What's required
The TE Supplement mandates that suppliers understand a set of specific terms
related to the tooling and equipment industry. They are: dry run, durability,
equipment, Gantt chart, fault tree analysis, feasibility, life-cycle cost,
machinery, maintainability, mean time between failures, mean time to repair,
perishable tooling, process, product, production, reliability and tooling.
The definition of these terms are provided in either the TE Supplement or
in the Reliability and Maintainability Guidelines.
The TE Supplement consists of three sections: ISO 9000-based requirements,
sector-specific requirements and customer-specific requirements. In addition,
two appendixes and a glossary aid the user in understanding and implementing
the process.
Let's examine each section in greater detail:
Section I: ISO 9000-Based Requirements
In the original QS-9000 requirement, Section I consists of ISO 9001 in its
entirety plus certain automotive industry requirements. The TE Supplement
includes all of Section I of the QS-9000 requirement with some notable exceptions
and additions.
4.1-Management Responsibility. This section
is the same as QS-9000 except that in 4.1.1-Quality Policy, quality objectives
are expanded to include reliability, maintainability and durability.
4.2-Quality System. Section 4.2.3-Quality
Planning is substantially revised in the TE Supplement. Suppliers are required
to "utilize an advanced quality planning process, embracing reliability
and maintainability through the life-cycle process." In addition, the
supplier is required to schedule material, operations and milestone dates
to accommodate the quality and reliability requirements of the customer.
Plus, a control plan must be established and documented which ensures that
quality and reliability requirements are met throughout the concept, design
and development, prototype, machinery build and test phases.
The TE supplement requires that feasibility reviews be documented and provides
a sample of a team feasibility commitment form in Appendix II.
The Failure Mode and Effects Analysis section of QS-9000 is replaced in
the TE Supplement with specific requirements to:
· Document FMEAs on all manufactured products.
· Use the Failure Mode and Effects Analysis manual for guidance as
to the application and format of FMEAs.
· Suggests that internal supplier processes use the FMEA process.
· Update FMEAs when changes to the original product or process occur.
The Control Plan section of QS-9000 is also changed in the TE Supplement.
It allows tooling and equipment suppliers to select the control plan format
best suited to their needs. In addition, control plans for "mature
products and capable processes" may be based on existing plans. It
mandates that control plans be reviewed and updated when changes to the
original product or process occur. And, finally, the Big Three reserve the
right to give final approval to control plans.
4.4-Design Control. This element has several
additions to the original QS-9000 requirements. In addition, as in QS-9000,
this element applies only to design-responsible suppliers.
· 4.4.2-Design and Development Planning. This section requires suppliers
to know the following skills: mean time to repair, mean time between failures,
fault tree analysis and life-cycle cost. The Reliability and Maintainability
Guidelines are suggested as a reference.
· 4.4.5-Design Output. This section adds requirements to QS-9000, mandating
suppliers to include analysis of test data and projections of reliability,
maintainability, durability and life-cycle cost.
· 4.4.7-Design Verification. The TE Supplement completely replaces
the QS-9000 requirements in 4.4.7. However, the ISO 9001 requirements remain
the same. A number of new requirements are added to design verification.
· 4.4.9-Design Changes. In addition to the QS-9000 and ISO 9001 requirements,
suppliers are required to maintain a log of all design changes through all
phases of the machinery build.
4.6-Purchasing. This element has only one
note. It confirms that section 4.6.2 of QS-9000 still applies but directs
suppliers to use the TE Supplement sections I and II as the fundamental
quality system requirement.
4.8-Product Identification and Traceability.
The TE Supplement directs suppliers to establish and maintain a tracking
system for components and subassemblies. Suppliers must have an "effective
system" to identify components to their next operation and by their
job number. Engineering drawings and bills of materials should be cross-referenced
to the tracking system.
4.9-Process Control. The TE Supplement completely
replaces 4.9.1-Process Monitoring and Operator Instructions and 4.9.2-Initial
Process Study Requirements of the QS-9000 requirements with new requirements.
However, the ISO 9001 requirements remain the same. The supplement drops
sections 4.9.5-Verification of Job Set-Ups, 4.9.6-Process Changes and 4.9.7-Appearance
Items. They are available for reference if needed.
4.10-Inspection and Testing. The TE Supplement
completely replaces the QS-9000 requirements in 4.10.4-Final Inspection
and Testing. The ISO 9001 requirements remain the same. A requirement for
suppliers to perform function verification for all tooling and equipment
has been added.
4.13-The TE Supplement drops sections 4.13.3-Control
of Reworked Product and 4.13.4-Engineering Approved Product Authorization.
They may be used by suppliers as reference tools if needed.
4.15-Handling, Storage, Packaging, Preservation
and Delivery. The TE Supplement replaces section 4.15.6-Supplier Delivery
Performance with specific requirements for 100-percent on-time shipments
and resource plans for capacity limitations. In addition, requirements for
subcontractor scheduling systems are established. Gantt charts are suggested
as a method for planning timing meetings. The production scheduling and
shipment notification system sections of 4.15.6 are eliminated but may be
used as a reference.
4.18-Training. The TE Supplement adds a paragraph
to the QS-9000 requirements that directs suppliers to implement a formal
training program to include reliability and maintainability.
4.19-Servicing. The TE Supplement adds a paragraph
to the QS-9000 requirements that directs suppliers to implement a procedure
for communication of information on machine uptime, reliability, maintenance
history and service concerns to manufacturing engineering, and design activities.
