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Radiological Hazards Request for Suppliers/Manufacturers

Started by , Jun 17 2019 07:47 PM
8 Replies

I am drafting a letter to distribute to all suppliers/manufacturers to have documentation on the radiological hazards associated with the materials being shipped to our facility. Just figured I'd stop by to see if anyone was willing to share a template if a letter of similar context has been sent. I'm stumped at the level of detail that should be provided to the supplier. I've asked for this statement from a few suppliers and am just getting back an irradiation statement. Thanks for any guidance! 

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If my suppliers have a GFSI-benchmarked Audit Certificate I don't bother sending them any questionnaires or letters.

I broadly agree with Hank - if they're certified to a standard that already mandates this then you're just adding to their workload whilst not really learning anything that improves your understanding of their food safety controls.

I say this as a technical manager at a BRC certified facility, currently being inundated with questions from BRC-certified customers who have decided that they need to ask questions about this in order to comply with the more specific requirements in the latest issue of the BRC standard. The same BRC standard to which we adhere and are certified...

 

If you *really* want to ask them questions and believe you're going to get some value from it then as a guide we're mostly seeing questions of the following sorts:

1) Wanting confirmation that our HACCP plan has considered and risk-assessed all potential hazards relating to radiological contamination. (Some are asking only for hazards that could "reasonably be expected" to occur).

2) Wanting confirmation that we're not sourcing ingredients from various regions "known" to pose a greater risk of radiological contamination. Exactly where people are concerned about seems to vary - Chernobyl and Fukushima are the obvious two, but we've also been asked about proximity to nuclear power stations in the UK and about wider sourcing from areas that were once problematic due to Chernobyl (large swathes of Europe were affected to some extent).

 

So far my overall impression, in the UK at least, is that (a) people are panicking a bit as the BRC wording on this has changed, and (b) very few people understand radioactivity.

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I broadly agree with Hank - if they're certified to a standard that already mandates this then you're just adding to their workload whilst not really learning anything that improves your understanding of their food safety controls.

I say this as a technical manager at a BRC certified facility, currently being inundated with questions from BRC-certified customers who have decided that they need to ask questions about this in order to comply with the more specific requirements in the latest issue of the BRC standard. The same BRC standard to which we adhere and are certified...

 

If you *really* want to ask them questions and believe you're going to get some value from it then as a guide we're mostly seeing questions of the following sorts:

1) Wanting confirmation that our HACCP plan has considered and risk-assessed all potential hazards relating to radiological contamination. (Some are asking only for hazards that could "reasonably be expected" to occur).

2) Wanting confirmation that we're not sourcing ingredients from various regions "known" to pose a greater risk of radiological contamination. Exactly where people are concerned about seems to vary - Chernobyl and Fukushima are the obvious two, but we've also been asked about proximity to nuclear power stations in the UK and about wider sourcing from areas that were once problematic due to Chernobyl (large swathes of Europe were affected to some extent).

 

So far my overall impression, in the UK at least, is that (a) people are panicking a bit as the BRC wording on this has changed, and (b) very few people understand radioactivity.

 

Thank you for your insight. I fall under group (b). We had a supplier audit a few months back and the consultant/auditor insisted that we thoroughly investigate the radiological hazards from our suppliers, down to the smoke alarms that may be in their facility. I'm assuming (albeit hoping) that those are just her personal best practices. 

 

I will take your advice and only pester those suppliers we come in contact with that may not have a GFSI scheme certification. Thank you! 

Oh, procurement department and their never-ending needs for more documents.  

 

It's so absurd.  And what do they even do with the information?  Nothing.  Here's my certificate.  Ok, now you want to see my entire audit?  Ok, fine I'll send it.  Now you want to see what my corrective actions are?  You're a purchasing agent, I know you don't care about this.  You're just going to file it away somewhere.

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Oh, procurement department and their never-ending needs for more documents.  

 

It's so absurd.  And what do they even do with the information?  Nothing.  Here's my certificate.  Ok, now you want to see my entire audit?  Ok, fine I'll send it.  Now you want to see what my corrective actions are?  You're a purchasing agent, I know you don't care about this.  You're just going to file it away somewhere.

 

In my facility at least, the Regulatory & Quality Manager (me) handles the Approved Supplier Program. My reasons for reaching out to suppliers/manufacturers to obtain radiological hazard information is simply because it is a required corrective action from a recent inspection. 

I asked this of a consultant and this was his answer, bare in mind we are food packaging:

 

"The only source from radiological hazards at your site would be in the water, since FSMA is not applicable to you, but SQF is, then you need to include radiological hazards in the hazard analysis. All water districts in the USA have to test for radiological components at least every 3 years, if you look at the city water report it should include it."

Thank you for your insight. I fall under group (b). We had a supplier audit a few months back and the consultant/auditor insisted that we thoroughly investigate the radiological hazards from our suppliers, down to the smoke alarms that may be in their facility. I'm assuming (albeit hoping) that those are just her personal best practices. 

 

I will take your advice and only pester those suppliers we come in contact with that may not have a GFSI scheme certification. Thank you! 

 

OK, this is quite an interesting take that, as you say, presumably comes down to one specific auditor's interpretation / views - whilst there is Americium in ionisation-type smoke detectors, one would hope that bits of smoke detector are not getting into products simply through basic GMP!

 

If it's a particular bugbear for the auditor then you may be in the unfortunate position of the GFSI argument not being sufficient (even if it is justified), in which case have patience with your suppliers as they'll be equally surprised about the level of questioning that is expected.

Out of interest, what audit scheme was this picked up under? Presume a customer rather than one of the GFSI standards, but am certainly curious, if only so I can be wary of it in future...
 

I asked this of a consultant and this was his answer, bare in mind we are food packaging:

 

"The only source from radiological hazards at your site would be in the water, since FSMA is not applicable to you, but SQF is, then you need to include radiological hazards in the hazard analysis. All water districts in the USA have to test for radiological components at least every 3 years, if you look at the city water report it should include it."

 

Yup this is correct. I only included radiological hazard for water ingredients used in the product because based on my research, unless there is another fukushima or chernobyl, the likelihood of radiological hazard is very very low.


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