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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Many labs have SOPs that were written by previous managers or years ago and have out-of-date or excessive details.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 Or when they are displayed, the information is poorly communicated and out-of-date, resulting in the key point of the process being lost.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.

Designed to benefit: Risks & Opportunities in ISO 17025

A good system recognises the strategic benefit of minimising risk and maximising opportunity.

The new ISO/EIC 17025: 2017 standard puts extra emphasis on this by promoting risk-based thinking, preventive action and process design. It is about optimising your organisation’s overall strategy by planning, taking, and recording actions that prevent risk and enhance opportunity.

There is no need for a formal risk assessment process (although these can be very useful and even fun to do). The implication is that your system will alert you to risks and opportunities because it will be based on a proactive, risk-based approach embedded into your operations.

It’s a balancing act

Risk and opportunity is not an either or thing  – you are weighing both all of the time as one usually corresponds with the other. If I avoid x I will attain y. If I attain y I will avoid x. Likewise, assessing risk in the context of a laboratory must be viewed with the organisation’s overall strategy in mind.

The concept in the new requirement (clause 8.5.1) about action on risks and opportunity comes from ISO 9001:2016, which has a strong customer focus. ISO 17025 and ISO 15189 are standards written by laboratory people experienced in what can go wrong. They are designed to ensure that testing-related risks are managed, including business risks such as reputational damage. By complying with these international standards and having accreditation, you are addressing all the areas of risk (and opportunity) for a testing service.

To give you an idea of some relevant risks and opportunities, below is an example of factors that would need to be assessed by senior management if you received a request to do on-site testing for the first time. As you will see, many of these are interrelated and require consideration of the bigger picture.

These are just some of the risks and opportunities that might typically be identified before embarking on a new area of testing. Once these have been identified, measures will be put in place to manage, revisit and continue to identify risks and opportunities going forward.

It is likely that your laboratory is already employing actions stipulated by the new standard. But how do you demonstrate to NATA that you have addressed the new requirement (clause 8.5.1) for action to be taken on risks and opportunities, and if your system needs updating to meet the requirement, how extensive an overhaul does it need and what are some approaches to take? Below, we’ve outlined three ways that we’ve seen laboratories address the “new” requirement in ISO 17025 and (not-so-new) in ISO 15189:

1. Explain how you already control risks

Include a section in the quality manual outlining the measures already in place to manage known risks and to identify new or unidentified risks. Bear in mind that any risks and opportunities identified through these processes must have corresponding records to show what decisions were made about actions to address these.

A laboratory within a larger organisation may find this is enough, as bigger picture risks will be handled by the company.

2. SWOT analysis

Many of our clients run their own SMEs and a SWOT analysis every couple of years and find them to be useful tools that ensure they have taken some time to think outside the square about risks and opportunities. They may then decide to put some of them on the agenda of their management review meetings. This way they do get followed up periodically, and perhaps incorporated into plans for business growth. The important thing to bear in mind with a SWOT analysis is that it is a creative task that works best when you do it quickly, preferably under some time pressure.

The SWOT analysis ties into the ISO 9001 theme of identifying external (as well as internal) factors when considering the context of the organisation. Other useful tools include PEST and PESTLE, which provide more prompts for where the opportunities or risks may lie.

3. Formal risk assessment

Some (usually larger) organisations who are introducing new tests all the time find doing a risk assessment for each new technique or test introduced is a reliable way to ensure they don’t head down a path that is only going to waste time and money. These risk assessments need to cover all conceivable risks, not just safety. If you have to produce a business case for the new tests, much of the information will overlap. Although this may sound like a huge task, once you’ve done one, the others will be much quicker, and if you are using established systems, many of the risks will already be controlled.

How to make sure you’ve got everything covered? Use the headings from the laboratory accreditation standard of course!

Take-home message

The key to all of this is to have records of what action you have decided to take on any risks and opportunities identified, and ultimately how well you did in controlling that risk. Does this sound a bit like a corrective action report (or your equivalent)? Do you have a form where you record staff suggestions too?

We know some labs that use these types of reports to cover off on any actions arising out of management reviews – that way they don’t have multiple systems to keep track of things and their NCA, CAR, OPPI, FROG, FART or MAD system gets a good work-out.

