Process Change in a Laboratory - Start Date for new Procedure - Management Opinions

T

tedac

#1
I am looking for advice on how to address the following: Our lab uses a procedure that is currently approved to test “specimens” that arrive in “runs” that consist of different numbers specimens and may take several days to complete. Currently, all specimens from the same run are processed following the same procedure. A new procedure will be introduced which will change the process and number of specimens that can be processed per run. The issue involves the start date of the new procedure and what to do with those runs currently being processed under the old procedure. Management wants to change everything over to the new procedure on a specific date, including those runs currently being processed, and make a notation of the change in the work log for those runs. As the quality manager, I would prefer start all new runs on the start date using the new procedure and let those runs that had already been started continue through completion using the previous procedure. I’m now getting push back from management. Am I wrong in my thinking? How can I make management understand?
 
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#2
Re: Process Change in a Laboratory - Start Date for new Procedure - Management Opinio

Why is your preference where it is? You likely have some rationale behind that preference...what is it? What assumptions have you made...are they valid?
- Will data be affected? Will you get different results using the new method?
- What analysis later may be affected? Will the new procedure preclude comparison between 'before change' and 'after change' data?
- Why is interrupting an ongoing run a problem in your opinion?

Mgmt likely has a rationale behind their preference, and some assumptions.
- Less chance for error
- Easier to manage for the transition period if there is no transition period.
- Assume data is that same before and after
- Assume no issue with comparing data before and after.

You each have opinions on the 'best way'...what are the bases of those opinions? Any negotiation will be from the bases...not the opinions/conclusions.
Have you looked into what's behind the opinions...yours and theirs?
 
N

NumberCruncher

#3
Re: Process Change in a Laboratory - Start Date for new Procedure - Management Opinio

Hi tedac

I will ignore the management issue. My question is about the analysis.

Will the change in procedure affect the analytical results?
If not, why does it matter how the change is carried out? The results will be the same either way.

If the change does affect the analytical results, you have a bigger problem than worrying about the paperwork. If the results depend on how long the samples take to get through the system, you need to find a better analytical method.

NC
 
T

tedac

#4
Re: Process Change in a Laboratory - Start Date for new Procedure - Management Opinio

Ninja ... Thanks for your response. Your questions are valid from both a QC and Mgmt view which makes the decision that more difficult. Although I am not able to disclose the specific type of work that our lab performs, I can tell you we aid multiple government agencies by forensically exploiting potential evidence obtained from various geographic areas across the globe. That said, my primary concern, and my rationale for not changing in mid-run, are the potential downstream consequences should one of these runs suddenly become an important issue that requires legal action by the government. In those circumstances, I do not believe it would do well under a third party review to have switched procedures in mid-run. In a typical forensic lab, once analysis has started on a case, the case would be worked to completion using the practices and procedures that were approved for use at the time the analysis was started. Then again, I am not dealing with your typical forensic cases and your response will have me revisit my generally accepted practices. Maybe under these circumstances, I need to be more open to modifying my view. Again, thanks for your response … it really helped my sit back and look at the issue through a different set of glasses.
 
T

tedac

#5
Re: Process Change in a Laboratory - Start Date for new Procedure - Management Opinio

After careful review of the issue, it was determined that the process change will not directly affect the results. It is more a management issue in how many samples can be processed per run vs. how many runs need to be processed per week/month. The % of positive results are low per run but the overall % positive increases with the increase in runs.
 
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