9.1
Overview
Purpose

Great Dane continually monitors its Suppliers to ensure they continue to meet Great Dane requirements, and to ensure that the Supplier continues to ship acceptable material, parts, or assemblies. This monitoring may consist of:

  • A Quality System surveillance audit at the Supplier’s facility.
  • An audit of the Supplier’s Control Plan.
  • A normal Material Quality Verification of a lot.
  • Source Inspection of product at the Supplier’s facility.
  • Review of Supplier-furnished Data Packages. 
9.2
Supplier Audits
Availability

The Supplier must make their facility available for on-site process verification by the Great Dane SQE (or Quality designee) at any time, with a minimum of 15 days notice. 

Personnel Involved

The SQE (or Quality designee) conducting the verification may be supported by the representatives from other Great Dane organizations (i.e., Quality, Purchasing, Engineering, and Manufacturing). 

9.3
Quality System Audit
Purpose

Periodically, Great Dane may audit the Supplier’s Quality System and manufacturing processes. This may be full or abbreviated documentation and on-site audits. The purpose of this audit is to evaluate any changes that may have occurred in the Supplier’s quality system and to assess the Supplier’s continuing commitment to quality improvement. 

9.4
Control Plan Audit
Purpose

Periodically, Great Dane may audit the Supplier’s continuing conformance to the Supplier’s Control Plan. 

9.5
QA & Production Inventory Control
Purpose

Great Dane expects its Suppliers to furnish material that conforms to all requirements, and that does not need to be inspected when Great Dane receives it. The Quality Technician or Quality designee (which may include PIC) inspects material that has not achieved Ship-to-Use status, or that is on Ship-to-Use suspension on a lot-by-lot basis. 

Sampling Plan

Great Dane uses a C=0 Sampling Plan (ANSI Z1.4) that rejects the lot when a single nonconforming part is found in the sample. 

9.6
Source Inspection at the Suppliers Facility
Purpose

Great Dane may inspect product at the Supplier’s facility, to detect potential problems prior to shipment to Great Dane. Great Dane may also inspect product at the Supplier’s sub-Suppliers. 

9.7
Supplier-Furnished Lot Documentation
Required Data

Great Dane may require the Supplier to furnish inspection, test, process performance, or other quality data with each shipment to ensure that the product meets Great Dane requirements. 

Timing

When data submission is required, the data must be e-mailed to the Great Dane plant QA Manager/corporate QA at the same time the lot is shipped. 

Identification

All documentation must be clearly identified with the Great Dane part number, and the Supplier’s lot number. 

Data Packages

When specified by the SQE (or Quality designee), the Supplier must submit via email monthly data packages to the SQE and/or designee. Data packages typically consist of copies of control charts and Cpk & Ppk calculations for specified characteristics. Other data may be requested by the SQE (or Quality designee). 

Elimination of Data Submissions

Once the Supplier has completed two consecutive quarters of data submissions, the Supplier may request the elimination of the data submission, if the records show that characteristic consistently satisfies Great Dane requirements for process stability and process performance and if the characteristic has caused no problems in Great Dane production. The Great Dane SQE (or Quality designee) determines whether data submission must be continued.