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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 quality 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 follow-up 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 audit 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 to far writing new procedures to meet new requirements. O’Dwyer Accreditation can help you implement new accreditation requirements without getting you 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.

AS/NZS ISO 17025:2018 is here!  Now what?

SAI Global has just released the 2018 version of AS/NZS ISO 17025 the updated laboratory accreditation standard, and NATA has finally explained how they will approach the implementation. So it’s time to start thinking about how you will approach the changes.

AS/NZS ISO 17025
What you need to know about the new version of AS/NZS ISO 17025

What you need to know.

(No time? Jump straight to our five steps to compliance).

The changes made to ISO 17025 are designed to:

  • promote increased confidence in the results your laboratory is producing,
  • to facilitate improved cooperation across international borders, and between laboratories and other related bodies.
  • to make the standard more flexible and easier to work with (which means less paperwork in some cases!)

The new standard reflects the latest approach in quality systems, which presumes that risk-based thinking must inform our decision-making.

ISO says:
“The main changes compared to the previous edition are as follows:

  • the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;
  • there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;
  • a definition of “laboratory” has been added”.

So far so good, and no need for any urgent action.

In their December 2017 Update, NATA gave us their take on the main changes to the standard.  Their list of 11 points included the following four that might require action:

  • greater emphasis on impartiality, risks and opportunities
  • requirements covering information technology and the validation of such systems have been included
  • the term ‘decision rules’ has been introduced in relation to pass/fail results for statements of conformity
    –   how MU is to be considered when making such statements
  • two management system options
    –   Option A = comply with the management system requirements as covered
    –   Option B = adoption of an ISO 9001 system”

The significant changes.

  1. Impartiality: The extra detail in the 2018 version means that some labs may need to explain more clearly how they manage this risk and what they do to monitor it on a regular basis (clause 4.1).
  2. Pass/fail testing: It’s clearer how to handle MU when testing to determine conformity with a specification (clause 7.8.6). This will save some arguments at assessments.
  3. LIMS: the standard now outlines what you need to do to manage risk with respect to IT systems (clause 7.11).
  4. Risks and opportunities: You need to show how you are considering risks & opportunities in your quality management system. This may require a tweak to your management review process and/or corrective action process (clause 8.5).
  5. ISO 9001: If you have certification to the quality system standard, you can opt for NATA to accept that your quality system is in place and concentrate on the technical part of the assessment (clause 8.1, Options A & B).
  6. Procedures: Many of the clauses look very similar to the previous version, but there are fewer mentions of procedures.  If your processes are working, or the clause is not relevant to your laboratory, you might be able to reduce the number of written procedures that you have.

What about NATA’s Transition Policy?

NATA have sent out a 17-page document that you must complete and return to them.  Reading through it, you might get the impression that you have to do something to address each point in the table provided. This is wrong. You need to examine your current policies, procedures and practices to see if you need to change anything to meet these new or re-worded requirements.

I would expect that many labs will need to do something to address points 1-4 above.  Most Australian laboratories will already meet the remaining changes that NATA has identified or will do so with small changes to the quality system.

NATA’s roll-out plan for AS/NZS ISO 17025

NATA will assess each laboratory to the new standard as their assessments come up. This includes surveillance visits.  Unless you have some pressing reason to gain accreditation to the new standard, you have some time to work on adapting your quality system.

What you need to do: 

Five steps to compliance with AS/NZS ISO 17025:2018

  1. Buy a copy of the new standard here.
  2. Have a look through NATA’s ISO/IEC 17025:2017 Transition Policy and use the final column of the transition worksheet to record the policies, procedures and practices you currently have in place that may meet the intent of the clause.
  3. Decide whether you need to change what you are doing now. Be conservative about making too many changes – you will already have processes in place to meet many of the new requirements (see Risk & Opportunities below).  Avoid putting something in place just to meet the new standard, unless you can see how it will benefit your business.
  4. Check the wording of AS/NZS ISO 17025 carefully to see if you need to write procedures to support your new process.
  5. Start making the changes and try to have them completed before your next NATA assessment / surveillance visit.  Keep a copy of the transition worksheet for your reference.

If you are ready for a major revamp of your quality system, take the next step: do a full gap analysis against the new standard and determine which procedures you can retire.

Risk & opportunities: Tweaks only

Looking at the new section in AS/NZS ISO 17025 titled, ‘actions to address risks and opportunities’ this might seem like a big change, requiring yet another new process. On a closer examination there is actually no need for a formal risk assessment process.

You are very likely already doing activities that could be used to demonstrate compliance. Such as:

  • a rolling internal audit schedule that focuses on areas that present greatest risk to your business
  • as part of accepting new work, you consider:
    –   is the information from your client clear enough?
    –   are there any conflicts of interest or other things that need to be considered to protect your integrity?
    –   Is there the potential for further opportunities to work with the client?
  • When reviewing any changes to the volume/type of work as part of your management review process, you look at:
    –   what risks there are to your business
    –   what resources you may need to look at to minimise any risks and maximise opportunities.

So, consider how you are currently running your business in terms of risk and you might find you don’t need to implement anything new. Or you might just need to tweak a current process here and there.

If you would like some help reviewing your quality management system against the new standard or need advice on how you can meaningfully fill any gaps in your systems contact us now.

Bullet-proof your laboratory accreditation

 

Keeping your laboratory accreditation (& business) safe

Good laboratory quality systems do more than just cover the things that NATA expects to see. They also support the laboratory management to make the right decisions.  

Whether you have laboratory accreditation, GLP or ISO 9001 certification, consider these key practices, which well-run organisations use to protect their accreditation status and their business: 

 

Say no. Decline work when it is not right (too much, too little, wrong type, wrong client, wrong time)

 

Prepare staff. Train your team thoroughly before sending them out on their own

 

Fill gaps. Replace departing staff members promptly

 

Keep a full team. Back-fill for staff members on extended leave. 

 

Price check. Review prices regularly.

 

Ideal clients. Cultivate ideal clients through suitable marketing

 

NATA know-how. Know the accreditation requirements and how you are meeting them

 

Stick to a system. Have a system in place and follow it

 

Testing expertise. Understand the science and measurement trace-ability behind the tests you do

 

Take stock. Regularly review operations, make decisions and follow through

 

Manage change. Plan changes thoroughly, involving all stakeholders

 

Apply feedback. Use incidents and complaints and internal audits to improve systems

 

Organisations that stick to these practices have happy employees who know they are in a secure, supportive job.  Staff know they will be given the time to learn before they have to do a task, and that there is always someone there who knows more than they do.

Celebrating success in lab accreditationSo when NATA comes visiting, these staff members may be nervous but not afraid.  They will be looking forward to showing the laboratory operations to the NATA assessment team and hoping that all their hard work will be obvious.  The discussions with NATA will be engaging and open, and disagreements handled without animosity.

Keep these practices up so you can celebrate after your next laboratory accreditation assessment.

 

Laboratory quality systems can help

Most of these issues are alluded to in ISO 17025, especially under “Management Review”.  But many labs with long-term NATA accreditation are just going through the motions to tick off on management review rather than finding ways to use these criteria constructively.  Unfortunately, NATA is often not in a position to really push labs on the fundamentals that underlie good laboratory management, until it is too late.

O’Dwyer Accreditation can review your laboratory quality system and help you to identify the risks to be addressed. We provide practical, experience-based advice. Contact us today.

 

 

How Safe is Your NATA Accreditation?

Danger ahead: warning signs for NATA Accredited Labs

NATA accreditation safe or at risk?

 

When a lab has their NATA accreditation suspended, it usually comes as a huge shock. But there are warning signs for poor assessment outcomes. You can determine whether there are issues that you should address before NATA arrives.

These are some of the red flags noticable in laboratories that go on to have a poor assessment outcome or have their accreditation suspended:

Senior technical staff have left and not been replaced.

The laboratory is chronically short-staffed . This may be due to illness or other unavoidable factors.

Business has expanded but staff-training and resources are lagging.  No time to train the front-line staff and update resources for quality management and internal audits.

Lots of phone calls from customers.

Technical problems that everyone is aware of remain in the lab.

Staff  members are putting off internal audits due to busy schedules.

New NATA accreditation requirements, but keep delaying working out how they apply to them.

Quality-assurance systems spread too thinly: NATA accreditation covers many different labs, some of which managers have never seen. In some cases, they haven’t even met the staff members.

Nobody knows where to find a copy of the last NATA assessment/surveillance report.

Last but not least – if you have had the same NATA lead assessor for many years and now a new one is headed your way.

No one of these problems alone spells doom for your accreditation. But if you are saying “yes” to two or more of them, this is a warning sign that you need to slow right down and take stock.

How to protect your NATA accreditation 

Take stock and review

Some labs are caught off guard by a sudden suspension of their accreditation. Others may have had a fair idea that things were rough around the edges and were just hoping for the best. There are things you can do to avoid both of these scenarios and protect your accreditation status.

If you think your laboratory may have a problem, take stock of your whole organisation (the accredited part at least).  The Management Review clause in ISO17025, ISO15189, and most other “quality” standards is the best place to start.  It covers all key aspects of a laboratory quality system. Add in financial indicators and you should have a full review of your operation.  Don’t just make up things to put under each category. Do try to include any relevant information that you can think of. And remember to record what is going well.

Decide which items you need to action and develop plans for each one.  Don’t aim too high – you need a good enough system, not a perfect one. Keep the bigger picture in mind. Being too narrow in your focus could waste valuable time. Start with the things that are clear technical problems, affecting the validity of your test results.

Implement changes

Implement the changes one at a time so that you can see how they work.  Involve all relevant stakeholders in the implementation process.

Measure the improvements and keep records.  Make sure you have data from the process both before and after the improvement.  This can help appease staff unhappy with the change, management asking about the cost, and of course, accreditation bodies.

Adopt the changes if you are happy with the results and management approves. Update SOPs/procedures and train staff.

Use your internal audit program to make sure that the improvements “stick”.

Get the auditors to look at the new process in detail. Choose internal auditors who understand NATA’s requirements and will give you frank and fearless advice.

NATA suspension procedures

NATA’s criteria for deciding when a laboratory should be suspended are kept quite vague.  Based on the Accreditation Procedures and the Rules (mainly 40 and 41), NATA can suspend “an accredited facility” if it: “at any time fails to comply with any condition for continuance of its accreditation”.  It sounds scary, but normally the non-conformances have to be quite serious and/or systematic before NATA will move to suspend an accreditation.

There are three main ways that your laboratory or site could have accreditation suspended:

Failing a NATA assessment

Failing a NATA assessment (or surveillance visit) is every lab manager’s nightmare.  Yet it can happen to labs that have always thought themselves to be completely “up-to-scratch” , as well as labs that know there are problems.  It’s always a shock when it happens.

You will (hopefully) realise during the assessment that things aren’t going too well, then receive a rather long assessment report. The NATA lead auditor will  probably warn you that the accreditation might be suspended.

Advice from an external body

NATA can act on information received from a range of external agencies such as RCPA, RMS, Victorian Government and many more. It can then put in place a process that leads to the suspension of your laboratory accreditation.

Choosing suspension of accreditation

When you know that your laboratory cannot meet the accreditation criteria, and can manage without accreditation for a while, you can choose to have the accreditation suspended.  Make sure you get a written agreement from NATA first as to what steps you will need to take to regain accreditation.

 

Avoid suspension at all costs

If NATA decides a laboratory is not meeting the criteria for accreditation, it will send a notice asking the organisation to demonstrate otherwise.

At this stage the horse has probably bolted.  Very few appeals to the suspension process succeed.

From our experience with several laboratories, once you are subject to an involuntary suspension, correspondence with NATA can become quite bewildering and difficult to interpret.  It can seem impossible to come up with a corrective action that will satisfy them. Certainly, there is no fast way back.

The best avenue is to avoid getting into this situation in the first place. If you want to keep your systems on-track but need help from auditors with NATA-know-how, contact O’Dwyer Accreditation. Practical experience with NATA accreditation is our game.

Are you wasting time & money on NATA requirements?

The assessment is over, you have ushered the audit team out the door NATA Requirements ticked offand you already know how you’re going to fix most of those niggly things they brought up.  The assessment team were really helpful and you know it’s going to feel great to get all of these NATA requirements ticked off.

