Quality and Risk revisited.

I read with interest an article in last month’s (September) edition of American Society for Quality (ASQ) Quality Progress which is about doing risk assessments throughout an organization.  (See Site Seeing by L.W. Yu, E. Urkin, S. Lum, R.S. Kennett, and R. Ben-Jacob.   www.quality progress.com).  In it, the many (!) authors make the point that companies need to keep their eye on RISK throughout the organization and that that is best done as part of risk-based audits.   Helpfully, they present a number of tools that can be used, especially an example of a probability of occurrence-severity grid which in my experience is very helpful for setting priorities.  Attack the issues that have the highest (occurrence X severity) product first, and address the lesser issues later. 

I agree with them.  In the medical laboratory we have an ISO document   ISO/TC 22367: 2008 Medical laboratories -- Reduction of error through risk management and continual improvement which gives the same message.    (Actually I agree with them so much that I wrote on the subject over a year ago – see MMLQR:  Medical Laboratory – Quality and Risk.  September 25, 2010).   

A few comments about measuring risk, especially for laboratories which do not follow or understand ISO standards, in particular ISO15189:2007. 

One of the expectations of Quality Systems as iterated in 15189 (and CLIA and CLSI GP26) is that the laboratory should demonstrate that it performs preventive actions.  Commonly this is an expectation that laboratorians struggle with because they don’t understand where or why they fit within the laboratory.

Risk analysis fits perfectly within the Quality Management systems as a direct approach to  Preventive Action.  Preventive actions are the process of looking at new equipment, new procedures, new policies, or the existing environment (think safety audits) to see if they have the potential to cause more harm than good, and then addressing the problems BEFORE they occur (ergo they are preventive).   

I think that the reason that these are so difficult for laboratorians is because thinking about problems before they occur seems like a lot of “blue-skying “ and a waste of time.  Well it is blue-skying, but with a safety mechanism built in.  If you dream up a potential problem that is either so implausible  (very low occurrence) or so inconsequential (very low severity) you don’t have to do anything about it.  But on the other hand if you discover only one thing that has a real potential impact on worker safety, or patient safety, or test performance, or quality control, or finances, or liability, then the risk-preventive action process has done you a real favour. 

So how often do you go through the exercise?  It depends.  How often do you do a safety audit?   When you are setting up your safety program you probably do them frequently.  Once the system has settled in, you probably do them less often; same with risk-prevention audits.  The only real problem is when you slow down to the point that you have essentially stopped. 

As a commitment, you can tie doing a risk-prevention audit to when you introduce a new piece of equipment, a new procedure, or a new policy, and again a few months later when it has settled in.     

In addition, this can be really valuable when you have made changes because of an imposed change in regulation or budget.  Not that I am a “I told you so” kind of guy, but recording and reporting potential risks in a constructive structure along with a resource strategy of how to prevent them, can be both helpful and powerful.

Risk-prevention audits don’t have to take a lot of time.    Often you can work through the whole process in a few hours.  But give yourself enough time to take the task seriously. 

You may be very glad you did. 

PS:  Some folks still write and sell software that includes the term CAPA which suggests that Corrective Actions and Preventive Actions are the same thing.  They are not the same thing and those software packages are a waste of electrons and machine language and money.

Quality Education: what's it good for?

We are putting together a Master’s in Laboratory Quality Management which we expect will be available both in an on-line option and an on-site option.  The on-line will primarily be for folks who are working and intend to continue to work.  The on-site will be for folks who want to take some time away and spend some time doing primary research in medical laboratory quality.  I will continue to write on the subject as the program becomes ready for prime-time.

In the process of putting the proposal together, we did a survey of the folks who participated in the UBC Certificate Course.  Rather than invite and re-invite folks to respond to the survey we made the decision to take the responders from the first pass.  Both approaches can be equally useful, as long as you take methodology  into consideration as you interpret the results.

So after 5 days we gathered about 25 percent of course attenders.  The distribution of folks from across British Columbia and across Canada, and from outside Canada were essentially the same as the total group.  In addition the responders  equally included participants from the early years, the middle years, and the recent years, and few from the current group.   As we did not put any pressure on this group we can interpret this as a reasonably representative group.

