9 replies to this topic

[bacon]

Hello all, it's been a while but I though I'd pop in and revive the concept of "Mock Recall" and "Traceability/Mass Balance":

 

I STILL see MUCH confusion on the terms and a lack of consistency of language; so let us "calibrate" as it is VERY easy, in the ivory tower, to "orchestrate" Traceability , but when it comes to the "evidence", where the rubber hits the road: I'd like see were we are all at when it comes to Best Practices of what is and what is not a Traceability  "exercise".

 

 

Forward Traceability (part of a Mock Recall) event: Identify a product, see what "batch" or "lot" it is in, find out where it all went.

EVIDENCE:

• Number of units manufactured or ingredient used (lbs of material, ingredient, packaging) in recall “Lot”
• The quantities of affected product that each customer received (to site Shipping)
• Any write-offs or stock waste (set-outs) that occurred for the finished product.
• Any re-work (re-canning) was transformed into another finished product.
• Reconciliation summary/report of units:
  • Manufactured product shipped

vs.

                   to units sold, and yet to be sent to customers.

• A summary that can explain the variances:

to waste/setouts.

to warehouse storage/Inventory.

 

 

 

VS.

 

 

 

Backwards Traceability event: Identify your source raw material (cans, lbs of raw material, tin, plastic film, etc), see where it went, explain the variances (yield, waste, theft, purchasing errors, etc).

EVIDENCE:

• Raw material supplier (supplier purchase source, ingredient, packaging)
• Relevant Inspection/Production records recording “lot(s)”
• Raw material receivable dates and quantities
• raw materials used and quantities
• Any waste generated (often recorded as “yield” or “recovery”)
• Work in progress identification to raw material batching:
•  WIP inventory 

           o   Yet to be shipped (not in "inventory") 

 

Thoughts?

 

[Ashfaq Hussain]

Hello all, it's been a while but I though I'd pop in and revive the concept of "Mock Recall" and "Traceability/Mass Balance":

 

I STILL see MUCH confusion on the terms and a lack of consistency of language; so let us "calibrate" as it is VERY easy, in the ivory tower, to "orchestrate" Traceability , but when it comes to the "evidence", where the rubber hits the road: I'd like see were we are all at when it comes to Best Practices of what is and what is not a Traceability  "exercise".

 

 

Forward Traceability (part of a Mock Recall) event: Identify a product, see what "batch" or "lot" it is in, find out where it all went.

EVIDENCE:

• Number of units manufactured or ingredient used (lbs of material, ingredient, packaging) in recall “Lot”
• The quantities of affected product that each customer received (to site Shipping)
• Any write-offs or stock waste (set-outs) that occurred for the finished product.
• Any re-work (re-canning) was transformed into another finished product.
• Reconciliation summary/report of units:
  • Manufactured product shipped

vs.

                   to units sold, and yet to be sent to customers.

• A summary that can explain the variances:

to waste/setouts.

to warehouse storage/Inventory.

 

 

 

VS.

 

 

 

Backwards Traceability event: Identify your source raw material (cans, lbs of raw material, tin, plastic film, etc), see where it went, explain the variances (yield, waste, theft, purchasing errors, etc).

EVIDENCE:

• Raw material supplier (supplier purchase source, ingredient, packaging)
• Relevant Inspection/Production records recording “lot(s)”
• Raw material receivable dates and quantities
• raw materials used and quantities
• Any waste generated (often recorded as “yield” or “recovery”)
• Work in progress identification to raw material batching:
•  WIP inventory 

           o   Yet to be shipped (not in "inventory") 

 

Thoughts?

it is very thought...

[CMHeywood]

Yes, very thorough.  Traceability will determine the extent of any potential recall or withdrawal of product.

 

If something is contaminated, then you need to determine where all the related finished goods are located.  This is primarily tracing one step forward.

 

You also need to determine where all the related raw materials where used.  This is primarily tracing one step back.  However, if a contaminated raw material was used in other finished products, then you need to extend your forward traceability to other customers, and possibly to other products that were not considered at first.

 

Mass balance means you can account for 100% of the finished product, including waste and scrap, and for raw materials, including waste and scrap.  You would need to get numbers from your reports to confirm that you have accounted for 100%.  No guessing is allowed:  "Well the rest must have been scrap!"

[GMO]

We do backward and forward traces as part of our trace audit but then also do backward and forward traces as part of a mock recall so you're right to say it's only "part of".  The latter should be scenario based to be really effective so rather than saying "trace this" give an incident and trickle information then only trace relevant information.

[Charles.C]

Hi bacon,

 

Thoughts?

 

As you say, there are a variety of interpretations relating Mock Recall / Traceability.

 

Just as an example, IIRC, an AIB interpretation can be worded diametrically opposite to yr OP.

 

IMO it simply comes down to providing a clear reference/ definition for any case under discussion to avoid comparing "apples and oranges".

 

If one wishes to determine the most useful interpretation, that would be another thread. Best handled via specific examples IMO.

[bacon]

Exactly Charles. The definitions regarding this subject are a bit nebulous.

 

So, what is an auditor to expect? Do the just take anything? I have not received clarity from the auditor (and would have opens up a long discussion that the audit time did not allow).  

