CONTROL OF NONCONFORMING OUTPUTS PROCEDURE
1. SCOPE AND PURPOSE
The procedure described in this section of the QPM (Quality Procedure / Manual) conforms to the
requirements of the standard: Clause 8.7 – Control of nonconforming outputs and defines the
controls of nonconforming product including review, identification, segregation and disposition.
2. REFERENCE DOCUMENTS
IMS Manual
3. TERMS & DEFINITIONS
P – Proprietor
MR – Management Representative
NCP – Non-conforming product
SOP – Standard Operating Procedure
Non – Conformity – Non-fulfillment of requirement.
4. RESPONSIBILITY AND AUTHORITY (R&A)
The Proprietor has the responsibility and authority for implementing all requirements of this
procedure.
5. NONCONFORMING PRODUCT PROCEDURE
Detection of Non-Conformity
a) Non-conforming products are detected through any of the following activities: -
Protocol and manuscript review.
Inspection and testing.
Customer feedback and complaints handling.
Quality audits.
Procurement process.
Product delivery
b) Identify/label and quarantine the non-conforming products.
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c) Abhinav Enterprises shall deal with non-conforming outputs in one or more of the following
ways:
I. Correction
II. Segregation, containment, return or suspension of provision of products and
services;
III. Informing the customer;
IV. Obtaining authorization for acceptance under concession.
d) Where non-conformity is detected during processing, it is suspended until action is taken to
eliminate the detected non-conformity.
e) Where non-conformity is detected in protocols and manuscripts, it is referred back for
effecting of suggested corrections or rejected outright.
f) Where non-conformity is detected during handling/delivery further processing/delivery
will be suspended until action is taken to eliminate the cause of the non-conformity.
g) Non-conforming products detected during quality audits or inspections are recorded on
corrective action request forms as non-conformity.
h) Where a concession is allowed on supply or receipt of a product that does not certain
specifications/characteristics a concession form is filled.
i) The relevant process owner shall review and investigate the non-conformance.
Prepared By: Approved By:
Doc No: SMS/PR/01 Date: 10/10/2023 Rev: 00, Issue: 01