Review how you are currently running your business in terms of managing risks and opportunities and you might find you don’t need to implement anything new, or you might just need to tweak a current process here or there.

Reporting Compliance in ISO 17025

Do you report results as pass or fail on test reports? As normal, high or low? Within spec, outside spec, complying or not complying? Would your clients like you to report with a statement of conformity? Then you need to know about decision rules in the new ISO 17025.

While you have utmost confidence in your laboratory’s test results, no test result is exact: there is always a band of uncertainty around it.  If the result is close to the limit do you really know if it passes or fails when you consider the band of uncertainty? Is this a decision or risk you are willing to take?

Uncertainty of Acceptance

The drawing shows

  • The tolerance limits: allowable results, normal range, standard specification, etc. Any result within this range is acceptable to the customer.
  • Four possible laboratory results  obtained, with the 95% confidence intervals shown.

decision-rules-iso-17025

We need a way of deciding if we will report the results as pass, fail, or even indeterminate.

The old approach

Using a standard decision rule that the results will be reported as pass or fail based on the numerical result, with 95% certainty:

A can be reported as a pass with a 95% confidence interval.

B can be reported as a fail, or above spec with a 95% confidence interval.

C can be reported as a pass, with a 95% confidence interval.

D can be reported as a fail, or below spec with a 95% confidence interval.

The new approach

The revised ISO/IEC 17025 uses the term “decision rule”and emphasises the need to communicate clearly with your clients about the strengths and limitations of the testing (clause 7.1.3) and to formally document decision rules (clause  7.8.6).

It might be more relevant to explain to your clients that:

A is a pass with a 95 or even 99% confidence interval.

B there is only 60% certainty that B is a fail, 20% of products that get this result could pass.

C There is a 2.5% chance that C is a fail.

D can be reported as a fail, or below spec with a 95 or 99% confidence interval.

Then you can discuss setting “grey zones” where results may be reported with additional comments to highlight that they fall close to the cut-off.

How you handle this depends on a range of factors, including the industry your clients are in, the uncertainty inherent in your method, the regulatory environment, the cost of false passes or fails to you and your clients and perceptions of risk.

Do we need a decision rule?

Before you get into the details, there is an easy and safe way out:  Don’t report pass or fail and let the client make the decision. You could report the tolerance and specification alongside the results to help the client make the decision, and reduce your risk in taking that final decision.

reporting-compliance-iso-17025

Developing a decision rule

Go to your client/s armed with some facts and thoughts on the following:

  • How big is the band of uncertainty? (i.e. what is the uncertainty of measurement). How does this compare to the tolerance?  Is that overlap in the band of uncertainty and tolerance likely to occur regularly?
  • Is it more important for the property to not exceed the limit or to fall below it? Or does it really need to hit the mark?
  • When you talk in terms of probability of a false positive/pass/accept versus probability of a false negative/fail/reject, how does you client see it?
  • Can they place a cost or risk assessment on the value of false passes or false fails?

You’ll get some other ideas by searching the internet with the following search phrases:

Accuracy Method

Consumer’s Risk

Shared Risk

Global Risk

Producer’s Risk

Guard Bands

Reporting compliance statements

If you are reporting compliance or non-compliance, make sure the reports are clear about exactly what you are passing or failing. The report also needs to clearly state:

  • Which results the statement of conformity applies to
  • Which specification/standard is met / not met
  • The decision rule applied (unless it is part of the specification/standard)

Examples of Decision Rules

The PME Services Decision Rule

The IKEA Test Laboratory Decision Rule

WADA Decision Rules

While these examples make interesting reading, you must get agreement from your customers for the decision rule/s you select. If you have significant customers, I would suggest conferring with them and getting their agreement before publishing a blanket rule on your website.

Useful Resources

An accessible and informative webinar put together by Fluke

NATA’s slide set on the new standard: look at slides 43-48.

