Hello FSSM and Charles,
Thanks for your comments.
Would it be useful to redefine batch as each time interval of temperature check?
FSSM
Yes, ofcourse. Actually I think (I know) that the manager's answer that the frequency is low because they see one day production as one batch is totally nonsense. I was quite astonished with her answer and couldn't even formulate a proper answer at the time.
Lack of info.on process and type of packaging.
Ok, I am sorry. I think it does not really matter for the case, but here is some more information:
The organisation receives whole fresh fruits (apples, melons, grapes, oranges, pineapples, berries). The fruit is washed (if necessarry), peeled, cut, mixed (if required) and packed in consumer cups (80 gr - 150 gr with spoon) and in 1 kg - 3 kg containers for restaurants/catering/bakeries/etc. Packagings are sealed. No MAP. The processes are mostly
manual. Some small equipment is in place, like apple cutting machine, pineapple peeling machine and assembling and sealing line for cups.
The organisation is supplying to a global restaurant chain.
Pathogenic growth is IMO not really possible. The products have a shelf life of 7 days and the pH of the used fresh fruits is < 4,5.
The usual type of cooling process requirement in meat industry is to reach XdegC within Yhrs. I presume the X is 7 degC for some, hopefully validated, reason. Perhaps analogous to the 4degC > 8degC for refrigerators.
There is a codex for the generalised fruit transport issue, cac/rcp 44/1995. Precooling recommended for quality reasons but no specifics given.
I am familair with the cooling processes in meat industry and ready to eat (meals, meal salads, sandwiches, meat products, etc)
The codex is new to me, but is really interesting.
Although it is ment for fresh fruits and vegetables, I can surely use this for other customers.
The appropriate number of samplings is surely related to the observed variation of target temperature and its typical absolute level. Data required, and perhaps also related to type of packaging. eg, best case scenario, if level is always 5+/- 0.5 degC, 1 sample is sufficient. If otherwise, statistics may enter in. Corrective action ?
Corrective action = do not load and inform quality supervisor and plant manager.
I like your statement about statistics and observed variation in relation to frequency. It seems quite logic to me and I am wondering why I have never thought like this. On the other hand, I have never seen applied these kind of information/statistics to establish frequencies for
CCPs or CPs. E.g. A company which always have negative
metal detector tests, can, according your statement, lower the frequency to weekly. I, as an auditor, the retailer, as customer and I hope the company itself will not accept this.
Well, thinking of it, it is used for setting frequency of glass inspections. These are mostly annual or quarterly. (accept when they are supplying to UK --> then the frequency of glass inspection is daily.
) I would say that the frequency for the
metal detector checks AND the glass inspections are established based on hazard analyses/risk asessment.
This is surely all about validation and verification.
I absolutely agree! The discussion actually started with a question about
CCP-validation. The company got a major on validation anyway. (a lot of things were not demonstrable validated)