be a punishment! The assignment of a corrective action investigation ( CA ) is a great opportunity to identify and correct a problem in our systems. Supervisors, especially, should take care never to use them as punishments sometimes it s hard to resist. But if they are used that way, it s not easy to go back. Without the active involvement of all staff, especially bench level staff, CA investigations are unlikely to find and successfully address valid root causes of nonconformances. Version: 2013-08-29 5
How to find good root causes: Finding a good root cause is critical to addressing it. You can t find a root cause by sitting at your desk alone. The people closest to the nonconformance should be most involved in the search for the root cause. Lack of training is almost never a good root cause unless you have a problem with your training system. Accidents are not quality system problems, unless there is something you should be doing to prevent them. Version: 2013-08-29 6
Root causes, continued: A good root cause is specific, under the control of the lab, and if you address it, there is a good chance that you will reduce the chance of the nonconformance recurring. To get at the root cause, try asking why five times, about different aspects of the nonconformance. Or try drawing a diagram of the contributing factors. Interview everyone who might have some idea on the subject, being careful not to be accusatory. Never take multiple corrective actions at once, unless there is a safety concern. Take one action at a time and monitor to see if the problem recurs. Version: 2013-08-29 7
Control charted process control data is very useful: It gives evidence that your processes are working as expected It is useful for determining your measurement uncertainty, without the need for complex multicomponent calculations Qualitative data can be quantitatively charted as zeros and ones Use your positive and negative process control data as audit evidence of fit for purpose and that your methods are performing as expected Version: 2013-08-29 8
How hard it is to capture and track the training records required by document revisions. We always have many documents in revision. Many users (nearly a different set for each document!) need to be trained on each issued revision, which means they must be notified, complete the training even if just read and understand and a training record needs to be kept. Consistently retrieving and maintaining these training records is a real challenge If you can afford it, get an integrated document control and training tracking system early on Version: 2013-08-29 9
It takes time years to build a good and efficient quality system. At first, we patched together fixes as problems were identified, but after a while, It started to get better! Eventually, you ll figure out how to make your systems work together, and more smoothly. Even if it doesn t seem like it will ever happen hang in there, because it will. There may be some systems you ll struggle with for longer than others. For us, examples are document control and training tracking. Version: 2013-08-29 10
It s useful to plan the structure of your documents before you start writing... Our Quality Manual is arranged with sections corresponding to the sections of the ISO 17025 standard We use the Quality Manual as a roadmap pointing to all our other documents This was a hint we got from another lab, and we re very thankful! It is much easier to find things, this way, especially when the standard changes, as our former bureau chief (Yvonne Salfinger) recently pointed out. Version: 2013-08-29 11
We didn t know how much trouble document control was, or how to set it up effectively. Manual document control systems are tremendously time consuming. A software system could buy you time for auditing and improvements. Version: 2013-08-29 12
We didn t know what kinds of documents to control so we controlled everything! Any document which could affect the quality of your results must be controlled. Basically, if you follow it to do your work, control it. Both internally and externally authored documents must be controlled if they can impact the quality of your work. Don t control everything! If it is NOT required for doing work, don t control it. We had no idea how difficult it would be to find all the external documents in our lab. We probably still don t have them all. Software and websites used to do your work must be controlled, validated (if necessary) and version/location tracked. Version: 2013-08-29 13
Vocabulary: Deviation vs. Nonconformance A deviation is a planned (and approved) departure from your procedures. Deviations must be approved by people with appropriate knowledge and authority, prior to their occurrence. A nonconformance is an unauthorized departure from your procedures. Version: 2013-08-29 14
Vocabulary: Corrective Action vs. Correction A Corrective Action is an action taken to reduce the chance that a nonconformance or other adverse event will occur. It is normally the outcome of a Corrective Action investigation into the cause of a nonconformance. A Correction is an action taken to correct an error. The difference between the two is a matter of both the relative seriousness of the error and the potential impact on results, as well as whether or not the action is fixing a previously documented systematic problem. Version: 2013-08-29 15
Vocabulary: Certified vs. Accredited (to) ISO 17025 The word Certified is not used in connection with the ISO 17025 standard. ISO 17025 is a standard to which labs are accredited, for specific tests on their scope of accreditation, and the proper way of referring to it is: (Lab name) maintains (Name of your accrediting body) accreditation to ISO/IEC 17025 for the specific tests listed in (Name of your accrediting body) certificates (certificate numbers). It is (will be!) important to refer to your accreditation correctly, to prevent confusion about which tests are on your scope of accreditation. Version: 2013-08-29 16
Vocabulary: Shall ensure vs. Shall include Shall include: Must be written. Shall insure: A process that can produce the specified result is the only thing required. Version: 2013-08-29 17