EUROLAB’s Cook Book No.8 Determination of Conformance with Specifications

OIML Guide 19 on conformity assessment decisions in legal metrology

Addressing impartiality in the new ISO 17025

On-the-road-to-reliable-results
Get help with ISO 17025 transition

A guest post from Karen Moore, originally posted on LinkedIn August 2018

The ISO 17025:2017 has a bigger emphasis on impartiality and managing conflicts of interest. How do you plan to address these issues in a way that you can discuss with NATA? If you’re like most lab managers, this is a difficult subject to talk about, and just saying “they wouldn’t dare” may not cut it. Read on to find out some of the methods that labs use to manage these issues.

It’s also a reality that some of the practices in the construction industry aren’t ideal and it can be a difficult environment for testers. There’s pressure from clients, overbearing contractors or even internal management for the “right” test results. And similar pressures exist in many other sectors too.

Situations of undue influence, 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 potentially have criminal implications.

So, what can be done to protect the reputation and integrity of your business?

Identify what situations could arise in your organisation and write them down.  Think broadly and while many situations may seem unlikely it is still useful to get them out there.

Risks to impartiality

1.      Testing for compliance on an in-house product – what if the test result shows non-compliance, especially if the tester also has production responsibilities?

2.      Getting on site and being given a limited available area for testing, or an overbearing site manager who just insists testing is done at a specific location.

3.      Being pressured onsite to give a pass result, repeat the test, probably with instruction for a slightly different location.

4.      Conflicts of interest due to shareholdings, family relationships, etc.

5.      Under-pricing jobs, putting time pressures on staff while allowing full processes to be completed.

6.      Details in contracts or requests for testing that present a risk to your laboratory: site selection; financial penalties for delays in construction; methods specified not not match the materials

Now that these have been identified, read on to find out what can be done to reduce or eliminate these risks or find out how we can help.

6 ways to reduce risk of impartiality effecting reliability of test results

1.      Technology

  • Direct capture of test data in the lab – for example newer balances and load cells can be hooked up to a computer and directly record readings, also eliminating the risk of transcription errors.
  • Directly logging data in the field into a tablet.
  • Is automation an option? – Explore any possibilities, as they will likely improve you process efficiencies at the same time

These steps don’t necessarily need one of the off the shelf expensive software packages.  An in-house system that captures the on-site or lab data and stores this in a secure way so there is no question on the integrity of the data can also be an option.

Are there other technical advances in equipment that would allow for further automation that the industry could look at? Can your lab be a leader in introducing this? What an opportunity!

2.      Training and education

Make sure your staff know the implications of the test results. What happens if a structure fails and it is found that testing was not accurate? What if your product gets on site and is found to be non-compliant? The implications of finding failure at this point are massive! If a failure is identified and dealt with immediately, any short-term pain dealing with someone who doesn’t want the true result is negligible by comparison.

Let your staff know what to do if they experience pressure to change results, or less obvious pressure such as to test at a specific location. Who should they report this to? When should they stop testing and leave the site? Look at formally incorporating these policies into your training program.

3.      Organisational structure and reporting lines

Review the structure and reporting lines: look for potential conflicts of interest (such as results being used internally). This is common for production related organisations but also those involved in design engineering. Where possible, removing direct reporting lines such as the laboratory technician or manager reporting directly to the Production Manager or Design Engineer. It may be an option to look at alternate reporting lines for different aspects of a position for smaller organisations.

4.      Checking the data

An independent review of results introduces a level of impartiality as well as the benefits of a fresh set of eyes for errors. If work is being done remotely on a site lab, perhaps introducing back to base reporting will reduce any undue pressure on the technicians on-site as well?

5.      Contract review

Technical review of contracts is important. Many clients want to minimise testing costs for what is 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 (see point 6 above for a couple of examples).

6.      Quality Culture

This comes from Top Management and installing a culture of openness, honesty and integrity goes a long way. Make sure employees know that they can speak up if they don’t feel something is right without the worry of some form of repercussion. No specific system can cover this, it is something that needs to be lived and breathed through the organisation at all levels.

Having a quality system that is integrated with the day to day work is an important part of this: encouraging non-conformances to be raised or renaming them to reflect a positive change approach can help; highlighting the benefits of processes such as internal audits are just some examples of how you can help instil a culture of quality within your organisation.

