Is Quality Management Window-dressing?

Every year at this time my Clinical Microbiology Proficiency Testing (CMPT) program hosts its Annual General Meeting and I get a chance to look back over the last year.  This year ww have a special meeting because it is our 30th anniversary.  

As much as we have stayed with our roots as a university department based PT program, over the years CMPT has certainly changed from being a small program primarily for the large laboratories in British Columbia to a whole province program, and then going regional and then pan-Canadian and finally international.  We started with very basic samples with lyophilized single bacteria, and have morphed into a very different format with live closely simulated clinical and water-testing samples, plus a broad range of targets including gram stains, bacterial toxins, Antigen testing, etc.  If samples are not typical of true samples, then what ever we are measuring, it is not proficiency or competency.  

Like most programs in North America we have had to deal with laboratory consolidation and public sector financial cutbacks, but have managed to remain active and relevant to the laboratory community and continue to be financially sustainable.

Perhaps the single most important decision that we have made in the last 15 years was our commitment to structure ourselves around a Quality Management model.  That decision has had some consequences especially around the consumption of time and energy and money, and it has not generated much interest within the university department, and so it is important for me to regularly review and reflect upon whether I have put us upon the right path.

I imagine that we could have reached the same point of success had we not focused on ISO 9001 as a road map, but I doubt it.  I suspect we never would have been able to sustain our integral practices.

Strategic Quality Plan (aka Quality Manual)
Every year we look at our policy base and reinforce or refine it and use it as our foundation for action going forward.  Having the policy base available has actually made making decisions on go-forward plans much easier.  Indeed when we were really getting hammered by consolidation and a dropping Canadian dollar (down to 62 cents at one time), our policies with respect to staffing and financial responsibilities made a lot of decisions about what is and what is not important much easier. 
Today the policy set is very encompassing, but even in the last 3 months we were faced with some issues with respect to succession planning, and we found that while we had some broad and basic ideas,  we had no policies or formalized plans.  That became a reason to reflect more broadly, and now we have a documented policies, and have been able to create a strategy and plan.  Good for us.

Internal Audits.
We have a regular process of internal audit that looks at the organization from both a technical and management perspective, and we can count how many times it has “saved-our-bacon” over the years.  It is amazing how often small weaknesses creep in.  Sometimes they reach to point of manifested errors which I think we pick up quicker because of the audit.  More often we pick up potential problems before they erupt and we get to make changes before the bad thing happens.  Every year we identify around 8 OFIs, the majority through the internal audit process. 

Customer Satisfaction
We focus a lot of time on customer satisfaction.  We monitor opinion and suggestions through surveys, and we monitor concerns, complaints, appeals and resolutions.  We have become very adept at gathering information and have developed very successful survey models that I see many others would benefit from.  [How often do you click out of an electronic survey because it is too long and too boring?] And we make a lot of decisions based on the information.  Many of our most innovative changes, including product improvements, new products, and new programs have arisen from this information.  

Management Review
Every year I take the time to review all our reports in all aspects of our program, including our annual goals and objectives.  It takes me a few days.  It lets me know if we are staying on track or doing what most organizations do… good ideas, good plans, no follow-through.  I know with confidence that nearly 90 percent of annual goals are met within a year, the about 90 percent of the remaining are met within the next year.  Over the last 10 years we have failed to meet only one of our established goals, and that one we have put on hold and on a new time table.  

Conclusion
Overall with all the pressures that come from being a small education oriented self sustaining university based program, I suspect that had we not got serious about our management model, the most likely outcome is that we would have disappeared years ago.    That we are still active and thriving and providing creative and innovative education, research and outreach because of our QM model.  We might have been able to get into a process of internal audit or management review on our own.  We never would have figured out monitoring of customer satisfaction.  From my perspective our success and sustainability is directly related to our commitment to Quality Management.

So to address the question “is Quality Management window-dressing?” for me the answer is simple and direct.  Absolutely.  But more importantly it is also the window, and the wall, and the foundation, and the whole darn house.

