9 replies to this topic

[DavidAR]

Greetings all, been a while since posting, in my new role i managed to get us an A after predecessors only managed poor B's the last 3 to 5 years :)

 

Anyways V7 clause 3.11.3 is the same as V6 i believe however we had a non-conformance here relating to not listing timings of key activities when doing the product recall test. 

 

Now the interpretation isn't so clear on what timings are classed as KEY so i am wondering what should i ensure is recorded within my procedure / recording of test/ occurrence  to ensure compliance here.

 

Obvious things i can think of would be:

Timing of staff being able to come to a meeting.

time taken to start and finish traceability test (<4hrs)

time taken to contact or get hold of customers if relevant

 

but beyond this im a little stuck.

 

perhaps somebody has an old procedure template laying around with some info i can get some ideas from?

 

[mgourley]

In no particular order:

Time distribution of affected product ceased

Time FDA Recall Notification Form was faxed

Time legal counsel was contacted

Time media statement was approved, released

Time all production records pertaining to affected product was gathered

Time affected product still under your control was placed on hold

Time Certification Body was informed of the recall

Time recall notice was released

 

I'm sure there may be more depending on the tasks that your recall plan direct you to carry out.

 

Marshall

[DavidAR]

Ahh some interesting points i had not considered, thanks.

 

these key timings, are these usualy part of an incident form seperate from say a recall form?

 

currently we use an incident form to identify / investigate an inssue which may or may not always result in product recall so thus would be no good for Testing the system.

We there fore have a point that where action is made to use the recall form.

 

perhaps both would have relevant timings on relevant to each?

[mgourley]

These are all items that are or have been on recall plans at several employers.

The recall plan is used once a year in a mock scenario.

We go through all of the steps in the recall plan, even though it's a mock recall.

Not much point in having a recall plan if it does not work when, you need it to work.

 

Marshall

[DavidAR]

Ok great, that really helps the plan or procedure should be singular i think using 1 layout 1 form. the end result can be obviously difrent but for testing / review for BRC 7 compliance would require worst case scenarios like power cut during recall process . HEAVEN FORBID :)

[Madam A. D-tor]

Dear DavidAR,

 

I agree with all the items mgourley and you has stated.

However my interpretation of key activities in a recall test is slightly different.

 

I go always back to the recall procedure of the company. All the activities stated in the recall procedure, should be demonstrated (including timing) in your recall test.

e.g. if the recall procedure states for example the activities:

- director is informed;

- director calls recall team;

- the infected batch is traced.

These are the items I am searching for in a recall test.

If you have a recall form, just add the timing to the information on the recall form.

 

The conclusion of the recall test, should also mention the timing. Was it good? Or is improvement possible? Which corrective actions to be taken, etc?

[Appendix G]

We do quarterly mock recalls and one of our customers requires total resolution in 2 hours.  We use an inventory tracking system that allows us to find all information regarding the raw materials used and the disposition of the finished good.  

 

The total time is 5 minutes if there are no kinks.  If we ran into an issue that required us to find all of the paper documents it would be MUCH harder.

[Madam A. D-tor]

Dear gthornton,

 

I think, you mean, the traceability takes 5 minutes.

The mock recall will take longer.

Mock recall includes for example:

- informing director/recall leader;

- getting recall team together (is everybody reachable? are deputies reachable? try to do a recall test, with one of two deputies to find out ,if they also now the procedure)

- decision if it is or is not a recall;

- getting scientifical information to motivate this;

- meanwhile do a traceability and block products;

- getting information of the processes of the infected batch (temperature records,  CCP records, incoming good records, loading bills, cleaning records, which staff was working, were they trained)

- fictitious inform authorities (e.g. try to find the page on internet where you have to report, or try if you understand al the question on the digital form provided by your authorities for the case you are dealing with)

- fictitious inform your customers (what would you tell? by mail? by phone? are all the contacts still actual? are the contacts, also the contacts in case of a recall (sometimes these are different persons), do you have 24/7 contacts where needed, etc.)

- and after all that the results of the mock recall has to be evaluated. (What was good? what was not? what took to much time? can we improve this?))

 

Please note: the goal of a mock recall/ recall test is to train the recall team in performing recalls.

So, the whole recall team needs to be involved in the recall test.

It is like a fire exercise: probably you will never need it, but once in a while you test if all staff know how to get outside when the alarm bells ring.

It is the same for recall exercise: hopefully you will never need it but at least annually you test of the involved people, know what to do on that critical moment.

 

Traceability is a part of recall.

Nowadays with all the digital ERP systems, traceability (When did I produce it? To whom did I send it? Whit which haulier? Which raw materials/ingredients/packaging did I use? Where did I get these?) may not take much longer than 15 minutes.

[Charles.C]

Hi DavidAR,

 

There are a variety of examples sprinkled about this forum, eg -

 

http://www.ifsqn.com...all/#entry71087

[DavidAR]

thank you everyone for replies, it really helps, good comments all round and the examples are also very helpful.

 

 

thanks all