Product Traceability (2.6.2)

Hello, all!

I am currently reviewing/revising our Product Trace Procedure, and need a few ideas. We already have a Product ID/Trace system in place, along with the Procedure, but I would like to include details about annual testing of the trace system--specifically how we will evaluate it after performing a trace exercise (SQF 2.6.2.1 iii).

Background info: We make PET hotfill bottles and jars for fruit juices and applesauce. The physical location and use of raw materials and product can be traced in our online system, but we also have things on paperwork, as well (mostly qualification check sheets, usage logs, finished goods inspection log, etc).

So what I'm looking for are objective or subjective items we can use to measure the effectiveness and efficiency of our system. What I have so far is:

• Time to complete trace
• Number of employees involved
• % completed/incomplete paperwork
• Completeness of trace (ie, are all required items included in the trace information package?)
• Teamwork of parties involved

If anyone has any ideas on how to judge the system, they would be much appreciated!

Thanks!

-Christina

Hi Christina ,

you can also add according to your process one of the following  :

1. Product traceability % =100%  :  it is the % of quantity of the product that we can trace it back , for example if it is a raw material , assuming we received 100 Kg so I shall be able to trace all the 100 Kg e.g.   50 processes + 10 reworked + 10 scraped + 30 inventory ( on hand stock ) so the % = 100 % , the 5he wareh0 processed 40 dispatched to X destination , 5 to Y and 5 on hand in the warehouse. , same for reworked qty.
2. Ability to perform the test out of the working hours : e.g. 8 pm .
3. are we able to collect the data in case of absence of key person , do we have someone can cover his absence.
4. Effectiveness of product identification : it will be through a GMP tour ( does all product well identified)
5. Physical Inventory is matching that on system : perform physical count for certain batch then match with the system print.
6. Try to trace the rework ( recycling , it is a tricky , does your documents clearly identified the rework and all the data till its raw material , initial production date ,...." Traceability is maintained where product is reworked "
7. Finally paper work precision and accuracy is crucial check its integrity frequently .
8. Frequency of performing the test like annually or if a change in the traceability system or traceability team members
9. Training frequency e.g. yearly for each team members.

I'd prefer to integrate it with the recall / withdrawal process to reduce the efforts as it is also required :

"2.6.3.3 The product withdrawal and recall system shall be reviewed, tested and verified as effective at least annually."

so you report one review covering traceability , recall and withdrawal  with adding the required parameters for recall verification.

best regards ,

Ehab

Hi Christina ,

 

you can also add according to your process one of the following  :

1. Product traceability % =100%  :  it is the % of quantity of the product that we can trace it back , for example if it is a raw material , assuming we received 100 Kg so I shall be able to trace all the 100 Kg e.g.   50 processes + 10 reworked + 10 scraped + 30 inventory ( on hand stock ) so the % = 100 % , the 5he wareh0 processed 40 dispatched to X destination , 5 to Y and 5 on hand in the warehouse. , same for reworked qty.
2. Ability to perform the test out of the working hours : e.g. 8 pm .
3. are we able to collect the data in case of absence of key person , do we have someone can cover his absence.
4. Effectiveness of product identification : it will be through a GMP tour ( does all product well identified)
5. Physical Inventory is matching that on system : perform physical count for certain batch then match with the system print.
6. Try to trace the rework ( recycling , it is a tricky , does your documents clearly identified the rework and all the data till its raw material , initial production date ,...." Traceability is maintained where product is reworked "
7. Finally paper work precision and accuracy is crucial check its integrity frequently .
8. Frequency of performing the test like annually or if a change in the traceability system or traceability team members
9. Training frequency e.g. yearly for each team members.

I'd prefer to integrate it with the recall / withdrawal process to reduce the efforts as it is also required :

"2.6.3.3 The product withdrawal and recall system shall be reviewed, tested and verified as effective at least annually."

so you report one review covering traceability , recall and withdrawal  with adding the required parameters for recall verification.

 

best regards ,

Ehab

These are great! Thank you very much, Ehab! :-)

Traceability was formerly included in our annual Mock Recall, but management decided to add additional traceability tests, as our plant is having unique issues with traceability of certain items. Testing the trace system itself is part of our solution to keep identifying areas where employees are deficient so we know who to retrain on assigning out materials without having continuous mock recalls, or relying solely on an annual mock recall.  

Product trace is still obviously tested in our Annual Mock Recall, as well. Additionally, I plant to apply similar measurements to our analysis of the Mock Recall performance and Business Continuity Tests.