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Ins and Outs of Internal Audits.

We are committed to our Quality Management system.  It was implemented through our decision to adopt ISO 9001 as our basis for a Quality pathway.  We have helped maintain our motivation to Quality through annual annual audits since 2004.  It has been a very effective approach for us and our customers.

One of our techniques for keeping our system fresh is to introduce variation in our implementation and follow-through.  An example is in our approach to Quality Audits.    

In our course we talk about four different approaches to Quality Audits:

Internal Audits (IAs) are performed by our own staff to generate information for our own internal purposes including monitoring and improvement.

External Internal Audits (EIAs) are performed by people from outside our program, but under contract.  They are performed to generate information for our internal purposes. 

External Audits (EAs) are performed by people from outside our program, either people from our certification body or by customers requesting an audit to ensure compliance for their own purposes. 

Internal External Audits (IEAs) are often paper challenges or internal inspections requested of us by an authorized agency to comply with regulatory requirements.  In these situations we perform the inspection with our own staff and send the agency a completed and signed form.  Sometimes the agency may choose to do a follow-up with their own personnel.

This week as we start to prepare for our next certification (EA) audit, we are going through the process of our own internal audit.  In the past we have done this by contacting a friend or colleague to come in and do the audit for us (an external-internal).  We usually find this has a lot of advantages.  EIAs tend to be a little more thorough because we know that there are certain areas that we tend to gloss over because we are confident that they are intact and working properly.  EIAs are certainly more objective because outside eyes tend to see things that we don’t.  

Depending on who you invite to do these they don’t need to be particularly expensive.  If they can drive over rather than come by plane, travel expenses can be kept under control, and if they are a good friend, sometimes you can get it done for a cost of a good meal and a bottle of wine. 

As long as you make it clear that you are going through the exercise because you actually are seeking a critical and thoughtful eye, EIAs can be very effective.  Make sure that the person you invite is not only a friend a colleague but actually knows and understands your standard and knows what is involved in doing a constructive audit.

This time we are not doing our assessment externally.  This year we are going with our own internal audit, I am doing it primarily myself along with our program coordinator.  It’s kind of like combining a Top Management Review and an Internal Audit together at the same time.

It’s not so much about saving money as it is about re-engaging.  As we have worked through colleagues I was feeling that I was getting more removed from the actual hands-on activity than I really wanted.

I recognize that there is the risk of introducing my own personal bias, but the reality is that with practice and experience that I have had over the years, I am confident that we can be fairly objective in the exercise.  In all fairness, I also understand that our regular certification officer is to going to check our work when he comes for our true EA.  Any deviation that he detects between what we say on paper in our EIA and we he sees with his own eyes is going to come back and bite me in the neck.  

In the meantime this gives me a chance to get back into the laboratory and see on a first hand basis what we are actually doing.  And that seems to me to be a good thing.

Overall it is going to take me about 8 to 9 hours over 2 to 3 days.

We will see what we do next time, but for now I am enjoying getting hands-on.

External - Internal Audits (EIAs)

Quality Management principles and ISO Quality standards all talk about the critical importance of Internal Audit. If you don’t go through the active process of seeking information, then it is impossible to make informed decisions on progress and strategic planning. In the absence of internal audits one cannot use the term “continual improvement” because the word itself implies that you are actually aware of areas that need improvement.

I think that it is of value to talk about two different types of internal audits: one being where you do the assessments in your own organization (let’s call that a true internal audit) and the other is where you hire a consultant or colleague to come and do it for you. I think the term External-Internal Audit has value to describe this latter situation. Both approaches have value and both can provide useful information, but the latter (an EIA) may have greater cost but is more likely to raise critical information based on the knowledge and expertise of the person brought in to do the assessment.

I have mentioned in the past my strong preference on voluntary quality and EIA are another manifestation of that voluntary quality. The information may be done by an outside person, but the information is intended for internal consumption only.

