4 replies to this topic

[mtelander]

I work for a dietary supplement contract manufacturer, and we are hiring a new role whose main responsibility is to create internal raw material specifications (proteins, aminos, various herbals, flavors, etc.). She has experience with some specifications but not necessarily figuring out how to calculate bulk density ranges, LOD, assay, etc. Can someone recommend some training material or resources I can use to give her to help her "learn" and understand more about this aspect of the spec creation? She will have access to the suppliers specs for the raw materials and then testing results but i am looking more for like "spec creation for dummies" type of material to just help support her training

[kingstudruler1]

Im not sure such a reference exists.  What is your goal in creating or updating your raw spec sheets?

 

Ive only worked in food, OTC, and cosmetics.   However, the main point of the spec sheet it the same.   What are the key characterics that must be met and what is the tolerance of those characterisitcis?   I still like to believe that specs should be agreed upon by supplier and customer.  Thus every thing, in theory,  should be on the supplier spec sheet.  

 

I think most would agree that creating a spec sheet from scratch is best not done by one person only as their are other perspectives that may neeed to be taken into account.   

 

not much help

[mtelander]

Well we had previously been relying on the suppliers specifications for the raw material, but as we have grown as a company we have many suppliers for each raw material and from that point it became a quality issue, meaning we wanted to hold our suppliers accountable to a spec that we created based on historical testing data, average of all supplier specs etc.

 

So for example, this person would create a Company specification for Vitamin C - she will need to fill in the assay, bulk density, LOD, etc that our company wants to have for that material not what just one supplier can provide. So I was wondering if there was any training or guidance out there about better understanding how to calculate and create those specs (assay, bulk density, etc). She will be collaborating heavy with our Product Development Department and Formulators so it won't solely be on her but i just wanted to equip her with as much training as possible because she will ultimately be writing over 1700 specs - Lemon balm, lemon lime flavor, magnesium, whey protein isolate, trademarks, etc 

[TimG]

I understand your question, but I think it will be difficult to find what you're asking for based on the following observation: I've worked in 4 different compliance management roles in food over the past 15 years, and the three with internal/external controlled specs were each so vastly different that I can't imagine any training guidance for any of them working for the others.

 

If one's out there, this is a great place to ask. I'm keen myself on seeing what people come up with.

 

My advice for what it's worth (not much, inflation>wages): Start work on a procedure but don't finalize it yet. Let your new hire have part ownership of creating that procedure as they learn what works while creating the spec binder. Get a spread sheet started where all the specs will have a corresponding document number. In that spread sheet, have columns with requirements for those specific specs that are in rows. Once that excel starts becoming populated, training on how to find those requirements (assay, pH, brix, aW, etc) can be targeted based on how many specs require those parameters to be met.

[nwilson]

I ma going to agree with others here in that this is a specialized process that is specific to your site.  An off the shelf procedure isn't going to get you in any better place than just rolling up the sleeves and creating one internally.  TimG stated to start a draft procedure and this is where I would start, along with creating a blank  specification template with the fields ready for input.  Basically set the new person coming into this role up for success and help keep/get them organized.  This way they can start documenting the procedures needed for anyone else that would need to step in at a later date.