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Control of Nonconformity Outputs Procedure

The document describes a procedure for controlling nonconforming outputs. It defines responsibilities and processes for detecting, identifying, quarantining, and disposing of nonconforming products through methods like review, inspection, testing, audits, and more. The procedure aims to comply with ISO quality standard requirements.

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9 views

Control of Nonconformity Outputs Procedure

The document describes a procedure for controlling nonconforming outputs. It defines responsibilities and processes for detecting, identifying, quarantining, and disposing of nonconforming products through methods like review, inspection, testing, audits, and more. The procedure aims to comply with ISO quality standard requirements.

Uploaded by

suryakant.frenchcert
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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.

Doc No: SMS/PR/01 Date: 10/10/2023 Rev: 00, Issue: 01


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

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