You’re not sure why these issues are important enough to be in the assessment report, but you need to get the response under control so the “Just Do It” approach wins.  You get the assessment report and hold a meeting to decide who will do what, including all the observations and recommendations.  Great work – you’ll have everything fixed and your reply to NATA post haste.

Can I just say whoa?!

When we behave like this we are focussing on one risk: the risk of NATA being annoyed with us for not having a response in time.  What about the other risks?  The real risk to your business presented by the issues the audit team identified?  The risk of wasting time and money on interventions for trivial problems?  The possibility of the same issue coming up in future assessments, which can threaten your accreditation and your reputation.

This is the time to slow down and take a quality improvement approach to each of the issues raised by the auditors. Here’s my step-by-step process to address these findings so that hopefully they never come back to haunt you again.

Understand the problem

Study the finding closely.  Make sure you have understood exactly what the auditors found that is wrong & why it is wrong.  Go and check what they were looking at if you haven’t seen it.  Look up the clause of the standard that they refer to in the report and check the wording of that.  Phone up the auditor if necessary, to ask for more context.

You should be able to say what the actual thing is that has gone wrong (or could go wrong).

For example, NATA finds a staff member working in section B who has not been signed off as competent in section B.  Is it that they are not signed off that’s the real problem? No!  It’s that a staff member could be working without all the skills and knowledge that they need to do the job and might stuff it up!

Whether you are accredited to ISO 9001, ISO 17025, ISO 15189 or GLP standards, what they are asking you to do is to make sure that you have trained, qualified and competent staff members doing the job.  The training or competency record is a tool for management and others in the organisation to be able to plan (training programs, rosters, recruitment drives, etc).

Investigate further

Check other staff, projects, samples, invoices to see how widespread that problem is.  Record this information, including dates and reference numbers.  If the problem turns out to be more serious than you thought it was, you will want to use this data as a benchmark.

Assess the risk

1.       Assess the risk from the issue to your business. Severity x frequency is the basic formula and there’s a whole Australian Standard on this if you want to formalise your process of risk assessment.  Usually an informal assessment of risk is good enough.

In this case the risk is the possibility that a person without adequate training works in section B and produces invalid results. How serious this issue is depends on the nature of the work, how much supervision is in place, how structured it is and how much impact it could have on your test results.  Frequency will be determined by discussing the training records with the relevant manager – how representative of the actual state of training are they?

2.       If it is a minor issue that has little or no impact on your business you can reply to the auditor at this stage, detailing your investigation and stating that you have corrected the issue they found.  However, do not neglect the risk of the issue coming up again at the next assessment.

Corrective action is for NATA requirements too

If the issue is serious and/or is happening on a regular basis, then you need to plan and implement corrective action.  Identify all the reasons why it is going wrong and prioritise these.  Use brainstorming to come up with ways to prevent it from happening.

Decide which actions are worth taking and implement following the change management practices in your organisation.  By this stage you will probably have sent a reply to your external auditor, but you must not drop the ball at this stage.

Once the changes have been in place for a while, assess how effective they are.  This is where the data from your original investigation will be useful: so you can demonstrate improvement.

NATA Requirements signed offIf the corrective action has been effective and is not costing too much (time, money) to implement, then this is the time to update your procedures and standardise the new steps in your process.  However, if it has not been effective you may need to go back and reconsider your corrective actions to find something more effective.  However, often we need to accept that our fixes will just be good enough and not perfect.

 

Can we change our minds about what action we take?

I’ve heard people say “but we told NATA we were going to do this, so we have to keep doing it”.  This is not an argument for keeping an ineffective or wasteful process in place.  Management of any organisation has the right to decide that something is no longer a problem, that they will bear the risk, or that they will investigate further when control measures have been ineffective.  So if you decide to adopt NATA recommendations, make sure you understand which risk they are trying to control so you can decide if it is working or not.

If you want assistance to respond to an assessment report, or to plan for your next reassessment contact us to discuss your requirements.

The easiest internal audit program ever

I recently discovered there’s a way to do internal audits that takes (almost) no time at all.  I got an invitation to a webinar Freshening Up Your Internal Audit Program featuring a dude who has been around the ISO 9001 certification scene for many decades.  (Aha! I thought.  I’m finally going to learn the secret from a real veteran of internal auditing).

