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Anatomy of a NATA non-conformance

Confused by NATA correspondence?Do you sometimes struggle with decoding the non-conformances in NATA assessment reports? Some labs come to us after they have replied to the assessment report, bewildered by the response they’ve got back from NATA. They thought they had already covered what NATA was asking them to fix and can’t see what to do differently. Not only that, they have to provide a response in a short timeframe.  It is largely an issue of language, or “official-ese”, which can sound over-complicated and even misleading. “Officialese” is the antithesis of plain english and often involves passive language, long words  and generalisations.

Difficult Language

Misunderstanding often starts with the way the assessment non-conformances have been written in the first place. Some NATA staff use quite bureaucratic language. I guess they think this is the “correct” approach. What it does is make it far more difficult to understand.

By the time you get to a couple of rounds of correspondence, the “offialese” can make it very difficult to work out what you need to do and how it is is related to the original non-conformance. 

Take this example:

Records to indicate which staff have been authorised to report, review and authorise test results were not available.

This could translate to:

You need to create records to show which staff are authorised to:

  • Report results
  • Review test results
  • Authorise test reports

Here’s another:

No documentary evidence was provided to satisfactorily address the condition raised (e.g. record of withdrawn date and record of equipment check even if withdrawn).

We translated this to:

Please send records showing the last check done on each piece of equipment listed in the original non-conformance. This applies whether the equipment is currently in use or not. For equipment that has been withdrawn from use please also include the withdrawn date.

What they are really saying

NATA staff do get it right as well. Here are some really good examples of clear assessment report communication:

The equipment register had the following problems:

  • The vernier scale isn’t included
  • It doesn’t include records of the last check on the {equipment}

Please fix these problems and submit a copy.

Or

There were no training records for staff members g and f. You need to produce training records for these staff and send copies for review.

Restating Accreditation Requirements

Others have a habit of restating the words from the standard and then adding the specific things that they found wrong. I’m not saying this is wrong, but it can lead to confusion. Here’s a classic example:

Evidence of verification that equipment conforms with specified requirements must be retained. There was no evidence to indicate that (one specific piece of equipment) meets the specified requirements.

The lab manager was totally distracted by the first paragraph and spent a bit too much time reviewing how they store this information in general. An old hand recognises the first paragraph for what it is: simply a restatement of the clause from ISO 17025 6.4.13 b). Skip to the second line to find out what they actually discovered during the assessment.

Once you have sorted out the issue in the second line (the specific), you may go back and review how that error occurred in the first place and that may warrant a closer review of the system for collection and storing calibration records.

Here’s another example of this common problem:

Documents must be periodically reviewed to ensure they remain fit for purpose. The following issues were noted and must be addressed:

  • Quality Manual references and incomplete list of accredited tests;
  • Quality Manual action 3 states that equipment records are kept for the working life plus 3 years, however, Section 8 states that these records are kept for the working life plus 4 years;

On reading the first sentence you may think they are saying that all or most of your documents have not been reviewed, not been reviewed periodically, or are not fit for purpose. Or is it all three?

Thankfully the specific issues have been listed for you. Fix those, then have a quick look to see if the problem is more widespread. Don’t revamp your whole document review system unless YOU determine that it needs that.

When “All” means none?

We have seen a surprising number of problem non-conformances that involved using the word “all” which made the scope of the non-conformance impossible to work out. For example:

“Competence assessment records were not available for review for all personnel.”

Does it mean that there weren’t competency records for ANY personnel? Do we have to send them all in again? Or were there just particular ones missing? Without any specifics it’s difficult to know how to respond.

In this case the lab manager interpreted it as none of the records supplied to demonstrate competency were adequate and started on a major revamp of the competency assessment system.

You have two options here: ask for a bit more information or do a small audit of the records yourself to see if you can find the problem. 

Addressing NATA non-conformances

Once you have waded through the difficult language, here’s how to go about addressing the non-conformance: 

  1. Identify the specific thing/s that NATA found wrong. Go and have a look at it and confirm the details (NATA can get the wrong end of the stick at times).
  2. Fix that particular problem.
  3. Investigate to see how it happened (root cause) and how widespread it is.
  4. Decide whether it needs more action.
  5. Plan corrective action and continue with the PDCA cycle.

More information on addressing NATA-non-conformances.

We literally translate assessment reports for many laboratories. Drop us a line if you would like to know more.

Addressing Impartiality in ISO 17025

Risks to impartiality are alluded to in both ISO 17025 and ISO 15189, but neither standard is really clear about what the sources of risk might be. These risks have always been around – they’re just more evident in some types of lab than others.

If you have identified possible risks to impartiality you will want some ideas on how to address them. Don’t forget to make the actions commensurate with the level of risk and likelihood. 

What can be done to protect the reputation and integrity of your business? After all, reliability of test results is likely to be central to your business model.  

Read on for a step-by-step approach to reducing or eliminating risks to impartiality. 

8 ways to reduce risks to impartiality 

1.  Technology in testing processes

Removing the possibility for results to be changed or left out is a complex task that may require a number of measures to be put in place, such as the following: 

  • Processes to ensure that all samples are individually logged and sample numbers cannot be reused – e.g. bar-coded sample labels.
  • Direct capture of test data in the lab – opt for testing and measuring equipment that can be hooked up to a computer to directly record readings without human involvement.
  • Logging field data directly into the laboratory information system via phones or tablets.
  • Remove manual steps from testing as far as possible – explore all options for automation.
  • Ensure all results are transmitted directly “back to base”.
  • Automated checks can include a comparison against expected results for that type of sample or previous results.

Don’t forget to make sure the data storage is secure and that there is an audit trail for any changes made.

2. Employment practices

Consider possible sources of motivation to alter test results. These can include bribery, not wanting to lose contracts, being nice to a favourite client or even just wanting to get lots of work done.

Many laboratories carefully screen job applicants to make sure they are not only a good fit for the type of work, but also that 

  • They have no connection to the industry they will be testing for (such as in drug testing).
  • Employees aren’t holding jobs with competitors.
  • They don’t have shares or other relationships that could present a conflict of interest.

You can simply get staff to sign a declaration when they start with you, or you may need to actively research if the risk is high.

3.  Quality culture

Creating an ethical work culture must come from top management. Instilling a culture of openness, honesty and integrity goes a long way towards protecting your company’s reputation. These values need to be lived and breathed through the organisation at all levels.

