Control of nonconforming products

Introduction:
In pharmaceutical quality management system number of terms are used which denote departure
from specified requirements. The requirements can be product requirements (specifications) or
process requirements (procedures).

The terms used are:

Non-conformance (used for product and process)

Out of Specification (used for product)

Out of Trend (used for product and process)

Deviation (Incident, Planned Deviation and Unplanned Deviation) (used for process)

Change Control (Planned Change used as synonym for Planned Deviation) (used for process)

Discrepancy (used for process)

This clause deals with non fulfillment of the requirements of product and states that, ‘The
organization shall ensure that product which does not conform to product requirements is identified
and controlled to prevent its unintended use or delivery’.

Control of nonconforming products

In order to ensure that nonconforming products are not delivered/used unintentionally,
these products are segregated from other products according to control of nonconforming product
procedure. Controls, related responsibilities and authorities for dealing with nonconforming
product and disposition of these products are also defined in the procedure.

Nonconforming product can be detected during inspection, testing or as a complaint. Any material
or product that is suspected of being nonconforming is considered nonconforming until proven
otherwise. Investigation of nonconformance depends upon the stage at which it is identified which
leads to root cause identification followed by corrective and preventive action. Once
nonconformity is identified an established procedure of handling of non conforming products
addresses the following steps involved in the control of nonconforming product:

Identification and segregation: Non conforming product that originates form, inspection, testing,
or customer complaint is identified, labeled and segregated, so as to prevent nonconforming
material/product from being used or shipped. Re-inspection and re-verification of nonconforming
product shall be carried out as per defined procedure. If required, customer is notified.
 Documentation: Authorized personnel will document nonconformance which shall include lot
number, description of nonconformance, and location of material. This information will be input
into the CAPA followed.

Disposition: Authorized person in quality department evaluates nonconforming product in

accordance with approved procedures and take one or more of the following actions:

a. Rework (reprocess) the raw material or finished product to meet specified requirements

b. Re-grade for an alternative application or product

c. Seek customer concession for delivery ‘As Is’

d. Issue a wavier

e. Reject to vendor

f. Dispose

Any product disposal will be in accordance with environmental controls to minimize impact on the
environment.

Note: Nonconforming products can only be dispositioned as having the status of ‘as is’ if
regulatory requirements are not violated and safety is not compromised. The criteria for release
of the nonconforming product must be recorded along with the justification.

Reworking: Product requiring rework must be done in accordance with rework procedures or
instructions. Rework operations are documented in written rework instructions that undergo
same authorization and approval as the original work instructions. A determination of any adverse
effect of rework upon the product shall be made and documented. Once the rework of a product is
complete, it must be inspected and/or tested and records are maintained.

Product return and recalls: When product non conformity that is detected by the customer after
delivery or use has started, nature and impact of nonconformance are reviewed and appropriate
actions taken including product recall.

Records: Quality assurance performs tracking, trending and reporting of nonconforming product.
Reports are used as inputs to management reviews and used to improve the process.