17 replies to this topic

[Simon]

Does anyone have an example of a SOP for dealing with an out of control or breach of a CCP covering the initial corrective action and longer term investigations and preventive action.

Thanks,
Simon

[Charles.C]

Dear Simon,

Not exactly sure what you want here.

Can give link to corrective action / SOP for ISO 9001 which is totally general of course.

In case of HACCP, the corrective action is more often presented as a specific combination of measures to take after a deviation from a particular SOP since there are so many possibilities (although some steps are often recurring similar to ISO). Can offer a "word" file compendium of these also if of any use.

Rgds / Charles.C

[Simon]

Surely there must be a process or procedure defined otherwise how would we know what to do if a CCP limit was exceeded. I just wanted to see some examples?

[Charles.C]

Dear Simon,

Can have a look - ISO 9001 -

http://www.qcinspect...icle/coract.htm

HACCP - http://sop.nfsmi.org/sop_list.php
(2 boxes up from the bottom, word or pdf)

I had the files but the uploading function here is only working sporadically (for me anyway). Had to re-google everything.

Rgds / Charles.C

[GMO]

Not got one with me (it's Saturday morning folks, I'm not at work all of the time) but a 'typical' corrective action would be along these lines.

Most monitoring is done periodically not continually and so this would work for metal detectors / sieves etc:

Stop production running through CCP X

Return all product since last good check. Call QA to inform of issue.

Resolve issue with CCP X (Engineers or QA may need to assist)

Only continue production once CCPX is operational and the monitoring check has passed.

Restart line.

Stock which has been recalled should then be passed through CCP X again or through an analogous machine on another line.

That wouldn't work however for an oven or cooking process though where a sensible corrective action would be to return it to the oven or pan.

On things like cooling times again, that's different. I'd always set cooling times to a tolerence level and have something in reserve where a decision could be made by a QA on the basis of past microbiological results etc. Not strictly a HACCP approach but a common sense one I think you'd agree?

On refrigeration, I've had the product or WIP temperature as a CCP before but it's monitored by the air temperature. So for that one, if the air temp is out of spec, I'd measure the product temperature to make sure it's safe and move the product while the fridge is fixed if it's looking like it will take more than half an hour.

[Tony-C]

Agree with GMO.

Corrective Actions are usually specific. A HACCP plan should really be set up to take action before critical limits are breached (whenever possible). So there should be 2 stages of corrective action - operating limits gauged on historical information where you can take action to retain control of the process and absolute limits where the process has to be stopped to regain control.

This does not necessarily apply to metal detection but can for many processes.

[Charles.C]

Dear Simon,

Enclosed is a (very) condensed generic HACCP corrective action / monitoring / critical limit in table form with example comments as applicable to the use of agrichemicals in crop management. Seemed to me that the left hand steps shown can approx. cover the previous examples given although the complexity (eg shout or cry ) of the necessary control measures will of course vary.

 generic_HACCP_corrective_action_et_al.jpg   150.7KB   147 downloads
(uploading now working, using non-shared line )

Rgds / Charles.C

[Simon]

Thanks all for your comments and the links. So in a nutshell I suppose there are three phases when the s#@T hits the fan.

1. Correction – the immediate action taken to eliminate the detected nonconformity e.g. clearing up the mess, recalling the product, reworking product etc.

2. Corrective Action – the follow up action to eliminate the cause of the detected nonconformity for example changing the batteries in the metal detector to prevent reoccurrence.

3. Preventive Action – action take to prevent a nonconformity occurring in the first place for example having an effective machine maintenance programme, live automatic monitoring of the line with failsafe alarms.

Well something like that. Do you agree?

Regards,
Simon

[GMO]

Yep sounds sensible but sometimes there will be no preventive action because things like sieves for example only have a limited (and not easily predictable) lifespan.

I normally find one of the best preventive actions on metal detection failures is changing the password lol as it's usually been someone messing with my levels!

[APPAJI]

Dear All,
I am sorry. But whole of HACCP system is Preventive Action in first place. That is the reason Why in HACCP we do not have Preventive Action requirement. This is because we had already done hazard analysis and come out of where controls are to be kept. So we are left with only corrective actions when the monitoring shows any deviations. So the correction is the action taken to correct the product which is effected and corrective action is correction done to operation so9 that we get safe product in future.
Hope I am clearly understood.
Please comment.
Regards
Appaji

[GMO]

Dear All,
I am sorry. But whole of HACCP system is Preventive Action in first place. That is the reason Why in HACCP we do not have Preventive Action requirement. This is because we had already done hazard analysis and come out of where controls are to be kept. So we are left with only corrective actions when the monitoring shows any deviations. So the correction is the action taken to correct the product which is effected and corrective action is correction done to operation so9 that we get safe product in future.
Hope I am clearly understood.
Please comment.
Regards
Appaji

Yes and no. HACCP is also constantly under review and implemented by real people not machines. In my example earlier I suggested changing passwords as someone had been changing settings on a machine who shouldn't have been. Sometimes an incident can reveal problems you didn't know you had or that your system isn't as robust as you thought. It would be a rare occasion that I wouldn't at least think about a preventive action.

