Microbiological testing in SQF is Mandatory or not?

My company is in the process of implementatino of SQF. i was going through SQF requirments. In that i found one point 4.3.6. Finished product specification. That the document says that finished prodcut specification shall include microbiological and chemical limits. Currently we do not test our final product in terms of microbiology and chemical. My qestion is that is it mandatory to have microbiological analysis of the product in SQF?

Dhaval

My company is in the process of implementatino of SQF. i was going through SQF requirments. In that i found one point 4.3.6. Finished product specification. That the document says that finished prodcut specification shall include microbiological and chemical limits. Currently we do not test our final product in terms of microbiology and chemical. My qestion is that is it mandatory to have microbiological analysis of the product in SQF?

Dhaval

Hi Dhaval

It might help if you explain what the product is and why you don't test it.

Regards,

Tony

We produce ready to cook powder mixes, like soup bases, pancake mixes, pudding mixes, whip topping mixes, drinks with sugar etc, but everything is in powder form. Basically our processing is just to blend all the powder we received and ship it. Also we receive COA for each raw ingredient supplier and most of them give us microbial testing results.

Dhaval

I suppose what would you put on your specification for your customers? Presumably you ensure that your environment is designed in such a way that it is unlikely to increase the micro loading but how do you verify your supplier quality assurance and environmental controls if you never test? I'm not familiar with SQF but I would hazard a guess that if you can use a risk assessment you could demonstrate that infrequent testing is justified but never not even at the product launch stage seems very low.

I don't know, imagine I was an auditor and explain why you never test to me.

Thanks GMO for your insight. We ensure suppliers quality assurance and environmental control from COA only.

We produce ready to cook powder mixes, like soup bases, pancake mixes, pudding mixes, whip topping mixes, drinks with sugar etc, but everything is in powder form. Basically our processing is just to blend all the powder we received and ship it. Also we receive COA for each raw ingredient supplier and most of them give us microbial testing results.

Dhaval

Ok thanks and do you have a finished product specification that includes microbiological and chemical criteria?

No Tony at this poing we do not have any specification for finished product which covers microbiological or chemical limits.
Dhaval

Ok thanks and do you have a finished product specification that includes microbiological and chemical criteria?

Yes, you definitely have to conduct your own micro testing. It's a validation that your own processes are functioning smoothly and works as a confirmation of your suppliers' COA.

The results, the type of product you sell, your clientele will determine how often you are required to test annually.

No Tony at this poing we do not have any specification for finished product which covers microbiological or chemical limits.
Dhaval

Dhaval

You will need these documented in specifications if you want to get SQF certification:

4.3.6.1 Finished product specifications shall be documented, current, approved by the supplier and their customer, accessible to relevant staff and include:
i. Microbiological and chemical limits

Have a read through Section 4.5 Verification, there are a number of requirements that you will need to meet including:

4.5.4.1 The methods, responsibility and criteria for sampling, inspecting and/or analysing raw materials, finished product and work in progress shall be documented and implemented. The methods applied shall ensure:
i. Inspections and analyses are completed at regular intervals as required and to agreed specification and legal requirements
ii. Inspections are conducted to ensure raw materials, work in process and finished products comply with the relevant specification, regulatory requirements and are true to label

Regards,

Tony

Micro testing, to my knowledge is not mandatory. I don't believe this is in the code. WIthout testing though, validation might be challenged as incomplete so at least some testing is advised.

It does not state in the code that finished product testing must be done as far as I know. Finished product specifications are to include micro limits. The detail level is based on risk. A micro limit can be as simple as the statement that the product will meet all FDA / FSIS regulatory requriements including absence of pathogens where applicable or the micro limits could be specified for each item as needed.