4.20-Statistical Techniques. Suppliers are
directed to have a knowledge of mean time between failures; mean time to
repair; short-run SPC; control charts; p, np, c and u charts; or "any
other appropriate statistical technique."
Section II: Sector-Specific Requirements
As mentioned earlier, one of the most significant differences between the
TE Supplement and QS-9000 is that the Production Part Approval Process does
not apply to tooling and equipment suppliers. This part of Section II is
replaced by the Machinery Qualification Runoff Requirements.
1.0-Purpose. This element begins with a statement
of purpose that basically says that the qualification requirements have
been established to ensure that purchased items will be of acceptable quality
when received by the customer in terms of function and reliability. Items
are expected to function properly upon delivery and throughout their service
life.
The qualification requirements have been established to:
· Reduce or eliminate start-up delays
· Improve the quality of components to conform to customer requirements
· Resolve software and control problems prior to launch
· Confirm that the equipment cycle time will meet the customer's requirements
· Verify reliability of tooling and equipment
1.1-Machinery Qualification Runoff Requirements.
This element requires that any failure during a machinery qualification
be documented and a root-cause analysis be conducted by the supplier. In
addition, a matrix showing the requirements for machinery runoff at both
the supplier and customer location is provided with equipment qualification
methods, study time, quantity of pieces and specifications.
1.2-Procedure. This element outlines the steps
necessary for suppliers in the predelivery acceptance procedure. They are:
· 50/20 Dry Run. This is the first step in the predelivery acceptance
procedure. It begins with an explanation of the 50/20-hour dry run established
in the Machinery Qualification Runoff Requirements. A 50-hour quality test
is required for robots and a 20-hour continuous dry run for all other machinery.
The 50-hour test for robots may be waived by the customer if the OEM wishes
to use its own test data in lieu of the on-site 50-hour quality test. In
addition, the TE Supplement outlines a number of steps to be performed during
the 50/20 dry run.
Tooling (for example, stamping dies, injection molds and perishable tooling)
may be exempt from the 20-hour continuous dry run. Check with your customer.
· Phase 1 of Initial Process Performance-Preliminary Evaluation. This
step requires suppliers to conduct a sample run with approved parts. This
test may be conducted without customer representation. However, parts must
be identified and available for customer review.
· Phase 2 of Initial Process Performance-Pp. This step refers suppliers
to the SPC Manual to perform an evaluation of process performance. The evaluation
is to be conducted at the supplier's site. The supplier must check with
the customer for clarification of: sample size and type, frequency, total
quantity, customer representation at the test, and acceptance criteria.
· Phase 3 of Initial Process Performance-Ppk. Again, this step refers
suppliers to the SPC Manual to perform an evaluation of process performance
and how it relates to tolerance location and tolerance width. The evaluation
is to be conducted at the supplier's site. The requirement allows suppliers
to use data from Phase 2. If the Ppk calculated from Phase 2 data is acceptable,
then Phase 3 has been met. Suppliers must again check with their customer
for clarification of sample size and type, frequency, total quantity, customer
representation at the test, and acceptance criteria.
· Reliability. Suppliers must demonstrate through exhibits that the
machinery is designed and built to the specified reliability requirement.
The Reliability and Maintainability Guideline is suggested as a reference.
After the equipment is installed in the customer facility, three additional
steps must be performed:
· 20-Hour Dry Run. An additional 20-hour dry run must be performed
at the customer facility. The system must run for 20 hours continuously
(unless the customer agrees to a different cycle time). Both supplier and
customer representatives must be represented throughout the run.
· Short-Term Process Study. The supplier must collect data from 25
subgroups (with a recommended 125-piece total). This data is to be collected
and recorded. The customer may request specific data summarization.
· Long-Term Process Study. Individual customer plants will require
long-term data collection and analysis based on their individual needs.
The customer representative at each plant should be contacted for specific
requirements.
2.0-Continuous Improvement. The TE Supplement
adds a requirement to QS-9000 section 2.3-Techniques for Continuous Improvement.
Suppliers must demonstrate a knowledge of mean time between failures, mean
time to repair, lean cycle cost and reliability growth. The Reliability
and Maintainability Guideline is suggested as a reference.
Section III: Customer-Specific Requirements
As in QS-9000, Chrysler, Ford and General Motors each have additional specific
requirements outlined in the TE Supplement. Because suppliers are probably
already familiar with their particular customer's requirements, we won't
go into detail about these individual requirements.
Is it all worth it?
To tooling and equipment suppliers, the final release of the TE Supplement
must have come as a relief no matter what it forces them to do. After months
of intense speculation, the suppliers now, at least, know what's expected
of them.
Is it worth it? Will the TE Supplement help suppliers by improving their
business processes and guarantee future business with the Big Three? Unfortunately,
nobody can answer those questions. However, Mary Pathuis suggests that the
supplement just may have been worth the wait.
"A common misconception is that this is going to take a whole bunch
of money, a whole bunch of people and a whole bunch of time," says
Pathuis. "We have found at Riviera that this is untrue. It does take
some discipline. It does take some time to document, but in the long run,
it pays for itself."
Radley Smith even hints that the TE Supplement may help some suppliers stay
in business. "All of the Big Three have said that they are going to
drastically reduce the number of direct suppliers in tooling and equipment,"
says Smith. "I don't think you have to strain your imagination to see
that the TE Supplement and compliance would be one tool that the Big Three
could use to say who gets to keep their business. It may be a litmus test
as to who remains a direct supplier to the Big Three."