Non-conformance is costly. It costs money and compromises reputation.
It can also have potentially disastrous consequences for companies that are required to comply with GMP, FDA, ISO or other standardised requirements.
Even if your business isn’t tied to these requirements, a good non-conformance management system is key for quality.
What is non-conformance?
Non-conformance is any failure to meet quality requirements.
A major non-conformance is a complete breakdown of an organisation’s quality management system.
A minor non-conformance doesn’t compromise the whole business process life cycle. It may be a result of failing to take corrective or preventative action. Or it may involve failing to implement certain standards or procedures.
Challenges in managing non-conformance
Although many companies have non-conformance systems in place, these tend to be haphazard.
Non-conformance reports (NCR) may reside on someone’s desk or in the company’s electronic filing system, slowing the turnaround time for resolving non-conformance issues.
NCRs often lack a standardised format. Isolated documents make it very difficult to track non-conformance issues over time.
Existing systems for identifying, recording and responding to non-conformances can also be difficult to scale as a company grows.
Key components of non-conformance management
There are four key components that should be part of every non-conformance management process.
Standard reporting method
NCRs should follow a standardised format that allows the person or department responsible for the non-conformance to take action.
The structure of the NCR should include:
- a description of the requirement affected by the non-conformance
- an explanation of what went wrong in the production or workflow process
- recommendations of what can be done to prevent a reoccurrence in the future
- an explanation of corrective actions to be taken, which can include a review of the efficiencies in the process, a review of the individual actions within the process, follow up meetings or observations, and full documentation of the non-conformance, together with actions and results of the corrective actions.
Non-conformance review process
The purpose of a non-conformance review is to determine the impact of non-conformances and of associated corrective actions.
This review can be done daily or at regular points throughout the product process lifecycle.
Ideally, a non-conformance review should be conducted by a group that includes representatives from across departments – for example, regulatory, engineering, quality, production and other departments.
This refers to the corrective actions that have been undertaken based on recommendations of the NCR. For example, these might include reworking, scrapping or returning materials.
For non-conformance management to be effective, the results of reviews and all actions taken in response should be documented and tracked. This helps quality managers catch problems early, reducing the likelihood of reoccurrence and associated costs.
isoTracker’s non-conformance management software
isoTracker’s cloud-based non-conformance management module ensures simple, effective and automated non-conformance management. Nothing is overlooked. Real-time analytics enable informed decisions and proactive response to non-conformance issues.
Non-conformance recording and management platform
The software allows users to identify and document non-conformance, create custom fields that are relevant to your unique business needs, and assign responsibility for resolving each non-conformance issue.
isoTracker’s software also allows users to evaluate and review non-conformances, automate task notifications, and ensure all steps of the non-conformance processes are followed.
Corrective and preventive action requests
All NCRs are created on the system, allowing users to identify the action required to resolve a non-conformance issue, record the action taken and assess its impact on the overall process.
Managers can use the system to generate correct actions, which are then automatically assigned to the relevant individuals or groups.
All proof for non-conformance issues are centrally stored on the system, including documents, emails, and images.
Managers are able to close correction action requests once the action has been completed and its effectiveness has been established.
Corrective actions can be reassigned to ensure timely resolution in the event that main assignee is unavailable or unable to complete the actions.
NCRs can also be reactivated if issues reappear.
Advanced analytics and reporting
isoTracker’s non-conformance management system analyses historical data to identify trends or common origins of non-conformance issues and determine corrective measures.
This helps to identify the root cause of non-conformance issues and further areas for improvement.
Reports are automatically generated and can be used for consultations with senior management and other relevant stakeholders.
Test isoTracker’s non-conformance management software system
Test our software for yourself to determine its value for your company.
At isoTracker, we offer an extended free trial of our quality management software, along with free advice and tutorials.