Issuance of Non conformance Report for a CCP Deviation
Dear All,
In our organization, we have a documented procedure in addressing non-conforming product. Non-conformance report must be issued when there is a refusal or failure to conform on the set standards.
For example, I have a product ABC 7319231 that did not reach the minimum drying temperature.The drying temperature ranges only from 89.0 to 92.3 degrees celsius. Standard temperature is 95 to 110 degrees Celsius. Drying is considered as CCP deviation within our organization.
However, we have a supported document to address such deviation (Food Safety Dispositions - Deviations during Drying) and the correction done for this incident was properly addressed as per the document guide. Take note also that the actions done for this incident is recorded in the monitoring forms and testing shows that product was safe for release/process to next step after re-processing the product.
Do I still have to issue the Non-conformance report with corrective action although set standards are properly followed by the organization??
Thank you.
Yes! You should issue the NCR with corrective action despite of all the activities you have mentioned.
Justifications??
1) All the activities you have mentioned are CORRECTIONS not CORRECTIVE ACTIONS. Be clear about both types of actions. In corrections you just take temporary actions to correct the product or situation or both. In corrective action you actually do root cause analysis and take actions to handle that root causes so that the problem do not recur.
2) You have mentioned that the deviation is related to CCP. So it has made the situation more critical. Control of Non-conformance procedures, in general, are more specific to be applied on deviations at CCP. No sensible auditor will ignore the skipping of NCR in such situation.
Regards.
Muhammad Zeeshan Zaki.
Yes! You should issue the NCR with corrective action despite of all the activities you have mentioned.
Justifications??
1) All the activities you have mentioned are CORRECTIONS not CORRECTIVE ACTIONS. Be clear about both types of actions. In corrections you just take temporary actions to correct the product or situation or both. In corrective action you actually do root cause analysis and take actions to handle that root causes so that the problem do not recur.
2) You have mentioned that the deviation is related to CCP. So it has made the situation more critical. Control of Non-conformance procedures, in general, are more specific to be applied on deviations at CCP. No sensible auditor will ignore the skipping of NCR in such situation.
Regards.
Muhammad Zeeshan Zaki.
Thank you for the inputs Sir, may I know also if the root cause always of this deviation is caused by wear and tear material (consumable) of the equipment is it still acceptable as root cause. There were NCRs raised before and the root cause found for this incident is replacing the defective parts of the machine.
Appreciate your response on this.
Thank you for the inputs Sir, may I know also if the root cause always of this deviation is caused by wear and tear material (consumable) of the equipment is it still acceptable as root cause. There were NCRs raised before and the root cause found for this incident is replacing the defective parts of the machine.
Appreciate your response on this.
The root cause would appear to be the fundamental reason why the temperature achieved was insufficient. Could be a number of reasons for which you need to do an internal analysis.
So what was it ? Failure to replace defective parts due ?????
Thank you for the inputs Sir, may I know also if the root cause always of this deviation is caused by wear and tear material (consumable) of the equipment is it still acceptable as root cause. There were NCRs raised before and the root cause found for this incident is replacing the defective parts of the machine.
As per the suggestion from Charles, I'd see this as being a failure in your preventative maintenance plan - the direct cause may be the wear of a part, but that should surely be replaced before it becomes so worn that it is causing problems?
Replacing the parts is certainly part of your corrective action, but I'd very much be looking at the frequency both of inspection and of parts change under your maintenance plan as being the probable (based on the limited information available here) fundamental issue that has precipitated the issue.
As per the suggestion from Charles, I'd see this as being a failure in your preventative maintenance plan - the direct cause may be the wear of a part, but that should surely be replaced before it becomes so worn that it is causing problems?
Replacing the parts is certainly part of your corrective action, but I'd very much be looking at the frequency both of inspection and of parts change under your maintenance plan as being the probable (based on the limited information available here) fundamental issue that has precipitated the issue.
Yes you are correct this was already raised before within the organization, however the management decided that not unless the part (consumable parts) is defective then, that is the time parts will change. This is due to cost involve regarding this matter. We also suggested to have a study on the consumable materials regarding its shelf life, but the problem was in months or past years frequency of machine usage is different since its depending on clients order.
Hope we can find alternative solution on this.
Thank you for the inputs Sir, may I know also if the root cause always of this deviation is caused by wear and tear material (consumable) of the equipment is it still acceptable as root cause. There were NCRs raised before and the root cause found for this incident is replacing the defective parts of the machine.
Appreciate your response on this.
