Managing errors

[Malcolm Needs ☆]

You are correct in one way Rashmi, and that is inspections can be extremely useful and one can learn from them. By no means have all of the inspections I have had been a "waste of time" and nor have all the inspectors been autocratic; indeed the vast majority of the inspections have been extremely useful, promoting change for the better, and the inspectors, in the main, have been very helpful. It is, perhaps, invidious to name names, but the inspector we had from the CPA, was absolutely fantastic (and, as soon as I can remember his name, I will certainly give him a name-check - old age is on the gallop)!*

The inspection that resulted in the delay of 5 months, however, was quite definitely NOT in that category. The delay was not caused by the Centre, but by the fact that the inspector kept changing his mind as to what he wanted us to do, as he changed his mind over what the EU Regulations actually meant, notwithstanding the fact that this particular activity was not actually covered by these Regulations. As the non-conformance was seen as a major, however, we thought it best to molify this particular inspector before we re-started. In actual fact, the changes he demanded have made no measurable difference to the screening programme whatsoever, and unless changes can be measured, they are changes for the sake of change.

*Eddie Welsh or Walsh was the chap's name - brilliant inspector and really helped my Laboratory.

Edited June 8, 2009 by Malcolm Needs
Old age regressing!

[dferia]

Yeah, I remember how opaque and broadly worded some of the EU stuff can be worded. Besides some interaction with EU reqs due to plasma shipment overseas, I spent a year working in the UK. Rather miss it. But enough about my traveling insanity...

Honestly, the details about that particular inspector is more than a bit disturbing, and I'm shooting under the line of the first few words that escaped me on reading that. If someone flat out admits to not knowing what they're assessing, they should step down in favor of someone who does, or barring that, learn about the subject matter themselves so they do have a clue. Just my opinion, but having run an audit program for an organization, I'll be the first to admit I didn't know everything about everything, and even by time I left that position I still wouldn't have made any such claim. I never thought I was deluded enough to believe it, nor a good enough liar to pull that off with a straight face anyways. But, knowing that I put in a great deal of time and effort to gain an understanding of the basics of those topics I was less knowledgable of, cultivated a network of individuals (independent and otherwise) of the process with which I could bounce questions off of to ensure I had a clue, and kept an open mind and ear when discussing things with those I audited. If nothing else, I learned something new (and personally I'm happier for learning something new every day) and I like to think the in the end the audits were of greater value for that.

Regardless, with the particular inspector at hand, even as the lead inspector, I can't imagine he doesn't report to somebody, either a direct supervisor if he works for a regulatory body (MHRA, etc) or the head of the inspection program if the person is a volunteer assessor (such as AABB). Taking such concerns, and I think if nothing else the admission of incomprehension qualifies as more than valid, to that responsible individual will hopefully provide some beneficial results. Then again, life doesn't always hold to common sense, but we can hope and dream, can't we?

As for the matter of change for the sake of change, I couldn't agree more. Unless a change is being made to meet a regulatory requirement, address a process weakness, improve control/monitoring or incorporate a necessary change (new equipment, new facilities, etc), then doing it is usually a waste of time. Worse, even if the change has minimal impact, positive or negatve, the change will result in a period of process instability as staff adjust, resulting in an increased liklihood for errors to occur, even if the error has no impact on the health/safety of patients and is just the bare basic 'not following SOPs as written'.

[Malcolm Needs ☆]

Thanks dferia.

I've decided not to say anything else on this thread, in case "the lady doth protest too much", but (there is always a but) this particular inspector was beyond the pale.

[dferia]

May the wind be at our backs, our friends close at hand with a smile and the clueless under the sea. Or something like that.

[eric1980]

Having seeing such things in my lab myself, I am of the opinion that retraining will not have an effect. (eric1980's boss: Blasphemy!)

The reason why I think it is so is due to that they will be able to recite what is the correct method, and they really do understand why they are doing it. This shows that it's not a matter of re-training. It might instead reduce the staff's morale and will contribute to more mistakes in future.

But If they could not tell you what is the correct steps/procedure, it shows that the staff is not well trained in the first place and whoever certified the new staff to work alone will be accountable.

To reduce mistakes, I think that we should review/streamline the process so that there will be no room for assumptions, or to implement an alternative safe blood transfusion practice to see if it suits the workflow. Add more steps into the procedure with caution! Adding unnecessary steps might increase chances of error instead...

^My opinion - not a proven fact everywhere, but I hope you could consider...

[RR1]

Thanks eric, that's very helpful. When we competency train our staff in certain procedures, this involves performing an examination audit against the key stages of the procedure, ( e.g performing final patient ID check prior to blood release), which is recorded within staff training folders. This should be adequate in showing that the person was able to understand and perform the task at the time of the assessment.

I fully agree with what you and others have mentioned, that the processes need to be examined and streamlined to find areas of weakness. It's all this 'lean six-sigma' we should all be trying to implement within our working environments, that will ultimately help reduce these problems.

[bmsjbatt]

Managing errors relies on a certain amount of trust,

In laboratories where qualified staff are treated like incompetent children, they will relinquish any responsibility for self checking, and so more errors will creep in as they subconciously lose self respect, and absolve responsibility for their actions to their supervisors and managers.

Empower your staff and they pick up their own errors and each others, they come up with useful suggestions on how to avoid errors and the overall inicidence of low level errors decreases.

The lab where all team members feel as though they have a valuable input to give and a voice that is listened to, has a remarkable performance.

So I agree with Eric, do not go putting extra steps into procedures and tightening procedures down to such a level that there is no ability to use judgement.

Sorry for the touchy feely speak but I have seen both environments in action, in several places and the results are always the same.

[RR1]

Some very good points Jo, thanks and I agree with what you say totally . I have also seen extra steps added to procedures, to theoretically improve safety- and all it's done is to stress the staff out so much, that it almost an incident waiting to happen. This sort of thing annoys me too.