Vocabulary: Reference standard vs. Reference material Reference standards are not consumed in the process of measurement. Reference materials may be consumed in the process of measurement. Standard reference material example: grape juice. Vocabulary: Reference weights vs. Working weights We use working weights to verify the balances daily and they're checked against the reference weights periodically, but the reference weights are safeguarded and they're kept in a cabinet. Version: 2013-08-29 18
We wish we had realized that the accreditation process is mutually beneficial. We re not trying to beat our accrediting body, and they are not out to get us. It s a necessary function for us (to improve the quality of our results), so it s in our interest to have them point out where we need to improve. They're there to provide that service, which means it's in their interest to help us find and fix problems in our systems. Version: 2013-08-29 19
How to write good equipment (or other) SOPs DO NOT write them for the ideal lab, or the lab you wish you were. Write them to reflect actual practice. Useful things to put in equipment SOPs: Calibration/maintenance intervals Filenaming conventions, locations of files, and backup procedures and frequencies. NOT too much detail Version: 2013-08-29 20
The application process: Timing is everything, and it lasts forever! Check with your accrediting body to see how your application date will affect your annual audit due date. Make sure that your annual audits will fall at a convenient time for all staff and that they are likely to be available in the 30 90 day interval following the annual audits, too. Version: 2013-08-29 21
It s good to have an assessor and/or consultant who works primarily with your type of lab, and this standard. Also, it s very important to have a consultant (if you use one) who is very familiar with your accrediting body. Some finer points are open to interpretation, and it s just human nature that opinions may vary. See whether your accrediting body offers guidance on common points of the standard. A small difference of opinion can cause a lot of work for you trying to meet that particular interpretation and it might not be necessary or you might be missing some work that you should be doing. Version: 2013-08-29 22
Vocabulary: Should vs Shall Should is a recommendation; shall is an inflexible requirement. It is a must. May, could, can all are recommendations. Will, shall, must are all requirements. Ignore them, and you will be cited for nonconformances. This applies to your own procedures, too! Be careful of these words when you are writing them. Version: 2013-08-29 23
Vocabulary: Records vs. Documents Records are evidence that an activity has taken place. Documents are instructions for how to perform an activity, and are not altered without following a specific procedure. Both documentation and documenting, however, refer to the generation of records, NOT documents don t get confused! Version: 2013-08-29 24
Vocabulary: Policies vs. Procedures Policies tell what you do, whereas procedures are how you do it. Policies must be in your quality manual. Procedures are more the step by step instructions, so to speak, and may be simply referenced in your quality manual, but written elsewhere. Version: 2013-08-29 25
Vocabulary: Raw data, Derived data, and Information Raw data are recorded observations of test results. Examples: lab notebook records of colony counts, or the raw data file on a GC instrument. Derived data are raw data which have undergone a transfer or manipulation of some type. Example: printouts of GC chromatograms, spectra, etc. Much information must be recorded and maintained about lab activities, but this information is neither raw nor derived data. Example: Name of person who reviewed a specific dataset. Version: 2013-08-29 26
Vocabulary: to the extent necessary This is really up to the lab to determine, but means neither more nor less. It is too easy to be too restrictive refine your processes by trial and error. Going through the process of refinement is not a waste it helps to build your in depth understanding of both your own lab and the standard. You will have a great benefit at audit time, in terms of understanding the standard and how it relates to what you have for processes, and being able to explain all of that to the auditors. Version: 2013-08-29 27
Take care of the big things first and you ll just keep finding more things to take care of! Audits can become more focused over time, as the larger issues are caught and fixed. Systems will get simpler over time, too. A good onsite assessment: All of the nonconformances, no matter how many there are, are easy to fix. None of them were potentially affecting your data to a significant degree. A couple of our big things to fix are now paying dividends: control charting and the training system. Version: 2013-08-29 28
How important it is to get top level support at the beginning of the process If you don t have it, it shows, and staff and auditors can tell You can actually be cited a deficiency for not having support at the top level. Benefits of accreditation include: Less stress increased probability of successful accreditation Reduced exposure/liability because of better recordkeeping Greater confidence in your data Version: 2013-08-29 29
Vocabulary: Readily Retrievable With respect to records, means that you must be able to produce them while the auditors are on site. If you use offsite records storage, contact your accreditation body well in advance of your onsite audit, and ask what they d like you to pull and have ready for them when they arrive. Version: 2013-08-29 30
We thought we were doing very well until we started the process. Be prepared to find more issues than you were expecting. You only have to control those documents which could impact the outcome of analyses. Say what you do, and do what you say if you follow this everywhere in the lab, that ll cover a lot of your issues. Don t be too prescriptive when writing instructions. Your quality procedures will get more and more complicated as you patch issues by adding on systems to deal with problems. But the knowledge you take away is invaluable. Eventually, there will come a time when staff are mostly comfortable with the standard, and improvements and streamlining will be possible. After that, things will be easier, and you can continue to improve and look more deeply at your overall Quality System. Continuous improvement isn t just a good idea, it s a requirement! Version: 2013-08-29 31
Thanks to: All of our staff, who built and support the quality system. APHL staff Our accreditation body: A2LA Version: 2013-08-29 32