While we all wish operations and suppliers were perfect, nonconforming material is a typical part of daily work for any quality professional. In this article, we’ll discuss the risk associated with the various dispositions for nonconforming material, and some expectations for each of the dispositions.
We will start with the lowest risk, and then work our way up the scale to the highest risk disposition for nonconforming product.
Scrap / Return to Vendor (Low Risk)
Any disposition where the material will not be used and disposed of is fairly low risk. There really isn’t any justification or rationale warranted, since the material will not be used.
However, as with most quality system data, these dispositions should be monitored for increases in rate / severity for potential escalation to your CAPA process.
Meets Specification (Low / Medium Risk)
Mistakes happen, and sometimes measurements or inspections take place using the incorrect specification. These are fairly low risk dispositions; just verify the data against the correct specification and if it meets the correct specification, release it.
On the other hand, if you go back and “double-check” measurements to decide it meets specification, you’ve decidedly entered the medium risk category. Be sure to document the process and your explanation and rationale for repeating the measurements. Please note that for pharmaceutical products, there is much more rigor required around this decision under the out-of-specification process – here is the FDA Guidance for OOS Results.
Sort (Medium Risk)
A quality engineer told me once that Sort really isn’t a disposition, it is an activity to arrive at a disposition, and I am firmly in that camp now.
At the end of a Sort, there is a “Scrap” and a “Meets Specification” disposition and the appropriate quantity tied to each. Be sure to perform a statistically-valid inspection on the conforming product from the Sort to determine that the Sort was effective.
Rework (Medium / High Risk)
While Sorting is separating nonconforming product from conforming product; Rework is changing a nonconforming product into conforming product through some activity. Rework is not sorting and the process/forms should clearly define the difference.
This is critical because there are regulatory requirements around rework – i.e. thinking about, documenting, and controlling for potential adverse effects caused by the rework. Take a look at 21 CFR 820.90(d) for medical device:
(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
Sorting product and calling it “rework” will confuse auditors/inspectors and they will look for these requirements to be documented as part of the activity.
Most companies document the action associated with a Rework disposition on a form that prompts the writer to think about these requirements.
Use As-Is (High Risk)
Finally we reach the disposition with the highest risk. To disposition nonconforming material “use as is”, expect to document a bulletproof rationale for use – including a review of risk management documentation (i.e. D/PFMEA), R&D evaluation, and maybe even testing with statistically-valid sampling to confirm use.
Effort Commensurate with Risk
Putting all of our effort into every single nonconforming material disposition is neither practical nor value-added for our organizations. As quality and regulatory professionals, our efforts should be commensurate with the risk – nonconforming material should be no different.