Accreditation Archives - Under the Objective

Internal Auditor Training

Recently I took an Internal Auditor training course provided by Seaglass Training and taught by Anja Einseln. Anja Einseln worked for ASCLD/LAB (now merged into ANAB) from 2006 to 2017. The training covered the main documents used during internal audits for crime laboratories: ISO/IEC 17025 2017, ANAB AR3125 Accreditation Requirement, and the 19011 Auditing Guidelines. The course was attended online with the instructor’s video/voice overlayed over a PowerPoint presentation. The course was taught in a 5 day period for 5 hours per day. We had two 15 minutes breaks each day…for those readers wondering about breaks. Although I took the course online the course has previously been taught in person. By the time you take this course, your experience may differ if the course was to convert back to in-person training.

Background

The course was structured where the instructor went through each section one by one. Ms. Einseln read most of the section aloud while the students took notes. We were provided with a PDF copy of the PowerPoint where we were able to take notes and read along. The PDF copy had fill-in-the-blank spaces every couple of slides, which meant that we had to be constantly cross-checking her PowerPoint against our own PDF to make sure we had all the information. This was done to make sure we were engaged throughout the course. Before starting the class, she explained her teaching methods to us. She explained that she structured her course to be able to help students who learn in different ways: Kinesthetic, visual, and auditory. Kinesthetic learners benefited from the fill-in-the-blanks, visual learners benefited from the PowerPoint slides, and auditory learners benefited from the audible reading of each section of the documents. She also asked us questions from time to time and required us to write the answer in the chat. They were usually simple questions, but they made sure we were engaged. We had to make sure we answered these questions because she would monitor the chat to make sure everyone in the class was participating. The last day included exercises that further engaged us and allowed her to test our knowledge. The exercises will be explained in the next section.

Day-to-Day Breakdown

Day 1

The first day was focused on background information. This included the background of ISO, accrediting bodies, and other organizations. Some organizations mentioned were OSAC, ILAC, IAAC, and NIST. She explained the importance of these organizations and how they relate or interact with one another. She also discussed how the overall auditing process is layered: General requirements, Accrediting body requirements, Community adopted standards, Agency orders/manuals, and Laboratory policies and procedures. Another topic heavily covered on the first day was a concept called Deming’s Wheel, which goes over the basics of auditing. The wheel consists of the following concepts plan, do, check, and act, which was created by W. Edwards Deming.

Rest of the week

The second and third day was allocated to covering the ISO 17025 2017 document. This was done through the method explained above where each section was read one by one. During this process, we were filling in our PowerPoints. The instructor allowed us to ask questions at any time and she was good at catching when a question was asked in the chat portion of our virtual meeting. All questions were answered thoroughly, and she ensured everyone understood the answer before moving on. The fourth and fifth day was dedicated to the ANAB AR3125 document. These days were structured the same as the days prior.

On the fifth day, two exercises were handed to us. One exercise required us to make a checklist based on a procedure. Then she showed us the final product of a couple of cases. We had to take the checklist we made and ensure that the final product matched up with our checklist. If the end result did not fulfill our checklist, we had to say that the case was not compliant and what areas caused the determination. For the second exercise, we were given a procedure and a video to watch of someone performing the experiment. We had to take notes when any deviations occurred in the video. This exercise had us practice case work observations. At the end of the video, everyone wrote in the chat the deviations they found. Some people went overboard with their findings, but most people found what was supposed to be found.

Final Thoughts

Overall, this class was helpful but very dry. BUT, the dryness of the class cannot be helped because there is no way to make reading these documents entertaining. She did try her best and created multiple ways to engage the students so that we had an easier time absorbing the information while also being stimulated. One of the best parts of the class was the question-and-answer dynamic. This allowed us to clarify anything from these informationally dense documents. I wish I knew about this dynamic because I could have asked the laboratory if they needed clarification on anything from the documents; because the instructor was very knowledgeable about everything within those documents. There were times when she didn’t have an answer right away but either after a break or the next day, she would have a detailed answer ready for the person who originally asked. She also made herself available during breaks and after class for any questions we had. I would usually stay after class just to hear what other people were asking and to hear her answer. I would recommend that anyone taking her class to listen carefully and ask your own questions. The answers she gives can help immensely during an internal audit. Lastly, make sure the notes you take, the documents that are marked, and the PowerPoints are kept in a safe place because they will be very useful as a reference in the future.

General Laboratory

ANAB Accreditation Explained

Important Terminology

ANAB is a name you will have to know when working for a New York State Crime Laboratory because of the accreditation requirement. This requirement is mandated by The Commission of Forensic Science which is part of the New York Division of Criminal Justice Services (NYDCJS). ANAB stands for The ANSI National Accreditation Board, and its goal is to accredit laboratories that follow the accreditation standards that the board sets.