I raise this because I am in the middle of an EIA in a mature and academically oriented laboratory in Canada. I am looking at the structure and function of the laboratory's quality system. It is a rather global review and we are taking our time to do it right so that they will end up with credible and useful information.

A question arose during the post-assessment discussion today about what is intended by the term “top management”. There was general understanding that TM means the folks who are in a position to make decisions for change based on their ability to make decisions on resources (also known as “the pursestrings”). I don’t think that is a correct understanding and in the public sector would almost assuredly be a terrible definition to envision or try to put into practice. The public sector by design is multi-layered with fiscal decisions being made at or very near the top. Almost assuredly the folks at that level are so removed from clinical or laboratory reality which again is by intent to reduce the risk of bias playing a role in fiscal decisions.

A more functional definition of TM (can we call them the function top management or FTM?) is that small group of people who are close enough to have an understanding of the organization’s mission and have the responsibility and authority to make decisions and change taking in mind all the resources available which may or may not include money. This is a really important group that when working well because they are high enough up on the food chain that they can think about the global organization, but are close enough that they can effect change at the local unit. It is a really good example of “Thinking Globally but Acting Locally”.)

Waiting for money to affect change is never a good idea. Positive assertive actions will begat money with a higher and sooner level of success than money will begat positive actions.

Updated for grammar September 2013

Ranting on a Rant.

A recent article in Quality Digest Daily (www.qualitydigest.com) posed the question “Internal Quality Audits – Valuable or False Security?”  The question was written within The QA Pharm, an anonymous blog focused mainly on issues in the Pharma industry.  

An interesting question, with an even more interesting answer.  QA Pharm contends that internal audits are not helpful because they tend to be done by auditors who have been working too long and who are too politically aware and avoid sensitive concerns, and senior management doesn’t support them anyways.  And they never get to the root cause because company culture gets in the way.  

In a way I am not too surprised by the rant.  My experience with folks who have transitioned from pharma to health care is that the pharma culture is hyper reactive to the point of absolute risk aversion, which tends to either paralyze or drive folks in the opposite direction.   People who care for pharma quality tend to get extremely passionate.  The rest get bashed to indifference.

Pharma does have certain problems.  Most drug release decisions are made through a series of graduated studies, on pharmaceutical effect, and then controlled safety studies, and then “larger” population studies, and then after-the-fact post-market analysis.  In their world even 6 sigma (3 defects per million) can be enough to sink the ship.  But they are not unique.  It only takes one airplane to fall out of the sky or one bridge to fall down to create industry chaos.  

In contrast the health care may be a little more tolerant, maybe too tolerant.

My biggest problem with QA Pharm is not on his opinions with respect to the frustrations of practicing qualitology in the pharmaceutical industry.  It is more with the folks who read the rant, and interpret the opinion as generalizable.  

Health care laboratories are just at the beginning part of the quality process and the introduction of internal quality audits is just being introduced in a significant way.  That is not only true in Vancouver, but it is my personal experience that this is the case across Canada, across the United States, and in many countries worldwide.  This is not the time for health care laboratorians to be thinking that internal quality audits are a waste of time, or too political. 

Internal quality audits can and should be an important component of technologist training, quality manager training, pathologist training.  They can and must (shall) be a component of quality monitoring infrastructure, and the foundation of quality research and outreach.

So QA Pharm can have his(?) point of view, and that is fine, if it is intended to apply only to the pharma industry.  That internal audits are a WOT, is not my point of view and it has no place in health care laboratories.

Memo to self: Ranting is a good thing, but don't expect everybody to agree with you.

m

PS:  Some of you may be in the receiving group for a POLQM Weekend Workshop blast out. next week.

PPS:  Some of you might consider sending the link to to friends and colleagues who might be interested.  All a part of being within an interest network.  Twitter works well as well.

Human Factors and Safety and Quality (?)