Of interest to us was that about 90% belief there is a market for people with a Master’s degree today, and that the same percentage see that the market will be much stronger over the next 5-10 years.  That is what I believe too.

One finding that interested me, and disappointed me at the same time, was that only about 65% of responders currently are holding positions involved directly  in Quality.  We didn’t ask how many had held quality positions but had changed jobs, in large part because that was not the primary point of the survey  But what was interesting was that folks who had taken the course but were not actively engaged in Quality positions still believed there are opportunities out there, and that the market will continue to get stronger.

Which all got me to thinking; there are all sorts of positions for people interested in and trained in Quality.  The most obvious position is as part of a quality team or a part of laboratory  management.  But there are lots of other places as well.  There are positions with all the quality partners, like the proficiency testing group and the accreditation bodies.  There are positions within public or civil service, especially within the Ministries (or Departments) of Health and the health authorities, where knowledge of laboratory quality is important.  There are positions with service and equipment and reagent suppliers who need to be aware of validation, verification, stability, and measurement uncertainty.  And there are consultant positions, especially as we in Canada move more and more towards official inquiries for laboratory error.  And importantly there are increasing opportunities within education with the schools of technology, as well as the medical schools.

Bottom line appears to be that Quality in health and in particular the medical laboratory is a growth opportunity; today and tomorrow, and from the folks who responded to our survey, for the next 5-10 years plus.

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.

Medical Laboratory Quality and Risk

From the beginning of classification, there have always been lumpers and splitters.  There are some who think that Quality Management, Risk Management, Financial Management, Safety Management, Personnel Management (Human Resources),  are all the same, just Management. 
I don't. 
But I do try to find the interfaces.


Laboratorians get Quality Management.  We may not all do it, but we understand why it exists, and work towards it, each in our own fashion.  What Qualitologists try to do is smooth that process out.  
And I think that laboratorians have a sense of Risk Management, although I think we see risk in three lumps: risk tolerance, risk avoidance and risk aversion.  What we tend not to see is where and how managing risk fits into the the process of managing quality.


There is a small, poorly known, ISO document entitled ISO/TS 22367:2008,Medical laboratories -- Reduction of error through risk management and continual improvement.  The TS in the title means it is a "technical specification" rather than a standard.  (Think of TS as "guideline").  But it is very helpful, because it links quality management and risk management together at the point of preventive action.  The point is that avoiding risk is something that can and should be done before the bad thing happens.  And using Risk Management tools like Failure Mode Effects Analysis can be useful.  The most common situation in the medical laboratory where FMEA comes into play should be before you purchase the new equipment, before you make an overhaul of management structure, before you introduce that LEAN restructuring.  Doing a swap out can be costly of TIME, EFFORT, ENERGY  and MONEY, so before you expend it ask "if this goes wrong, why is it likely to happen, and what can I change now to prevent it".  It is stunning how often we see changes that go in, and later after all sorts of problems have been discovered, it has to get pulled out.  And I know that you have seen it too.  

Now we all know the Rumsfeld classification of known problems, known unknowns, and unknown unknowns, and the unknown unknowns will always bite you in the neck.  But there are so many problems we can prevent by a little risk management FMEA before hand.

But there is another Risk Tool that I was introduced to a few years ago by an excellent Project Manager - the likelihood-outcome table.  It is a valuable part of risk and equally part of priorities planning.  By sitting back and looking objectively at a series of choices or problems to address, as yourself, "when these go south, what happens?  How often do they occur and how bad is the outcome?"  Those things that occur rarely but with a fatal outcome have to come before the event that occurs commonly but causes some maybe some annoyance or inconvenience.   

Below is a theoretical table, in which I structured likelihood of occurrence from remote to frequent and outcome from trivial to critical.  We can put a value on those from experience, or literature, or estimation.  In this table any L/O product greater  than 0.2 has to have high priority.  Any with an L/O less than 0.1 can have a pass.  And those in between need to be addressed, but after the high priority ones are taken care of.  

From personal experience, it is a very helpful way of looking at projects and getting things done.

There are a number of courses on the web addressing risk management.  From what I have seen, they all cover similar concepts, but look at the one on www.westgard.com.  As far as I can see, it is the only one that includes ISO/TS 22367:2008.