When we got to the secret, I was amazed by the completely different approach to auditing.  This was more than a freshen up, it was radical surgery.  There are no horizontal, vertical, process, observational, or outcome audits: they have all been excised.

This quality manager produces a detailed Compliance Matrix (it’s like a gap analysis with much more detail) and updates it every year (you can get a copy if you make it to the end of the webinar).  And the Compliance Matrix is it.  There is usually quite a vigorous discussion with the ISO auditor when they come, but he manages to get it across the line.

Now I wasn’t quite ready to adopt this approach whole-heartedly, but there were some great lessons in the webinar that I’d like to share with you:

There is no right way to do internal audits

The ”tell me, show me” or process method used by certification and accreditation bodies is not mandatory.  Many of us are married to the belief that observational process audits are the only “proper” kind of audit (you know, the ones we learn about in the NATA/SAI/Lloyds internal audits courses). I know I was for many years and I love auditing that way because it suits my curious nature and visual learning style.

However, if you follow the requirements trail for internal audits, it leads you back to a fairly general description of what an audit is.  Look at AS NZS ISO 19011-2014 Guidelines for auditing management systems if you want to find out more.

Focus on quality improvement

Quality managers should be involved in quality improvement, right?  That’s meant to be the whole purpose of the quality system.  To improve.  And all too often we get bogged down with our systems and dealing with compliance.

Try to spend more time fixing problems than finding new problems. Invest in quality improvement activities a la Deming, 5S and so on.  Spend time studying important processes, measuring, and trialling improvements using tools such as brainstorming, affinity diagrams, and hazard barrier analysis.

Managers aren’t doing their job?

To wait until an internal audit reveals problems is courting disaster.   Managers do have to keep an eye on the things that may be part of an internal audit program all year ‘round.  Things like making sure that customer requirements are met and that people are following the quality system.  I hear many over-stretched quality managers cheering at this point!

Make sure there are measures in place for all the critical points in your processes.  Adding these to your gap analysis or Compliance Matrix is one way to keep track of them.

Give up on traditional internal audits?

I have to admit I find this difficult to contemplate.  I love auditing: being on my feet in the workplace, looking around, getting alongside scientists to see how they work, how the tools are organised, and how the work flows (or not) towards a result or product.

But when you have been in the same organisation for years, it is very difficult to see anything new when you audit. That’s why I always recommend training your staff to do internal audits and don’t rely on one person.

There are so many benefits that flow from a well-designed internal audit program:

  • Improvement suggestions arising from an ‘outside pair of eyes’ looking over the laboratory processes
  • Staff gaining confidence to talk about their work and the importance of it
  • Staff from different areas learning about their up- and down-stream customers & what their difficulties are
  • Effective identification of root causes
  • Harmonisation of common processes across the organisation
  • Organisation gets practice at following the PDSA cycle to address non-conformities
  • Risks identified and documented
  • Different interpretations of the requirements
  • Sharing of improvement ideas from different sections
  • Genuine confirmation of the effectiveness of corrective action
  • Facilitating communication between front line staff and their managers
  • Staff members learning how the accreditation/certification requirements apply in their area

While it is true that many of these benefits will come out of brain-storming, force field analysis and other quality improvement tools, nothing beats getting alongside your frontline workers, observing their work environment and listening to their concerns while they show you how their work is done.  This is something that a traditional process audit allows you to do in a non-threatening way.

Back to the Compliance Matrix

This is a very useful process to go through at least once, and possibly more often if you are one of those people who hates being “caught out” by external assessors/auditors.  Use it to educate staff who will be answering questions during your external audits or assessments – this avoids non-conformances from not knowing where you had a clause covered in your system.

Help is at hand

If you need to take a fresh look at your audit program, have refresher training in internal audits or just want someone to do the audits for you, we can help.  O’Dwyer Accreditation offers quality system consulting, training and contract internal auditing services. Call or email now.

10 Tips to Avoid NATA Paper Warfare

Buried in correspondence with NATA?