In 1986 Briggs Phillips published a small, probably near forgotten, but important study in laboratory safety (see in Laboratory Safety: Principles and Practices.  ASM Press 1986).  The author was able to identify two groups of people: one group of 33 who had experienced at least one laboratory accident in the last 2 years, and another group of 33 who had been accident free during the same 2 years.   The two groups were matched by job classification.    

The two groups were interviewed and surveyed for additional information.   

While not matched for the following characteristics, all including age, years of education, years on the job, weight, height and gender and marriage status were identical.  In addition, wearing glasses, medication use, showed no differences.  Also of interest, accidents outside the laboratory, and driving records were also equal.  

The factors that had significant differences were (A) smoking  (B) the number of accidents and injuries and infections acquired in the 2 years prior to the current 2 years (C) personal attitude towards safety (D) opinions of the safety awareness of their supervisors and co-workers, and (E) importance of training and communication versus personal experience.  In all these, the accident involved were more likely smokers (remember this was 25 years ago), had a long history of accidents,  believed that technique was more important than attitude, but thought that personal experience was more important than training.   

The accident free group were significantly more critical of the supervisors and significantly more critical of their co-workers safety consciousness, and believed that safety attitude and awareness were more important than having techniques and equipment.  

[If you are safety aware you will avoid getting into the high risk behaviour of rushing or allowing distraction.  If you are not safety aware, you are more likely to assume that equipment will allow you to go faster and increase risk.]

The message of the study points to importance of attitude and awareness in the avoidance of having a laboratory accident or injury.  

So why am I bringing up 25 year old studies?  Two reasons.

First, a recent study in ASQ’s Quality Management Journal V18, N:1, 2011 on factors associated with continuous  improvement in patient safety  by E. Naveh et al came to a similar finding of the relative importance of opinions on attitude and priority.

Secondly, and more importantly, what made the first study possible was that records were maintained on who had been involved in a laboratory accident or injury.  In many laboratories today, we have virtually no records of Quality accidents, and where we do have records,  the names of the people are commonly deleted.  So in many (most?) laboratories if we wanted to study the human characteristics associated with increased error, it would be impossible because we have no place to even begin.

Deming wisely called to “Drive out Fear” and I agree with that.  He also said that most error was systemic, and I agree with that too.  But Quality in the medical laboratory is a new field, and it is important that we study why errors occur.  Confidentiality is important, and so if avoidance of a sense of retribution.  But let’s not “throw the baby out with the bathwater”.  Continuous improvement requires having data to study.

That’s why they call it PDSA.

Resolutions 2011

I used to think that New Year’s resolutions were pretty much a waste of time. Most people that I know still do. I vow to be good; I resolve to quit eating; I resolve to quit smoking:   I resolve to get more exercise.  I resolve to stop being sarcastic. Yeah, yeah, and ...yeah.

But over the 5 or 6 years, the concept of resolutions started to make a little more sense. New Year's Resolutions are just a variation on the theme of setting Objectives and Goal.
I mentioned before that CMPT`s quality system has been certified to ISO9001: (2000 - 2008) since 2002. Every year in October we set quality and programmatic goals and objectives and then monitor to ensure that we meet our goals.  When we started we did this so that we would continue to get certified, but after a while we saw the value in the exercise, and did it for us... to keep CMPT on path and on track.  And it seems to actually be effective.

So it started to make sense that if we can do this positively and painlessly for a proficiency testing program, we should be able to do the same thing for the Program Office for Laboratory Quality Management, and for my teaching commitments, and also for the medical laboratory at which I worked as a medical director for Quality. And again, the experience reinforced itself by actually being productive. 

Go figure.  Those guys like Deming and Crosby actually knew what they were talking about.

And now that MMLQR goes though its first New Year,  it is time to start setting some objectives for it too.  Actually MMLQR has only been running for 6 months, but this is sort of like setting or re-setting an organization's fiscal or operational calendar.

