So, your new audit report just came in, and it doesn’t look good: Process inefficiencies, products not meeting quality standards, incomplete documentation, dissatisfied customers and a stack of nonconformance reports (NCRs)… the list goes on and on. And to make matters worse, you still have a lengthy task list of corrective actions from the last audit. Now you’re overwhelmed.

Unfortunately, this issue isn’t going away. Between the growing number of new standards for product manufacturing, constant regulatory updates and more rigorous customer demands, you’ll always have a full to-do list for compliance management and quality control.

You’re playing a high-stakes game with the risk of regulatory fines, product liability issues and customer churn. While you can’t afford to skip out on audits or avoid taking corrective actions, you can invest in a solution to manage compliance at scale and avoid an audit tidal wave.

The compliance challenge: managing a growing sea of audits

As a quality professional, isn’t navigating the world of compliance tough enough? Getting hit from multiple angles, you have lots of diverse and rigorous requirements across multiple compass points in order to track:

• Is your business adhering to regulatory requirements such as ISO 9001, Food and Drug Administration (FDA) regulations, and Good Manufacturing Practices (GMP) guidelines?
• Do your products meet customers’ performance, usability, and safety standards?
• Are your suppliers meeting product specifications, testing and packaging requirements?
• Do your manufacturing processes match company policies and industry quality standards?

In a perfect world, only one centralized audit could satisfy all compliance requirements. Unfortunately, that isn’t always the case.

It takes multiple assessments across different departments, locations and even countries (each with a unique purpose). So, there are lots of moving parts. How do you maintain visibility for each audit? Or, how do you track each of the findings and forward them to the right person?

Better yet, how do you ensure timely corrective action based on the findings?

It’s challenging, especially for businesses achieving rapid growth and suddenly absorbing the blow of a growing sea of audits.

ETQ Reliance: your lifeboat to achieving compliance at scale

ETQ Reliance is a cloud-based quality management sys- tem (QMS) that enables you to be audit-ready, giving you access to crucial audit information anytime, anywhere. It lets you streamline audit management activity and manage compliance at scale through its core features:

•  Central repository of audits: Provides a single interface to plan, build, execute, and collaborate on an audit program for internal, external, supplier, product, and process audits.
• Mobile data capture: Gives you real-time audit updates and insights on the findings directly to your phone and tablet.
• Automated workflows: Auto-delivers findings to appropriate personnel after completing the audit and automatically delegates, escalates, and tracks corrective action tasks for swift resolution.
• Risk assessment tools: These tools let you evaluate the operational or financial impact of making (or not making) corrective changes per the audit.
• Change management module: Captures new or changed requirements and tracks implementation progress while auto-documenting change activity to leave a clear audit trail.
• Training management features: Lets you plan, administer, and maintain evidence for employee training per compliance requirements.

ETQ Reliance helps Owen Mumford expand its digital footprint and cut audit findings in half.

Owen Mumford is a prominent global medical device manufacturer with a solid reputation for producing quality products that improve patient outcomes. After years of paper-based compliance to adhere to FDA regulations and other requirements, they jumped at the opportunity to move to an electronic QMS system that supported operational agility and corporate objectives.

Selecting ETQ Reliance and integrating it with their enterprise resource planning system, they were amazed by the results:

• Form 483 submissions for the FDA to submit inspection concerns dropped to 0 (since 2015)
• Corrective and preventative actions (CAPA) across UK sites were down 45% from 2016 to 2021
  — leading to fewer NCRs
• Customer complaints dropped 50% due to maintained product quality
• Customer opinion of the company shifted from “Average” to the highest possible “Excellent”

→ Read the Full Story Here

ETQ Reliance empowers Cooper Tire to centralize audit activity for production consistency and quality while reducing audit findings.

Cooper Tire & Rubber Company supplies tires to a global market, specializing in passenger cars, SUVs, and trucks. After shifting its focus to producing original equipment and supplying it
directly to manufacturers, Cooper became engulfed with new compliance and product feasibility requirements that adhered to the new customer demands.

They adopted ETQ Reliance and integrated it with their SharePoint app to centralize audit data, workflows and communications into one system across all locations. The result: Reduction
of internal audit findings and improved transparency that led to 80% less time administering their audit. On the financial side, they also cut manufacturing costs significantly and reduced operational risk.

→ Read the Full Story Here

Chart your course to compliance at scale

Don’t overwhelm yourself by juggling too many audit findings at once. Get yourself on the right course to reducing your compliance risk with ETQ Reliance.