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Any organization trying to build a culture of quality will have to keep one leg each of two approaches; One, a reactive approach to quickly handle quality performance issues and ensure these are prevented in the future; Two; a proactive approach to improve quality performance on an ongoing basis with a deep focus on continuous improvement. The trick is not about choosing one way or the other but embracing both.

From a compliance perspective, all regulatory bodies recommend a proactive approach. However, there has always been a debate over the best method to achieve quality. In this blog, we will compare the two approaches across scenarios and industries, and propose why both are absolutely necessary.

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By definition, a reactive approach to quality focuses on managing any issue that has surfaced. The school of thought to reactive approach is along the lines of containment than refinement. For instance, it could be looking at a product’s quality after a customer records a complaint. Once a complaint has been identified, the key is to move with speed and agility. Resolve quickly but also prevent a recurrence.

A proactive approach is about having all of the defences up and ready to face any situation. Here, the company has prioritized quality and minimized the room for customer complaints. With a proactive approach, the company has a plan in case of contingency, teams that are constantly on the lookout for discrepancies, and, most importantly, quality has become the responsibility of the organization and not just an individual. It is really about building a culture of quality as we detail in this whitepaper.

Regulatory Requirements across sectors

ISO 9001:2015 mandates risk-based thinking when it comes to quality management. The ideology takes a ‘plan-do-check-act’ cycle that helps understand quality throughout the entirety of the quality management process. ISO 13485:2016 insists on organizations taking a proactive approach to risk management to monitor and mitigate risks of quality. By focusing on the way the QMS approaches quality, ISO 13485 seeks to embed quality into the fabric of medical device companies. Similarly, automotive parts manufacturers adhering to IATF 16949 are encouraged to take a consistent quality approach that places customer satisfaction at the center of its service offerings.

Proactive vs. Reactive Approaches Across Key Quality Management Processes

Complaint Handling: A typical process for customer complaints involves the customer service team resolving issues as they get recorded. When a company takes a reactive approach to complaint management, it can result in poor complaint handling procedures as it is about “putting out fires rather than understanding what started it in the first place”. On the other hand, a proactive approach allows companies to focus on everything from complaints in-take to evaluating risks, understanding regulatory impact and submissions, and organizing quality investigation with root cause analysis, resolution, and continuous improvement. This approach allows organizations to listen to the Voice of the Customer (VoC) as a means to improve the business’s quality, customer experience, and overall revenue.

Training Management: Regulatory compliance is ever-changing. When an organization focuses on delivering quality, the employees too must have the right training to understand what factors impact quality performance. Training has to be considered part of the process rather than a regulatory requirement in this situation. When proactive training happens within an organization, it shows both the authorities and the employees that quality is paramount to the organization. It also equips the employees to develop an attitude of quality, enabling them to participate in the quality process by contributing suggestions and identifying conformances in a timely manner.

Dealing with Nonconformances: Product recalls, increased Cost of Quality, and product rework are some direct effects of nonconformance. Nonconformance issues can result in loss of time and additional costs to the company. However, an organization can use techniques such as predictive analytics to capture nonconformance trends proactively and identify possible errors and patterns of issues effectively. The key is to stop issues before it leaves the proverbial four walls of the organization. Do whatever it takes to capture data and analyze it so that it doesn’t reach an end-user or customer.

Do Whatever it Takes: It is Not About Reactive or Proactive

Here, we highlight why a proactive approach is critical to improving quality performance across various industries. A reactive approach cannot be ignored because each and every quality lapse cannot be predicted. But, most can be and that’s where a proactive approach to risk management comes in.

  • Pharmaceutical industries are constantly dealing with regulatory warnings, audits, and consent decrees. As the regulations keep changing, these companies must take a proactive approach to improve visibility, collaboration, and control that will help adapt and comply quickly to avoid non-compliance charges and write-ups.
  • By taking a proactive approach to quality, Oil and Gas companies can reflect on incidents or accidents, assess probable causes, and improve risk perceptions within the organization.
  • As a highly regulated industry for quality, manufacturing companies must prioritize delivering profitable, differentiated, and quality-compliant products. Given the regulatory requirement, players in the industry must adopt a system that will effectively help shift the focus towards risk and quality compliance.
  • Medical device companies will need to change their risk approach from the beginning of the design cycle and throughout the product value chain. This proactive change of direction will help reduce the cost of compliance while meeting FDA requirements.
  • Construction industries deal with stringent quality policies and must record every adverse event and near-miss. Regulations including ISO 9001:2015 mandate a proactive approach to handling and mitigating quality risks with tools to minimize and capture errors, investors, training records, etc.

ComplianceQuest EQMS for Both Proactive and Reactive Quality Management with Data at the Core

ComplianceQuest offers a highly flexible, 100% cloud-based Enterprise Quality Management Software (EQMS) built using the Salesforce platform. CQ’s Quality Management System allows companies to move from reacting to quality events to predictive and proactive quality management.

The software can be used to streamline quality, compliance, content, and collaboration management workflows across the company and global supply chain networks. ComplianceQuest EQMS aligns with industry compliance standards, including IATF 16949, ISO 9001:2015, ISO 13485, and more. Most importantly, thanks to being built on a truly next-generation platform, the whole QMS process can become data and analytics-driven. With integrated risk management, it becomes easy for quality leaders to handle both “current issues” while at the same time using data to adopt a preventive mindset.

To book a demo, visit https://www.compliancequest.com/online-demo/

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