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Navigating External Quality Audits With Ease The very mention of audits often elicits groans, particularly when they're driven by cumbersome manual processes. The typical audit journey includes:
Rummaging through stacks of papers to validate compliance.
Ensuring finished products align with the customer's standards.
Painstakingly documenting the testing process.
For many manufacturers, it's a daunting process that feels like a detour from their primary mission. Non-conformities raised during external quality audits often necessitate corrective actions, causing delays in production, product releases, and payments from customers. These delays can also impact the overall supply chain, product delivery schedules, and ultimately, customer satisfaction.
In a manufacturing process, non-conformities refer to deviations from specified standards or requirements. They can arise from a variety of sources and can affect product quality, safety, and compliance. Here are some common non-conformities in a manufacturing process:
Manufacturing products not adhering to regulatory standards or certifications (e.g., AIAG, API, AMS, AS, ASME, ASTM, ISO, NADCA, NADCAP, SAE, TS, ITAR, EAR, MedAccred, ETC. ).
Use of substandard or wrong materials.
Materials are stored improperly, leading to degradation or contamination.
Equipment operating outside of defined parameters.
Deviation from specified process steps or sequences.
Equipment is not calibrated or maintained properly.
Use of outdated or faulty equipment.
Mistakes in manual operations.
Inadequate training of operators or technicians.
Misinterpretation of instructions or procedures.
Missing, incomplete, or outdated process documentation.
Failure to record critical data or changes in the manufacturing process.
Finished products do not meet dimensional, functional, or appearance specifications.
Inconsistent product quality or performance.
Lack of or improper use of personal protective equipment (PPE).
Unsafe handling or storage of hazardous materials.
Quality Control & Testing:
Failure to conduct specified tests or inspections.
Quality control equipment is not calibrated or functioning properly.
Even after the resolution, customers might demand additional audits for verification. But what if audit durations could be slashed by half?
Digital Transformation: The Catalyst for Efficient Quality Audits Embracing digital change is the solution. Integrating your workflow with a comprehensive Quality Management System and Manufacturing Execution System (QMS + MES) can reduce audit times dramatically, by up to 50%. Here's what that means for manufacturers:
Reduced operational disruptions.
Elimination of the exhaustive search for paperwork.
Key Advantages of a Unified QMS + MES solution:
Real-Time Monitoring: Every production detail is tracked instantly.
Deep Data Insights: Data from every production phase is captured, simplifying root cause analyses.
Equipment and Maintenance Oversight: It monitors tool qualifications, repairs, and maintenance.
Employee Training Logs: Documenting training and operator qualifications becomes streamlined.
An advanced MES + QMS platform automates the audit trail, ensuring that nothing slips through the cracks. The result is a seamless, efficient, and stress-free audit process.
Streamlined Documentation Process With an all-inclusive digital audit trail:
Verify compliance with global standards, such as ISO 9001, AS9100, and more.
Understand user access, procedural modifications, and historical changes.
Leverage paperless reporting for quality documentation oversight.
Benefit from centralized storage of all test data, enhancing transparency.
Holistic Control for Superior Compliance Using a solution like Bluestreak’s QMS + MES prevents oversights that might compromise quality or instigate audit challenges:
Monitor revisions in work order specifications.
Ensure operators are adequately trained for tasks.
Validate equipment qualifications.
Confirm vendor qualifications for specific tasks.
Maintain up-to-date logs on changes in qualifications or certifications.
The Rewards of Enhanced Audit Processes Adopting such systems translates to superior audits, boosting internal morale and enhancing customer perception. By streamlining the audit process via QMS + MES, manufacturers can realize cost savings. The time savings alone—potentially halving audit durations—can be redirected to profit-generating activities. Ultimately, it’s not just about speeding up audits. It’s about reinforcing customer trust and solidifying your industry reputation. Seamless audits are a testament to a company’s commitment to quality, signaling reliability to both current and prospective clients. Embrace Efficiency and Savings Lengthy audits needn’t be the norm. With the right tools and systems in place, audits can be more efficient, economical, and less daunting. If the idea of halving your audit times while fostering stronger customer relations resonates with you, it's time for a change. Reach out for a complimentary demo today!
Bluestreak™ is a powerful Manufacturing Execution System (MES) and a fully integrated Quality Management System (QMS), designed for the manufacturing environment and service-based manufacturing companies ( metal-treating/powder-coating, plating, heat-treating, forging, and metal-finishing), businesses that receive customers’ parts, perform a process (service) on them, and send those parts back to the customer). Companies need MES software tailored to specific functionality and workflow needs such as industry-specific specifications management, intuitive scheduling control for staff and machinery maintenance, and the ability to manage work orders and track real-time data. If different work centers on the production floor aren’t “speaking” to each other via the MES, the data loses value and becomes disjointed or lost in disparate silos.
Bluestreak | Bright AM™ is an MES + QMS software solution specifically designed to manage and optimize the unique requirements of Additive Manufacturing’s production of parts and powder inventory usage.