Some lab / quality managers enjoy corresponding with NATA and arguing the point with them.  But most of us don’t.  Other labs inadvertently get caught up in three, four or even more rounds of correspondence with NATA following an assessment.  It can be frustrating and time consuming.  You seem to be talking at cross purposes at times and you may even start to wonder if the NATA staff were actually at the same assessment as you were!

After an assessment you need to get the follow-up over and done with as quickly as possible so you can turn your attention to more significant issues.  It’s not that NATA is not significant, but that many of the issues they find are compliance issues with no immediate impact on your output or business security. In the normal run of business they would be prioritised much further down the list.  So we need to minimise the amount of time spent dealing with these issues, whilst managing the risk of having a poor NATA assessment in the future.

Here are my key steps to stay out of the mire:

1. Be a good host

Before the assessment, make sure everyone knows who is who on the assessment team: who the technical assessor is, who are the NATA staff members and what the difference is.  If you don’t know much about the technical assessor you can google them to find out a bit more about their background. This gives you an opportunity to establish rapport right from the start and have good open lines of communication. This is small task that can make things run a lot smoother.

2. Stick like glue

Do not leave any assessor or NATA staff member alone to interview junior staff members.  Try to avoid them going through your records, methods or QAP / Proficiency testing results without a tour-guide too.  This practice leads to many ill-founded non-conformances in assessment reports.  So just keep popping in, or even better, find space right in with the senior scientists and let them go through the information there where someone can explain it to them.

3. The exit discussion belongs to you

This is one of the most important parts of the assessment so don’t let the NATA team short-change you on it!  This is when you get 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.  This is your chance for the big boss to hear how well your lab is going.

Print enough copies of the interim report for each senior scientist / quality manager to have a copy during the exit discussion.  This will help them to follow what is being said, check it for accuracy and they can write notes on it too.

4. Practice active listening

Ask for details for every non-conformance mentioned.  Ask those clarifying and reflective questions you learned in your internal auditor course. 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.

If you do not immediately understand what the issue is about, ask the relevant assessor.  If it is a technical issue, direct your questions to the technical assessor.   They are far more likely to identify issues of real concern & you will want to know exactly what the technical assessor has found. Technical issues can be lost in translation when the NATA staff member is putting them into the report, so no matter what ends up in writing, make sure you know what the technical assessor thinks.

Make sure everyone is on the same page before the assessment team leaves.

5. Be economical with your response

This is super important.  Do not reply to observations or recommendations.  If you really want to you can thank the NATA team for their helpful suggestions.  But don’t waste your emotional energy at this time on things that may be wrong or wide of the mark.

Now to the Cs and Ms: Log them all into your corrective action system.  I find this process helps to place some distance between the emotion of the assessment day and the issues laid out in the assessment report.

6. Explain to your management team the approach you’re taking

You are keeping your correspondence with NATA as minimal as possible (you’ll be doing NATA a favour too) so that your organisation will have more time to work on high priority issues, no matter how they have been coded by the assessment team.  So ask your team not to address world peace in their replies.  Just what’s in the report.

7. Don’t let body language fool you

This is super important too.  Remember all that stuff about non-verbal communication? It is at play in a big way during an assessment. However the non-verbal messages you receive during the assessment have no role to play in the follow-up.  When you’re putting together your response to NATA pretend that you weren’t at the assessment.  Read what the Cs and Ms actually say and respond only to those issues.

If the report doesn’t seem to reflect what you discussed on the day don’t argue! It’s more efficient to just reply to what is in the assessment report and then you can deal with the ‘real’ issue in your own time.  If you have to send in evidence that the assessor could have seen if they had asked for it, just roll with it.  The aim of the game is get NATA to tick off each of the non-conformances that they have identified with as little discussion as possible.

8. Let it mature

Put together your response with evidence for the Cs (don’t forget that you only have to tell them what you plan to do for the Ms) and put it away for a day or so before you send it in.  Oh, and advise NATA if you will be sending it in late.  Always send in a complete response unless it is absolutely unavoidable.  The pull of being able to completely close out the assessment will mean that a few minor wobbly bits in your response may get through.

9. Get on the phone

If you get a response from NATA asking further questions, get straight on the phone and make sure you understand what they are asking for.  Remember though, they should not ask you for specific actions in response to non-conformances – they should let you decide how you will meet the requirements.

