13 replies to this topic

[noahchris97]

Morning All,

                I would like to be a little more educated a bit on NCR's and the proper way of running a NCR process / program. We have a current NCR process but its way out of control. everything and everything is getting NCRed. I have only been here for a short period of time at this food contact packaging facility. Its getting very overwhelming....

 

 Is there categories for what falls under to be considered a NCR? What are NCRs suppose to be used for? Quality / process only?

 

What I'm getting to is that the president wants me to redo,revamp, simplify the NCR process. NCR's are taking to much time away from the supervisors to get them investigated, corrected , trained on what ever the issue is.

 

I'm looking for advice on how to run a successful, simple NCR process....

 

Thanks,    

JJ

[Setanta]

Well, even if you specify that it is food packaging, there is a lot left unknown. 

What kind of NCRs in particular?  What's your..pardon the expression...low hanging fruit?  The biggest issue you have now?

[SpursGirl]

I guess the first thing to understand is whether the NCR's that are being raised are actually justified.

 

If they are justified it would suggest that it is not the NCR system that is out of control but your systems/compliance that is out of control.

 

A non conformance should be raised where something (document, result, system, physical performance) is not compliant to standard/procedure/policy.A NCR can be raised from anywhere - not just quality or process but from audits, pest control visits, validations etc etc.

 

There are so many ways in which to set up a NCR system - it will be down to you to set up something that works - but the basis of the system should:

• Provide a reference number for each NCR
• Identify where/when raised
• Catagorize severity (ie minor, major, critical)
• Identify person responsible for investigating, actioning NCR
• Identify timescale for completion/close out
• A process for issuing out the NCR to the person responsibel (physical form, electronic form)
• A process for completed NCR to be reviewed and signed off
• Be able to track and trend

 

I personally have a NCR system which captures live factory based issues and then a seperate log which captures issues from audits. I just find it easier to differentiate between live issues (compliance) and system issues.

 

Hope that helps,

 

S

[noahchris97]

Morning

Setanta

 

  , to be honest here, its everything... I'm the SQF Practitioner with no control of what the VP of quality does with the NCR process. I was called in by the president to fix, change, simplify the current NCR process. the NCRs are generated for anything and anything.. short a bag in the order, someone not filling out documents correctly, hairnet not worn properly and so on... 

 

I just need to know what a standard NCR process consist of.. How is layed out / structured and or if there is categories on what can generate NCRs

 

Thanks,

JJ

Edited by noahchris97, 25 February 2015 - 02:49 PM.

[SpursGirl]

I would be raising NCRs for incorrect wearing of hairnets and not completing documents correctly.

 

It appears to me as though your current system is correctly identifying issues howver it may not be so good at allocating NCRS for investigation (to find root cause) and implementing corrective/preventative actions. Only by doing this will the actual numbers of NCR's raised begin to fall.

 

S

[fgjuadi]

This can be super onerous when you're transitioning and you don't have a program fully developed yet.  If a program is still being implemented, you'll have way more NCRs .  For ex, if you do a gap assessment and then fill out an NCR for everything that's a gap, you'll have hundred s of NCRs if you're moving to a bunch of new systems.   I've made this mistake before - we didn't have a solid vendor approval program, so I was writing NCRs for every frickin purchase.  It ended up being easier to create one NCR (NCR #88675309 - Ingredients received without proper documentation) and then add specific instances of the same issue to that one.  ( For hair nets, NCR # 1 - on 2/13/14, Stabby entered production without a hair net.  GMP training was given on 2/12/15.   Training was reviewed and discussed.  On 2/17/15, Knuckles entered production without a a hairnet. Here's a record of Knuckles training, and a verbal warning was issued etc)   Then your corrective action becomes a little clearer - if it solves all of the related issues, hooray!  If not, try again.  

 

Focus your energy on only root cause issues that will give you a major violation.  If you have  oil leaking over a product zone, that's more important than not having a letter of guarantee from Harry's Soda and Pet Supply Store. 

[Setanta]

LOL Stabby! 

[it_rains_inside]

It took some time for me to figure out the boundaries of the NC program too. This is what we established.

 

      A corrective action form must be filled out for the following conditions:

      A critical food safety limit not met

      A critical food quality limit not met

      A product placed on hold due to quality issues or a customer complaint that can be determined as a risk, either currently, or in the future

And/ or any minor infractions that happen repeatedly.

 

In doing routine GMPs audits I captured all the little piddly stuff, like Knuckles and Stabby not wearing hairnets correctly. These forms addressed closing out minor infractions immediately and provided a 'temporary resolution" - so then we started trending these GMP inspections to see which were the bigger fish to fry. 

 

"Ok so we had 543 hairnet violations ins February, let's do a shift training so that everyone knows what the expectations are, then we start issuing warnings"

 

Really, depending on the issues, the scale of intensity can be very different. That's why we set up two. Minor stuff gets the immediate resolution, which can be trended to look for bigger problems, then  your big problems get the full on root cause investigations and all that jazz. or it can be a big problem from the start (like those mentioned above) and would be subjected to the NC program. 