Just to make sure we are on the same page, I use the term Objective to mean a large scale outcome that may take a number of steps to reach, and I use the term Goal to identify the individual steps.  To be credible the objectives should be achievable and the goals should be measurable.

So here are my goals and objectives for MMLQR for calendar year 2011

Objective 1:

MMLQR will be recognized as an active and credible and readable website to promote diversity of opinion and discussion for the full range of issues that surround quality management of medical laboratories.


Goal 1
To meet the measure of "recognized" I will promote MMLQR to support current readership and to encourage a broader audience.

Goal 2
To meet the measure of ``active``, I will generate at least one new entry each week.

Goal 3
To meet the measure of ``credible`` I will actively seek review and comment by others with long term interest in medical laboratory Qualitology.  This might be in the form of another shot at an electronic survey, or in the form of an external-internal audit.

Goal 4
To meet the measure of ``readable`` I will reduce the number of spelling and editing errors per entry.  (This one will be tough because I am terrible at proof-reading).

Goal 5
To meet the measure of ``diversity of opinion and discussion" I will invite and publish comments and commentary of differing opinion (as long as words like "jerk" and "pinhead" are not included) . 

Goal 6
To meet the measure of "full range of issues that surround quality management"  I will expand the topics covered including more commentary on politics and quality partners, as I see it.

So that is a good start with an achievable objective and a series of measurable goals.  MMLQR is a young start-up which has met reached a certain level of fragile stability (similar to how they describe the Canadian economy).  Going to the next step will take the discipline of setting some objectives and goals and PDSA.  We will see how I do by the end on the year.

See you in 2011.

m

Assessing the Assessors

A number of years ago (2000-2001) I was invited to give a presentation about my proficiency testing program.  When I finished, I invited the audience for questions and comments.  A technologist stood and angrily complained that proficiency testing and accreditation bodies set themselves up as authorities, but were not required to meet any requirements or expectations.  She was absolutely right.   

So in 2001 I decided that we had to fix this, and in 2002 we were thoroughly assessed and our organization was certified has having a quality management system that served us well.  We have continued the process of external assessment and re certification ever since.  In 2010 a new ISO standard for Proficiency Testing bodies was developed (ISO17043:2010).  We are considering that recognition process as well.

My biggest regret was that I didn’t get the name or contact information of the technologist  who woke me up to the critical importance of demonstrating commitment to quality.

I tell the story for two reasons: the first to brag, and the second to make the point that despite my regularly raising the issue accreditation bodies in Canada have been much slower off the mark.  Indeed my above story could be almost as relevant today as it was 9 years ago.  

To be fair, in Canada we have a distributed responsibility health system with each province responsible for its own health oversight, so  there is no single oversight body that demands provincial accreditation bodies have themselves external assessed for quality and/or competence.  But it is not a matter of requirement.  It is a matter of obligation and commitment.

But now 2 provincial medical laboratory accreditation bodies (plus 1 more) have stepped up to the plate and achieved international recognition.

In 2004 the province of Ontario decided that it was time to get into laboratory inspections.  It was timely because the new international standard ISO15189 as a standard for quality and competence of medical laboratories had just been published.  The newly minted OLA (Ontario Laboratory Accreditation) arm of QMP-LS (Quality Management Program – Laboratory Services) created a standard that incorporated the new standard and others, to ensure that medical laboratories were implementing quality management systems (and other measures of competence).  They have become world leaders in ISO15189 accreditation.  ISO Accreditation in Canada is done officially under the authority of Standard Council of Canada, through its signatory relationship with the International Laboratory Accreditation Cooperation (ILAC).   

In 2010, my province of British Columbia, going a different route has none the less achieved international recognition through accreditation of its laboratory accreditation standards by the International Society for Quality in Health-care (ISQuA).  This is a complex process similar to the certification process that I underwent with ISO9001.  

There is a third organization which is not a provincial program, but a not-for-profit, independent organization known as Accreditation Canada which has for a long time run a voluntary program of accreditation of all (or nearly all) hospitals in Canada. A truly remarkable job.  Recently it has been working under contract in one province to assess its laboratories.  Accreditation Canada’s standards have also been accredited by ISQuA.   

