Introduction
- In the pharmaceutical quality management system a 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 a product)
- Out of Trend (used for product and process)
- Deviation (Incident, Planned Deviation and Unplanned Deviation) (used for the process)
- Change Control (Planned Change used as a synonym for Planned Deviation) (used for the process)
- Discrepancy (used for the process)
This clause deals with the non-fulfillment of the requirements of a product. It 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
- To ensure that non-conforming products are not delivered/used unintentionally, these products are segregated from other products according to the control of nonconforming product procedures. Controls, related responsibilities and authorities for dealing with nonconforming products and disposition of these products are also defined in the procedure.
- The nonconforming product can be detected during inspection, testing or as a complaint. Any material or product 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 for handling of non-conforming products addresses the following steps involved in the control of non-conforming products:
Identification and segregation
- The 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 products shall be carried out as a defined procedure. If required, the customer is notified.
Documentation
- Authorized personnel will document nonconformance which shall include lot number, description of nonconformance, and location of the material. This information will be input into the CAPA followed.
Disposition
- The authorized person in the quality department evaluates nonconforming products in accordance with approved procedures and takes one or more of the following actions:
- Rework (reprocess) the raw material or finished product to meet specified requirements
- Re-grade for an alternative application or product
- Seek customer concession for delivery ‘As Is’
- Issue a wavier
- Reject to vendor
- Dispose
- Any product disposal will be in accordance with environmental controls to minimize the 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 the 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 the 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 is detected by the customer after delivery or use has started, the nature and impact of nonconformance are reviewed and appropriate actions are taken including product recall.
Records
Quality assurance performs tracking, trending, and reporting of non-conforming products. Reports are used as inputs to management reviews and used to improve the process.
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