As with many portions of the code, you can document and present a risk analysis to support how you handle this. If your product has no history of outbreaks or known micro hazards, you may be able to minimally address this in your specifications and still meet the intent of the code.

a certificate of analysis, from a customer approved supplier of raw materials should meet this criteria as long as the supplier does all of the suitable testing that which the customer requests per, the customers specification of testing of thier raw materials, you need to have these specifications, and some sort of hold & release procedure in place. as far as packaging materials you need to have a certificate of conformance confirming no chemical migration through primary packaging materials. SQF is not what your doing, its that you're doing something that will meet their criteria of the code
as far is finished products go concerning items with high biological risk which was identified in your HACCP PLANS, you need to take retains and regularly test those for biological risk. for the most part this type of thing with the customer requested , especially for co packing plants.which I work for, so generally the customer requests that the testing be done. amen to Kathy's last paragraph , in the hazard analysis of HACCP U should the able to identify where you can limit the risk to an acceptable level in your process.

Dear Cathy,

It does not state in the code that finished product testing must be done as far as I know.

I would hv thought that most (all?) auditors would regard this as a core procedure for the verification (but not necessarily validation) of a HACCP Plan ?. Admittedly, logistical considerations might necessitate a rotational product sampling scheme although IMEX, many customers demand a COA for every lot code of any purchased product (lot size definition typically unspecified though ). (Good example of "back-protection" neutralising one intent of HACCP).

I appreciate that an auditor has to follow the literal text (or gear-up for arguments). Suggests that the code may be in need of some rethinking.

Rgds / Charles.C

My understanding regarding the need to do micro testing per SQF is whether or not it's called for in the finished goods specification agreed upon between the manufaturer and the customer. Is this a false assumption?

My understanding regarding the need to do micro testing per SQF is whether or not it's called for in the finished goods specification agreed upon between the manufaturer and the customer. Is this a false assumption?

Based on the quote in TonyC's post # 9, I would say Yes. At a minimum for safety related parameters (genuine or regulatory), the reason being my previous post.

Rgds / Charles.C

Based on the quote in TonyC's post # 9, I would say Yes. At a minimum for safety related parameters (genuine or regulatory), the reason being my previous post.

Rgds / Charles.C

The code states that the finished product spec sheet must have micro limits, not test results. My employer is a low risk dry food co-manufacturer, and we require micro testing on some of our vendor's product COA's, limits on others (for example if it's a spice like black pepper we require actual micro results on all COA's, while for low risk products (e.g. salt) we only require limits.

Assuming we randomly check the higher risk raws for micro load and have validated SSOP's along with a solid pre-requisite program I'd like to think that this would be sufficiant for a SQF auditor.

Dear esquef,

No problem. it's just a matter of opinion regarding interpretation of HACCP.

I guess the auditor can decide.

Rgds / Charles.C

Now that can be done. But if we check the product microbial load periodically (suppose once in a week) and in one test we found product positive in pathogens than the products from last whole week will be in question. As this positive pathogen test might be faileure in sanitation or malfunctioning of any eqipment and we will not know from how long it started.

Another comment is that, we produce cup cake dry mix (powder) which is not ready to eat. It will require preparation. I guess according to FDA regulation we need to have microbial checking if the prodcut is ready to eat.

Basically our process does not have any step to get control on micro. We bring raw powder material in and blend them and pack them. The only way we control micro is by COA from raw material supplier.

Correct me if i assumed something incorrect.

Dave

Another comment is that, we produce cup cake dry mix (powder) which is not ready to eat. It will require preparation. I guess according to FDA regulation we need to have microbial checking if the prodcut is ready to eat.

Basically our process does not have any step to get control on micro. We bring raw powder material in and blend them and pack them. The only way we control micro is by COA from raw material supplier.

Correct me if i assumed something incorrect.

Dave

Hi Dave

This would be on the assumption that you have carried out your Hazard Analysis and decided from the intended use and instructions to the customer any micro hazards will be eliminated.

Regards,

Tony

Dear Dave,

Now that can be done. But if we check the product microbial load periodically (suppose once in a week) and in one test we found product positive in pathogens than the products from last whole week will be in question. As this positive pathogen test might be faileure in sanitation or malfunctioning of any eqipment and we will not know from how long it started.

I presume you are referring to a zero tolerant (ZT) pathogen species.

Well, if yr process / supplier are appropriate, the results should be negative ?? If not, and yr environment is appropriate you have probably verified that the COA is incorrect (eg, fictional or [more likely] the sampling is inadequate to detect contamination [as is common]).

