What is a Nonconformance?
Non-conformance is an ISO 9000 audit designation indicating the QMS or a portion of it does not meet the requirements established by ISO 9000. This failure maybe due to not meeting a work product standard, a predefined procedure, a work product specification (such as form, fit or function), or a documented plan. Alternative terms include deviation, out of specification, validation failures.
What to do when a Nonconformance is discovered?
A best practice is to have a formal process for managing a Nonconformance. Organizations participating in the Life Science, Aerospace, Food and Automotive industries typically will have a procedure, often supported by a controlled document. Frequently, a software application within the corporate ERP (Enterprise Resource Planning) or QMS (Quality Management) system is used to manage the work flow and provide trend reporting.
The procedure would describe what information needs to be initially gathered, when and who needs to address the Nonconformance, possibly a method to assess Risk and a process for resolution, such as who can dismiss further action or whether it needs a potential Corrective Action review.
Assessing Risk or Severity
A Nonconformance can be very minor to a severe risk to ongoing operations. A common approach is to establish 3 levels of importance: (1) Critical; (2) Major; (3) Minor. Each category may have a different process for resolution, timeliness of response, organizational level notification and degree of investigation.
For example, a Critical Nonconformance may require:
- a set of specific individuals to meet immediately to assess the situation;
- a production line to be suspended or a vendor to be immediately notified;
- senior management notification
- automatically require a Corrective Action
A best practice for assessing the impact of a Nonconformance is a combination of Severity and Likelihood. An extremely unlikely to recur Nonconformance with a medium level of impact may n be considered Minor, for example, but one that is likely to recur may be considered Major. Here is a graphical representation of how one company established a means of categorizing issues
Each of the values of Severity and Likelihood are defined as part of the procedure for managing a Nonconformance and may be unique to each company. The color codes are associated with Levels:
- Critical = Red
- Major = Yellow
- Minor = Green
Not only will categorization drive the response for each Nonconformance, but it is vital for assessing trends and management actions.
What follows the Assessment?
The Nonconformance procedure would describe further actions once reported and assessed. Some form of investigation should follow with a cause analysis, and once Risk and Severity are reassessed, a disposition with any necessary actions, ownership and due dates may be defined. Again, a software application may be used to notify, document and possibly electronically sign any reviews and approvals.
At any point during the cycle, a Corrective Action may be necessary and the complete record of the Nonconformance will be desirable as part of that workflow.
How to reduce the incidence of a Nonconformance
The most common reasons for a Nonconformance within the Calibration Management organization is poor scheduling of asset reviews and incomplete record keeping of those activities. Spreadsheet or paper based systems are particularly vulnerable to errors but older systems which are incompletely implemented can be a cause as well. An inability to track and report on issues cripples the department’s ability to continuously improve performance and stay within compliance. A well implemented Calibration Management software application is a proven solution to these problems.
A robust process for capturing, assessing and acting upon Nonconformance is necessary to establish and maintain a culture of compliance and continuous improvement. This is particularly true if participating in certain industries as a supplier/partner as well as a producer. Ineffective calibration management tools not only are the root of many nonconformance issues, it creates risks and difficulty in timely reporting and analysis and lower productivity. Investing in a modern Calibration Management software tool can address those problems. Reputable vendors can help you and your company assess if the time is right to make the move. You can learn more about how CompuCal Solutions has helped companies improve their calibration management here: