“To err is human,” it is said. But in sectors like healthcare, medical device or life sciences, these errors can often prove fatal and therefore have to be eliminated altogether. Moreover, customer complaints and dissatisfaction can damage the reputation of the company, hurting the enterprise both financially and otherwise.
To aid businesses in reducing errors and thereby risks, various governing bodies such as the Food and Drug Administration have laid down regulations to cover the entire product development lifecycle. This also increases the responsibility of the business to comply with necessary regulations, as non-conformance can lead to product recalls or even hefty fines.
Additionally, in today's customer-first world, success in terms of key quality metrics can be a significant competitive advantage.
A few red flags that companies must pay attention to include:
- High number of NCRs (non-conformance reports)
- Mistakes being repeated
- Non-conformances that are not getting closed
- Minor non-conformances that snowball into major ones
- The ISO or API certification gets revoked
- Unmanageable number of complaints
The need for an efficient RCA process
Many times, businesses are in a fire-fighting mode and will often see a problem recurring. Sometimes, a problem may have certain triggers, but be rooted in a deeper process-oriented issue that needs to be addressed to prevent a recurrence or an escalation.
Root cause analysis (RCA) is defined as a systematic process for identifying “root causes” of problems or events and an approach for responding to them. It involves identifying the contributing factors and resolving them for long-lasting impact.
The first step in RCA is analysis to understand the problem itself, how it happened, what caused it, and solutions for preventing its recurrence.
Not only will implementing RCA help in rooting out the problem but it will also establish a clear method of problem-solving using available data, as well as predicting probable future scenarios. Corrective measures can be developed to rectify the root causes instead of merely addressing the symptoms.
One of the keys to the success of the RCA approach is the need for a systematic process that is supported by evidence.
An RCA approach can be broken down into the following steps:
- Defining the problem
- Gathering data for insights and evidence
- Identifying all causes of a problem
- Identifying the root causes
- Analysing possible solutions for mitigating problems and preventing their reoccurrence
- Implementing the identified solutions
It is not just about the process, but also about improving the quality of the product, and thereby, customer satisfaction.
The Plan-Do-Check-Act cycle (PDCA) is one of the most established methods of improving conformance. It covers the four main aspects of design, documentation, implementation, and finally an audit, leading to Continuous Improvement.
Corrective and Preventive Actions
Eliminating causes of non-conformance, commonly referred to as CAPA or Corrective and Preventive Actions, is a business need today and an integral part of a good quality management system. ComplianceQuest, a cloud-based EQMS built on the Salesforce.com platform, is a scalable, robust system that integrates the processes and acts as a gold source of data for effective RCA.
It begins with Problem Definition, where all relevant information is culled for a detailed analysis. It also helps identify and include the relevant resources from within and outside the company to address the issue.
The access to data enables an in-depth analysis, identifying patterns, assessing risks and their impact. This helps in locating and documenting the root cause(s) of the non-conformance, devise a remedy, validate the effectiveness, review at the management level and document accordingly.
A good CAPA management tool such as the one from ComplianceQuest helps with:
Change Management: The proposed action plan may transform into change projects, including replacing machines, revalidating a specific process or equipment, changing documents, creating new documents or ensuring that knowledge is properly propagated.
Document Control: It should be supported by appropriate documents that are updated and aligned with the improvement to the processes that are being worked on.
Training Management: Knowledge dissemination due to changes or creation of new content requires transferring and assessing that new knowledge to the appropriate parties. The success of that transfer and assessment are important parts of evaluating the effectiveness of how well a CAPA was implemented.
The ComplianceQuest solution also facilitates collaboration between complaint handlers, whether in the same or different locations, and draws from the experience of subject matter experts. It allows documentation of multiple root causes, including supporting tools, documentation and evidence that is used to act upon on the root cause analysis. Investigators can utilize the “Cloning” capability to perform additional investigations and reuse the analysis. The system also provides capability to identify if the failed component was from a supplier, and trigger the initiation of a Supplier Corrective Action Request (SCAR).
If you are facing any challenges due to non-conformance and would like to get to the root of the problem, we’re here to help.
We believe, ComplianceQuest is well-placed to become one of the best EQMS products in the market for various sectors including Life Sciences, Healthcare, Automotive, CPG, Aerospace, Manufacturing and Cannabis segments.
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