If a positive result, several options can be considered, (a) one corrective action (before the problem) is to use, for example, daily lot codes and re-sample (increased sample) the problem day(s). And/or reject back to yr supplier / change supplier, (assuming you trust yr own environment).
Or (b) you can simply trust to luck and re-sample the original 1-week batch. The laws of sampling are (usually) on yr side. Admittedly, yr results hv now proven the likely continuing existence of a ZT pathogen in the lot so you may consider re-sampling unethical although it is a commonly utilised principle, yr opinion may depend on the specific situation also, eg product risk status, history - two successive detections is perhaps rather different to once in 5 years. You can find proposed sampling schemes in the microbiological literature, eg ICMSF (the work involved may well be substantial / expensive). Or © perhaps the simplest, reject the relevant lot of raw material back to the supplier, this assumes item / lot identification is possible. Of course, the supplier may only co-operate if his delivered goods are specifically tested. Sometimes a question of leverage.

Another comment is that, we produce cup cake dry mix (powder) which is not ready to eat. It will require preparation. I guess according to FDA regulation we need to have microbial checking if the prodcut is ready to eat.

If yr question is whether finished product which is ready-to-cook is different to ready-to-eat, ie has a different risk status, obviously yes (and particularly from a regulatory aspect).

Basically our process does not have any step to get control on micro. We bring raw powder material in and blend them and pack them. The only way we control micro is by COA from raw material supplier.

The point is that, from the consumer's side, you are responsible for the final quality / safety, not yr supplier. Therefore you hv to act accordingly.

Rgds / Charles.C

Now that can be done. But if we check the product microbial load periodically (suppose once in a week) and in one test we found product positive in pathogens than the products from last whole week will be in question. As this positive pathogen test might be faileure in sanitation or malfunctioning of any eqipment and we will not know from how long it started.

Another comment is that, we produce cup cake dry mix (powder) which is not ready to eat. It will require preparation. I guess according to FDA regulation we need to have microbial checking if the prodcut is ready to eat.

Basically our process does not have any step to get control on micro. We bring raw powder material in and blend them and pack them. The only way we control micro is by COA from raw material supplier.

Correct me if i assumed something incorrect.

Dave

Hi Dave,

In regards to your cup cake dry mix (powder) and others like it: have you considered that some consumers will eat this raw once egg, milk etc are added to produce a dough? Yes, yes I know the pathogens will probably more likely come from the egg or milk but what are the chances of your food processers potentially passing on their staph or any other pathogen to the powder mix?

Are there any products within your product range that a unique consumer will either:

• eat raw / doughie / etc
• undercook, therefore not killing off any potential pathogens

Besides, contrary to popular belief not all pathogens are killed off /remain dormant outside of the danger zone.

Micro testing on your finished product is an assurance that YOUR processes are safe; not so much your suppliers if they all supply you with a COA that is relevant to the batch of raw material you used.

Hope this helps.

well frankly telling that. Each and every reply is very important to me as i am a beginner... just passes out from school, and thanks to IFSQN that people like me can get great great great help from heighly experience people like you guys.... .

I prefer to see product testing but i find process control so much more important than measurement at the end of the process - particularly for micro issues which are rarely able to be tested in a statistically valid and practical manner. I think most product testing is a feel-good finishing touch that makes buyers and consumers happy but scientifically it is somewhat ineffective. For example - I would be more interested in the results of a robust environmental monitoring program for listeria than a finished product testing program.

I agree with Cathy: swab testing is quite important.

Dear Cathy,

Well, HACCP supports yr chronological prioritisation.

But it also demands verification. And ideally not just visual checking of internal records. Or a nicely presented appearance on audit day.

I agree microbial statistics is a problem but willingness to sample, etc is equally important IMO. A question of the bottom line perhaps.

Rgds / Charles.C

I agree Charles - willingness is an important sign and doing the testing is good verification of commitment and the status of the system. At this point, the tools aren't in place in the U.S. to require it except under limited circumstances. I tend to de-emphasize finished product testing because it can be a cruch. Some might rely on it when it is not a good picture of the overall system. I think k this is why SQF doesn't require it. It's important to take a system approach and verify each component as needed.