Home > Audit, ISO, Software Quality Assurance > Major Non-Conformance Vs Minor Non-Conformance

Major Non-Conformance Vs Minor Non-Conformance

Major Non-Conformance

Minor Non-Conformance

Total breakdown of system, control, or procedure.
Absence of an ISO 9001 requirement

Failure to conform to a requirement which (based on judgment and experience) is not likely to result in QMS failure

A number of minors related to the same clause

A single observed lapse or isolated incident

An nonconformity that would result in probable shipment of nonconformity or un-inspected product
A condition that may result in the failure or materially reduce the usability of product for intended purpose;
A nonconformity that experience and judgment indicate will likely result in QMS failure or materially reduce its ability to assure controlled processes and products

Minimal risk of nonconforming product or service

Majors represent serious problems in the system that must be addressed with attention and resources on a priority basis. It puts the business at risk with customers and the Registrar.

Minor nonconformities have little likelihood of allowing nonconforming product or service to be delivered or causing a breakdown of system control. It does indicate that there are occasional lapses that must be formally addressed through corrective action.

Examples:

 

No documented procedure for any required element of the standard

Document changes routinely carried out in an unauthorized manner
Critical purchases made from unevaluated suppliers

Product shipped without required inspection and tests

Examples:


A drawing marked up with unauthorized changes
A purchase order released without review and approval
An inspection instrument past its calibration date
A training record not available

About these ads
  1. Mike
    March 1, 2009 at 2:51 pm | #1

    Just passing by.Btw, your website have great content!

  2. Rhona
    November 8, 2012 at 9:56 am | #2

    Thanks, of great importance

  1. No trackbacks yet.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

%d bloggers like this: