QMS/9000+TM
Features and Functions
4.10 Inspection and Testing
Inspection and testing are critical for quality management. QMS/9000+
allows you to specify and maintain on a central database: product
specifications, test procedures, acceptance criteria, sampling
plans and the individual test results by characteristic for all
material purchased and/or manufactured internally. User-defined
lot acceptance determinations are automatically made in real
time; and current source [e.g. external supplier/internal
manufacturing stage] performance can be statistically compared
with past performance as well as with the performance of other
sources [e.g. alternate suppliers/alternate production lines].
Inspection Features Shared by all Stages
Inspection needs at incoming, in-process and final inspection
have many similar requirements. QMS/9000+ architecture takes
advantage of shared functionality while addressing the
differences that must be met for each of these areas.
- Open-ended number of products / parts / intermediates
- User-defined sampling plans for attributes and variables
- Historic performance determines sampling intensity
- Skip lot and skip characteristic capabilities
- Specifications/procedures displayed at workstations
- Download of graphical images from CAD systems
- Logs defects in real time
- User-defined acceptance criteria
- Both manual and automated test equipment for data entry
- Out of range values flagged on data entry
- Computer executed pass/fail determination, based on
stored acceptance criteria
- Nonconformances automatically transmitted to
Nonconformance Control in real time
- Traceability of rejected material or faulty processes
- Periodic summary reports and statistics
- Graphical comparisons of source quality using ANOVA
- Pareto ranking of source quality from inspection data
- Pareto ranking of lot rejections by quantity and cost
4.10.1 Receiving Inspection and Testing
Quality starts at suppliers, with incoming material. QMS/9000+
enables users to define quality test procedures, acceptance
criteria and sampling plans. Pass/fail decisions are made in real
time so defective materials are not introduced into the
manufacturing process.
- Supplier certification lot management
- Supplier final inspection data entered via EDI. Pass/fail
made before supplier ships. Cycle time cut.
- Quality results transmitted to supplier quality system in
real time [see 4.6 Purchasing]
4.10.2 In-process Inspection and Testing
QMS/9000+ manages in-process product inspection
and conformance much like receiving inspection. In addition,
because proactively detecting adverse process trends is more
cost-effective than correcting problems after they have occurred,
QMS/9000+ also provides a real-time, distributed,
SPC environment. Optionally QMS/9000+ compares the
current status of each product characteristic with targets,
providing immediate feedback of adverse trends to the factory
floor before defects are produced. Historic information is
maintained in an on-line database which provides management
summary information and ad hoc inquiry access for extended
analysis of the processes [See 4.1 Management
Responsibility].
- Sampling from in-line test equipment
- Real-time adverse trend detection
- Alarming and warning protocols
- Correlations of process failures with product defects
4.10.3 Final Inspection and Testing
The release of products into the warehouse for shipment is
the last opportunity to guarantee one's reputation for superior
quality. QMS/9000+ allows you to set your outgoing
quality level and assure its maintenance using an optimized
release strategy ranging from low level auditing to 100%
automated testing. Data gathered at the final "release
gate" can also be used to relate product defectives to
adverse process trends.
- Lot source reference tracing available
- Historic records for each product shipped
- Collates test groups and produces certificates of
analysis
- As-built configuration records maintained
- Customer specific reporting of results
4.10.4 Inspection and Test Records
QMS/9000+ automatically maintains a database of
both observed data and the results of acceptance/ control
checking [See also 4.16 Quality Records].
- Complete inspection history
- Archival storage
- Link of results to acceptance criteria
JKA, Inc.
Phone: 732.991.2256
FAX: 609.607.8527
E-mail: jka@qmsprograms.com
copyright 1998, JKA,Inc.