6 replies to this topic

[Abdul Qudoos]

Greetings!

Can any one share the below draft documents as soon:

• Cleaning schedule
• Surface and hands swabsanalysis schedule

Many thanks in advance,

[Charles.C]

Dear Abdul,

You may hv to (substantially) expand yr request, eg type / risk process ??

Try a search ? (I/others hv linked/posted various cleaning programs in other threads}

Rgds / Charles.C

[Abdul Qudoos]

Dear Abdul,

You may hv to (substantially) expand yr request, eg type / risk process ??

Try a search ? (I/others hv linked/posted various cleaning programs in other threads}

Rgds / Charles.C

Greetings,


Attached the schedule for your perusal, comments are welcome to improve.

Attached Files

•  Swab Analysis Schedule.doc   72.5KB   668 downloads

[Charles.C]

Dear Abdul,

Regarding cleaning schedule, here is a basic table scheme which i posted some while back -

http://www.fda.gov/F...s/ucm064458.htm

 

comment added 250714/Charles.C - above link seems to have now morphed into >>

 

http://www.fda.gov/F...s/ucm064458.htm

(go to section VII - A - Fig4)

Clearly, yr details will depend on the process/equipment etc. The table shown illustrates basics for a fairly simple layout, would expect further documented details as per the comments listed under the table.
(Some people compile a set of SOPs for each separate activity and then cross-reference into a master table. I recall there are quite detailed examples of this on the USFDA site somewhere.)
I would add to reference example that the chemicals etc must hv appropriate documentation, eg approved for food factory use / approved supplier whatever (this is sort of automatically assumed in the ref. i think due to the specific example)

Regarding yr swab schedule - it depends as usual on the particular process however I think many people (approximately) split the areas based on a "risk" evaluation and then propose an appropriate sampling scheme to suitably cover the various designated areas.
I don't know what microbiological you are analysing yr swabs for or the process risk however a routine 6 swabs/week seems a large amount to me if a low risk scenario (?).
I didn't see any reference to a results form / evaluation standards?. IMEX, it is also quite common to hv a documented corrective action plan crosss-referenced somewhere? (Most people need it at some time or other.)
Not exactly sure what "worker" means - hands? gloves? clothing?
Some schedules include an evaluation of items like post-toilet worker's hand status.

Do you already hv a system running ?

Rgds / Charles.C

[Abdul Qudoos]

Dear Abdul,

Regarding cleaning schedule, here is a basic table scheme which i posted some while back -

http://www.fda.gov/F...s/ucm064458.htm
(go to section VII - A - Fig4)

Clearly, yr details will depend on the process/equipment etc. The table shown illustrates basics for a fairly simple layout, would expect further documented details as per the comments listed under the table.
(Some people compile a set of SOPs for each separate activity and then cross-reference into a master table. I recall there are quite detailed examples of this on the USFDA site somewhere.)
I would add to reference example that the chemicals etc must hv appropriate documentation, eg approved for food factory use / approved supplier whatever (this is sort of automatically assumed in the ref. i think due to the specific example)

Regarding yr swab schedule - it depends as usual on the particular process however I think many people (approximately) split the areas based on a "risk" evaluation and then propose an appropriate sampling scheme to suitably cover the various designated areas.
I don't know what microbiological you are analysing yr swabs for or the process risk however a routine 6 swabs/week seems a large amount to me if a low risk scenario (?).
I didn't see any reference to a results form / evaluation standards?. IMEX, it is also quite common to hv a documented corrective action plan crosss-referenced somewhere? (Most people need it at some time or other.)
Not exactly sure what "worker" means - hands? gloves? clothing?
Some schedules include an evaluation of items like post-toilet worker's hand status.

Do you already hv a system running ?

Rgds / Charles.C

Thanks Charles,

Answering the above:

We have well written SOP's- Hygiene conditions, cleaning and sanitation, pest control, etc. and approved suppliers with all appropriate documents, my company is not a high risk we do blending and manufacture jams, we have done risk analysis and the chances of split is less,

We do total aerobic plate counts, yeasts and molds. from my point 6 swabs/week is large amount for low risk factory as compared to the microbiological results.

Worker means hands only not gloves and clothing, and we do post-toilet worker's hand status.

The system is perfectly running.

[Charles.C]

Dear Abdul,

I'm not quite sure the exact sequence of steps involved in your "blending / manufacturing of jams" but I presume the result is a RTE product which IMEX would be automatically classified as a high risk process, and even more sure if a heating pasteurisation stage is involved as perhaps the vacuum cooking item in yr attachment ? If I understand the flow correctly, this would also tend to indicate the location of higher risk sections.

Either way, I would hv thought that, numerically, yr proposed sampling sceme would be auditorily acceptable if done on a monthly basis, (assuming that the results are generally satisfactory) (? ).

Rgds / Charles.C

[Abdul Qudoos]

Dear Abdul,

I'm not quite sure the exact sequence of steps involved in your "blending / manufacturing of jams" but I presume the result is a RTE product which IMEX would be automatically classified as a high risk process, and even more sure if a heating pasteurisation stage is involved as perhaps the vacuum cooking item in yr attachment ? If I understand the flow correctly, this would also tend to indicate the location of higher risk sections.

Either way, I would hv thought that, numerically, yr proposed sampling sceme would be auditorily acceptable if done on a monthly basis, (assuming that the results are generally satisfactory) (? ).

Rgds / Charles.C

Thanks Charles for your valuable comment,


There is a CIP in place + hot water treatment heating pasteurization stage is in vacuum cooking vessel which is a close reactor, swabs are not possible for this item because there is no contact with food, even though i kept for surface swabs only, the process line is not exposed to air from loading raw material to finished product in bottle is closed, since 4 years we never face higher risk in the process. all the results are satisfactory.