To have standards accredited they have to be externally assessed and demonstrate the 6 principles of Quality Improvement , Patient/Service User Focus, Organizational Planning and Performance, Safety, Standards Development , and Standards Measurement (reference: www.ISQua.org).

The other provinces either don’t have a provincial accreditation body, or they have one that has not yet taken the step forward for external assessment and recognition.

There clearly are differences between the ILAC process and the ISQuA process, and their strengths and benefits for the clinical and laboratory settings can be debated for a long time.  It is similar to the discussion that sees value in differentiating between the accreditation process and the certification process. I’m not going to get into that at this point, largely because I see the argument is all too often driven by bias and competitive commercialism.   What is important is undergoing external assessment demands discipline and rigor and demonstrates a commitment  to quality improvement

So in Canada, we are fulfilling a process that I have been promoting for near a decade.  If Canadian oversight bodies want respect, they need to demonstrate they deserve it, and to do it by independent external assessment.

And so, congratulations to the province of Ontario OLA program, and to the province of British Columbia Diagnostic Accreditation Program and to Accreditation Canada (and to CMPT!) for allowing the external light of audit and assessment to be shone on their programs. 

And my heart-felt thanks to my anonymous friend who got me to get the ball rolling.

m

PS: 

Please visit
www.POLQMWeekendWorkshop.ca 
for an important notice.

Heresy?

 American Society for Quality has a number of  journals, and some excellent, and others pretty good.  One of the latter category, at least in my opinion, is the Journal for Quality and Participation.  Without wanting to be harsh, I tend to find articles, while generally interesting,  tending to be more  opinion than fact.  (The irony of me, an opinion oriented blog writer making this distinction is not lost!).

Nonetheless there were three interesting articles in the October 2010 edition that I received today.  One was “Improving Project Performance with Three Essential Pieces of Information” by Portnoy, and another “Creating a Self-Confident Workforce” by Denton.   The last one is  "Training on Trial” by Kirkpatrick and Kirkpatrick.  

I don’t intend to go into any (the journal is available at www.asq.org/pub/jap) in detail other than to say that the first article made the point that when designing a project briefing (the deliverable) it is useful to make it brief and unambiguous.  The point was that the more the number of words and the more jargon included, the more variable is the document's interpretation.  The training article was making the point that training can have a lot of challenges demonstrating that it actually provides a service that will address significant business results.  And the third article made the point that workers are more self-confident with less stress when they are empowered to make certain decisions on their own.

I can support all those points.

Which brings me to the heresy. 

At a laboratory where I was working, I often found myself in conversations that suggested that some of the standard operating procedures (SOPs) were so detailed and so “precise” that in my opinion, they were largely unfollowable.  Even with an adjoining process map they were unfollowable.  They were better when pictures were added in,  but especially better when pictures were used in place of words.  In the process of trying to make SOPs that were all encompassing, I felt we were laying the foundations for error.

And so I started to think that maybe it is not so important to tell microbiology technologists how they have to hold and streak a petri dish, but to let that happen on its own.  And defining precise colony counting methods was so rigid that it likely wasn’t followed anyways.  And trying to define all the combinations and permutations of bacterial growth was confusing.  

Now there are many procedures involving many pieces of highly precise equipment that do need precise instruction (I understand that) but if we pollute those instructions that are challenging to follow, I think we run the risk of some documents  that need attention and clarity getting lost in the shuffle.  

So my point is that SOP writers and trainers and supervisors need to take a closer look at the procedures that they create to make sure that they actually are useful for training, and more importantly allow the business purpose of the procedures to come through.  Its not only about the value stream, but also creating documents that give technologists the professional autonomy.  Smaller and selective documents, it  seems to me, make the procedure and much of the decision making process both more efficient and more effective.