 

A flow chart may be more helpful. I hope this makes sense...

Edited by it_rains_inside, 25 February 2015 - 04:43 PM.

[Charles.C]

Morning

Setanta

 

  , to be honest here, its everything... I'm the SQF Practitioner with no control of what the VP of quality does with the NCR process. I was called in by the president to fix, change, simplify the current NCR process. the NCRs are generated for anything and anything.. short a bag in the order, someone not filling out documents correctly, hairnet not worn properly and so on... 

 

I just need to know what a standard NCR process consist of.. How is layed out / structured and or if there is categories on what can generate NCRs

 

Thanks,

JJ

 

Dear noahchris,

 

AFAIK , NCR stands for non-conforming result.?

 

I don't understand how this can be a process / program.

 

If i understand correctly, this discussion needs some context as per posts #2,3 from the OP to avoid going round in circles.

 

Rgds / Charles.C

[noahchris97]

Charles,

               Point trying to make is, I know what it is, I know what can trigger a NCR but there should be a limit what a NCR can be consider a NCR. or if it falls under this category it will constitute a NCR, under this category its not considered a NCR.....Plant personnel is chasing / investigating all these NCRs and loosing sight of their main responsibilities. Just would like to put in some classification on what can generate a NCR....

 

Thanks,

JJ

[fgjuadi]

I have this in our procedure -

1. As part of our commitment to continuously improving quality and food safety, minor corrective and preventative measures will be taken constantly. 
2. A documented corrective action will be initiated by QA anytime
   1. EMP or 3^rd party laboratory testing results come back outside of acceptable limits
   2. A customer complaint is filed
   3. Any time non-conforming product is not part of the Remelt/rework process flow
   4. When the conditions of SOP #blah blah exist, but a  deviation request was not completed prior to the deviation  (change to HACCP plan / equipment deviation)
   5. Internal or 3^rd party audits reveal major or critical deficiencies which had not been previously recognized on the CAPA log.

Edited by magenta_majors, 25 February 2015 - 08:05 PM.

[Charles.C]

Charles,

               Point trying to make is, I know what it is, I know what can trigger a NCR but there should be a limit what a NCR can be consider a NCR. or if it falls under this category it will constitute a NCR, under this category its not considered a NCR.....Plant personnel is chasing / investigating all these NCRs and loosing sight of their main responsibilities. Just would like to put in some classification on what can generate a NCR....

 

Thanks,

JJ

 

Thks.

 

Yes, i get yr drift.

 

It sounds like bedlam.

 

It appears to me  from yr OP  that the basic problem is you are unable to decide how/where to set limits which may then generate a NCR.

 

This is where the context comes in. The scope  for the limits is up to you/your product/your Process/your Specifications/your Policies, etc, as per the various set-ups already posted, be it Non-Safety or Safety-related. There is no fixed range of application.

 

Can you provide an example from your own situation which you don't understand so as to better appreciate yr dilemma ?

 

Rgds / Charles.C

[mesophile]

Hi All,

 

I think you could wipe out a lot of these NCR's through better management practices and staff training.

 

NCR's are really important and simplifying these too much might mean some important aspects are missing. Usually it is not the simplifying that is required, it is the engagement of the staff and management to not causing the NCR's in the first place. 

 

Who issues an NCR? Have they been trained to the correct policy/procedure/SOP in the first place?

 

Is there one member of staff that issues considerably more NCR's than anyone else?

 

When you take your Quality Manual/SOP etc... if the NCR justified?

 

What I would do is:

1. Take the top 3-5 NCR's you have received over the last 12 months. Don't do more than 3-5 issues at a time it becomes too much.

2. Give the staff/supervisors correct training in each of these areas (preferably off the floor so they are not distracted by other activities, and it makes it look more serious)

3. Give them each a copy of the SOP they have just been retrained on

4. Follow up with practical advice when they are conducting these activities and ask them questions to ensure they understand what is required

5. Stand back and give it a few weeks and see if the NCR's in those areas drops

 

If they drop, move on to the next top 3-5 NCR issues. If they don't, you may have to spend some time in the problem areas and really see what is going on. If the staff are doing their job correctly, it could be a disgruntled manager filling in NCR's just because they are frustrated with the world around them...

 

Good luck, and let me know how you get on.

 

Thanks,

 

Simon

[Ekivlen]

I echo some of the above mentioned sentiments, but especially the comments that state the fact that you either need to gain control of your process (due to the number of non-compliances) or re-define/re-train as to what a non-compliance really is.

The name of the game is food safety and food quality. Research industry standards, define parameters, validate, train, implement, and verify. Also, as stated above, it is IMPERATIVE to forecast for continuous improvement.

Baseline validation studies are huge.