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Compliance Issues with Quality Control Documentation
Joel E. Ross states in his book, Total Quality Management, that the cost of quality isn’t defined by creating a quality product; it’s the cost of not doing so. Those costs can be dramatic for organizations—especially fledgling Additive Manufacturers or those with brand-new Additive Manufacturing (AM) initiatives—so avoiding manufacturing compliance issues is a top priority.
Remaining in compliance with quality standards is all about the documentation. AM can’t rely on the methods designed for traditional manufacturing. Quality control documentation must evolve to meet the ever-changing demands of Additive Manufacturing, to keep the total cost of quality from spiraling out of control.
Documentation must be automatic
Without proper documentation, you cannot establish a clear chain of responsibility or provide vital recordkeeping for compliance, and it’s difficult to create consistency or set a clear precedent. If your documentation is in chaos, your quality control will suffer.
Instead of focusing on erasing the natural human inclination to lose track of detail or investing in endless training sessions that don’t remove the issue, you can try a more innovative solution. Automation removes many of the obstacles to a robust documentation process.
Human error: Too many manual processes in AM puts companies at high risk for human error. Automation reduces human mistakes and ensures that there are no gaps in reporting.
Digital “paper trails”: Missing information can be just as destructive as errors. Automation is critical to complete recordkeeping.
AM-specific documentation: When employees come from traditional manufacturing, it can be a learning curve to document the processes for AM. Automatic documentation aligns with AM’s unique challenges for robust process control.
Automating documentation gives you the consistency needed to ensure that your process remains under control, a vital component of avoiding manufacturing compliance issues. Each quality control measure receives the proper follow-through and allows your organization to pivot quickly when necessary.
Documentation must reside in a unified source
Fragmented and siloed data prevents Additive Manufacturers from gaining a unified perspective. With departments producing their own documentation using their own systems, the lack of fluidity with important data can prevent manufacturers from gaining clear insights to improve efficiency and reduce waste.
The biggest challenges that manufacturers will face include the integration of their data and receiving the full breadth of insight that their data could provide.
Disparate systems prevent accurate reporting and make pulling reports laborious and time-consuming. When it comes to quality control, it can make audits slower and quality difficult to maintain.
A “single source of truth” model keeps all departments on track. Communication between customers and departments can happen in real time, and transparent specifications will always be available.
A unified source establishes a chain of responsibility for compliance and auditing follow-ups. Nothing gets missed and everyone knows whom to report to.
A single source of truth ensures that all data is accurate, consistent, and accounted for. You’ll have access to better quality insights that will inform your decisions moving forward. Without such quality data, you’ll have difficulty avoiding manufacturing compliance issues and improving or scaling the business.
AM must implement workflow software
Handling processes by hand is time-consuming and inefficient. A software system designed specifically for AM is the final part of an insightful quality control process. Integrating documentation into workflow software reduces manual processes for better, more insightful data.
Implement feedback control, aka “closed-loop feedback”: Automatic documentation within workflow software ensures that quality control managers can better lead teams.
Make documentation:
Paperless
Real time
Traceable
Searchable All of this ensures the proper digital paper trail for easing quality control audits, building real-time insights, and leaning up processes for less waste and better output.
Reduce manual processes for streamlining the process: To reduce waste and ensure consistent quality, documentation should be an integral part of workflow software.
Automation eliminates the time that your best people waste trying to keep up with documentation and chasing each other with updates. With the unique challenges of quality control in Additive Manufacturing, a specialized workflow designed to bring communications, process, specification, and quality control under one automated roof is essential for business success
Documentation is only the first step
Avoiding compliance issues involves having the right documentation, but that’s just the beginning. Implementing data-driven principles, such as “single source of truth,” and automation ensures that Additive Manufacturing has the solutions it needs to remain in compliance and scale operations as necessary.
A robust workflow designed to automate documentation across the board reduces waste from manual processes and provides a single source of truth. It accounts for the challenges of quality control within Additive Manufacturing materials and helps you avoid compliance issues due to bad data or missing information. It could be a serious differentiator for successful Additive Manufacturing businesses or initiatives in Industry 4.0.
Bluestreak | Bright AM’s solutions provide Additive Manufacturing with customized solutions designed to overcome quality control challenges and avoid noncompliance. It’s time to see how a solution designed specifically for AM can transform your process.
Bluestreak | Bright AM is designed exclusively for the Additive Manufacturing industry. Our best-of-class MES and QMS solutions bring quality control management to new levels. Contact Bluestreak | Bright AM today for a free demo!