A quality culture of “this is the way we do it here” will help protect your company and staff from undue pressure.

Start with your induction process and continue to emphasise your values throughout a staff member’s time with your company. Make sure they know that they can speak up if they don’t feel something is right. Talking about recent incidents or problems at regular meetings and encourage staff to hold each other to account.

Your quality system, which should be seamlessly integrated with the day-to-day work, is crucial to developing a culture of commitment to quality best-practice. Staff should know to look up your organisation’s methods or procedures when they’re not sure what to do.

This helps develop a “this is the way we do it here” culture. It also empowers staff as there is a clear process in place if they feel pressured to change results, or test only at a specific location. Who should they report this to? When should they stop testing and leave the site?

Make sure your staff learn about these policies when they join your company and design opportunities to revisit the policies on a regular basis.

4.  Checking data & reports

An independent review of results introduces a level of impartiality as well as the benefits of a fresh set of eyes for errors. An experienced eye can often pick up unusual results or trends.

5. The laboratory environment

The lab environment can influence the reliability of results. There are a number of ways you can reduce this risk: 

  • Provide a secure lab environment where the lab staff can work undisturbed by interested parties.
  • Keep addictive or valuable materials in secure storage, requiring two staff members to access.
  • Try not to leave staff working alone for extended periods without interaction with seniors to support and mentor them.
  • Install security cameras in specimen reception areas to reduce the risk of samples being interfered with (and prove chain of custody).
  • Install security cameras in laboratories, particularly if there may be accusations of testing not done.

6.  Managing Conflicts of Interest

Review the structure and reporting lines: look for potential conflicts of interest (such as results being used within your company). This can be an issue for production-related organisations and those involved in design engineering. Where possible, remove problematic reporting lines. For instance,the laboratory technician or manager should not report directly to the Production Manager or Design Engineer. 

Potential conflicts of interest related to external relationships should be declared upon employment and confirmed again on a regular basis. (This particularly applies for company directors). Show that you are aware of these potential conflicts by excusing staff or management from certain projects or decisions as necessary.

7.  Contract review

Technical review of contracts is critical in industries where pressure may be applied to get favorable results. Clients may want to minimise testing costs as they are seen as an overhead.

Checking the technical, as well as financial details of the contract will help make sure you are not left out of pocket or pressured to complete inadequate testing due to time or financial constraints. Similarly, over-testing can lead to a devaluation of the test results – “it doesn’t matter so much if one (or a few?) are not quite right”.

If a client insists on an inadequate testing regime, it might be time to re-consider whether you really need to work with that client. Some of our clients have taken this option and have a much happier life because of it.

8.      Training and education

Make sure you and your staff are well-versed in the importance of the test results. If you have technicians who don’t understand why they’re doing the tests, they won’t place much value on them being correct. What happens if a structure fails and it is found that testing was not accurate? What if your product gets released and is found to be non-compliant?

Staff need to understand that the implications of failure at this late stage can be huge, sometimes leading to court action. To avoid this potentially disastrous scenario, your team needs to be prepared to identify and deal with a compromised result immediately. Any short-term pain from dealing with someone who doesn’t want the true result is no matter compared to the long-term consequences for your business.

Get extra help

We have been helping our clients assess the risks to impartiality since the changes came in with the new ISO 17025. We can give you peace of mind that you are doing what you need to without reinventing the wheel or making unnecessary wholesale changes. If you need this kind of help, get more details here or contact us via our contact page.

Risks to impartiality in ISO 17025

On-the-road-to-reliable-results

Risks to impartiality and managing conflicts of interest are hot topics in lab accreditation since ISO 17025 was updated. These risks are also alluded to in ISO 15189, but neither standard is really clear about what the sources of risk might be. These risks have always been around – they’re just more evident in some types of lab than others.

Expect tough questions

The tougher requirements regarding impartiality mean you should now expect NATA to ask you about these issues at assessments. If you’re like many lab managers, this is a difficult subject to talk about, and just assuming that your staff “wouldn’t dare” will not cut it. 

Situations of undue influence, or conflicts of interest can lead to test results being either intentionally or unintentionally incorrect. If this is discovered after the results have been issued, it could not only be devastating to your business but it could also potentially have criminal implications. Read about one laboratory’s troubles here.

So, what can be done to protect the reputation and integrity of your business? After all, reliability of test results is likely to be central to your business model.

Know the warning signs

Identify what situations could arise in your organisation and write them down.  Think broadly. While many situations may seem unlikely it is still useful to get them out there. There are many different situations that can lead to compromised testing.

Here are just a few:

  • Testing for compliance on an in-house product, especially if the tester also has production responsibilities.
  • Being pressured to give a pass result or repeat the test until you get a pass result.
  • Being on site away from the support of lab management and developing close relationships with clients.
  • Conflicts of interest due to shareholdings, family relationships, second jobs, etc.
  • Under-pricing jobs.
  • Contracts that constrain your ability to conduct the testing correctly and honestly, such as: specifying which site samples must be taken from,  financial penalties if testing causes delays, methods specified that do not match the materials to be tested, only paying for pass results.
  • Media interest in a project or product.
  • Pressure to finish testing in unrealistic time-frames.

Any of these issues, combined with self-interest (let’s face it, we all want to cover our own backsides) or an over-developed sense of helpfulness could lead to someone being tempted to alter or ignore certain test results. But a lot can be done to protect your lab from this scenario.

Read our blog on ways to address risks to impartiality for a look at different approaches to reducing or eliminating risks to impartiality. (You can also get in touch to find out how we can help).

How to get NATA Accreditation – The Ultimate Guide

laboratory quality systemsSo you want to get NATA accreditation for your laboratory, but you’re stuck on where to get started? It seems like an arduous process and you want to know you are going about it in the right way, and not wasting time.  Perhaps you’ve contacted NATA and they referred you to a bewildering array of documents on their website, telling you to get back to them when you have developed your QMS Quality Management System?

But before you start pulling the proverbial cart before the horse, take note: there are other steps you need to go through first to get clear on your plan for securing NATA accreditation. Follow these 9 steps to ensure that the application process is as smooth, efficient and productive as possible. 

