NADCAP Rejection Response to Root Cause Analysis and Corrective Action.

#1
Good Day
We have recently had our Nadcap audit, and my operator did not visually look at the calibrated clock during the entire water break.
NCR AC7108/12 Operator perfomed Water Break test but did not use calibrated timer.

Our response was as followed:

.Immediate Corrective Action Taken (Containment Actions)
Operator notified immediately of issue.
Temporary Calibrated Handheld timer was implemented.
New calibrated timers were ordered, that will be permanently mounted on each side of the line.


2.Root Cause of Nonconformance
Internal procedure of water break does state that timer must be in the line of sight, timer was present but not visible to the operator.
While timers are throughout the process, the operator did not have sufficient position to visually look at the timer during the water break.
Actual Call out for the Water Break Time is not on the Process Card.


3.Impact of all Identified Causes and the Root Cause
No Impact, lot verification all have been acceptable
Operator constantly is observing parts during the part process to ensure parts are clean enough prior to running the parts and observing the parts after the process to ensure the parts are acceptable


4.Action Taken to Prevent Recurrence
Digital Calibrated Wall Clocks we were purchased – 9/8/2021
Operator has been trained on SOP-0031 Water Break Procedure. 9-16-2021
Digital Calibrated Wall Clocks were installed on 9/21/2021
Process Card now includes water break 30-60 seconds


5.Objective Evidence Attached
please see attached evidence.

6.Effectivity Date
9/21/2021

This response was rejected back to me.

1) Current procedure states "Timer must be in visible or audible to operator completing the visual inspection of the
water break test." as such why didn't the operator ensure that this was being followed. Please readdress root cause to determine why operator was not following the procedure.


2) Please also readdress action to prevent recurrence once root cause from above.


I'm not sure how to respond to this.
 
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John C. Abnet

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#2
'm not sure how to respond to this.
Got to go with your auditor on this one. As long as your internal requirement states "must be in the line of sight", then, well....must be in the line of sight (i.e. visible to the operator)

Your organization:
Internal procedure of water break does state that timer must be in the line of sight, timer was present but not visible to the operator.

Your auditor:
Timer must be in visible or audible to operator completing the visual inspection of the water break test." as such why didn't the operator ensure that this was being followed ? Please readdress root cause to determine why operator was not following the procedure.


Without having intimate understanding of your organization, I see three (two) potential options...
1- Replace the requirement for the operator to be in line of sight...."watch" the clock, with an automated, or tactile, or audible, method ..or ...?
2- Change the location(s) in regard to where the test WILL take place with the line of sight of the available clock so that testing cannot take place in an area where "line of sight" to the clock. (although this does NOT address the root cause of the nonconformance identified by the auditor).
3- Change (systemically), the training (curriculum) , review, competence method/verification of the associates to ensure this associate and FUTURE associates have a robust orientation, understanding, monitoring in place.

Hope this helps.

Be well.
 
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