What SOPs do I need to put into place?
I've recently been promoted to a management position within my company. I work for the corporate division at a company that makes flavored seltzers (we dont actually manufacture the product, but rather we utilize copackers to produce it and we supply the raw materials and recipes). I've been tasked with developing an SOP manual and I have no idea where to start. I know that I need things like testing raw materials for micros and COA validation periodically as well as finished products for the same things, but what are some other SOPs that I should be considering given the industry and product. Any help is greatly appreciated.
I've recently been promoted to a management position within my company. I work for the corporate division at a company that makes flavored seltzers (we dont actually manufacture the product, but rather we utilize copackers to produce it and we supply the raw materials and recipes). I've been tasked with developing an SOP manual and I have no idea where to start. I know that I need things like testing raw materials for micros and COA validation periodically as well as finished products for the same things, but what are some other SOPs that I should be considering given the industry and product. Any help is greatly appreciated.
Hi mlong,
SOPs are used for a variety of different purposes.
For example, you need SOPs to be able to comply with GMP. (I hope you are familiar with GMP).
If you are in USA you likely need SOPs as collected within the grandiose Title of SSOPs (Sanitation related SOPs).
If you are involved with HACCP you need SOPs to fulfil the requirement for PRPs (which overlap GMPs).
Can you add a little more context as to what yr SOPs have to cover, eg to enable production of a HACCP manual, only for GMP, or ?
Like a Co-packer expectation manual?
If so:
I would pick a GFSI scheme and start with that. they all would contain all of the programs you could consider. You can leave out the sections that you feel might not be needed. In your case, you would add your specific requirements for programs you have added expectations.
for instance, if you use SQFI as a Guide.
2.1.1 - maybe nothing needed.
2.1.2 maybe nothing needed.
2.1.3 - outline the expectations on complaint handling + who in your organization investigations and CAPAS are sent to and timelines. special forms.
2.2.2 maybe something simple
2.2.3 - Something simple + who in your organization production records, test data records, shipping records, etc are sent to and frequency/timelines.
the trick is to make is simple enough that gives the required expectations, but not so large and complex that it becomes a space taker upper on a shelf.
Like a Co-packer expectation manual?
If so:
I would pick a GFSI scheme and start with that. they all would contain all of the programs you could consider. You can leave out the sections that you feel might not be needed. In your case, you would add your specific requirements for programs you have added expectations.
for instance, if you use SQFI as a Guide.
2.1.1 - maybe nothing needed.
2.1.2 maybe nothing needed.
2.1.3 - outline the expectations on complaint handling + who in your organization investigations and CAPAS are sent to and timelines. special forms.
2.2.2 maybe something simple
2.2.3 - Something simple + who in your organization production records, test data records, shipping records, etc are sent to and frequency/timelines.
the trick is to make is simple enough that gives the required expectations, but not so large and complex that it becomes a space taker upper on a shelf.
Hi ksr,
I agree yr GFSI proposal in Principle but personally i would only pick SQF as a last (desperate) resort. Despite yr above useful suggestions, many people seem to believe SQF require a "SOP for everything" solution . :smile:
PS - These 2 files may be of some assistance -
Prerequisite Programs.pdf 60.65KB 46 downloads
Prerequisite_Programs_and_Validation.pdf 616.26KB 40 downloads
They have to cover whatever quality related testing or protocols we would be responsible for as opposed to the copacker such as coordinating destruction of out of spec product, customer complaint investigations, yearly audits of the copacking facilities, etc
Hi mlong,
SOPs are used for a variety of different purposes.
For example, you need SOPs to be able to comply with GMP. (I hope you are familiar with GMP).
If you are in USA you likely need SOPs as collected within the grandiose Title of SSOPs (Sanitation related SOPs).
If you are involved with HACCP you need SOPs to fulfil the requirement for PRPs (which overlap GMPs).
Can you add a little more context as to what yr SOPs have to cover, eg to enable production of a HACCP manual, only for GMP, or ?
Think of the SOPs (Standard Operating Procedures) as an instruction manual. I am building on the prior messages from this thread because your operation is unique. Therefore, you need to fill in the gaps from these boiler plate documents. Anytime someone asks you a question about how wash something, find a new supplier etc... Or if once an employee calls in sick, everyone scrambles to figure out what to do. For each of these tasks, you would need an SOP.
They have to cover whatever quality related testing or protocols we would be responsible for as opposed to the copacker such as coordinating destruction of out of spec product, customer complaint investigations, yearly audits of the copacking facilities, etc
So i had it wrong - correct? Not a Copacker exectations manual, but what needs to be completed by your company - Correct?
So i had it wrong - correct? Not a Copacker exectations manual, but what needs to be completed by your company - Correct?
Correct. We already have a production and quality manual put into place for our copackers. What I'm tasked with developing now is a SOP manual for the things WE need to do as a company when it comes to raw materials, finished products, and everything else that could become an issue once we take custody of the product after its released to us from the copacker after passing quality testing.
Correct. We already have a production and quality manual put into place for our copackers. What I'm tasked with developing now is a SOP manual for the things WE need to do as a company when it comes to raw materials, finished products, and everything else that could become an issue once we take custody of the product after its released to us from the copacker after passing quality testing.
Hi mlong,
Thks for the (considerable) clarification.
I'm afraid that any detailed attempt to answer yr OP will require knowledge of yr products and their, presumably, mutually agreed specifications which I deduce are confidential. :smile:
It's an energy drink and the specs for quality are things like sensory testing (appearance, odor, taste) as well as analytical (pH, TA, brix, CO2, weight).
Micro testing is pretty standard. Absence of pathogens, yeast and mold, etc.
Hi mlong,
Thks for the (considerable) clarification.
I'm afraid that any detailed attempt to answer yr OP will require knowledge of yr products and their, presumably, mutually agreed specifications which I deduce are confidential. :smile: