NADCAP Nonconformance for Timer not used for Time period

O

omartinez

#1
Guys I got I need a lityle help :
I did answer some NADCAP NC and get rejected by the auditor :
Here is the finding

Per AC 7108 Rev. F sections 3.10-3.10.1-a., 5.11.1 & AC 7108/2 Rev. B section 4.10.1 all shop equipment used to set, control or monitor the control of a process is to be calibrated and in this facility's calibration/recall system. All timers are to be available, suitable to the purpose, calibrated and visible or audible from the processing or testing area.


When the operators performed the process for the internally generated 10 seconds time period there was no timer used to ensure that the 10 seconds that process t was perform for this prescribed time. (adequacy)

My response was :
Immediate Corrective action
Procedure has been modified to ensure the use a calibrated Timer.
Personnel involved the process were trained to this new requirement.

Root Cause
The 10 seconds time requirement for the process is attached to our spec, but there?s no specific requirement into the procedure in order to use an available and calibrated timer.


Preventive action
Procedure has been reviewed to declare all the equipment needed for the monitoring of the process variables as Temperature, Time, Conductivity, TDS, pH
Procdure has been reviewed to include AC7108 & AC7108/2 as documents that will be reviewed. The responsibility of doing these revisions has been attached to the procedure
Manufacturing & Specials Process Engineers has been trained into new changes.

I found those as a Root Cause but got rejected Could you please help to clarify what exactly the auditor would like to see ?
 
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BradM

Leader
Admin
#2
Re: NCN for timer not used for time period

Hello there!

OK, this is the requirement:
Per AC 7108 Rev. F sections 3.10-3.10.1-a., 5.11.1 & AC 7108/2 Rev. B section 4.10.1 all shop equipment used to set, control or monitor the control of a process is to be calibrated and in this facility's calibration/recall system. All timers are to be available, suitable to the purpose, calibrated and visible or audible from the processing or testing area.
This was the "finding":
When the operators performed the process for the internally generated 10 seconds time period there was no timer used to ensure that the 10 seconds that process t was perform for this prescribed time. (adequacy)

Your root cause explanation:
Root Cause
The 10 seconds time requirement for the process is attached to our spec, but there?s no specific requirement into the procedure in order to use an available and calibrated timer.
So... you were required to have calibrated timers, have them available, and to demonstrate using them for the process. Yet, it does not seem your root cause explanation addresses that.


Consider:
  • Why were there no timers available?
  • Are there insufficient timers, or no timers at all?
  • Did someone just "write" down they timed the cycle, or did they use their watch/Iphone, etc.?
  • Did no one use a timer because it was not in the procedure to use the timer?
Saying... I would dig a little deeper and determine what really happened.
What are the causes for the calibrated timer not being used?

Also, have all your procedures had a gap analysis performed against the standard? Maybe consider doing this, so you don't miss anything else. :)
 
#3
Re: NCN for timer not used for time period

I do not know your process, but have a few questions ...
How was the 10 sec determined for the process
What was the tolerance like +/- 1 sec ? or so
Was the timer built into the process like a countdown to shut off process ?
Or was an operator just mentally counting upto 10 mentally or looking into his wrist watch or cellphone or a handheld stopwatch ? and taking actions thereafter.
How critical is this 10 sec time for your process as determined by you ?
Try to do a 5 why analysis to the detected problem ...
 
O

omartinez

#4
Re: NCN for timer not used for time period

I do not know your process, but have a few questions ...
How was the 10 sec determined for the process
What was the tolerance like +/- 1 sec ? or so
Was the timer built into the process like a countdown to shut off process ?
Or was an operator just mentally counting upto 10 mentally or looking into his wrist watch or cellphone or a handheld stopwatch ? and taking actions thereafter.
How critical is this 10 sec time for your process as determined by you ?
Try to do a 5 why analysis to the detected problem ...
Somashekar
The operator just mentally counting upto 10 mentally.
The time is 10 to 30 secs
And is not very critical , the process is just to clean the parts.

I have create a 5 whys :
(1) WHY: The operator is unaware of the proper measurement devices that are needed for some processes.

(2) WHY: The applicable procedure do not specify the use of a timer or any other time measurement device for some process.

(3) WHY: It was unclear for the Process Engineer who designed the procedure, when to dictate the need of a measurement device and when do not.

(4) WHY: There was not a benchmarking process to investigate when to properly point out the use of time measurement devices.

Root Cause: The Process Engineer did not completely clear out his questions regarding time measurement devices and applicability.
 
O

omartinez

#5
Re: NCN for timer not used for time period

Hello there!

OK, this is the requirement:


This was the "finding":



Your root cause explanation:


So... you were required to have calibrated timers, have them available, and to demonstrate using them for the process. Yet, it does not seem your root cause explanation addresses that.


