Part Qualification

In this section
This section is divided into the following subsections

3.1 Overview    3.2 Approved Supplier List    3.3 Failure Mode & Effects Analysis    3.4 First Article Checklist          3.5 Control Plan    3.6 Assembly Bill of Material    3.7 Pilot Fabrication    3.8 Sub-Supplier Certification                3.9 Material Safety Data Sheets    3.10 Supplier Gages & Standards    3.11 Gage Repeatability & Reproducibility Studies    3.12 Gage/Standard Correlation    3.13 Process Capability    3.14 First Article Inspection                           3.15 Part Qualification

3.1
Overview
Approval Requirement

All Suppliers of production materials to Great Dane are required to complete a PPAP level 3 submission. Exceptions are for non-critical components and are jointly approved by VP Procurement, VP Engineering, and Executive Director of Corporate Quality.

3.2
Approved Supplier List
Qualification

Great Dane Purchasing maintains a list of the approved Supplier(s) for each production part. Only Approved Suppliers are allowed to ship volume production to Great Dane. Suppliers must successfully complete the general Supplier Approval Process described in section 2 and pass the Part Qualification requirements listed below to a specific production part or material (Part Number). 

3.3
First Article Checklist
Requirements Identified

For each new or changed material, part, or assembly, the Great Dane SQE/R&D engineer (or Quality designee) prepares a First Article Inspection Checklist (CORP5QA-003) or in lieu, a generic level 3 requirements apply. This checklist identifies the requirements that must be completed for the qualification of the material, part, or assembly for volume production. 

3.4
Failure Mode & Effects Analysis
Process FMEA

The Supplier is required to perform a Process Failure Mode and Effects Analysis (Process FMEA).

The Process FMEA considers all reasonably foreseeable potential failure modes of each process. Based on the potential seriousness and likelihood of the problem, the Supplier develops manufacturing controls. The Process FMEA should be a living document, and should be updated when one of the following occurs:

  • The process is changed.
  • Defective material is produced.

Process FMEA methods, examples, and forms can be found in Potential Failure Mode and Effects Analysis published by AIAG. 

3.5
Control Plan
Defined

The Control Plan is a detailed description of the Supplier’s proposed processing steps required to produce the part, and the controls that are put into place to control the quality at each step. The Supplier must develop a Control Plan Template (CORP5QA-005), or equivalent and submit it to Great Dane for approval. 

Format

Suppliers may use their own format, but the Control Plan must include all items contained in the AIAG Control Plan manual. 

Components

The Control Plan must include the following information:

  • All in-house processing, external processing, inspection, packaging, and shipping.
  • Measuring devices and fixtures designed and built to check Great Dane parts. These devices/fixtures must be identified with a gage number and drawing. Table of Contents
  • All critical product and process characteristics.
  • Where detailed instructions are required, the Supplier details those instructions in an Inspection Method, or equivalent, which must be listed in the Control Plan.

Inspection methods, sample sizes, and sampling frequencies should be based on the process capabilities, seriousness and likelihood of potential nonconformances, and process stability. 

Critical Characteristics

Critical characteristics that do not meet Great Dane process capability requirements must be inspected 100%, unless the Great Dane SQE (or Quality designee) approves alternate control methods. 

3.6
Assembly Bill of Material
When Required

Where needed and when designated by the SQE (or Quality designee), the Supplier is required to submit an Assembly Bill of Material (BOM). 

Components

This BOM must include a list of all Suppliers for each part. 

3.7
Pilot Fabrication
Defined

The Pilot Fabrication is a Supplier-produced production run of material for material qualification for either a new or substantially changed design impacting the performance of the finished product. The required quantity is specified in the Purchase Order. 

Production Environment

The material must be produced under volume-production conditions, including material, machines, tooling, processing parameters, cycle times, etc. 

Exceptions

Any exceptions to the volume-production conditions must be approved in writing by the Supplier Quality Engineer/R&D engineer/Lab Manager, and recorded in the data package submitted to Great Dane. 

Timing

The Supplier must coordinate the timing of the Pilot Fabrication so that the SQE/R&D engineer and other Great Dane representatives may be present during the production run. Great Dane must validate and verify the process before any product is shipped. (The Pilot Fabrication must be synchronized with Great Dane volume demands.) 

3.8
Sub-Supplier Certifications & Tests
Required Documentation

For material and other specified requirements for which the Supplier does not have the equipment to test, the Supplier must obtain material certifications (or test reports) from their sub-Supplier(s) or other test agency. 

Components

The material certification reports must include the following information:

  • Specification/Drawing number
  • Specified material/dimensional/physical requirements
  • Inspection/test results.
  • Signature of the organization that performed the testing.

