Supplier Risk Analysis
If you do a little searching on this forum, you will find a variety of proposed schematic procedures.
It may well depend on yr specific product / specific objective but the simplest basic procedure typically consists of choosing the appropriate criteria for graded scoring, eg X percent of defective lots in a given time frame followed by generating the data. Safety / non-safety type criteria may also be required to be analysed separately.
A further refinement may also use switching rules for grades of suppliers as in some international procedures, eg iso 2859.
iso 2859 sampling.pdf 276.1KB 297 downloads
Rgds / Charles.C
Or were you trying to produce a questionnaire - type document for initial supplier approval ? Your post was unclear. There are examples of this on the forum also.
Here is what I use, rather simple but helps me
RAW MATERIAL RISK CATEGORISATION
In order to establish a suitable and effective sampling, analysis and supplier approval system for raw materials each material has been categorised according to its risk using the following definitions:
Raw material A material which undergoes some form of processing as part of its incorporation into a finished product.
Category A Materials which, during their incorporation or processing into a finished product do not undergo adequate heat treatment to effect pasteurisation.
Category B Materials which, during their incorporation or processing into a finished product undergo adequate heat treatment or any other process sufficient to effect pasteurisation.
High Risk (H) a. Any material which is a known source of pathogens.
b. Any material which has a known history of contamination with pathogens from the environment, people, animals, insects or water.
c. Any material which has a known incidence of pathogen contamination and which may support growth.
Medium Risk (M) a. Any material that has been implicated in isolated pathogen incidents but not confirmed.
b. Any ingredient which could reasonably be suspected as a source of contamination from pathogens although no direct evidence is documented.
Low Risk (L) No evidence of or reason to suspect contamination from pathogens.
Examples of Risk Categorisation
Skimmed milk powder is a known source of staphylococcal food poisoning and does
not undergo any adequate heat treatment in the making of XYZ products to effect pasteurisation. However food poisoning outbreaks have been linked to the holding of reconstituted milk powder (Ref: Risk evaluation for staphylococcal food poisoning in processed milk produced with skim milk powder Soejima et al.) It is therefore categorised as AM.
Glucose syrup shows no evidence of pathogenic contamination and is processed at
pasteurisation temperatures, therefore it is categorised as BL.
Thanks for the input.
Out of curiosity, how many items in yr database ? What are the approx. percentages of H, M, L constituents ?
My first reaction to the structure was to consider deleting M since at first sight it looks suspiciously like another name for "Others", ie unknown significance but classified as potentially dangerous to avoid looking silly afterwards. (Been there, done that
Auditors tend to love HML also of course.
Rgds / Charles.C
We have about 40 classes of materials and we make low risk products. We have 1 material which are in the "H" section, two in the "M" section and the rest in the "L" section. The "H" one we have does not undergo any further heat processing and is in the "AH" so this we we need to control very tightly, one in "M" is not heat treated therefore AM and needs control and one is cooked, i.e. BM, and is lower risk.
As I said it seems to work for me aand the auditors so everyone is happy
im busy drawing up a supplier risk analysis. it is really difficult to grade suppliers as everyone defaults into high risk suppliers. does anyone have a format that i can follow?
You could follow a HACCP format where you assess the severity of a potential hazard assocaiated with the material/service the supplier provides and multiplying it by the probability.
Regards,
Tony
How complicated or simple do you want this to be. I can provide you with a checklist that is generic or you can develop your own matrix. Previous suggestions using LMH have been suggested. These are just the tools based on hazard and risk analysis ( HACCP ) you will also need to understand the associated issues with your own process, as I am sure you know. The mitigation plans are really the most important part.
David
We have about 40 classes of materials and we make low risk products. We have 1 material which are in the "H" section, two in the "M" section and the rest in the "L" section. The "H" one we have does not undergo any further heat processing and is in the "AH" so this we we need to control very tightly, one in "M" is not heat treated therefore AM and needs control and one is cooked, i.e. BM, and is lower risk.
As I said it seems to work for me aand the auditors so everyone is happy
Sorry but I missed above reply.
The happiness is more or less self-explanatory!
The % of L is amazing. Are you part of the space program ?
Think I would still delete M albeit without knowing what we are talking about. Innocent until proven guilty.
Rgds / Charles.C
Hi,
The mitigation plans are really the most important part.
David