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Statistics and Sampling - Accounting for Failed Tests

SRQAAuditor

Starting to get Involved
#1
Hi, I haven't seen this question on here, and need some help. I work for a medical device manufacturer. I am the internal auditor. While auditing one of our production lines, I requested that a specific test be demonstrated. The individual demonstrated the test, and since we deal with thin wires, I asked what happens if the wire breaks during the test? He told me that he just scraps the broken wire, and chooses another one to do the test again.
This doesn't feel right to me.
Any suggestions?

Thank you,
 
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Jim Wynne

Staff member
Admin
#2
Re: Statistics and sampling

Welcome to the Cove. :bigwave:

It's impossible to say whether it makes sense or not without knowing more about the product, the test method and the purpose of the testing. Could you give us a little more information?
 

SRQAAuditor

Starting to get Involved
#3
Re: Statistics and sampling

I can provide some more information:
The product is used to retrieve stones in the human body (gall stones, etc), so it is a thin wire.
The test method is pushing the wire through a fixture that has bends. To simulate the wire passing through the human body.
Let me know if you need more information.
Thanks for your questions.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
sounds like the wire shouldn't break...is he "testing to pass"?
this is often done when the (all too convenient and denial based) the tester 'believes' that the test was incorrectly performed.
 

Bill McNeese

Involved In Discussions
#6
Nothing wrong with doing the test again, but if the failure does not get recorded anywhere, that is a problem. The process performance is not what the data would indicate in this case. How often does this happen is a question to ask.
 

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#7
Yes, this sounds very questionable to me. A few things to consider:

1. What is the cost to the company of the product that fails the "test" and gets scrapped?

2. How do you know that performing the test doesn't shorten the life of the wire since you have now bent it and presumably straightened it again? Have you put in some fatigue cracks?

3. Yes, if the test is intended to test the wire, a failure is a failure of the test and should be recorded as such. If the "test" is considered part of the manufacturing process, I suppose it could be excused, but then how do you know how the wire will behave in its use? What is the test then that you, the manufacturer performs?
 

SRQAAuditor

Starting to get Involved
#8
Thank you for the additional thoughts to follow up with! This test is not performed every day, but I have requested to be present during the next test, and will follow up!
 

Jim Wynne

Staff member
Admin
#10
Is this written down anywhere?
Thank you for the additional thoughts to follow up with! This test is not performed every day, but I have requested to be present during the next test, and will follow up!
You should pay special attention to Marc's question. If this is a required test, it should be documented:
  • Reason for testing
  • Frequency of testing
  • Method of testing, including gages, equipment, etc.
  • Objective pass/fail criteria
  • Reaction plan--what to do in the event of failure
  • Record keeping, including retention of test specimens if necessary or prudent
If the test is important enough to be doing on a continual basis, it should be properly documented.
 
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