1  Work out your NATA Accreditation budget

Getting NATA accreditation is a financial investment. Not only are their application fees and ongoing fees for accredited labs, you need to factor in equipment, calibrations, staff time, and management time. The first thing you need to do is calculate how much room there is in the budget to invest in this project – how much can you justify spending on it based on the estimated benefit and return to the business?

Once you have a general idea of your budget, you can begin getting into the details of Step 2. If you’re doing a business case for NATA accreditation, we can help with scoping and defining what the costs will be.

2  Decide on your scope of NATA Accreditation

If you are already 100 percent clear about which tests you are going to get accreditation for, you can skip this step. Whether you’re getting accreditation to service existing clients or chasing new work, there are a few questions to consider when deciding which tests you need NATA recognition for. 

Are you going for accreditation for every test that you do, or just a selection? Which ones do your clients want NATA accreditation for? Will some tests be easier to get accreditation for than others? Do you have a priority list? NATA can work with your priorities by letting you know which tests will lead to extra costs, helping you budget appropriately and optimise your time management. You can apply for accreditation for some tests first and then add others in the future, once you know how the system works.

Factors to consider for deciding which areas of testing to apply for are:

  • What your customers need/want and areas you want to expand into
  • How accreditation-ready each test is
  • Budget – does the benefit of getting accreditation in that area and any investments you need to make to attain it justify the cost? Can you afford it?

It is worth looking up the scope of accreditation of a few competitors in the NATA Directory to see how they are written. If you describe the tests you want accreditation for in their language, NATA will be able to assess your application much quicker, and direct it to someone who can get the ball rolling straight away.

3  Get organised

Many labs come to us for help not just with the nitty gritty of getting NATA accreditation, but  also further down the track when they find that they are having difficulties keeping up with their NATA responsibilities. We often find that their main problem is disorganised records and documents. Setting up a robust system for your records right at the start will stand you in good stead for a successful assessment and will save you money and time down the track. Grab a handy guide to setting up your files.

If you’re not sure what records you really need to keep, get in touch to see how we can help. 

4  Work out where the GAPs are

Doing a GAP Analysis against the lab accreditation standard (and any other requirements you may need to meet) will help you develop a clear priority list for your NATA accreditation preparations. This can end up being one of the most valuable tools in your preparations for accreditation.

  1. Make a table from the accreditation requirements.
  2. Review your CURRENT operations versus those requirements and document both what you do and don’t comply with.
  3. Record questions that you need to follow up with experts and get their clarification

Making the judgement about whether what you are doing now complies with accreditation requirements is the most difficult part of this process. It is important to strike a balance between being “good enough” and wanting to make everything the best it can possibly be. Setting your sights too high can make attaining NATA accreditation seem impossible!

5  Fine-tune the technical tasks

It might not seem so to the uninitiated, but developing a QMS is relatively straight-forward. The problems that end up stopping labs from getting NATA accreditation are always technical issues. NATA will focus much of its attention on sample handling, testing and reporting. 

Using your “Accreditation-Ready” matrix, prioritise the tasks needed for those tests to be ready for NATA to review. Some will have budget associated with them, so may have to be scheduled for when money becomes available.

Typical deal-breakers for tests are:

  • No proficiency testing results
  • Poorly trained/incompetent staff
  • Equipment is not calibrated
  • No clear method written
  • No regular quality control

To ensure you steer clear of any of these snags, you may need to invest a bit of time into fine-tuning the technical tasks central to your lab’s operation. If you need support with this, O’Dwyer Accreditation can help assess what areas need improving and also train your staff. 

6  Develop your quality system 

Now that you’ve spent some time on fine-tuning the technical tasks that already happen in the lab or will need to happen in order to meet the regulations, you can focus on developing your quality management system procedures. Develop any processes or procedures that are missing from your system. You can determine what is missing by referring back to the GAP analysis you did earlier. Remember, a good GAP analysis is one of the most useful parts of your preparations.  

If you haven’t already, start conducting internal quality system audits. If your staff are time-poor or you do not have a dedicated auditor, consider engaging an audit professional. The value of having an outside review of your systems is something many of our clients appreciate.  This is also a good time to hold a management review meeting to ensure that you have thought about the bigger picture issues that will come up when accreditation is granted, like how you will manage the extra workload and setting up your billing processes.

7  Get real value from the advisory visit

When you think you are ready for some feedback from NATA, email them a copy of the quality manual and the list of tests you want accreditation for. NATA will come and do an Advisory Visit at your laboratory. This is a fairly informal process, but NATA will give you feedback on your quality system and any obvious gaps in the technical operations.  Don’t miss this great opportunity to ask questions about specific accreditation criteria and how to apply them in your laboratory. Make a list of questions ahead of the meeting that you want to discuss with them. Take good notes on the issues of concern to you, as much of the discussion will probably not find its way into their written feedback.

8  Make the most of your NATA Assessment

Once you have sorted out any issues raised during the advisory visit, NATA will arrange an assessment. This assessment will be far more technical in focus than the advisory visit, as a volunteer assessor from a similar industry to yours will review all of the technical aspects of your laboratory (the technical assessor). Meanwhile the NATA auditor will be reviewing the quality system in detail. It’s important that you make the most of this visit and prepare for it well. Some tips: 

  • Find out who your assessors are and a bit about their background so you can build rapport at the outset.
  • Be ever-present during the assessment or ensure a senior staff member is – leaving assessors to speak with junior staff unsupervised leads to many ill-founded non-conformances. 
  • Own the exit discussion – this is your chance to clarify details and correct the record if they have got the wrong end of the stick. Make sure your key personnel are able to get there, especially senior management. Print enough copies of the interim report for each senior scientist / quality manager to have a copy during the exit discussion to help them follow what is being said, and check it for accuracy. 
  • Listen actively and ask clarifying questions for details about every non-conformance mentioned. You need enough detail to be able to go back and find what the assessor saw or you will not be able to identify the root cause and fix it.

For more handy detail on how to nail the assessment as well as assessment follow-up communications, read steps 1-5 in our previous blog,  10 tips to avoid NATA Paper Warfare.

9  Stay focused post-assessment

NATA will leave you with a detailed assessment report, including non-conformances.  These ALL need to be addressed before NATA grants you accreditation. Sometimes this stage can drag on a bit, so be patient! Here’s our top tips for navigating this stage well: 

  • Be economical with your response – only respond to what you really need to: not to non-urgent observations or recommendations 
  • Explain your approach to your team – ensure they also take an economical approach in their replies 
  • Stick to the report even if it seems different to what was raised on the day. Read what the Cs and Ms actually say and respond only to those issues, not to how you perceived the assessor’s take on an issue. 

For extra tips on making the most of this stage, read through steps 5-10 in this blog.

Get Accreditation! 

Once all of the assessment findings have been settled, NATA has a few internal processes to go through. Ultimately, NATA will send you a certificate that you can proudly put on display. You can start issuing NATA-endorsed test reports and using the NATA logo in your marketing materials from the date of accreditation.

Keep Going

No you don’t get to just sit back and relax after all that!  NATA returns on a regular basis to reassess your laboratory and quality system. Read more about NATA’s accreditation procedures.

Succeeding in laboratory quality management

Laboratory Quality HelpWe see that many laboratory quality managers inadvertently waste time due to misinformation and misunderstandings about  NATA requirements. They may do too much, creating unnecessary or inefficient processes in an effort to please the NATA assessor. Or they may do too little in the areas that really matter – the things that will actually affect test results. Or they may simply hit their head against a brick wall trying to change lab processes that don’t really need to change.

If only these well-meaning, conscientious (but often over-worked) lab quality managers had inside access to the tools and tips of others who have walked the same or a similar path with NATA. If only they could pick the brains of their peers in exchange for sharing their own insights.

Well that’s what the Australian Organisation for Quality’s new Special Interest Group aims to provide for labs. The Laboratory SIG is a virtual space where labs can speak openly about issues, pitfalls and wins with NATA and beyond. The idea of the group is not just about getting the NATA “tick” but about helping labs succeed in all areas of quality that determine their lab’s success.

Bringing Australian labs together over discussion and professional development 

When it comes to negotiating NATA issues such as the seemingly “new” requirement about addressing risk and opportunity in ISO 17025, there are common traps and common work-arounds across different kinds of testing. Beyond that, implementing excellence and continual improvement in your quality system is not something you can do alone, or by guesswork. 

Collaborative exchange with peers is one of the most valuable learning resources we have at our disposal – successful organisations and managers understand this well. The SIG serves to facilitate this exchange, linking you up with other labs as well as NATA accreditation and quality experts on a monthly Zoom call. Each call has a focus topic, with time for breakout groups to get to the more granular level of the discussion. You can opt-in to follow the discussion topic offline in a chat group where participants post further questions and answers. 

Labs discuss their approach to risk and opportunity management

The AOQ kicked off their first Laboratory SIG in June, focusing on the topic of Risk and Opportunity Management. A range of participants were eager to join the first discussion including 8 from medical, metallurgical, paint and workplace health and safety labs, as well as  6 consultants from across Australia. Various approaches to managing risk were shared with some using purpose-built enterprise-wide systems, some using commercial software, and others using home-built systems that didn’t seem to meet the business risks terribly well. For some it has been a case of bolting it onto the existing CAPA process and escalating it as appropriate to those higher up the tree, depending on the identified risk. For others, it is just a part of their everyday work.

The key take-homes were: 

  • Labs taking on riskier work due to increased competition in the CoVID 19 economy. Therefore, adequately addressing risk and opportunity in the tender process is increasingly critical for labs.  
  • Some risk is inherent in lab work. i.e. risk is not a bad thing per se but it is important that it is known and addressed.
  • Need to consistently account for and address known risks, expose hidden risks, and simultaneously identify opportunities.
  • The requirement to addressrisk and opportunity is aimed at ensuring test results are as reliable as possible for the customer (which is essential for lab’s viability/business). It can be addressed in a range of ways:
    • Treating all risks and opportunities through the same system, to evaluate and ultimately come up with an action plan.
    • The bottom-up approach where you follow a process through end-to-end and identify the risks that exist in the “live” process 
    • The “top-down” approach, common in larger organisations, where broad categories of risk are identified such as equipment functionality, resource availability and staff training and addressed in procedures documents.
    • Approaches such as “safety notes” for a safety risk
    • Complicated spreadsheets depending on the type of task and the level of the organisation
    • Creating a risk register and populating it with identified risks 
    • Acknowledging that the purpose of measurement uncertainty calculations is to identify major sources of error in methods.
  • Some difficulties with NATA include:
    • understanding the requirements to address opportunity & risk
    • NATA putting unreasonable requirements on labs
    • the benefits of option A or B Management systems (with B sometimes causing labs to get non-conformances even though they have identified and are addressing a shortfall in their system)
  • Common difficulties for auditors & quality managers
    • Explaining to lab management the level of risk in a certain activity. Lab management saying “it’s never happened so it will never happen”. How to clearly flag risks in audit reports.
    • Getting management buy-in for the risk assessment process. Management leaving it up to the quality manager to deal with.

The aims of the Laboratory Special Interest Group: 

  • To bring together laboratories across Australia to learn from each other on matters to do with quality and laboratory accreditation.
  • To provide a place where laboratory quality managers can openly share issues they are facing with respect to quality and accreditation.
  • To provide a setting for professional development of laboratory quality professionals through formal learning seminars with experts in various aspects of quality.

How to join the laboratory SIG 

Membership of this group is open to AOQ members only. Join AOQ for a very reasonable annual fee, then request to join the Laboratory SIG. 

If you’re already a member of AOQ and didn’t receive an invitation to the last SIG, email admin@aoq.net.au to request membership.

Creeping criteria: when auditors stray

Creeping criteria: this wonderful term was coined by my old boss at NATA (Helen Liddy) for those times we put a “condition” in an assessment report that was almost a requirement (but really an opinion on how to address a requirement), or when we had taken a criterion from one part of the accreditation documents and applied it to a completely different situation. It also referred to when we heard something from a technical assessor and applied it without looking up the standard.

Whether you work for NATA or as an internal auditor, you will almost certainly fall prey to creeping criteria from time to time. Luckily most internal auditors have their work checked by the quality manager before the audit report is issued. The same cannot be said for NATA auditors, many of whom have approval to issue assessment reports without review by another staff member.

What you need to know to successfully respond to audit and NATA reports 

To avoid wasting time on unnecessary tasks, you need to be fully across what really constitutes a requirement and what does not. You cannot rely on auditors to know every detail of how the requirements apply to your lab. 

But aren’t the auditors and NATA the experts, I hear you ask? Don’t they know?

