Non conformance, corrective and preventative action

What is ‘Non-Compliance’?

Non-compliance:  Any instance where something does not meet the quality, health and  safety, legal, or company standards or specification. This could be any aspect of the business that is not performing as specified.

Non-conformance / non-compliance may be found in any aspect of the business; raw materials, finished product, business activities, people, equipment, documentation, facilities and utilities, or something highlighted through a customer complaint.

An important part of a good Quality Management System (QMS) is having a robust process for identifying and determining any non-conformances potential effect on quality as well as detailing how to record, report and evaluate information and explain the completion of forms and logs used.

This is certainly a requirement for Clients operating or aiming for accredditation to ISO:9001:2015 standard. FutureSure builds and maintains Quality Management Systems to the ISO:9001:2015 Standard, whether you’re going for the accreditation or not it is a well used, understood and understandable system recognised throughout the world. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.

WHY CAPTURE NON-CONFORMITY INFORMATION?

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It is important to capture all adverse event, non-conformance, errors, deviations and accidents etc. information to maintain the quality of products and service and the safety of personnel and visitors.

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It is necessary to collect as much relevant and detailed information about the non-conformity as possible, so it can be trended and analysed for its risk by the quality department.

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Depending on the risk to quality or safety, non-conformity should be investigated for a root cause so that appropriate and effective action to correct and eliminate the cause can be taken.

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It is also important to think about non-conformities that have the potential to affect quality or safety so that processes, procedures and documents can be improved pro-actively to prevent future quality or safety issues occurring.

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It is therefore essential that non-conformity information be fully documented as it may provide the basis for future investigation and corrective and preventive actions.

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The system used to record, analyse, investigate, correct and prevent non-conformities is usually known by the acronym CAPA (Corrective And Preventive Action).

FutureSure we offer our Clients full Quality Management compliance including consultancy support in the writing and operating of your non-conformance procedures.

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This includes, but not limited to:

  • Non-Conformance Investigations;
  • Corrective And Preventative Action (CAPA);
  • Risk Assessments;
  • Root Cause Analysis;
  • Defining Responsibilities;
  • Communication and Training;
  • Logging and reviewing faults, issues and complaints;
  • Trend analysis;
  • KPI’s (Key Performance Indicators);
  • Continuous Improvement;
  • Customer Satisfaction;
  • Reports and Management Reviews;
  • AQL Sampling systems; design and implementation;
  • Quality Auditing; Conducting audits, training, writing and implementing systems;
  • Change Control Processes; Writing and implementing systems;
  • Review and writing of Standard Operating Procedures (SOP), Lab Work Instructions (LWI), Good Manufacturing Practice (GMP), Safe Systems of Work (SsoW) and other working documents, policies and procedures.
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Why choose FutureSure?

We develop Key Performance Indicators (KPI’s) for you to monitor your specific objective targets performance and analyse trends.

 

We carry out COSHH and Environmental Risk Assessments of the site/s to identify risks and develop suitable control measures to mitigate or reduce these risks as far as reasonably practicable.

We conduct SWOT and PESTLE analysis with your organisation’s team leaders and conduct employee consultation surveys to identify risks and opportunities and other aspects that affect the company and it’s employees. These exercises open up communication and identify gaps and concerns within environmental, quality, health and safety and other aspects of the business to help you identify issues, develop controls and ensure continuous improvement.

During a recent certification audit for 9001:2015 accreditation for a Client the external auditor from Lloyds Register stated that the Quality Management System that we implemented for the Client was the most robust he had seen in his thirty years as an auditor.

At FutureSure we offer a full range of services to help you maintain or develop your QMS to ISO:9001 standard, whether you decide to go for the accreditation or not. We help you assess your current systems, sites, procedures, products, training and activities. We then carry out a thorough gap analysis to highlight what your company needs to improve upon.

At FutureSure we help your company write policies, and procedures specific to your site with your directors and companies objectives clearly defined.

The scope and depth of your Quality Management System depends entirely on the size and activities of your company. There isn’t a one size fits all solution, this is an active engagement process and requires commitment from an organisation at all levels to be a success.

For a free consultation to discuss your Quality Management needs please email us at info@future-sure.co.uk