Dear,
If by taking action on this root cause the situation get improved and problem get resolved then it can be tagged as "root cause" but management science says something different. If each time a similar nonconformity occur and you always find the same root cause then in reality it would not be so. The real root cause in such case will be something else say no preventive maintenance schedule, no allocation of any responsible to do preventive checks or no strict monitoring system on compliance of preventive maintenance schedule.
Remember a simple principle: If the problem recur then either your root cause analysis had some deficiencies or your derived actions were not up to the mark. Solution will be then to focus on either or both.
Regards.
Muhammad Zeeshan Zaki.
Yes you are correct this was already raised before within the organization, however the management decided that not unless the part (consumable parts) is defective then, that is the time parts will change. This is due to cost involve regarding this matter. We also suggested to have a study on the consumable materials regarding its shelf life, but the problem was in months or past years frequency of machine usage is different since its depending on clients order.
Hope we can find alternative solution on this.
Interesting case :)
Honoring the management decision, can not we implement a routine (preferably of short time-interval) preventive maintenance checks on critical check points to have a judgement that how long the consumable will work? The next date should depend on the previous judgement. Also, as a management personnel, you should calculate the cost of losses and compare it with the cost of parts. Probably in this way management will be convinced. Sometime the cost of losses get increased due to not considering lead time to purchase the parts and other factors related to purchasing.
Interesting case :)
Honoring the management decision, can not we implement a routine (preferably of short time-interval) preventive maintenance checks on critical check points to have a judgement that how long the consumable will work? The next date should depend on the previous judgement. Also, as a management personnel, you should calculate the cost of losses and compare it with the cost of parts. Probably in this way management will be convinced. Sometime the cost of losses get increased due to not considering lead time to purchase the parts and other factors related to purchasing.
Hello!
Please be detailed in regards on your suggestion of preventive maintenance checks on critical check points. I would like to hear more regarding this action.
Consumable parts are always readily available as per Maintenance Department, and as per directive those materials will be changed if the machine parts were already defective.
Thank you.
Hello!
Please be detailed in regards on your suggestion of preventive maintenance checks on critical check points. I would like to hear more regarding this action.
Consumable parts are always readily available as per Maintenance Department, and as per directive those materials will be changed if the machine parts were already defective.
Thank you.
Offhand, the operational details are likely to depend on yr historical experience, ie failure rates. Sounds like you have plenty of data already ?.
Dear All,
In our organization, we have a documented procedure in addressing non-conforming product. Non-conformance report must be issued when there is a refusal or failure to conform on the set standards.
For example, I have a product ABC 7319231 that did not reach the minimum drying temperature.The drying temperature ranges only from 89.0 to 92.3 degrees celsius. Standard temperature is 95 to 110 degrees Celsius. Drying is considered as CCP deviation within our organization.
However, we have a supported document to address such deviation (Food Safety Dispositions - Deviations during Drying) and the correction done for this incident was properly addressed as per the document guide. Take note also that the actions done for this incident is recorded in the monitoring forms and testing shows that product was safe for release/process to next step after re-processing the product.
Do I still have to issue the Non-conformance report with corrective action although set standards are properly followed by the organization??
Thank you.
Yes. I had this raised in a GFSI audit a few years back that corrective action for CCP failure isn't just about the product but also should consider the root cause analysis to prevent recurrence.
Hello!
Please be detailed in regards on your suggestion of preventive maintenance checks on critical check points. I would like to hear more regarding this action.
Consumable parts are always readily available as per Maintenance Department, and as per directive those materials will be changed if the machine parts were already defective.
Thank you.
Thanks to Charles for answering to the point the question addressed to me.:)
Offhand, the operational details are likely to depend on yr historical experience, ie failure rates. Sounds like you have plenty of data already ?.
Just listing down in sequence some points which elaborate somewhat my previous post.,
1) Thoroughly discuss with the production and maintenance staff with past and current failures and identify critical check points and their actual causes.
2) Where in doubt or having less information, plan a short-interval checking plan and physically monitor its implementation and outcomes. This will give you an idea regarding failure intervals and hence help you to estimate preventive action frequencies. If some points get failed before due date, reduce their checking intervals on your short-interval checking plan.
3) Your plan and reports should contain details of spares needed, assurance of availability or lead time to arrange the spares, associated responsible to check and do maintenance, references to relevant SOP's, cost of maintenance, training requirements of operator and maintenance staff regarding daily preventive check and monthly or quarterly preventive plans.
Regards.
Muhammad Zeeshan Zaki