NATA-auditorsThe truth is that auditors have a huge amount of information to deal with and process, particularly when auditing in labs they’re unfamiliar with, so sometimes they get it a little bit wrong, or even a lot wrong. It can really pay to look up the documents that they reference in the assessment/audit report to get a better idea of what they are referring to and what the real requirements actually are before responding to the report.

Here are some examples of how creeping criteria happens and the best way to respond:

Clause creep

Taking a requirement from one part of the standard and applying it to another part, or from one piece of equipment and applying it to other pieces of equipment. This real scenario happened many years ago during a NATA assessment:

Condition: Whiteout must not be used in controlled documents. Methods in the Serum Rhubarb section contain multiple examples of use of whiteout.

Clause referenced: Medical Testing FAD section 4.13.

Investigation: Clause 4.13 is about test records. It is talking about making sure that all original test data is preserved in a way that is permanent and legible. We then spoke to the lab manager concerned, who explained that she can’t stand having typos in the bench copies of test methods. She just has to fix them & doesn’t want to print them out again.

Response: Gently pointed out the reference was to test records, not controlled documents. 

Corrective action: None required. However we did update our document control procedure to define how hand-written and white-out changes to documented procedures could be accommodated.

Take-away: Always look up the requirements if a non-conformance does not make good solid sense. If we had followed through with this for controlled documents, we would have prohibited a practice that is in fact allowed.

Context creep

This happens when an auditor hears something during an audit of one laboratory and applies that to another laboratory. This can be a battle you have with staff who are technical assessors and come back from assessments and apply these criteria during internal audits. A simple example that happened to me once:

Condition: Each line in the training records must be individually dated and initialled – you can’t draw a bracket around a group of training topics and mark them with one date and initials.

Clause referenced: ISO 17025: 6.2.6 & 8.4.1

Response: We don’t see in those clauses that it says we can’t record training this way.

Auditors response: But the NATA lead auditor at the lab assessment I did last week said that they couldn’t do this. I thought it was “a thing”.

Quality manager’s response: You’re asking them to do busy work. What is the benefit for them? There’s nothing specific in the requirements to prohibit this unless you are saying it’s not clear when or what training was done because of the way they’ve recorded it?

Take-away: This may be a requirement for the other lab because of the way their system is designed, or the way they have approached their training. All non-conformances, whether raised by NATA or others, are highly influenced by context and even the questions that we asked at the time. The NATA auditor may also express thoughts during the audit that do not end up in the assessment report.

The never-ending story

Something along the lines of this scenario happens to one of our clients every now and again:

Condition: “Staff member Orange at lab G conducted testing to method One; however, records to indicate whether the staff member had been assessed for competence or authorised to conduct the testing were not available.”

Response: Sent in the training records for the whole lab (as an extract from the database, the easiest way to do it).

Auditor’s response: Thank you but there do not appear to be records to show that staff member Brown or Green have been approved to do test methods Two, Four or Seven.

Response a: Staff member Brown does not do methods Two, Four or Seven as he is mainly out on field work. Staff member Green was trained at one of the other labs – her records are in their system. Attach copies of training records for Green.

or

Response b: We have supplied the training records for staff member Orange and are unsure why you are asking for other training records which were available at the assessment. (This response is for those who are feeling assertive)

Corrective action: non required 

Root cause analysis: the lab manager didn’t know where to find the training records for staff she hadn’t trained herself. 

Take-away: Audits and assessments are finished when the audit team leaves the building (whether that be literally or figuratively). You do not have to keep answering additional questions after the assessment. 

Implied corrective action

Sometimes an auditor tells you what to do instead of what is wrong. In this case the message came through from a combination of what was discussed at the assessment and what ended up in the assessment report.

Condition: “The lab has held two meetings in the past 7 months, about 4 months apart.” (No indication of what was wrong with that.)

Clause referenced: ISO 15189 4.1.2.6 Communication (closest clause in ISO 17025 is 5.2.7a)

Laboratory management shall have an effective means for communicating with staff. Records shall be kept of items discussed in communications and meetings.

Laboratory management shall ensure that appropriate communication processes are established between the laboratory and its stakeholders and that communication takes place regarding the effectiveness of the laboratory’s pre-examination, examination and post-examination processes and quality management system.

The lab was planning to reply that they would hold lab meetings every month. This seemed to be what the auditor was asking for. The quality officer investigated:

Investigation:

  • A small lab with 4 staff members who all work day shift and infrequent changes to methods or processes. They see and speak to each other 5 days a week. There was no problem with the meeting frequency given these factors, the scope and stability of the lab.
  • The quality manual did not mention lab meetings, nor how often they should be.
  • We looked at the clause mentioned, and saw that it is about communication, not meetings per se. 
  • We discussed what communication needs the lab has other than the things they normally cover in staff meetings and how these can be recorded. Some examples include:
    • Notices
    • Read receipts for document updates

Response to NATA: Reported on our investigation and advised that current meeting frequency is sufficient for the needs of the lab. Refrained from pointing out that the condition reads like an observation. To be a condition there must be a specific example of something that is wrong.

Corrective action: Maintain informal approach to scheduling meetings as required. Keep copies of notices and read receipts in a dedicated folder.

Take-away: Always look up the original requirements if a non-conformance does not make sense for your laboratory. Don’t jump too quickly to adopt whatever the auditor seems to be suggesting!

Giving extra backbone to the requirements

Condition: The laboratory must document a procedure for addressing risks and opportunities

Clauses referenced: ISO 15189 4.14.6 or ISO 17025 8.5.

Investigation: 

  • A small lab with very limited capacity to carry out additional administrative processes.
  • Part of a larger organisation with risk management processes that can be accessed if needed. Required to consider risk when deciding on corrective action.
  • Risks have been identified and controls put in place – these are detailed in the regular data review processes, management review, internal audit program, and extensive QC checks.
  • We read through all of the clauses mentioned by the assessor and found no reference to formal risk management systems. You have to DO risk management, not write about how to do it.

Response: we can’t find any requirement for a formal risk management system in the documents referenced.

Auditor’s response: nil 

Take-away: Standards say we have to use risk based thinking and evaluate risks but they don’t say we have to have a formal system or procedure for doing this.

