199 replies to this topic

[Charles.C]

Hi,

 

I think CCP should be addressed to "STEP" which means a part of "Process Step". if metal detection is considered as a part of process step in HACCP manual(not monitoring), then it might be considered as a CCP. remember, Establishing Process step is necessary prior to Determining hazard.

 

correct me if I am wrong, that argument is not 100% valid

 

Dear mamad,

 

You are not exactly wrong but Risk Assessment is a (very) subjective field. And thereby HACCP also.

 

The conceptual/operational difficulty(s) revolve around the flexibilities within the interpretation/terminologies of  hazard analysis / CCP / haccp generally.

 

For example, the Codex tree is (knowingly) "fudged" to readily generate a MD as a CCP. It's convenient for all parties concerned.

 

Rgds / Charles.C

[Esther]

As usual, all the points addressed in this forum are very interesting.

 

Charles, regarding your question I would go further. Why not both? Why not an oPRP?

 

By reading your comment I reminded  a discussion I got with a company which belongs to  Coca Cola company. The final conclusion was that we ( quality  managers, auditors, people involve in food safety issues….) sometimes  loose the real point training to fit actions and measures  into the theory.

 

At this point, I do not care how you call it as long as the risk is under control.

 

On the other hand, setting a metal detector at the end of the line, in my opinion, is a control of how well the metal foreign bodies are controlled along the line.  A different thing is what king of control is that? It is the king of control any industrial company should get rid of as it is a CORRECTIVE measure.

The global thinking in a production process, or even  in the HACCP system, is to have in mind always a preventive philosophy.

 

Glad to talk to you again, Charles, after such a long time.

 

Best regards

Esther

METAL DETECTOR: A Monitoring Activity or a CCP?

Generally, most companies in the food industries today have Metal Detectors in their process lines designed for the purpose of detecting metal hazards. Often this step of the process is considered significantly risky to be classified as a CCP (Critical Control Point) - most food auditors insist it is anyway.

The issue that I am arguing here is that a Metal Detector does not "change the product or ingredients" in shape, by improvements, in aroma, or product enhancement or alterations of any sorts". Instead, all that it does is to alert any presence of ferrous hazards in the product when detected.

And, when ferrous hazards are detected, it is often at the end of the procees line meaning it is way too late hence, rendering the product not safe for public consumption.

The argument here is if a Metal Detector is deemed a CCP, where and what is the CONTROL POINT that support the process step in making food safe or to be safe?

Unlike a sieve which does change the shape of the product or ingredients, why then should we classify a Metal Detector as a Critical Control Point when itself is NOT a Control Point in the Process at all.

If we agree to this line of argument, shouldn't we correctly classify the Metal Detector as simply a monitoring function and as important as it is, be termed as a "Critical Monitoring Step" instead of a "Critical Contol Point / Step" or as I like to term it "Quality Control Point"

As a "Critical Monitoring Step" it would just be a record keeping procedure whilst categorising it as a CCP would certainly attract the auditor's attention and viewed from a more serious angle. (Mind you, calibration remains a requirement anyay you take it)

What is the general consensus? A "Critical Monitoring Step / Quality Control Point"" or a "Critical Control Point" ?

Cheers

Charles Chew

[V.R. Reddy]

Dear Charles, 

 

What is the temperature parameter you are referring here

 

"By this intervention step, frozen products that were stored above the "new" temperature parameter resulted only in a quality issue but NOT a food safety risk issue"

 

Regards

 

Venkat

[Charles.C]

Dear Charles, 

 

What is the temperature parameter you are referring here

 

"By this intervention step, frozen products that were stored above the "new" temperature parameter resulted only in a quality issue but NOT a food safety risk issue"

 

Regards

 

Venkat

 

Dear VR Reddy,

 

Apologies if above post was addressed to me. I never saw it.

 

Or was it Charles Chew ? Who obviously also never saw it.

 

Unfortunately I couldn't see where yr quote originated from ?

 

And (not yr problem) am equally confused for post 152 which contains a 10 year flashback. Esther !

 

Rgds / Charles.C

[manju.saffron]

Food auditors are used to seeing metal detectors as CCPs in every factory they go to and therefore expect it to be a CCP in yours.

However it is you and your HACCP team that know most about the risks in your factory not an auditor who is only on site for a day or two.

If you can say that there is not a significant risk of metal contamination or metal contamination can be controlled at a previous step then metal detection is not a CCP.

If you are 100% confident in your HACCP and the way the study has been carried out then you should stand up for yourself against the auditors. What your team say is a CCP is a CCP

Because most food machinery is made out of metal then there is a risk of metal contamination which is most usually controlled by metal detectors.


My big question in metal detectors is do they reduce the hazard to an acceptable level?
Do we feel that a 3mm piece of stainless steel is not a hazard?

Hi,

 

I agree on the point you made. Metal detectors are machines made to detect and not to reduce the metal hazards. But we have modified the machines in a manner that after detection, we can collect the product in question in a rejection basket or stop the line. This helps in identification and removal of the hazard

 

As per Codex definition a control measure is "Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level"

 

we generally keep the last metal detector in the line as CCP, as beyond this point there is no other control measure available and the control at this point is essential.

 

Metal detectors only helps in controlling hazards by detection. However their detection limit is a big question. Most metal detectors are unable to sense small metals sizes e.g. 2 mm.

 

Food industry is dependent upon metal detectors for metal control however the technology itself is constrained. Hence most of the industries have kept their metal control limits as per the detection limits of their metal detectors.  Practically it is ironical but there is little one can do about it.

 

I think smallest metal will be a hazard as it can damage human system after ingestion and we cannot predict easily. 

 

However FDA has a say about metal hazards and their control. I hope the below document may be useful to you.

 

http://www.fda.gov/d...n/UCM252440.pdf

 

MNS

India

[Antores]

If we could generalize and "tag" common processes (such as washing, metal detectors, heating) as CCP. then we would not need to do a risk assessment, but we would simple have a chart or list of what is a CCP or not.. and out lives would be much easier..

 

Although we like to generalize (such as heating/cooking is always a CCP) the determination of a CCP depends of you particular operation, your location, your product... your situation.. That is why you need to do a risk assessment.. Basically, What could happen? What is the possibility of this to happen? If it happens, What would be the consequences? Is there a further control step in the process? Do I have a way to control the risk in this step?.... and so on..

[farshad2008]

Hi

lets see the the terms:

 

“Monitoring” is checking, by testing, measuring, observing etc., whether a Critical Control Point is under control. Whenever possible, the monitoring results should be available in real time, so that corrective actions can be taken before the situation is "out of control". Microbiological tests are often not usable for monitoring, because it takes too long for the result to become available. Target values are used in monitoring. Even if the value is slightly higher or lower than the target value, it is still acceptable as long as it remains within critical limits; otherwise, the product is considered unacceptable and cannot be released.

The word “control” is used in the HACCP concept both as a noun and a verb. It means “having things under control;” for instance, as it is used in the expression “traffic control”. As a verb it means “to direct”, “to regulate”, “to command” etc. It does not mean “to check”, “to test”, “to verify” etc. Other terms are used for testing, measuring and observing, which play an important role in HACCP.

 

[Charles.C]

Hi

lets see the the terms:

 

“Monitoring” is checking, by testing, measuring, observing etc., whether a Critical Control Point is under control. Whenever possible, the monitoring results should be available in real time, so that corrective actions can be taken before the situation is "out of control". Microbiological tests are often not usable for monitoring, because it takes too long for the result to become available. Target values are used in monitoring. Even if the value is slightly higher or lower than the target value, it is still acceptable as long as it remains within critical limits; otherwise, the product is considered unacceptable and cannot be released.

The word “control” is used in the HACCP concept both as a noun and a verb. It means “having things under control;” for instance, as it is used in the expression “traffic control”. As a verb it means “to direct”, “to regulate”, “to command” etc. It does not mean “to check”, “to test”, “to verify” etc. Other terms are used for testing, measuring and observing, which play an important role in HACCP.

 

 

Hi  farshad,

 

Thks.

 

So what was yr conclusion on may 12th ?

[jesgotcerv]

I think it depends on where the metal detector is placed in the system. We have to remember that on Indication of a step being a CCP is it being the last step to control a particular hazard. 

[CernencuLaura]

It's a ccp

[CernencuLaura]

Metal detectors are machines made to detect and not to reduce the metal hazards.

