By Conrad Leiva, International Board Member of MESA International and member of MESA’s Technical Committee
In today’s progressive organizations, quality assurance is no longer viewed as a silo department verifying product quality at the end of the manufacturing process. Best practices are to integrate and build quality management into the production process. The MESA association has published the Quality and Regulatory Compliance Strategic Guidebook to give examples of how an organization can leverage manufacturing information technology to improve efficiencies in quality management.
For example, a Manufacturing Execution System (MES) can reduce the need for 100% verification on some processes. MES can do this by enforcing skipping or sampling rules that will automatically prompt the technician when inspection is needed. MES can also keep track of when auditing is required by an inspector. These rules could even vary according to each technician’s experience level on different types of jobs. This level of efficiency in dispatching verifications cannot be achieved with confidence using manual methods; it requires MES to track and enforce the rules automatically.
The following quality management functions are discussed in the guidebook along with recommendation on how manufacturing Information Technology can help in each area.
- Process Standardization and Visual Aids
- Process Enforcement
- Configuration Verification
- In-Process Inspection
- Statistical Process Control (SPC)
- Personnel Qualification
- Tool Control
- Final Product Inspection Plans
- Documenting Problems and Failures
- Corrective Actions
- Failure and Correction Metrics
- Device History Records
Documentation and instruction
Standard procedures should be documented for commonly used manufacturing processes, and personnel should be trained on these procedures. Clear work instructions should be provided for each manufacturing step to further ensure process repeatability. Pictures, 2D, and 3D illustrations in work instructions help clarify tricky work sequences and prevent incorrect operation. The integration of CAD/PLM systems can be critical in some industries to ensure 2D and 3D visualizations of the product and process reflect the correct engineering revision level and configuration.
MES can enforce other aspects of the manufacturing process to help ensure repeatability and consistency. The system can enforce a prescribed sequence for operations, and can prevent operations from being signed as complete until certain data is collected.
Along with enforced controls comes the need to handle exceptions. Therefore, an MES must also provide easy methods for handling deviations that have been approved for specific units or lots by the appropriate personnel.
Organizations that assemble products with complex configurations and variations need to confirm that all component parts are coming from the correct bill of material (BOM) at the correct engineering revision level. An MES integrated with an Engineering system can ensure that the list of parts reflects the proper component parts and cross references to any incorporated Engineering Change Notices (ECNs), approved deviations, and part alternates.
Process and personnel inspection
In-process inspection verifies critical product attributes and characteristics during the manufacturing process, and are usually performed by the technician instead of the inspector. These measures can relate directly to the product specifications or to intermediary dimensions specific to a production process, tooling fixture, or machine setup.
Statistical Process Control (SPC) is a technique that utilizes statistical methods and control charts on collected data to detect and control variation, change, inefficiencies and deficiencies.
SPC serves to:
- Produce early warnings on out-of-control processes before out-of-spec products are produced
- Detect out-of-spec products immediately at the data collection point
- Detect process inefficiencies that are otherwise hard to find with manual systems
Control charts are used to detect unexpected variations in processes. When a process shows variation with an unexpected, non-random pattern, such as a shift, trend or cycle, the process is unstable, unpredictable and “out of control”.
In addition to enforcing process sequence and data collection, MES can enforce that personnel are qualified to perform a job.
An MES with integrated tool calibration management can automatically verify that a tool or gauge used is still under calibration and is appropriate for the tolerance required. An advantage provided by an MES is that recalibration can be triggered based on tool usage and not strictly on dates.
Some QA organizations have people dedicated to collecting log books from the shop floor and manually verifying that all the appropriate forms have been filled out. This function can be fully automated with an MES system for organizations that have to assemble this type of paperwork as part of the documentation package that is delivered with the product to the customer.
Failures and corrections
Failure Reporting, Analysis and Corrective Action (FRACAS) capabilities are used to document nonconformance issues, approved deviations, rework and corrections, and track corrective actions to eliminate the recurrence of problems.
Organizations evaluating QA and MES applications should take a close look at this guidebook and not miss out on the opportunity to elevate quality management practices. In today’s fast pace manufacturing world, we must manage quality throughout the entire manufacturing process and leverage manufacturing systems to support consistent disciplines. It is not enough to simply track defects, failures and corrections; we must integrate quality management practices that prevent errors and catch them as early as possible. Manufacturing technicians must be responsible for their own quality and an MES can help them do it.
“Quality and Regulatory Compliance Strategic Initiative Guidebook”, MESA, © Copyright 2013. All Rights Reserved.
Conrad’s career has included consulting with many Aerospace & Defense companies on how to streamline the paperwork and information flow among Planning, Inventory, Quality, Production and Supply Chain disciplines. Recently, his work has focused on manufacturing intelligence and the integration between engineering, business, and manufacturing systems working with PLM and ERP partners. Conrad is VP Product Marketing and Alliances at iBASEt. Conrad holds an M.S. in Industrial Engineering from Georgia Tech, certification in MES/MOM manufacturing operations management methodologies, and is a certified quality auditor.
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