C of C (Certificate of Compliance) for Production Batches of Medical Devices

[ssarangapani]

In our component fabrication list, we have a place for signature of the line worker and a supervisor. When we assemble the lot records, we staple all the component records together, which have the approval signatures.
I beleive you can also create a table of lot codes of components and expiry dates, for a given batch and obtain signature from both the line worker and the supervisor.
SS from NOrwood

[lamorenita_QA]

Thx! this is general how our action plan is laid out, but haven't tried it out yet, has this worked for your company well?

[ssarangapani]

Yes, it has worked well over two extensive FDA audits and six ISO/CE audits.
We never got an observation on this aspect -i.e., production records.
Good Luck!

[Ronen E]

In Reply to Parent Post by lamorenita_QA

Hello our complany received a minor finding from CB auditor rgarding ISO 13485 7.5.1.1-Process control. Desc of nonconformity-the process for verifying and approving batch records is not sfficiently effective. Supporting audit evidence-reviewed lot control records provide not sufficient evidence for formal verification and approval of the 'batch records'. Specifically this addresses our component date lot code entry in our pick list,of closed work order were missing evidence of verification and approval. Our action plan is to state when the component date lot codes are entered by our stockrom and floor stock personnel, this is the verification requirement, and at the end of the completed work order- a final QC inspector will sign and final approval of the batch record. If anyone has a similar problem with a better action plan, I would appreciate your advice. BTW, our MRP system is not sophisticated enough to automate this process, it needs to be perfomed manually.

To me, it sounds reasonable that the component identification details are recorded on the batch history forms when the component is picked from stock for a specific work order, then signed-off by the picking person and by the person who assumes responsibility for them in production. However, this will not cover any potential mixes and mistakes within production.

The greater the criticality of the component (risk of making a mistake WRT it), the more extensive the control measures should be. Have it formally analysed and documented, then act upon it.

from my own experience, errors related to picking correct components do happen from time to time, almost regardless of the quality of personnel and of picking controls, and the consequences are sometimes severe. If you could implement a barcode system to verify the identity of any component right before its integration into the product, that'd be a much more robust control.

Cheers,
Ronen.

[lamorenita_QA]

Again, Thank You for your valuable advice. I will share this information with our corrective action team meeting today!! this forum is outstanding!