Getting help

We have been giving guidance on dealing with impartiality and other changes to ISO 17025. Get more details here or contact us via our contact page.

The 4 Big Benefits of NATA Accreditation

 

As business-owners, we must always think long-term and resist the tendency to be forever caught up in day-to-day demands. “A stitch in time saves nine” goes the old saying. This could not be more true than it is for laboratories offering quality-assured services, and vying for client trust in competitive markets.

benefits of NATA accreditation

There is no better way to ensure you are getting the most out of your lab and not wasting time and money in the long-term than to invest in the benefits of NATA accreditation.

Here’s why you should get your systems sorted:

1. Feedback

Knowledge is Power

You need to know what is working and what is not in order to have confidence in your processes. But often we are too enmeshed in our own organisation and work to be objective, and no matter how professional we think we are, we all need that ‘second pair of eyes’. NATA’s independent peer review provides your lab with detailed feedback according to the most up-to-date checks on the competence and reliability of your testing, calibration, or inspection services.

A nudge in the right direction

By going through the accreditation process, you can be certain of how your lab’s quality assurance systems perform against others. Then, if change is needed, you can direct time, resources and money into necessary improvements. At the same time, you will avoid wasting time on unnecessary reviews in areas that NATA confirms comply with its standards. NATA’s feedback not only ensures you comply with standards but can lead to fundamental improvements in how you run your laboratory and business. Especially, in many cases, when you get support dealing with NATA.

2. Expert Advice

The money and time you spend going through NATA’s accreditation process is a win-win. Whether or not your lab complies with NATA standards, NATA’s technical advisors will advise you as to where to make changes in order to pass the final assessment. Even if you were to fail, which does happen in some cases but is less likely if you get support, you have gained expert guidance on what steps to take next. This is gold for the systems & processes in your organisation. NATA takes a constructive approach and is clear with applicants. But if you need help putting their advice into place and communicating points of disagreement, O’Dwyer Accreditation can help ensure you pass the final assessment.

3. Business boost

As well as giving you and your staff a feeling of pride that your lab is providing services of the highest standard, a successful NATA assessment also gives you a marketing edge. You can enhance your credibility by advertising that you are NATA-accredited and using the logo on your website. Even if accreditation is not a regulatory requirement in your industry, NATA’s stamp of approval may enable you to raise your prices or gain access to international markets (NATA accreditation is recognised and accepted globally).

Public and private sector organisations increasingly require accreditation credentials, with so many benefits to the public across the supply chain, from fishing to forestry, transport to technology, construction to communications. Ensure your business is accredited before the market or industry demands it. NATA offers accreditation in a wide variety of areas – not all of them are traditional testing. If you need help making sure your business is reaping the financial benefits of NATA accreditation, contact us today.

4. Foundation for growth

Setting up the right management system for your business lays the foundations for continued success into the future. It means that when your business grows you have the frameworks in place to manage that growth in a way that maintains the highest quality standards. Recently a client in this situation said to me; “I wouldn’t have a business now if it wasn’t for NATA accreditation. The NATA assessment process taught us the importance of having systems: defined ways of doing our work. This meant that, as our business grew it was easier to train new staff, delegate tasks and to be confident that everything was running efficiently.”

For further information on how to leverage the benefits of accreditation into the future visit our ongoing support page.

 

 

 

 

 

 

 

 

 

 

Five steps to implement new accreditation requirements

Easy-accreditation-requirements

Wondering when you will get time to deal with all those new accreditation requirements?

You’ve been notified of new standards, guidelines, or regulations that need to be implemented. It’s time to get busy writing new procedures, right?  Jumping in without enough thought and preparation leads to woolly procedures, written solely to meet requirements, that clutter up your document system.  And they are not much fun to audit against or keep up-to-date either!

Approach new requirements documents with caution and your own quality system with curiosity. Just because a requirement is new doesn’t mean your lab is not already meeting it.

Follow these simple steps to keep your system on track without creating unnecessary procedures.