Consider:
  • Why were there no timers available?
  • Are there insufficient timers, or no timers at all?
  • Did someone just "write" down they timed the cycle, or did they use their watch/Iphone, etc.?
  • Did no one use a timer because it was not in the procedure to use the timer?
Saying... I would dig a little deeper and determine what really happened.
What are the causes for the calibrated timer not being used?

Also, have all your procedures had a gap analysis performed against the standard? Maybe consider doing this, so you don't miss anything else. :)
Thank you BradM ....

Why were there no timers available?
The operator didnt know he have to use the timer
[*]Are there insufficient timers, or no timers at all?
We have timers , but we didnt use for this process
[*]Did someone just "write" down they timed the cycle, or did they use their watch/Iphone, etc.?
They just count mentally , they didnt use any watch.
[*]Did no one use a timer because it was not in the procedure to use the timer?
Yes It was not in the procedure to use the timer , so the operator start count mentally
[/LIST]Saying... I would dig a little deeper and determine what really happened.
What are the causes for the calibrated timer not being used?
I have this 5 why little more dipper what do you think ?

There is no proper time measurement devices used on some processes.

(1) WHY: The operator is unaware of the proper measurement devices that are needed for some processes.

(2) WHY: The applicable procedure do not specify the use of a timer or any other time measurement device for some process.

(3) WHY: It was unclear for the Process Engineer who designed the procedure, when to dictate the need of a measurement device and when do not.

(4) WHY: There was not a benchmarking process to investigate when to properly point out the use of time measurement devices.

Root Cause: The Process Engineer did not completely clear out his questions regarding time measurement devices and applicability
 
#6
Re: NCN for timer not used for time period

Somashekar
The operator just mentally counting upto 10 mentally.
The time is 10 to 30 secs
And is not very critical , the process is just to clean the parts.

I have create a 5 whys :
(1) WHY: The operator is unaware of the proper measurement devices that are needed for some processes.

(2) WHY: The applicable procedure do not specify the use of a timer or any other time measurement device for some process.

(3) WHY: It was unclear for the Process Engineer who designed the procedure, when to dictate the need of a measurement device and when do not.

(4) WHY: There was not a benchmarking process to investigate when to properly point out the use of time measurement devices.

Root Cause: The Process Engineer did not completely clear out his questions regarding time measurement devices and applicability.
As it is AS9100 QMS, I will exercise caution.
What if someone does not clean at all ? What if someone cleans for a minute ? what are the risks.
What is the part and what is used to clean ? How does this effect the performance.
Kindly answer these yourself to determine if your way of cleaning and timing is good and safe to meet the cleaning requirement consistantly.
You may have to address Validation and then the procedure where the time control method is adequate to requirement, or think how to eliminate operator by getting in some ultrasonic cleaning bath or some sort of vibrator bath than has the process time inbuilt.
 
#7
Re: NCN for timer not used for time period

Hello there!

OK, this is the requirement:


This was the "finding":



Your root cause explanation:


So... you were required to have calibrated timers, have them available, and to demonstrate using them for the process. Yet, it does not seem your root cause explanation addresses that.


Consider:
  • Why were there no timers available?
  • Are there insufficient timers, or no timers at all?
  • Did someone just "write" down they timed the cycle, or did they use their watch/Iphone, etc.?
  • Did no one use a timer because it was not in the procedure to use the timer?
Saying... I would dig a little deeper and determine what really happened.
What are the causes for the calibrated timer not being used?

Also, have all your procedures had a gap analysis performed against the standard? Maybe consider doing this, so you don't miss anything else. :)
I'm pretty much on board with this explanation. The auditor found a problem. You stated in your root cause that it really wasn't a problem. The auditor didn't accept that answer, basically telling the auditor that he was wrong.

I don't know a whole lot about NADCAP, but some of my clients are also NADCAP for some of their processes, and from what they tell me, NADCAP is REALLY fussy about timers. They pretty much believe you have to have them and that they must be calibrated.

The funniest nonconformance I have been told about concerning a NADCAP audit for a plating process was getting written up for have a non-calibrated timing device in the plating area because the plater was wearing a watch. The watch wasn't being used to time things there, it was just there and that was justification to be a nonconformance.

So I would suggest you reconsider your root cause to show that the plater was not aware of the criticalness of using a timing device. Neither was the person that set up the process controls. Your immediate action may be to ensure there is an appropriate timer available for use and the corrective action (speaking to the root cause) was to train the plater and the person setting up the process the importance of providing and using precise timing information (between 10 and 30 seconds is precise).

Good luck. If you haven't discovered it yet, NADCAP is extremely strict (and that's about the most diplomatic way I can state it).
 
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