The policies and procedures for Control of Nonconformity, Corrective Action & Preventive Action are, basically, three of the mandatory requirements for ISO 9001 to have a documented procedure. This template will provide you the basic foundation for establishing such procedure to address the requirements for your Quality Management System. Also, since this is generic, this procedure can be used to establish the requirements for Control of Nonconformity, Corrective and Preventive Action of ISO 14001 and even OHSAS 18001.
The following are some of the details your will find in the procedure:
Objective : The purpose of this procedure is to establish a uniform and consistent system for: controlling non-conformities; root cause analysis; corrective action taking and verification to eliminate the cause of non-conformities in order to prevent recurrence or preventive action taking and verification to eliminate the causes of potential non-conformities in order to prevent their occurrence.
Scope : This procedure applies to all non-conformities and potential nonconformities that maybe detected either in product/service or QMS process.
Reference : Quality Manual subsections: 8.3 Control of Non-conformities; 8.5.2 Correction Action and 8.5.3 Preventive Action
Definition of Terms:
Correction – is taken to eliminate a nonconformity
Corrective Action (CA) – is taken to eliminate the cause of a detected nonconformity
Non-conformity (NC) – non-fulfillment of a requirement such as service failures and deviations from process requirements/standards. Generally, NCs are classified into the following:
Major NC – a type of NC that has adverse impact on customer satisfaction or regulatory compliance; or a non-fulfillment of the whole requirements of a procedure or policy statement (i.e. subsection) stipulated in the Quality Manual.
Minor NC – isolated case or cases of deviations from specific requirements of the QMS.
Preventive Action (PA) – is taken to remove the causes of potential nonconformities