On any incident (CCP failure or otherwise) IMO it's always handy to do some root cause analysis. For example, if a cooking programme failed to achieve the core temperature after the set programme time; why? Hasn't that programme been used several times without incident? Maybe it's been changed? Maybe the ingredients have been put in at a colder temperature? Maybe the oven needs servicing? Maybe the turntable isn't working properly or the oven isn't balanced? Maybe the person probing the food didn't do it properly? You can see that a CCP failure could be caused by many issues and although the corrective action makes the situation safe now, it doesn't prevent recurrence.

[Strait Consulting]

Don't sweat it: one deviation = one corrective action. If its keeps happening just keep generating corrective actions. Of course you'll have to be increasingly more creative in your corrective actions until you bring it under control.

[Tony-C]

Dear All,
I am sorry. But whole of HACCP system is Preventive Action in first place. That is the reason Why in HACCP we do not have Preventive Action requirement. This is because we had already done hazard analysis and come out of where controls are to be kept. So we are left with only corrective actions when the monitoring shows any deviations. So the correction is the action taken to correct the product which is effected and corrective action is correction done to operation so9 that we get safe product in future.
Hope I am clearly understood.
Please comment.
Regards
Appaji

Preventative action may come as a result of HACCP/Verification results review.

Regards,

Tony

[MKRMS]

In my opinion, a sensible approach to Corrective Action should cover the following:

1 Corrective Action - Emergency intervention to re-establish control at a CCP, which must be made immediately after the loss of control is detected and is specified in advance as part of preventative action (HACCP system).

2 Investigation - to find the source of a fault; can be quick in obvious cases (e.g. missed switch, blown fuse).

3 Changes in Operation - to prevent re-ocurrence, if necessary. This is not always needed, though.

While 1 is a requirement under the Codex HACCP standard, 2 and 3 are not required in all cases. Codex Alimentarius Commission states: "Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur.
The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping." (CAC/RCP 1-1969, Rev 4-2003, page 27).

2 and 3 should only be started once 1 has been sufficiently addressed! Loss of control is serious and re-establishing control must be given priority!

If changes to the operation are made following an investigation after a loss of control (Step 3), this must be reflected in HACCP documentation.

A more specific list of requirements is given in ISO 22,000:2007, Clause 7.10.2: Corrective Actions

Matt

[QA assistant]

Dear All,
I am sorry. But whole of HACCP system is Preventive Action in first place. That is the reason Why in HACCP we do not have Preventive Action requirement. This is because we had already done hazard analysis and come out of where controls are to be kept. So we are left with only corrective actions when the monitoring shows any deviations. So the correction is the action taken to correct the product which is effected and corrective action is correction done to operation so9 that we get safe product in future.
Hope I am clearly understood.
Please comment.
Regards
Appaji

>I agree on you with this Appaji, we are doing hazard analysis to exhaust all possible hazards that may be encountered before, during or after production. Critical control points must be done using your Codex decision tree and from there validated critical limits must be established. if in case a CCP was breached then we proceed to the corrective action, if there are successive failure in the CCP then the HACCP team must review that particular step.


thanks and regards,

[Sean H]

Our current corrective actions basically use the format in GMO's post. Generally the corrective action should make the product safe and/or prevent any potentially unsafe product from entering the supply chain so as per GMOs post
1) Stop unsafe food from entering supply chain:
> Stop production, Isolate all product since last in spec test.
2) make product safe
> Correct /repair process at CCPX, all isolated product inspected/re-passed through CCPX once operating correctly
> alternativley all suspect stock should be destroyed & disposed if it cannot be safely re-worked. eg. maximum storage temperatures exceeded.
Regards,
Sean

[Dr Ajay Shah]

Dear Appaji,

We all know that HACCP is about preventing or eliminating the hazard, but I totally agree with the comments posted by GMO. If you produced stock which is not safe then you will need to reassess this stock for CCp if this had failed. For example if the metal detector being a CCP had failed. you would isolate the stocle and quarntine it and later pass it through the metal detector once it had been fixed.

Cheers

[jtang]

just want to add to the CPPs corrective actions...


Metal detector failure... that's why after maintenance or any other corrective actions, products are put through the metal detector again...

Similarly, pasteurization failure (ie. temperature not reached), products are re-worked and re-pasteurized.


:)