10. And now go back to the observations

OK this is not really a step to avoid paper warfare, however it is related as it is a serious risk management step, so listen up!

You thought I said just to ignore the observations?  Well no, I said not to get into a discussion with NATA about them.  Once you have calmed the NATA beast, you must go back to the Os and review all of them, on the ground in the relevant labs, with the right managers, to find out if there is something behind them.  Some observations are there because the assessment team has sniffed out something unhealthy, but they can’t quite put their finger on it.  I have seen a number of observations declared a can of worms after the right manager had looked into it.

Log the ones that turn out to be on the nose into your non-conformance system.  Yes, my poor labs have at times ended up with more non-conformances logged than the number of Cs and Ms in the assessment report.

If you need assistance from someone who really wasn’t at the assessment and knows the ropes give Cathy a call!

Are internal auditors better than managers?

Internal auditors can be better at identifying process improvements than most managers – let me tell you why.

What a manager may never see

There are things that internal auditors see that a manager would never have known about if not for the audit program. These can include: tests failing and needing to be repeated; risky work-arounds to compensate for poorly designed processes; retesting QCs until a result falls within spec; using calibration factors incorrectly; biased sampling; poor labeling practices; unsafe work methods; some staff having their own special way of doing a task; continuing to perform tasks made redundant by process changes.

Most of these you will never know about unless you directly observe them.  So why does an internal auditor see them when the manager walks through the laboratory every day and does not see it?  I can think of a couple of reasons.

When a manager strolls through the lab their mind is filling in the picture with all sorts of details that they believe happen in that lab. This is not a fault of the manager, this is being human.  Unless they go into the lab with the intention of studying a particular process, they will likely see very little of interest.

When a manager arrives in the lab, they are thinking “I am the expert on this process” whereas the auditor is thinking “I don’t know much about this process”.  Neither of these is wrong, but they have a big effect on what types of questions are asked, and how the answers are listened to.  A good internal auditor approaches the audit with a child’s mind – curiosity and wonder.

When an internal audit has been arranged, everyone is primed and ready to demonstrate and discuss the process. Time has been put aside and outputs are expected.  There is a structure for collecting information and defining issues that need attention.  And there is a rigorous system for following up on these issues.

Unless the manager has very good rapport with their staff, staff members will not necessarily open up to them and may even modify their answers to what they think is the expected answer. Even worse, if they’ve opened up about work problems in the past and nothing eventuated, the level of trust may not be sufficient.  There is an interesting paper on this from Harvard Business School.

A well trained internal auditor can get alongside a scientist and really understand what they are doing and what the problems are.  This is a privilege afforded to few outside of that particular laboratory. Unfortunately the manager is often not one of those few.

So what are managers good for?

A managers role is to keep their eye on the bigger picture and enable their staff to do their jobs well.  Many improvements introduced by managers are larger scale and therefore disruptive changes.  This is not a bad thing, but the continuous small improvements that are generated through internal audits or handled in the non-conformance system can also lead to sustained improvement.  They are easier to implement and to check for unintended consequences without getting to a point of no return in the project.  Whereas introducing a new LIMS entails a myriad of changes and limitations that can end up slowing down your work flow as you try to cope with them.

Benefits of a good internal audit program

There are real benefits that can come from a well-designed internal audit program whether non-conformities like the ones above are found or not: staff learn how their up- and down-stream customers work & what their difficulties are; they gain confidence to talk about their work and the purpose of it; auditors improve their knowledge of the quality system; improvement suggestions arise from an ‘outside pair of eyes’ reviewing processes; better standardisation of lab processes; risks identified and documented; effective identification of root causes; staff learning how accreditation/certification requirements apply in their area; and so on.

Not seeing the benefits?  Help is at hand

You may be the lab manager and doing all of the internal audits, or you may simply have run out of ideas on how to get value from audits.  If you would like to get more from your audit program, O’Dwyer Accreditation can help.  We offer expert internal auditing services so you can get best benefit from your resources.  Or we can review your program and help you implement a different approach with training and mentoring services. We also run training courses on internal auditing and audit programsEnquire now.