The Benefits of a Functioning Nonconformance Management System

Introduction

Nonconformances occur when a service, product or process does not meet defined specifications or industry regulation and standards. Nonconformances negatively impact organisations in terms of cost, reputation, efficiency and effectiveness. Non-conformance management is a very useful quality tool in that it is a key Quality Management System (QMS) performance indicator and can quickly identify systemic issues within the organisation. Nonconformance management is the process whereby the organisation manages nonconformances such that they are promptly identified, documented, evaluated/investigated, segregated and dispositioned as per applicable regulations and standards.

A functioning nonconformance management system will bring many benefits to your organisation such as:

• Reduction in the occurrence and costly impact of nonconformances in terms of reputation, cost and resources
• Improvements to product/service and resultant customer satisfaction
• Efficient use of resources.
• Reduction in number of Customer Complaints
• Improved QMS effectiveness

It makes business sense to invest resources at the outset into designing a fit for purpose system that will deliver these benefits. If the nonconformance management system in your organisation is not fit for purpose it would be prudent to overhaul the system and redesign and the organisation will very quickly see the benefits.

What does a functioning non conformance management system look like?

A fit for purpose nonconformance management system is built on an well designed risk-based documented system that allows for effective implementation. Its foundation is the Plan Do Check Act cycle.

A functioning system is first and foremost reliant on everyone in the organisation engaging with the process which is underpinned by the culture of the organisation. Nonconformance management is not just Quality’s responsibility, all employees have a responsibility to report nonconformances and indeed potential nonconformances to responsible person(s) in the organisation. A blame culture within an organisation will impact negatively on the system as described below as it will result in under reporting of nonconformances and potential nonconformances.

Impact-Under Reporting of Non conformances

Non conforming service or product reaching the market place and associated consequences for the organisation
Non compliance with the process and resultant regulatory non compliance and related consequences.

Impact-Under Reporting of potential Nonconformances

Increase in number of nonconformances that occur and associated consequences.
Non compliance with the process and failure to meet an organisation’s requirement to implement continuous improvement
Failure to attain benefits of continuous improvements to product, service or process

Design, implementation and audit of a robust easy to use non conformance management system that allows for early detection, timely reporting, timely processing and accurate documentation of nonconformances is critical to its success.

A functioning nonconformance management system is in essence a series of building blocks namely design, documentation, implementation, audit, and continuous improvement cemented together with a clear understanding of the process and process objectives through training, communication and a supportive culture. Each of the nonconformance management system building blocks is described below. If any of the building blocks are missing or there is a disconnect then the non conformance process will not function.

Nonconformance management system building blocks

1. Design

The process design must be fit for purpose, the design of a nonconformance management process for a small organisation is very different to that required for a large organisation. The design must be continually reviewed for ongoing suitability as the organisation grows, the structure of the organisation changes or to meet changes to industry regulations and standards. The process should be designed by the process owner(s) who will be the subject matter experts. The design must be robust, easy to use and be clearly understood and supported within the organisation to ensure it is effective.

The process design should allow for categorisation of nonconformances as major or minor such that the Corrective/Preventive action (CAPA) is proportionate to the identified non conformance. Nonconformances should also be coded to allow trending of the data, code will identify the type of nonconformance i.e document, material, QMS and source of non conformance.

Design of quality record data templates is very important to facilitate the documentation process and ensure accurate recording of the nonconformance such that the cause of the nonconformance is correctly identified. If the cause of the nonconformance is not accurately identified then the correct CAPA will not be assigned to the nonconformance and will result in a reoccurrence of the non conformance and consequent waste of resources.

2. Documentation

The nonconformance system to be implemented within your organisation must be documented in a Standard Operating Procedure. The SOP must be clear, concise and unambiguous, the inclusion of a process flow chart is advised to aid understanding. A well written SOP will facilitate training and result in better compliance. All personnel must be trained in the SOP and training must be maintained. Documentation of a nonconformance must occur as soon as possible after identification of the nonconformance and contain as much detail as possible to facilitate reporting of high quality data and correct identification of the root cause of the nonconformance. Quality records generated from the process must be completed to the highest standard such that data integrity is achieved for subsequent trending of the data and accurate data analysis.

3. Implementation

A fit for purpose nonconformance management system is built on an excellently designed risk-based documented system that allows for effective implementation.

How do we effectively implement the nonconformance process?

• Process owner
• Clear Process Flows
• Training
• Timely actions
• Documentation
• Continuous monitoring

Implementation of the process is dependent on co-operation and communication between all stakeholders. A process owner should be assigned to oversee implementation and ensure all personnel are adhering to the documented process. The process owner will monitor implementation of the process from identification of the nonconformance through to close out of same and feedback into the process. Continuous monitoring of the process is essential to effective implementation. Weekly meetings with stakeholders where metrics for all nonconformances (Open, Closed, Closed Awaiting Verification) are discussed are a good continuous monitoring tool. The meetings can also be used to discuss CAPA’s, trends, process understanding and resource issues. Quality tools such as auditing and actively seeking feedback from employees are also very useful in monitoring effectiveness of the implementation of the process.

4. Audit

Regular auditing by personnel independent of the process is another very useful quality tool. Well executed audits can identify weaknesses and potential process improvements. Identification of weakness and correction of same within the process can result in prevention of nonconformances and associated impact in terms of reputation and costs. Identification and implementation of improvements to the process may also result in a reduction of number of nonconformances. Audits are also needed to ensure compliance with the process, measurement of process efficiency and to report back into the QMS. Audits of a process can also facilitate resource planning.

5. Continuous Improvement

Continuous improvement of the process will result in a more efficient system and consequently a reduction in the number of nonconformances and enhanced benefits of a functioning non conformance management system for your organisation. Continuous improvement is achieved by analysis of outputs from audits, CAPA’s and feedback from employees. Data analysis of these sources is used to identify process improvements and any systemic issues in the organisation which are addressed through update of the process and delivery of the benefits of the improved process.

Conclusion

Investment in a well designed, effectively implemented and maintained nonconformance management system will bring many benefits to your organisation.

Contact Real Regulatory to help you design a bespoke non conformance management and your organisation will very quickly reap the benefits of the investment.