 

There are many similar examples, especially arising from more recent ISO 17025 assessments, which is much less prescriptive of procedures. You have DO your processes, not write so much about them. If your processes are well designed, they will be visible and easy to follow without having to write procedures for them.

Other helpful articles on dealing with audit non-conformances.

Are you wasting time and money on NATA requirements?

10 tips to avoid NATA paper warfare

How to write great SOPs and declutter systems

The art of tidying up your SOPs

When was the last time you thoroughly sorted through and updated your laboratory’s standard operating procedures? Perhaps

procedure-writing, how to write great SOPs
Procedural clutter weighing you down? It’s time to Marie Kondo your SOPs!

you have some great procedures buried in long-winded prose that should be converted into a flowchart or diagram and proudly displayed around the workplace? 

Likewise, perhaps it’s time you finally culled those overly complex multi-page procedures and instead replaced them with visually clear and useful working documents. Below are our top tips on how to write great SOPs and declutter your documents (Marie Kondo-style). 

What is an SOP?

An SOP refers to any of the routine steps staff carry out. The how-to’s, the contingency plans, the checklists. We may also call them procedures, methods or instructions. These critical documents are not just there to cover the organisation when it comes to the bare minimum of compliance, output and OHS. They exist to streamline and thus improve the way individuals and departments carry out their tasks, minimise errors, identify opportunities and communicate with each other. Not only that, when SOPs contain information that makes the procedure relevant, i.e, linking it to an overall quality outcome, staff are more autonomously engaged in continual improvement. 

Decluttering paperwork to find procedural gold for your laboratory

Just as having a tidy home free of unwanted parafernalia brings more “joy” (as the famous decluttering expert would have it), having slick, relevant, visible SOPs can bring more sanity and productivity to the workplace. 

Many labs have SOPs that were written by previous managers or years ago and have out-of-date or excessive details. Or they might have been written by a consultant who doesn’t really understand what SOPs laboratories need. These are often just “official” documents for accreditation purposes, not prominently shown around the workplace as an ever-present prompt and check on quality. Or when they are displayed, the information is poorly communicated and out-of-date, resulting in the key point of the process being lost. 

If quality systems are key to your organisation’s business model, then you can’t afford to acquire the equivalent of procedural paperwork “junk”. For an SOP to achieve its aims of ensuring service quality and staff safety, minimising risk and conflict, and boosting efficiency, they must be:

  • Frequently reviewed and updated. Organisations and accreditation requirements are frequently adapting and with them, requirements for their processes. 
  • Up-to-date 
  • Visible
  • Goal-oriented. It should be clear why a certain procedure is required 
  • Addressed to a specific team member or members

“Tidy” SOPs are critical when it comes to systemising and documenting your processes, and they improve your organisation. 

Consider the value of each SOP

While we won’t dare to recommend holding each procedure and asking yourself “it is bringing the workplace joy?”, we do suggest the systematic approach of the “KonMari method”. Take an inventory of your SOPs and really consider their relevance and quality to ensure your lab is free of distracting procedural clutter.

While it’s tempting to jump straight in and start updating those SOPs you know are out of date, some planning will lead to lasting improvements. Put your SOPs through the following tests to assess whether it’s time to make changes to them or even let them go! 

  • Is it on high rotation with front-line staff? 
  • Do staff value it? Ask if they really need and appreciate the content. 
  • Is the process described highly operator-dependent?
  • Does it describe a step-by-step process or just one aspect of a process (such as safety)
  • Does it make a complex process clear and easy to follow?
  • Does it contain key data that must be used in day-to-day testing?
  • Would bringing the procedure up-to-date be relatively simple and quick? 

Use the answers to prioritise how you spend your time. 

Plan a structure 

If you want your organisation’s SOPs  look slick (think handy visual charts), work effectively and achieve their ends, make the process  easier by planning out a structure based on your key processes. Using the process approach makes the path to decluttering SOPs so much clearer. It gives you a clear structure and a way to decide WHERE, WHEN and by WHOM each piece of information is needed.

  • Draft flowcharts of all your main processes and link ONE procedure to each step. (If there are multiple SOPs, you might have more than one process at work or you may need to combine some.)
    • This process may need to be repeated in each department or section if you’re part of a large laboratory.
  • Arrange detailed instructions and methods linked to the relevant SOPs.

Problem SOPs and what to do with them

  • The SOP is a total mess. It’s out of sequence, with an excruciating level of detail, and seems to have been written by multiple authors over time. Start again and just borrow lines from it where needed to fill in details.
  • It is a “must-have” procedure in accreditation requirements, but it’s rarely referred to. Try to deal with these in a high-level operations/ quality manual.
  • Rarely used, but important technical procedures. Write these in a good amount of detail and clearly reference them in other procedures at the point that the operator will decide they need to use the process/method.
  • SOP describes safety precautions or environmental measures only. Safety and environmental requirements for specific processes should not exist as stand-alone documents. Include the information on how to comply in the process document (SOP) at the relevant point in the process. Or even better, use official signage and provide the safety equipment at the point where the process is conducted!
  • Long wordy descriptions of times, requirements, decisions and options. See if you can extract data and put into tables that can be displayed in the laboratory.
  • Very long and wordy SOPs, with excessive amounts of detail for well-established processes. Remove obvious, superfluous or repetitious information, otherwise this detail distracts staff from the more important detail they may need to look up. Check with staff how much information they need.
  • Memo announcing a change in process issued as a controlled SOP, instruction or method. Find the SOP it belongs in and include at the correct point in that process.
  • Generic ISO9001 SOPs that, combined with all the test methods, forms, templates and quality manual, add up to an overwhelming number of pages. Get rid of the generic ISO 9001 SOPs and replace with a few lines in the quality manual, and/or add instructions to the forms.

When you’ve transformed your procedures / manuals from a huge pile of unrelated documents to a manual or set of SOPs that describes what you actually do, you’ll find it’s easier to update them when processes change and new requirements are introduced. You’ll find the internal audit program can focus on quality outcomes, rather than getting bogged down with out-of-date instructions.

Drawing on our combined experience with NATA and various fields of testing, our team has helped many laboratories to replace the proverbial “300-hundred page tome” gathering dust with 30 pages of relevant information that staff actually refer to! Contact us today for a chat about how we can help.

4 Steps to Reducing The Mental Load of Lab Managers

Following on from our previous post on the topic, here’s a step-by-step guide to show you how to implement the process approach. 

How to implement the process approach

1. Start at the top:

Getting your team to embrace the process approach starts with YOU

Do you like the sound of having more time to focus on the work you enjoy most instead of a disparate array of management responsibilities? Then it’s time to get serious about fully implementing the process-approach. 

In case you missed our last post, the process approach is a revolutionary management strategy where every single process in an organisation is frequently reviewed and given a clearly defined purpose that relates to other processes in the organisation. In other words, it guards against inertia ensuring that all of your systems are feeding into each other and working well together. 

The result? Better output, happy customers, engaged staff and business gains. But let’s rewind this scenario because none of that is going to happen without the 100 per cent commitment of one key individual at the outset. 

Managers must take the time to evaluate, review and update processes, as well as engage others in doing so. It might seem counter-intuitive , but it is a fact that the more engaged senior management is in the quality system, the more freedom they have to walk away. Why?

Cultural change begins with key decision-makers who are the link between departments, the ones to invest in training or call interdepartmental meetings.

If you are a manager, you are the figurehead who sets the tone of the organisation.

Working in competitive and rigorously-regulated fields, laboratories must find smarter ways of doing things, and doing them well. And they must do so exponentially, year on year.

In order to set your business up for long-term success and to ensure it doesn’t fall behind or stagnate, you have to bake excellence and continual improvement into all of your operations. A best-practice, business-savvy quality system won’t happen by accident or from the bottom up.

If you communicate about your organisational vision and quality system well, your staff will also communicate with each other well. It is a virtuous cycle – one that may in turn help you refine your vision and open you up to new fields of testing and service areas.

If you truly embrace the process-approach (and the powerful Plan-Do-Check-Act cycle) and embed it into every level of the organisation, continual improvement will take care of itself.

Talk to your staff in terms of processes, measures, inputs and outputs and ask for all documentation to be presented in process format. Use flowcharts to show how processes link together and engage your staff in making sure these are correct. Talk about why a process exists – what it is supposed to achieve.

Weave the process approach into the everyday, combine it with continual improvement, and your team will be on quality-system cruise control.

You’ll have staff suggesting efficiencies and pointing out risks and opportunities not just for compliance’s sake, but because they are intrinsically motivated towards continual improvement and understand the rationale behind all of your laboratory processes.

2. Take a closer look at the purpose of accreditation and recent ISO changes.

Once you have the fundamentals of the process approach and continual improvement in place you are ready to really reap the benefits of accreditation.

To understand how to go about gearing the process-approach towards long-term success for your laboratory, it helps to take a close look at new requirements around risk and opportunity.

Continual improvement and operational excellence are not just about complying with the bare minimum requirements of ISO’s increased emphasis on risk-based thinking.

By making the continual assessment of risk and opportunity central to your operations, the ISO standards are setting you up to become more efficient and competitive as a business (now and in the future). 

The fact is businesses need to remain efficient in the face of 21st century challenges such as increased competition, new technology, and higher customer expectations. The new requirements are a recognition of this. 

So bear in mind, when it comes to complying with the risk-based thinking requirement, the process-approach is your friend. Don’t be intimidated! Having a clear view of your key processes makes it so much easier to identify opportunities and risks. This is where things get exciting from a business point of view.

Managing risk effectively while always seeking opportunities will actually enable you to take risks and chase bigger goals – whether that’s for your organisation and team (moving into new service areas and fields for instance) or for you personally in your life (think more holidays, earlier retirement!).

3. Tailor how you meet requirements:

Develop your own approach to risk-based thinking for the purpose of bigger goals (not just compliance)

How strategically you meet the requirements of the new ISO standards is up to you.

Perhaps your organisation is already well within the bounds of what NATA expects you to be doing (as a bare minimum) regarding the process-approach and risk-based thinking.

But as the new standard also provides increased autonomy in the amount of  documentation you use to meet these requirements, it really is up to you how fully you embrace the opportunity. You don’t need to write long involved procedures to meet these requirements – it’s about thinking and designing in a process-orientated way and ensuring that risks and opportunities are considered and taken account of. 

Placing the process approach  at the heart of your systems with risk-based thinking will unlock a new level of freedom in your role. 

It will also provide career development and fulfillment for your staff, and this will flow back to your business, customers, and again, YOU. You’ve worked hard to get your organisation to this point. Don’t you want the peace of mind of being able to delegate and reduce your own mental clutter, and the freedom to grow or sell your business if you desire?

4. Make yourself more-or-less replaceable.

(Your business will flourish!)

One of the key purposes of having a defined quality system is that it doesn’t depend on just one person.

Instead of holding all the pieces of the puzzle, unable to step aside in case it all falls apart, ensure the processes that make up your laboratory slot together without constant oversight.

With a manager-led improvement culture (based on the process approach), your quality system will become highly-valued by your team.

Silos between departments will be broken down, ensuring everyone is continually kept on the same page about organisational processes.

Your quality system then becomes a dynamic, defining and tangible part of your organisation, not just words in a quality manual. That way you can leave the organisation in the safe hands of your staff and your system, and maybe even take that long overdue email-free holiday?

Here’s those details again in a printable PDF for those of you who like visual reminders. Click here for a downloadable copy.


Get support

We help managers and teams implement all of the above and more. The time involved in establishing the process-approach throughout your organisation is often less than managers expect. However, without a dedicated day or team member to do this critical work, the day-to-day takes over and plans for improvement are shelved.

Check out our courses and consulting services below if you or your staff require extra facilitation to implement the process approach and improve your quality system.

Transition with Confidence

The Best-Practice Internal Audit Program Your Lab Needs

Or sign up to our email list for regular tips and insights about how to ensure your accreditation is serving your business goals.

Tools and Tips for NATA-Ready Cause Analysis 

How to get root cause analysis right for NATA

We allSuccessful NATA Response love that feeling when NATA accepts our first response to an assessment report! But since NATA introduced their new reporting format, we’re seeing NATA reject many responses from labs because they haven’t included an adequate root cause analysis.

If you’re struggling to understand what NATA expects for cause analysis, you are not alone.

The new reporting format, introduced in February this year, requires a detailed root cause analysis for any non-conformity. This is a good thing because without an adequate root cause analysis the same issues crop up again and again. But many labs are stumped as to how to get root-cause analysis right for NATA and the betterment of their quality system.

NATA tells us that some labs are just skipping this section and submitting responses with NO cause analysis at all. These responses are automatically rejected by NATA and will lead to an extra round of correspondence

Meanwhile, those that do fill it out, even labs accredited for many years, are often failing to identify the root cause of an issue raised by NATA. So what is NATA looking for in this section of the non-conformance report? Here’s some root cause analysis tools and tips that will help you please NATA, while also improving your quality system.

1. Tell the truth 

You don’t have to have some amazing technological problem that caused the issue they found. It could be that the person simply did not know they were supposed to do a particular step and the root cause would then be “ lack of training”, “poor work instructions”, or “lack of communications about changes introduced while staff away on holidays”. Or in some cases, it could simply be human error. Whatever the cause, put it plainly. There is no need to window-dress what happened. 

Often the issues identified by NATA are potential problems, i.e. someone COULD get in and inadvertently change some test results. So your root cause analysis for this might say that you did not think the risk of that happening was high enough to address the issue previously. Or you might say that you had overlooked this risk when you designed the process.

Another common cause for non-conformity is when new requirements are put out by standards-writing bodies or regulators. Be honest and explicit – write; “had not updated the system to new regulatory requirement” or “was unaware of new regulatory requirement”. These are root causes that you can address effectively and simply, through your internal audit program for example.

2. Make sure the answer is something that can be addressed

There’s no point telling NATA that the root cause of everything was “human error”, even if human error played a part. To err is human, and we can’t have full control over that. Focus your investigation on the PROCESS and see what could be changed to make it easier to get it right every time. Fixes for human error generally fall into categories such as adding checklists, extra checks, removing the step from the process, incorporating automation, etc.

If you can’t think of a possible fix for the root cause, it’s probably not worth documenting.

3. As many causes as necessary

Most of us know that when something REALLY goes wrong, there are multiple steps that have failed. Even in the most straight-forward laboratory processes, there are always checks in place that will pick up errors. So at least one step, plus the checking step must have failed for an error to occur.

4. Use these tools to help you

If you’re really stuck, there are some tools that provide a structure for doing a root cause analysis. Here’s our top 3:

1.  The 5 Whys

Simply asking why until you get to a cause that can be fixed is often all that’s needed. Five Whys is a questioning technique used to highlight the cause-and-effect relationships leading to a particular problem. The goal of the technique is to determine the root cause of a defect or problem by progressively repeating the question “Why?”. Each answer provides the basis for the next question. Here’s a simple example:

Often you will identify several possible causes and perform Five Whys on each of those causes. And of course you may end up asking fewer or more than five questions!

2. Fishbone analysis

A cause-and-effect diagram that resembles a fish’s skeleton. This visual tool helps managers pinpoint the reasons for imperfections, variations, defects, or failures. The problem is at the head and the causes for the problem feed into the spine leading to the head. This illustrates point 3 above about multiple causes leading to an error. 

3. Flowcharting

When you can’t identify a particular cause, flowcharting the process can be a good place to start. By flowcharting the complete process involved in the non-conformance, you can pinpoint where the weak points in the process could be (this can be at more than one point). You then identify who has involvement at each step and all the inputs. Often, just creating this flowchart will be enough to inform management of the problems with the process and clarify what needs to be tightened up.

With all of the approaches and tools outlined above, keep in mind that the purpose of a root cause analysis is to minimise the probability of an issue occurring again. It is an important process aimed at getting to the bottom of problems, safeguarding quality and creating a more reliable and efficient laboratory. 

 

From busy to business-mastery

Process approach

Why all lab managers should fully embrace the process approach outlined in ISO17025, ISO9001 and ISO15189

No email-free holiday in years? Scared to take a day off? Alarm bells should be ringing.

It may be the last thing you want to hear, but if you are overworked, always too busy or want bigger things for your laboratory business, there is one thing you really need to start doing. Now.

To reduce the risk and burden of one person holding too much responsibility in your organisation, you need to fully embrace the process approach.

You know the term well. It pops up all through ISO 17025 and 9001 but perhaps you’re not too sure what it means? It’s more than just quality-compliance jargon. It’s a piece of quality wisdom that will help you spread the load of leadership in your organisation.

It’s your ticket to greater freedom in your management role.

Freedom to think big, but also freedom to take a break or step aside.

Pay-off for pro-active managers

In many years helping labs design, tweak and implement optimal quality systems that meet (and exceed) NATA’s expectations, I have seen first-hand that a bit of lifting early on has a surprisingly big-pay off later.

The trouble is, managers often don’t believe what is possible or don’t know where to start with what may seem like big or difficult changes. As a result, they unconsciously hold on to knowledge that should be shared.

Starting with a proven strategy for improvement – the process approach – will help you get the ball rolling. You’ll begin to move towards new possibilities you previously couldn’t see on the horizon. Not least – freedom to take a solid break!

The process approach in a nutshell

The process approach is a management strategy in which managers decide on, “manage and control the processes that make up their organisations, the interactions between these processes, and the inputs and outputs that tie these processes together.” (The Process Approach, Praxiom Research Group)

This means every process has a reason behind it and no process occurs in isolation to the whole, or without being reviewed. Learning how to see your laboratory business as a series of processes instead of a series of departments, people or isolated tasks is liberating. It becomes easy to see what is happening and how to measure the success of it.

A process diagram for a laboratory looks something like this:Process-Approach-ISO 17025

The inputs to the whole process are user requirements, and the outputs are customer satisfaction. Each step in this process can also be treated as a separate process, and measures put in place to make sure they are working effectively. When aligned with the organisation’s vision and communicated effectively to staff, the process approach boosts staff engagement and performance by giving your staff more responsibility and more opportunity for recognition.

This enhances intrinsic motivation and initiative among staff, making you a happy and proud manager who is free to walk away and take a break.

Tip: Many managers get into a habit of holding important information in their heads or just not adequately training up other senior staff to take over the reins. This is both a business risk and an unnecessary burden on you.

Stay tuned for our follow-up post on this topic : 4 Steps to Reducing Reliance on Constant Management Oversight

Check out our courses and consulting services below if you or your staff require extra facilitation to implement the process-approach and improve your quality system.

Transition with Confidence

The Best-Practice Internal Audit Program Your Lab Needs

Or sign up to our email list for regular tips and insights about how to get the most out of your accreditation.