 

Are my examples of evidence above for the various "trace" exercises too tight/unrealistic?

-B

[GMO]

I think the thing is a "mock recall" should be testing your crisis / recall process not just your traceability.  It's testing how you respond to an incident.  For example, even recognising an incident is an incident can be a problem.  A complaint or an incident in a factory may not make it to the right person.  A senior team may not chose to recall a product when they should or may not see the patterns in data indicating a more serious issue.  You may have people who really buckle under pressure and realise you need different people in your team.  It's also a great way to test you have everything you need in terms of skills.  One role which is often forgotten is the scribe.  The only thing we don't do which would be more "real life" is to run the scenario over several days which when I have been in crisis situations is more likely.  We always limit it to 3-4 hours for expediency. 

 

I've always run recall / crisis exercises as an exercise.  When I joined my current company, they used to run it as a trace exercise without anything more (which I didn't realise until we were in an external audit in my first few months).  Not in a BRC audit but in a retailer audit, this was raised as not being a proper recall / trace exercise and we were told to do as I described before; a scenario.  I'm really not sure if BRC auditors will "catch up" as I can't see any other way of differentiating the two requirements but in any case, doing something over and above tracing the product is sensible as it's a better test of your systems also limiting trace to what you actually need to know for the incident shows you're thinking about it and limiting workload for your team when they may be experiencing significant stress if it were real.

[GMO]

This is from the interpretation guideline:

 

Interpretation Tests of the withdrawal and recall procedures

 

It should be emphasised that traceability is only a part of a recall test which is expected to be a test of the effectiveness of the full recall procedures.

The withdrawal and recall procedure must be tested at least annually. The aims of this testing are to:

•demonstrate that the system works

•highlight any gaps and where the system requires improvement

•demonstrate how quickly the required information can be collated, and thereby corrective action taken, such as materials being isolated and quarantined

•act as a training exercise for personnel to ensure that clear roles and responsibilities are undertaken in the event of a real withdrawal situation.

The test of the recall and withdrawal procedure must include verification of the decision-making process, traceability of raw materials through to finished product, verification of contacts and timings of key activities.

Records must be kept of tests of the recall and withdrawal procedure and must include a review of the result of the test and any action for improvement.

If the site has had an actual withdrawal or recall which fully tested its recall procedures, then this would be a substitute for a recall test as long as records are maintained, an analysis of the effectiveness of the recall process is carried out, and any areas for improvement are identified and acted upon.

[Charles.C]

Exactly Charles. The definitions regarding this subject are a bit nebulous.

 

So, what is an auditor to expect? Do the just take anything? I have not received clarity from the auditor (and would have opens up a long discussion that the audit time did not allow).  

 

Are my examples of evidence above for the various "trace" exercises too tight/unrealistic?

-B

 

Hi bacon,

 

A few comments –

 

BRC7 Standard actually makes no mention of "mock recall". Nearest equivalent is in 3.11 as detailed by GMO in Posts 7/8. BRC also mixes in the (presumably for UK due diligence) withdrawal aspect.

 

Regarding recall and withdrawal procedures the minimal requirements are spelled out in 3.11. Afai can see BRC leaves the choice of quantitating “recall” up to the auditee inasmuch as the IGs are not considered  to be auditable content. To quote BRC –

The product recall and withdrawal procedures shall be tested, at least annually, in a way that ensures their effective operation.

 

Regarding Traceability, BRC have previously published some informative examples of their expectations which have been posted on this Forum. I have attached 2 below. Some aspects of yr OP seem not required, eg variances.

 

 BRC - F070.pdf   3.53MB   827 downloads

 

 BRC - F054.pdf   5.89MB   789 downloads

(also includes mass balance)

 

BRC do define the above (used) features in the Glossary but the definitions (barring mass balance) IMO fall short of clarity.

[bacon]

Thank you GMO and Charles C, this clarifies allot:

 

per in BRC’s F070 Issue 1, Introduction to Traceability - 4.2 How to test the traceability system, “You will also need to complete a quantity or mass balance check. This is basically a traceability test but assessing the quantities of material i.e. assessing how much finished product was manufactured and ensuring this matches the amount of raw material used. During the BRC audit, the auditor will complete a full vertical audit which will include a test of the traceability system and associated production paperwork such as weigh-up records, CCP records or metal detector checks ”. This is what our previous auditor did.

 

However, this year with a different auditor, the "traceability challenge" burden was places on myself during the audit. Hence my initial inquiry on what the auditor was looking for in a "traceability challenge".

•    3.9.2  Traceability is a lots in/lots out and quantity check/mass balance to account for material (within 4 hrs, as a minimum annually)
•    Product Recall test that “tractability” is a component (that, per 3.11.3, does not have a time requirement, tested as a minimum annually); should be testing ones recall process not just ones traceability.
 

There was some confusion in the organization as to the difference latter requiring more “hands”, the former more facility specific that the auditor in 3.9.2 must verify during the audit.

 

Not being an auditor, I generally don’t read the guidance documents for the auditor, I make sure the our facility is adhering to the standard requires. This identifies why the auditor could not point out the requirement in the standard (and senior management thought I was crazy/out of line).

 

Cheers,

-B