In any Quality Management System (QMS), you might be familiar with hearing conformity and non-conformity terms being used. What is the definition of non-conformity, and why is it essential for your QMS? Read on!
Conformity, or conformance itself, is the fulfilment of a requirement or specifications, whereas non-conformity is defined as the non-fulfilment of a requirement or specifications. These definitions are taken from ISO 9000:2015 Quality Management System – Fundamentals and Vocabulary. The terms are widely used in many quality management standards, not just in ISO 9001 but also in other ISOs such as ISO 13485, ISO 27001, and ISO 22000.
Here we list down some samples regarding the clauses in which the non-conformity process is defined and used in each management system standard:
“Failure is the seed of success,” said Kaoru Ishikawa, the quality guru. We know that having any non-conformance is nothing embarrassing but a chance to grow, while we hold the key to improving all the time.
Non-conformity, described as non-fulfilment or failure to meet a requirement in practice, could vary. This may happen in any step and aspect of the management system. It could also be present in the organisation’s process, product, or services.
We can say that a “defect” that arises in the product during the manufacturing process is also a form of non-conformity against its intended or specified use.
Both conformity and non-conformity are usually detected through processes such as inspection and audit. While seeking conformity during those practices, there will also be a chance to find non-conformities. Other sources whereby non-conformities can be detected are customer feedback, testing, reviewing, observations, etc.
Can non-conformity be graded?
Non-conformities can be graded depending on your organisation’s context and organisational risks. It can be generally qualitative (e.g., major non-conformity and minor non-conformity) or even quantitative with any grade (e.g., 1 to 5).
It is common to grade the non-conformities qualitatively, for example:
Minor Non-conformances
An isolated lapse in the content or implementation of procedures or records could reasonably lead to a systematic failure or significant system deficiency if not corrected.
Suppose a trend of minor non-conformance occurs over successive assessments. In that case, it may represent a systematic failure or considerable system deficiency, resulting in the issuance of major non-conformance.
Case study:
An auditor found out that the auditee from a specific department was inconsistent in recording the processes in the provided form template; hence auditee did not conduct a process according to the published standard of procedures. Although this issue caused no severe consequence, a minor non-conformance report is required to ensure specified requirements have been met.
Major Non-conformances
A systematic failure, or significant deficiency, occurs when a single wrong incident or a combination of several similar inappropriate incidents are conducted. Several non-conformance cases identified against one requirement of the relevant standards can represent a total system breakdown and thus be considered a major non-conformance.
Case study:
An auditor found that the company conducted no internal audit and management review for the previous period of a year. The auditee provided no records to prove that they had performed these operations. The auditee’s statement also supported that no such internal audit and review was conducted last year as they lacked resources. This could be classified as major non-conformities.
Yorumlar