Handling of Non Conforming Materials

1.0    PURPOSE

1.1    To lay down the procedure for handling of Non- conforming materials. 

2.0    SCOPE

2.1    This procedure is applicable in Quality Assurance, Quality Control, Purchase, Production and Warehouse.

3.0    RESPONSIBILITY
 
3.1    Head - Quality Control    

3.2    Head - Production

3.3    Head – Warehouse

3.4    Head – Purchase

3.5    Head – Process development Laboratory

4.0    ACCOUNTABILITY

4.1    Head – Quality Assurance

5.0    PROCEDURE

5.1    The analysis of all Raw Materials, Packaging Materials, Intermediate and finished goods are performed as per approved test procedures and specifications.

5.2    The analytical results of those fall outside the specifications or acceptance criteria shall be described by this SOP.

5.3    When any non-conforming result in accordance with specification is identified during analysis in QC laboratory, analyst shall inform to Head / deputy - QC immediately. 

5.4    Head / deputy - QC shall initiate the laboratory investigation for the non-conforming results within 24 hours as per format xxxxx for raw and packaging materials (Procured materials) and as per xxxxx (SOP for OOS) for intermediates and finished goods (Processed materials).

Procured Materials

5.5    Head / deputy - QC shall assign the investigation number and organizes for investigation.

5.6    After completion of Lab investigation, Head / deputy - QC shall review the details of investigation and accord his recommendations. Head / deputy - QC shall send the filled format xxxxx Quality Assurance.

5.7    Quality Assurance shall review the details of investigation and forwards the filled format xxxxx to Production, Warehouse and intimates Purchase regarding the non -conformity. 

5.8    Head / deputy - Production shall review the non-conformity and the product planning requirements.

5.9    Head / deputy - Warehouse shall verify for statutory and other regulatory obligations of the material.

5.10    Head / deputy – Purchase shall review the non-conformity and liaise with the vendor.
 
5.11    After review by Production, Warehouse and Purchase, Quality Assurance shall decide if

5.11.1    The material to be rejected and returned to the vendor.

5.11.2    The material to be checked for usability studies

5.12    If the Usability study is to be done, the filled format xxxxx shall be forwarded to Head / deputy – Process development.

5.13    Head / deputy – Process development reviews the non -conformity and the options for performing the usability study are developed and performed. 

5.14    Head / deputy – Process development shall recommend the usability options and forward the filled format xxxxx to QA.

5.15    Based on the recommendations of Production, Process development and warehouse, QA shall decide about the material

5.16    If the material is decided to be used, then the approved format xxxxx shall be forwarded to QC for approval of the material. QC shall mention, “the material Does not comply with the specifications with respect to …….” on the COA along with the remarks “Material approved as per NCM……”. 

5.17    QC shall record the failure of the material in non-conforming material register and record “Approved” in the inward register. 

5.18    If the material is found not suitable or decided to be rejected, then format xxxxxshall be forwarded to QC for Rejection of the material. QC shall mention “the material Does not comply with the specifications with respect to …….” Along with the remarks “Material Rejected as per NCM …….”

5.19    If the materials to be destroyed, then the material shall be treated as Solid waste and procedures of Safety and Environment shall be followed.
 
5.20    Vendor records shall be updated regarding the non -conformity and used while vendor evaluation.

5.21    The batches produced with this material shall be reviewed for any abnormal variances with respect to quality and yield.

5.22    The non -conformity data shall be reviewed annually and based on frequencies observed, the specifications of the materials shall be reviewed.

Numbering

5.23    QC department shall assign number on Non-conforming review form. Numbering shall be as per following example.

Serial number starts with 001 for Non-Cephalosporins area, 201 for D & E area and 401 for F & G area.

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Non conforming materials, quality assurance