And how heretical is that?

m

Some easy and cheap things that you can do that will improve laboratory quality (Part 2)

I previously mentioned the Juran Quality Cost Model which points out that doing small things to improve prevention and assessment, have a big impact on to Quality spending, because they drive the costs of failure down by reducing the amount of failure.

I think that the model has merit.

The extension of the model is that inexpensive and easy to perform improvements can save TEEM (time, effort, energy and money).  As much as I am truly fatigued of the term, think about the “low hanging fruit” that will improve Quality. In part 1, I mentioned simplifying procedures, and improving procedure communicability, and introducing Quality discussion. 

So, continuing on the discussion: 

Create your own personal Quality Checklist.

There are a bunch of things that you know you should do on a regular basis, but for the most part they usually don’t get done until something official comes along.  Maybe its an upcoming accreditation, maybe it is a post-complaint investigation.  I know that we are all well meaning, but we can be busy or distracted.

So set yourself a check list (aka “to do” list or “personal audit” list).  Don’t wait for someone to make one for you (when it comes from your spouse, it becomes a “honey do” list).

A few things to put on your list:

1:         Have I checked the procedures that I am working on now in the last 3 months for changes?

2:         Have I checked to see if my personal short notes on the procedure are still consistent with the changes that have occurred?

3:         Did I update my own short notes?

4:         Did I check to see if there are short notes attached to my bench or analyzer, and have they been similarly kept current?

5:         Did I have one incident during the last month or three months that would quality as a learning opportunity or opportunity for improvement?  Did I make a personal notation in my own OFI book (more on this later.)

6:         Did I have at least one continuing education activity in the last 3 months, and did I record it.  That might include:

•         Read a book or article or website or see a video related to my work
•        Attend a seminar or meeting or interest group related to my work
•         Participate in a continuing education related course either in person or on-line

Keep the checklist in a private place, but check it at least once every 3 months.  It will take no longer than 2 minutes to check, and should generate no more than 10 minutes of activity.   But in a year you will have 4 checks of 6 points (that’s 24 check points) and in two years you will have 48.  

Do one internal audit a month.

We all know and understand that working in a laboratory is a lot like working in forestry.  Most of your time is spent jumping from one fire to another, and soon all you are doing is stomping out fires.  That is really important work, but some of those fires are self-induced because you never got back to check that the fire was actually put out.  That is what internal audits are for.

I find that so many of us like to think BIG.  That’s good for dreams, ambition, and goals.  For internal audits, thing SMALL.

An internal audit does not have to be much more that taking the personal checklist as above, and make it a little broader.  We need to be checking to make sure we are on track.  It’s just part of the Plan-Do-Check-Act thing, but make it really narrow and make it really specific.  And don’t take anymore than 30 minutes to get it done (45 minutes tops).  For example ...

1. Check the benches to confirm they are neat and clean at the end of the day?
2. Check the reagent kits to confirm that some one recorded the “open date” and the “expiry date”.
3. Check the equipment temperature recording charts to confirm they are being filled in.
4. Check the Proficiency Testing results to confirm that someone looked at them, and signed them off.
5. Check the SOPs to confirm that they have been reviewed on time.  (If you set that to happen with a few review times each month, then you don’t have the burden of doing them all year’s end).
6. Check to see if the preventive maintenance schedule is being followed on time.

Then write the results down and give a copy to someone in laboratory management.  That is all you need for an internal audit report.  You can draw up your own list, but keep it fewer than 12 (if the list gets too big, most will just drop it).  Once again, if you did each of these once every 6 months, at the end of one year you would have 12 completed internal audits and at the end of two years you would have 24.  If your list had 12 and you did them each twice a year, then at the end of a year you would have completed 24 internal audits.  That is huge!

The reality is that most of our colleagues would like to focus on doing better, and doing error free work, but we tend to make Quality tedious and excessive and overwhelming.  Too many rules and too many requirements.  And administration sees it as expensive.  So try this as something different.

More cheap and easy later.

m