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Traceability SOP Audit Finding - SOP does not describe the extent of the traceability

#1
Dear all,

As required by the standard ISO 13485, it is required to establish documented procedure for traceability.

To fulfill this requirement, our system actually have this SOP which also describe the extent of the product traceability.

The auditor have issued us a NCR for having this SOP which did not descibe the extent of the traceability!

Can anyone there can help me how to describe it? or perhaps can share a comprehensive SOP with me here?

Tiff:)
 
R

rclanzillotto

#2
Re: Traceability SOP Audit Finding - Does not descibe the extent of the traceability

Please share what your SOP says about extent of traceability; identification of released devices and the way you track their disposition. Best Rich
 
#3
Re: Traceability SOP Audit Finding - Does not descibe the extent of the traceability

It is basically as required in the ISO 13485:2003 - Clause 7.5.3.2.

We have actually defined the traceability from the incoming of raw material until the delivery of the medical devices in the SOP. But the auditor still questionning how does our organization define the extent of traceability in our organization.

The auditor does not accept it. What else we need to define the extent??
 

Jim Wynne

Staff member
Admin
#4
Re: Traceability SOP Audit Finding - Does not descibe the extent of the traceability

It is basically as required in the ISO 13485:2003 - Clause 7.5.3.2.

We have actually defined the traceability from the incoming of raw material until the delivery of the medical devices in the SOP. But the auditor still questionning how does our organization define the extent of traceability in our organization.

The auditor does not accept it. What else we need to define the extent??
Please post the auditor's finding exactly as written. It would also be helpful if you could post your document.
 
#5
Re: Traceability SOP Audit Finding - Does not describe the extent of the traceability

Here is the NCR statement issued by the auditor.

Traceability for implantable products are indicated in the Quality Manual and in a documented procedure. It is not clear of the requirements set forth in the quality Manual is sufficient to facilitate traceability.

Based on this procedure, the Reviewer is unable to determine if the Company has defined the extent of traceability for its medical devices.
 
R

rclanzillotto

#6
Re: Traceability SOP Audit Finding - Does not describe the extent of the traceability

I could help but I need to see your procedure. You can PM me if you wish. Best Rich
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
Re: Traceability SOP Audit Finding - Does not describe the extent of the traceability

I agree that seeing your procedure would help. It would be good to understand if your definition of tracability includes the ability to identify the manufacturing process(es) that were in place and used to manufactuer that implanted item. The expectation is, a customer should be able to return a defective item and you provide an analysis of what happened to cause the defect in that item. Traceability facilitates that - usually by lot number.
 
#8
Re: Traceability SOP Audit Finding - Does not describe the extent of the traceability

Hi mates,

The SOP is as below for traceability. Your comments and help is appreciated.

6.3 Traceability

(a) Each job order has been identified by the manufacturing lot number to ensure suitable traceability.

(b) This respective manufacturing batch / lot number is assigned and is traceable throughout the product realization and until the shipment delivery.

(a) Should there be any recall or customer feedback on the product, the Manufacturing Lot Number is the unique number for traceability.

(b) The respective departmental/division personnel shall be responsible to ensure lots at the respective section are traceable through the information as in the production & inspection records. This records/information shall be kept properly for traceability purpose.

(c) The QA/QC Officer shall be responsible to update the finished goods stock inventory and prepare the Production Lot Released Summary for MD to approve and released the products to the customer.

(d) The Production Lot Released Summary for each production lot shall contain the following details: -

(i) Production Lot Number;
(ii) Total Quantity of that Production Lot;
(iii) Customer Name;
(iv) Total Quantity approve for distribution ;
(v) Date released; and
(vi) Released by.

(e) Prior delivery to the customer, QA/QC Officer / designated personnel shall record the name and address of the shipping package consignee in the Delivery Log for traceability purposes.

(f) QA/QC Officer shall also require the customers/ agents/ distributors maintain records of the distribution of ABC Sdn. Bhd. medical devices for traceability purposes.

Also attached a table which described the traceability in three phases.
 

Attachments

Miner

Forum Moderator
Staff member
Admin
#9
Re: Traceability SOP Audit Finding - Does not describe the extent of the traceability

I do not have experience with ISO 13485, but I do have some experience with traceability.

Usually, when you have a traceability program, you are interested in being able to do two things:

  1. Forward traceability: You find a problem with a given lot of raw material/supplier components/in-process product. Can you identify where all material produced from this lot was sent in order to recall it?
  2. Backwards traceability: You find a problem in the field. Can you identify the lot of raw material/supplier components/in-process product that produced this product in order to trace forward and identify the other customers that received material from the same lot?
While you do specify the information recorded, you did not describe how you use this to achieve forward and backward traceability. This may be what the auditor meant by his finding.
 
C

cclee

#10
Re: Traceability SOP Audit Finding - Does not describe the extent of the traceability

Hi Tiffany,

Looking at the statement from the finding and the information you provided from your established procedure, I think the auditor was not able to determine the extent of your traceability from raw materials, production processes, and leading to release of finished goods.

I could not open your attached file. My opinion is that the procedure that defines identification/traceability of the raw materials up to release and delivery of finished products may include the following details:

For raw materials:
1-purchasing
2-receiving process
3-lot assignment
4-inspection/acceptance
5-inventory storage

For finished goods:
1-production process
2-DHR/Traveler creation
3-Mfg lot assignment
4-Production process (e.g. sterilization)
5-Receiving/transfer
6-Acceptance/delivery activities

This can be represented in a process flowchart with reference to any lower tier procedures/work instructions.

Hope this helps,
 
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