Non-conforming product form

ejs8900

Registered
Hi all
Could anyone help me with a template for a non-conforming product form that adheres to ISO 13485:2016 section 8.3? My conpany has one but the auditior said there was not enough information for a non-conforming product.

Also is there a non-conforming product form that interlinks with a CAPA form?

Thanks in advance
 

Bev D

Heretical Statistician
Leader
Super Moderator
What did your auditor say was missing? Did they write up a nonconforming finding? If so please post the exact wording of the finding. What does your form say? What does section 8.3 say (you can post a short quote here)
Without this information we can’t really help you other than give fairly random advice that may be overkill or underkill…
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Part Number
Description
Lot No.
Quantity
Date
Identified By
Defect
Disposition


Thats ours.

8.3 Control of nonconforming product
8.3.1 General
The organization shall ensure that product which does not conform to product requirements is
identified and controlled to prevent its unintended use or delivery. The organization shall document
a procedure to define the controls and related responsibilities and authorities for the identification,
documentation, segregation, evaluation and disposition of nonconforming product.

The evaluation of nonconformity shall include a determination of the need for an investigation and
notification of any external party responsible for the nonconformity.
Records of the nature of the nonconformities and any subsequent action taken, including the evaluation,
any investigation and the rationale for decisions shall be maintained

You need controls for predelivery and post-delivery to customers.

8.3.2 Actions in response to nonconforming product detected before delivery
The organization shall deal with nonconforming product by one or more of the following ways:
a) taking action to eliminate the detected nonconformity;
b) taking action to preclude its original intended use or application;
c) authorizing its use, release or acceptance under concession.

Using a Risk-based approach:

Based upon 8.3.2 b if you can demonstrate you identify, segregate and prevent use of that product you can meet the requirements of this part.
 

FRA 2 FDA

Involved In Discussions
Here is the bare bones of our form-

Initiator: Date started:
Nonconformity Description
Product that is nonconforming: Reference, e.g. batch, serial number:
Description and details:


Containment & Disposition (complete as appropriate)

Scrap Use As Is (UAI) Rework: Return to Supplier:
SNCR:
Rationale for Release:

If rework of product, reference to the work instruction or rework plan for conducting the rework—including any inspection methods that are required:


Role Name Signature for all affected departments (engineering, quality, manufacturing, accounting, purchasing)


Type of impact or potential impact (safety, financial, company image, other - multiple may apply) and rationale:


Source of problem (human error, process, or unknown – choose one only). Include rationale unless transferred to CAPA):


Risk Assessment result (refer to SYS-028): Transferred to CAPA (or N/A):
If not sent to CAPA, any correction or corrective action taken:


Closure actions taken— including batches returned to inventory, scrap disposed, rework completed and inspected, evaluation of adverse effects from rework, reference to reports:

LST-008 updated ☐

Closure
Role Name Signature
Quality Manager

Not all of these fields are required. Some are just for our own tracking and information.
 
Top Bottom