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In a world of shrinking margins and overly competitive environments, there is a temptation to view quality processes and regulation as just another laborious and costly disruption in the manufacturing environment.
Quality is as much of a people issue as a process and technology one. Therefore, companies who strive to establish a culture of compliance will view this as part of the journey to build a wider data culture and a systematic approach to streamline processes, improve risk management and efficiencies, compare the performance of business units, and ultimately boost the standard of quality and assurance it can deliver to its customers.
The Audit
The need in Investing in quality support, compliance, security, and operations is found in most (if not all) industries. A well-managed audit trail is a key indicator of good internal business controls, security, and operational actions that include the date, time, and user information associated with the “event” or operation. This may include user activities, access to data, login attempts, administrator activities, or automated system activities.
The audit trail, whether internal or external, provides a “baseline” for analysis or an audit when initiating an investigation. The goal of the audit is simple-to determine if there are discrepancies between what has been documented and what has been implemented.
Here’s where it gets complicated for the auditee. Not only must the auditee’s records/reports be accurate, comprehensive, and in a specified format, but regulators are demanding evidence of the source, or ‘traceability’, of the data to verify its credibility, leaving a clear audit trail that can be revisited every time.
Most auditors are looking to ensure that organizations have an effective system in place for document control. Satisfying these various requirements can be a major headache, especially for those organizations with complex structures and disparate systems, where data and documents are typically stored in a range of formats and must be pulled together manually becoming a full-time job for one or more employees within an organization.
Why then, are so many organizations today still coping in a piecemeal fashion with multiple systems and time-consuming manual data entry on spreadsheets? With the advancement of technology and endless options for automated software on the market, there is no excuse for not investing in quality, to implement an automatized Quality Management System. Why? Because the cost of producing poor quality products is much higher than the initial software system investment when compared to the money that is wasted on poor quality:
· Discarded materials
· Reworked products
· Handling product returns
· Costly recalls
· Failing an internal/external audit
· Losing customers!
Once an organization applies the quality concept to its entire management system and all of its processes, then the effect on the bottom line will really be noticeable.
Today's organizations have the benefit of selecting from an extensive range of solutions that can often result in an overwhelming process. Functionality is not the only driver in selecting a new system, other factors such as flexibility, integration capabilities, and configuration management should be key factors in your decision-making. But, for the focus of this article, we have compiled a list of the most important factors to consider when comparing software systems in terms of functionality.
The Top Key Functionality List
1. Audit Management
2. Real-time Metrics
3. Advanced Product Quality Planning
4. Product Specification Management
5. Document Management & Control
6. Integrated, Role-Specific Training
7. Failure Modes and Effects Analysis (FMEA) Assets, Calibration, and Maintenance
8. Nonconformance Reporting
9. Compliance Obligations
Regardless of which system you choose, it is imperative that users receive consistent training on the system. Technology is always advancing and a good software system will constantly offer updates for additional functionality. And remember, the quality of the data the system manages, is only as good as the data that is entered. Junk in, junk out.
About Bluestreak™:
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 both 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. Contact us today for a free demo!
Written by Ron Beltz, Director of Strategic Accounts at Bluestreak™.