Can I issue a NCR if the auditee did not comply what he is suppose to do?

johnnybegood

Involved In Discussions
#1
Can I issue a NCR if the auditee did not comply what he is suppose to do but the activity is not documented?
Is there a time frame that a CA has to be determine and implemented?
 
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johnnybegood

Involved In Discussions
#4
The process engineer had introduce the SPC program for solder paste printing where the operator is required to check for solder paste thickness every 2 hours and the data is then plotted on the SPC charts. However this activities are not documented but the operators were trained. During a roving audit I found that some of the operator did not carried out the task. Question is, can I file a NCR for failing to perform the task?

My next question is on the CA. Very often the auditee did not provide CA timely. Though we did not spell out the time frame in responding the NCR, I find it very tiring to follow up for the NRC closure. Is there and guideline on the NCR respond time? 1 week, 2 weeks? Pls. advise.
 
M

M Greenaway

#5
Johnny

The fact that people arent doing something is symptomatic of something else. Some suggestions are:-

The process of SPC checks is not adequately defined.

Training was inadequate.

Motivation is poor (top management commitment ?).

Inadequate resources.

Try looking for root cause on one of the above (or others you might think of).
 

gpainter

Quite Involved in Discussions
#6
Based on info given YES, " No record of checks for solder paste thickness every two hours as required by training" I would assume that you checked the trainers notes to see that this was covered in the training on the form used. I have seen various response times from 12 hours to 90 days, most that I have seen have fallen in the 14-30 day range.
 

SteelMaiden

Super Moderator
Super Moderator
#7
johnnybegood said:

My next question is on the CA. Very often the auditee did not provide CA timely. Though we did not spell out the time frame in responding the NCR, I find it very tiring to follow up for the NRC closure. Is there and guideline on the NCR respond time? 1 week, 2 weeks? Pls. advise.
I won't spend a lot of time on whether or not you can request a corrective action be done, you've gotten good info from others.

As far as timely response to corrective action requests, you do have the right to expect answers, but you need to make sure that your time frames are documented.

As background: What I have found throughout the years is that people confuse investigation with corrective action. You want to set deadlines of when you expect an investigation to be done and documented. From there, it will be decided what actions are required and those actions must also have their own due dates. It is not always possible to complete ALL corrective actions in a week or two. Some may take a year or more.

And so, set a due date for investigation results and a corrective action plan to be submitted. We use 1 week for a major (high priority), 2 weeks for a normal priority item, and 3 weeks for a low priority item. The priorities are set by the auditor (originator), myself, and manager of the area involved. By the due date, I expect to see an investigation documented along with identification of the root cause and some sort of action plan. Those actions do not need to all be recorded, but a plan does.

The next step, is to coordinate documenting the actual corrective actions needed and to set due dates for each. Make them realistic, if you are purchasing big ticket production equipment to correct a problem, don't say the corrective action will be done tomorrow, it takes time to research, purchase, build, ship, install and test something like that for capability. On the other hand, if you just need to create new or revised documentation, you sholdn't need a month to do it. (the sandbagger effect :biglaugh:)

I have found that if you get everyone submitting their investigations on time, the scheduling of corrective actions becomes more second nature to people, it is mostly just a matter of discipline. Do not be afraid of bringing up names when you have folks that don't do their part. If you are sitting in your steering committee meetings and one area is always ignoring deadlines, peer pressure may work to your advantage

Good luck, it takes a while to get everyone on board. BTW, the SPC problem you encountered is pretty common, there is always one, I once had a guy that would take all his charts home and fill them in during the weekend! I solved that one by going real-time with data collection SPC software.:p
 
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