The ANAB standards are based on the ISO/IEC 17025: International General Requirements for the Competence of Testing and Calibration Laboratories. The calibration portion of this document is not relevant for Forensic Laboratories, therefore it will be ignored for the rest of the article. ANAB takes the ISO standards and adds the AR3125 document, which is a supplement that adds more specific requirements for forensic service providers. Below we will dissect the ISO requirements, which are separated into different numbered sections. These sections are usually mimicked by the Quality Assurance’s (QA) Standard Operating Procedure (SOP) to ensure that the laboratory follows all the standards. The ISO document is generally vague when it comes to requirements, it’s up to the laboratory to get more specific in their QA SOP, and then ensure that all the requirements are followed at all times.

Beginning Sections

The sections that start the document are more introduction based than the actual standards that a laboratory should follow. Section 1 is the “Scope,” which explains the purpose of the document. Section 2 is “Normative References” and Section 3 is “Term and Definitions.” These sections are self-explanatory and they do not go into any specific requirements.

Section 4 is the first section that creates requirements for the laboratory and it is appropriately titled, “General Requirements.” This section mainly focuses on impartiality and confidentiality. The next section, Section 5: “Structural Requirements,” discusses the management and personnel responsibilities, along with the activities and their requirements. Sections 4 and 5 are small when compared to the next two sections, which are the sections that make up the majority of a Laboratory’s QA manual.

Section 6

Section 6, “Resource Requirements” is one of the biggest sections and is one that the QA section will focus most of their manual on. The sub-sections of Section 6 are split up as follows: General (6.1), Personnel (6.2), Facilities and Environment Conditions (6.3), Equipment (6.4), Metrology Traceability (6.5), and Externally Provided Products and Services (6.6). Below I will explain some of the sub-section for better clarity. I will skip 6.1 because it does not contain anything of value for a general examination of the document.

(6.2): This section goes over the education, qualifications, training, and experience of the personnel. The agency needs to have the requirements for these categories and the records to support them. The personnel should also have competency in their laboratory activities.

(6.3): Requirement to list and record all the environmental factors that can affect the validity of the results.

(6.4): To keep a record of the equipment that is used in testing and to ensure the equipment conforms to specified requirements: measurement accuracy and measurement uncertainty. There must also be recorded calibration and checks on the instruments.

(6.5): There has to be documentation for metrological traceability. These measurements must be traceable to SI units.

(6.6): Records of what will approve a product and what will make it conform.

Section 7

Next is Section 7 which is the review of requests, tenders, and contracts. This section is split up into 11 sub-sections. This section will affect more of the report writing and the way analyst must conduct their examinations. The sub-sections cover the following:

(7.1): Procedure for the review of requests, tenders, and contracts

(7.2): Selection, verification, and validation of methods that must be appropriate and correct. There must be a manual for the methods, standards if applicable, and a verification process.

(7.3): This section goes into depth about sampling. There must be a plan and must address any factors.

(7.4): This section goes into the handling of test or calibration items. Also requires a procedure for storage, transportation, receipt, etc. of these items.

(7.5): The testing records must be complete so they can be replicated. The original observations, data, and calculations at the time they were made must be recorded.

(7.6): Evaluation on Measurement Uncertainty. There will be another article posted on measurement uncertainty and its importance at a later date.

(7.7): Requiring the monitoring of results so that trends can be detectable. This can be done through functional checks, retesting of retained items, replicate testing, etc.

(7.8): This section dives deeply into the reporting of results. The results must be accurate clear and unambiguous, and objective. The section also provides guidance on what the report should include: title, the method used, data, etc. On top of report writing the section addresses calibration certificates and what they should include. To keep this section brief I would like to conclude that most of the guidance in the final product is found in this sub-section. This sub-section is very important to the QA section and other sections in the laboratory when crafting their own SOPs.

(7.9): This sub-section goes through the complaint process when a customer files a complaint.

(7.10): Anything dealing with non-conformance work is found in this sub-section

(7.11): Lastly this sub-section finishes off with control of data and information management.

Section 8

The last section of this document is the management system requirements, which is section 8. They split this section into an “A” option and a “B” option. The “A” option is usually taken by crime laboratories and the “B” option is taken by laboratories that use the ISO 9001. The “A” option goes over control of documentation of the laboratory, corrective actions, internal audits, identifying areas of improvement, and policies and objectives for the fulfillment of this document.

Conclusion

This article is just to teach you the basic idea and summary of the ISO/IEC 17025:2017 document. Overall, the document is just general requirements that any laboratory can take and mold into its own SOPs. The ANAB Accreditation Requirements (AR 3125) has all the same sections as the ISO 17025 document, but the information is geared more towards forensic laboratories. Although the AR3125 document is still pretty general in nature, it does have more forensic-specific requirements. Once these documents are incorporated into the QA manual and the other section’s SOP is when they become more specific to the specific laboratory they are incorporated into. At this point, the laboratory is responsible for following its own manuals in addition to the ISO and AR documents when an assessment is performed on the laboratory.

This information can be used by the scientist who is preparing to help their lab with accreditation. They can use also use this article as a quick reference or to better understand what the ISO standards are. This information can also prove to be very useful for the student who is looking for a job or internship. This knowledge is sought after when hiring because this is huge for the laboratory, but is usually eclipsed by casework.