[redfox]

Hello,

 

It is a CCP. MD can detect and reject product contaminated with metal hazards.

 

regards,

redfox

[Hobgoblin]

The obvious answer to this question is "it depends".

 

Before you go on to consider whether a point is a CCP it is expected that the team will consider whether the hazard is controlled by a prerequisite.  So if you have checks on your suppliers, maintenance checks, operator checks, training etc. (all prerequisites) then the hazard may be controlled. 

The key stage in any HACCP is the analysis of the hazard and assessing the likelihood and severity of metal ending up in the final product.  If the likelihood is very low then it is reasonable to suggest that the risk is controlled by GMP prerequisites.  Remember HACCP is about eliminating or reducing the risk to an acceptable level.

If on the other hand the likelihood of metal is high or that it can't be controlled by GMP (e.g. nuts and bolts on machines that can't be inspected easily etc.) then it is more likely that you should consider it a CCP. 

If metal detection is a CCP then what happens if your metal detector breaks down?  Does production have to stop?  If it is 'critical' then surely its absence means there is no control.  The controls are all the things you do to reduce the likelihood of metals and the detector is verification that your controls are working or not.

What if a business doesn't have metal detection?  Is there then no control of metal contamination?  Then what about other contaminants?  How is glass, wood, plastic etc. controlled?  In a manufacturer of goods in glass bottles then x-ray is more likely to e critical due to the risk of glass splinters etc.  This is due to the increased likelihood of glass contamination in this particular business. 

Metal detection is useful as it gives confidence in your procedures and reduces the likelihood of metal contamination ending up in your product but the likelihood may already be at an acceptable level, so all you are doing is reducing it further. 

The European Commission wrote some guidance of the application of HACCP including the flexibility provisions and assessment of risk which is well worth a read.  HACCP provisions like most food law (in the EU anyway) was written to be flexible to suit any business and therefore is not prescriptive.  So what is required depends on the nature of the business.  Therefore the answer isn't as simple as always yes or no.  It depends.

[Vinit Mhatre]

Charles,

I know what you're getting at, unfortunately I would have to agree with the food auditors.

If you go by the CODEX guidelines a CCP is:

"A step at which a control can be applied & is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level"

If you follow the CODEX decision tree

Q1 - Do control preventative measures exist?
A1 - Yes

Q2 - Is this step specifically designed to eliminate or reduce likely occurence of hazard to an acceptable level
A2 - Yes

Outcome - This is a CCP


Regards

Richard

thanks...

[Dhanvanthri]

Hello

metal detection, this would be the test piece sizes. Because, if we take the 2mm stainless steel test piece as an example – you are in effect saying that you can guarantee that there will be no stainless steel in the product of 2mm or more in size. You cannot guarantee the safety of the product, if it was to contain stainless steel of less than 2mm.

[Charles.C]

Hello

metal detection, this would be the test piece sizes. Because, if we take the 2mm stainless steel test piece as an example – you are in effect saying that you can guarantee that there will be no stainless steel in the product of 2mm or more in size. You cannot guarantee the safety of the product, if it was to contain stainless steel of less than 2mm.

 

Not necessarily since the operational MD/LOD for SS may be > or < than 2mm depending on factors like intrinsic sensitivity, food matrix, metallic orientation.

[Danielle D]

Hello,

 

I am resurfacing this again as we are having our annual HACCP review in a month or so. We have possibly discussed removing Metal Detection from our Dry Blending line. We make dairy flavors and blended spice flavors. The reason I would want to reduce down to a CP verses a CCP is because we had a customer inquiry in regards to the reason why we had Metal Detection. They wanted the risks we had identified in our receiving raw materials that would warrant Metal Detection to be a CCP. This had me questioning.

 

We do not treat, reduce, or eliminate any foreign material as this is covered under our Preventive Controls at the supplier level.

 

From reading the 8 pages of this forum( which has some great discussion), I also agree that we eliminate the hazard (if identified) from entering the supply chain HOWEVER, there are no identified risks prior to this to warrant metal detection on the final product.

 

Any thoughts on this?

[Scampi]

No risks Antond?  You don't have any metal equipment????  Surely your risk cannot just be your raw materials?

