Manufacturing Control
In this section
This section is divided into the following subsections
4.2
Required Effectiveness
Where specified in the Control Plan, the Supplier is required to apply effective statistical process controls. Effective controls must include:
- A Process Control chart that displays correctly calculated control limits. (Specification Limits may not be used as control limits.)
- A Process Control chart that is at the process area, visible to the operator, or persons who are responsible for controlling the process.
- Actions to be taken to bring the process back into control (for each out of control condition). These actions must be documented and maintained.
- The sorting, scrapping, reworking, or dispositioning of all products produced during any out-of-control condition must be documented (via the Supplier’s material review process).
4.3
Required
The Supplier must maintain an effective End of the Line stop capability to ensure Great Dane is protected from receiving any nonconforming product. The stop capability includes all features on GD drawings as well as industry-relevant standards. The goal should be to stop the nonconforming material at the source gate with the actions in place to monitor and reduce occurrences. The supplier is required to store and furnish the Gate data as requested by Great Dane and relevant data as requested by SQE shipped with the lots.
4.4
Process Performance (Ppk) is the comparison of the actual process variation to the specification limits.
Performance Requirements
The following process performance requirements apply:
Critical Characteristics
A Ppk at least 1.33 is required. Evidence of ongoing Ppk calculation and appropriate reaction plans must be maintained.
Any critical characteristic failing to meet the minimum requirement requires a containment and improvement plan.
Other Characteristics
A Ppk of at least 1.00 is required. The Supplier is not required to calculate and report process performance for non-critical characteristics unless requested by the SQE (or Quality designee). When specified by the SQE (or Quality designee), other characteristics failing to meet the minimum requirement also require a containment and improvement plan.
Required Method
When required to submit process performance data to Great Dane, the Supplier must report process performance using the following method:
Unilateral Tolerances
For unilateral tolerances, the same logic is employed, except that only the specified side of the tolerance is used to calculate Ppk.
4.6
A lot consists of product of one part number and revision that are made at the same time, under the same processing conditions, from the same lot of raw materials.
Identification
Each lot of material shipped to Great Dane must be identified with the Supplier’s lot number. Inspection records must be traceable to lot numbers. The primary purpose for identifying lots is to determine the scope of actions that must be taken when problems arise during further manufacturing or with customers.
Number Changes
The following are typical conditions that result in a change of lot numbers:
- Change of part number or revision
- Change of part number or revision of components
- Interruption of continuous production (typically for more than a few hours)
- Repairs or modification to the tooling or equipment
- Tooling changes (other than a minor adjustment, or replacement of consumable tooling)
- Change to a different lot of raw materials
- Change in shift
- Significant process changes
4.7
Traceability ties the finished product back to the components used in the product. When traceability is specified, the traceability marking should be effective down to the individual component (i.e., lot code, batch, or serial should be identifiable at a customer rework station).
4.8
4.9
At no time should any customer or person at a Great Dane facility be exposed to hazardous material or situations that are not inherent in a component’s structure.
Inherent Hazards
For items with inherent hazards, safety notices must be clearly observable. As applicable, MSDSs must be provided during the First Article process.
Standards
Residues, films, out-gassing products, and packaging materials should comply with all Occupational Safety and Health Administration (OSHA) standards. Great Dane subscribes to the current industry standards of environmental awareness and requires the same from its Suppliers. Third-party certification to the ISO14001 standard is strongly encouraged.
4.10
Maintenance Level
The Supplier must maintain all facilities, manufacturing machines, tools, measuring devices, and other equipment in such a manner that the Supplier can support Great Dane production requirements, and the quality of material, parts, or assemblies manufactured for Great Dane are not degraded in any way. Preventative maintenance of equipment should be in line with the manufacturer’s instructions and recommendations.
Great Dane Supplied Equipment & Tooling
All of the above maintenance requirements apply equally to any and all Great Dane-supplied equipment and tooling. This customer-supplied equipment and tooling must be maintained in such a manner as to maintain quality products throughout the expected life of the equipment or tooling. The Supplier also is required to notify Great Dane if any Great Dane-supplied equipment or tooling is expected to exceed its usable life within the following 12 months.