  1. Identify the new requirements – depending on who has issued them, this may be simple or very tedious.
  2. Do a GAP analysis of your current systems against the new requirements. Look for evidence of compliance. This where the curiosity comes in.
  3. Be analytical: Identify any gaps in processes and document them without deciding how to address them. Talk to NATA if necessary to find out the intent of any clauses that are confusing.
  4. Consult: Get together with your management team to agree if the gaps are really there and discuss conservative ways to address them.
  5. Plan: Make a plan and tackle it one step at a time.

When you review your own quality system, you can tend to see holes everywhere, and go too far writing new procedures to meet new requirements. O’Dwyer Accreditation can help you implement new accreditation requirements without getting tangled in unnecessary red tape.
Contact us now for a quote.

Behind the scenes: how our clients make the world a safer place

With World Accreditation Day highlighting the theme of safety this year, we want to celebrate the incredible work our clients are doing behind the scenes. From ensuring the reliability of rail infrastructure to safeguarding food production, these businesses remind us what accreditation is all about.

As an accreditation specialist, it’s no surprise that I have developed a portfolio of specialists as my clients. I am often struck by the fact that these specialists are keeping us safe in ways that most of us are not even aware of.

On the road

Did you know that there are sensors that detect light levels and adjust the light at tunnel entrances so that you don’t slow down as you approach and cause traffic problems?  Or that traffic lights are tested to make sure that when the sun shines on them they don’t appear to be on when they’re actually not?  There are some very special people at Steve Jenkins & Associates who do this and a whole array of other tests involving photometric measurements. Having accreditation means that we can all be sure that SJ&A don’t just get to have fun using their physics knowledge at work, but produce results that are reliable, meaningful and can be used by other scientists and engineers to ensure our safety.

Oil & gas, food and chemical processing

Whether it’s medical and industrial gases, steam, milk, petroleum or grain being processed, valves are used to control the flow and provide pressure release in the case of dangerous pressure build-up. In every application the valve design, trim and construction must suit the fluid in the pipelines, both chemically and physically. The valve must also be able to withstand certain pressures, and release at the correct pressure if a safety valve. Valve Services have been repairing, refurbishing and testing valves for 20 years and have become the authority on valves for many manufacturers as their own technical workforce is diminished. With accreditation of their valve testing service in the mix, we know that as well as being gurus on process automation, safety and stop valves, their results are reliable and traceable to international standards.

Transport upgrades

In Victoria right now, there are infrastructure projects at every turn: level crossing removal projects, metro tunnel, freeway upgrades for the Monash, Ring Road and Tullamarine, and countless other road projects. We are getting used to seeing asphalt trucks, cranes and rollers on our daily commutes.  Have you ever wondered how all this work is happening at such pace and can still be safe for us to use?  Thankfully we have accredited organisations such as Pearce Geotech who are testing the materials and construction processes as they are completed to provide regulatory authorities and engineers reliable test results.  They test aggregate, soil and rock and conduct site investigations during the design phase to help engineers build the road correctly.  They even check to see if those rollers have compacted the road to the right degree. An important part of their role is knowing how to select samples that are representative of the whole batch (of aggregate, soil, asphalt). All these activities are accredited so both we can all be sure that their test results are meaningful and accepted by a range of regulatory authorities.

Food safety

There’s something special about agronomists. They’re proud of the work they do to ensure a reliable and safe food supply to our growing population and they’ve got their feet firmly on the ground. When you eat fresh fruit and vegetables, you expect that there’s nothing harmful on the food. The agronomists at Kalyx Australia run field trials to ensure that the food we eat doesn’t contain residues of the pesticides used during their cultivation. Kalyx has sites in farming districts all over Australia where they trial new pesticide applications to be registered with the Australian Pesticides & Veterinary Medicines Authority.  From locating suitable sites, praying for rain, to sowing the seed and harvesting the crop, they treat these trials like they are their babies.  They check in on them regularly, delight in seeing new growth and do all they can to promote healthy development. Their GLP accreditation means we know the trials have been run according to international standards and the results will be accepted in Australia and internationally.

While their highly-specialised work is largely hidden from the spotlight, these businesses make a crucial contribution in maintaining the highest standards of testing and safety. It is a pleasure to support them in attaining and keeping the stamp of world-recognised NATA accreditation.