 

A CCP is meant as a critical control when there is NO OTHER STEP that will reduce or eliminate the hazard. So IMHO it may or may not be a CCP depending on the individual process

[Chef_K]

I have fought this same argument with auditors for years, and have refused to list metal detection as a CCP. Though we use metal detection, it is used based on customer request. In the 10+ years I've worked here, we have had no known instances of metal to our customers and therefor I deemed it "not reasonably likely to occur" on my HACCP plans. 

 

However, with the new requirements of the Preventive Control Plans or (HARP-C), I am having to add metal detection as a Preventive Control. This is based on the FDA's wording of "In the Absence of Control". I have documented only about a dozen instances where my metal detectors have found metal in my products over the last decade, but never made it to the customer. But, if there was no metal detection at all, those dozen would have made it to the customer.

[Charles.C]

Do FSMA not require a risk assessment ?

 

It is sometimes more meaningful  to interpret the "risk" based on  queries such as -

 

(a) Given the nature of the process steps/equipment/materials, what is the likelihood of an occurrence of metallic fragments ?

(b) Given an occurrence, what is the worst case consequence ?

(c) Is there a subsequent step which eliminates / removes to acceptable level etc etc

 

What is the minimum FDA (a x b) criterion for a Significant Hazard for a, so-called, non-vulnerable consumer ? (If such terminology exists in HARPC)

[Scampi]

Found this

/www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/webcontent/ucm074554.pdf

 

REGULATORY ACTION GUIDANCE:

The following represent the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and direct reference import detention to the appropriate Field Offices within the Human and Animal Food Program*.

a. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm, in length. and

b. The product is ready-to-eat, or according to instructions or other guidance or requirements, it requires only minimal preparation steps, e.g., heating, that would not eliminate, invalidate, or neutralize the hazard prior to consumption. Samples found to contain foreign objects that meet criteria a. and b., above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1).

 

The following represent the criteria for recommending legal action to CFSAN Office of *Compliance, Division of Enforcement* (HFS-605). c. The product contains a hard or sharp foreign object that measures 7 mm to 25 mm in length, and the product requires additional preparation or processing that may have an effect on the presence of the foreign objects in the finished food. For example, additional sifting of a product may or may not remove foreign objects, depending on the measurements of the objects and the mesh aperture of the sifter. In these situations, the preparation or processing of the food must be described in the recommendation submitted by the appropriate *office within the Human and Animal Food Program*. or d. The product contains a hard or sharp foreign object less than 7 mm in length and if a special-risk group, as defined in the background section, is among the intended consumers of the product. or e. The product contains a hard or sharp foreign object over 25 mm in length. A sample found to contain a foreign object that meets criterion c., d., or e., above should be considered adulterated within the meaning of 21 U.S.C. 342(a)(1) if a health hazard is established by CFSAN review.

[mgourley]

I find it interesting that this topic has been going on for 14 years.

 

One would assume the question would have been answered by now.

 

As has been discussed other places in this thread, metal detection has over the years become a de facto CCP. BRC basically requires it and most all customer requirements mention it.

 

Marshall

[Charles.C]

I find it interesting that this topic has been going on for 14 years.

 

One would assume the question would have been answered by now.

 

As has been discussed other places in this thread, metal detection has over the years become a de facto CCP. BRC basically requires it and most all customer requirements mention it.

 

Marshall

 

Hi Marshall,

 

 

FWIW,  the data on which quotation in Post 171 (!!) was based is, i think, pre-2000.

 

Should perhaps be a PRP by now.

[mgourley]

"Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve the protection of final products from metal contamination. Where metal detectors are not used justification shall be documented. The absence of metal detection would only normally be based on the use of an alternative, more effective method of protection (e.g. use of X-ray, fine sieves or filtration of products)."

 

BRC pretty much makes it mandatory, and thus a reverse CP, if not an outright CCP.

 

Marshall

[Charles.C]

"Metal detection equipment shall be in place unless risk assessment demonstrates that this does not improve the protection of final products from metal contamination. Where metal detectors are not used justification shall be documented. The absence of metal detection would only normally be based on the use of an alternative, more effective method of protection (e.g. use of X-ray, fine sieves or filtration of products)."

 

BRC pretty much makes it mandatory, and thus a reverse CP, if not an outright CCP.

 

Marshall

 

Hi Marshall,

 

How about FSMA ?