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.
Tool calibration
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.
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Referenced Material:
“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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