A simple statement that the material meets the requirements is not acceptable. 

Traceability

The reports must be traceable to the Supplier’s material through lot/heat/coil/ batch numbers or the like. 

3.9
Material Safety Data Sheets
Materials Affected

The Supplier must furnish Material Safety Data Sheets (MSDSs) for all materials shipped to Great Dane facilities. 

3.10
Supplier Gages & Standards
When Needed

The Supplier should have appropriate gages and/or standards to:

  • Control the Supplier’s processes.
  • Inspect the product 
Acceptable

Gauges or standards used to inspect material may be attributed (go/no-go) gages, color/texture standards, or variable gages designed to inspect the aesthetics and functionality of the material. 

Approval

Wherever possible, the Great Dane’s SQE approves gages or standards for use to control processes. 

Duplicates

Duplicate gages or standards may be used at Great Dane to verify the Supplier’s First Article inspections including adherence to all color and texture standards and are provided by supplier when commercially not available. 

3.11
Gage Repeatability & Reproducibility Studies
Require Study

For those characteristics specified by the SQE (or Quality designee), the Supplier must:

  • Perform a Gage Repeatability & Reproducibility (R&R) Study using procedures described in Measurement Systems Analysis published by AIAG.
  • Analyze the study results using the ANOVA method in Minitab™ or other Great Dane-approved statistical software package. 
Variable Gauges

For variable gages, normally three different operators measure ten (10) samples three times each. 

Alternate Methods

The Great Dane SQE (or Quality designee) must approve alternative methods. 

3.12
Gage/Standard Correlation Studies
When Required

For those characteristics specified by the SQE (or Quality designee), the Supplier must perform a correlation study. 

Study Process

The correlation study is composed of the following steps:

  1. The Supplier identifies, measures, and records a specified amount of production material.
  2. The Supplier sends the sample material to Great Dane for measurement confirmation.
  3. The SQE (or Quality designee) compares Great Dane measurements with the Supplier’s measurements to determine the correlation between the gages or standards. 
3.13
Process Capability
Defined

Process Capability (Cpk) is a comparison of the inherent variability of a process output to specification limits under statistically stable conditions. Most methods for estimating capability require that the characteristic being evaluated is approximately normally distributed, and in statistical control. The distribution should be determined prior to estimating capability. If the process is not in statistical control, all assignable causes must be identified and removed. Special techniques are available for calculating capability when inherent assignable causes, such as tool wear, are present. 

Required Cpk

Where applicable, the following Process Capability requirements apply:

  • A Cpk of at least 1.33 is required for Critical Dimension & Features. For 1.0<Cpk<1.33, the process may be acceptable to start production and meets Great Dane requirements on a limited-time basis. Requires SQE/R&D engineer’s (or Quality designee) written approval.
  • After part approval, begin production following the approved Control Plan with additional attention to the process until an ongoing Cpk>1.33 is achieved. 
Required Method

Although a number of techniques exist for assessing the capability of processes, Great Dane Suppliers must use methods defined in Statistical Process Control (SPC) published by AIAG for determining process capability and process performance. Alternate methods may only be used if approved by the Great Dane SQE (or Quality designee). 

Calculation Method

When required to submit Process Capability data to Great Dane, the Supplier must calculate Process Capability using the following method, unless an alternate method is approved by the SQE: 

Cp = Process Capability =       USL – LSL
                                                           6s

Cpk = the minimum of either: USL – Avg.  or   Avg. – LSL
                                                              3s                           3s

Where:

USL  = Upper Specification Limit
LSL   = Lower Specification Limit
Avg. = Process Average = X
s = Estimated Standard Deviation   s= R
d2       
R      =  Average Range
d2     =  Constant from statistical tables

 

Unilateral Tolerances For unilateral tolerances, the same logic is employed, except that only the specified side of the tolerance is used to calculate Cpk.
3.14
First Article Inspection
Sample Selection

The Supplier must select representative material, parts, or assemblies from the Pilot Fabrication run for First Article Inspection. The SQE (or Quality designee) notifies the Supplier of the quantity to be inspected. 

Inspection Process

The inspection process is as follows:

  1. The Supplier inspects or tests each sample for ALL dimensions, drawing notes, material requirements, and specification requirements listed on the current revision of the Great Dane drawing.
  2. The Supplier records the results on the First Article Report (CORP5QA-006) or equivalent. 
  3. The Supplier numbers a copy of the Great Dane drawing and specification to correspond with the Supplier’s results. 

Handling Nonconforming Characteristics

For all nonconforming characteristics, the following must occur:

  • The Supplier investigates and corrects the tooling, process, etc., and produces new product.
  • Nonconforming samples are sent to Great Dane only after the Supplier has done all that can be done to correct the parts, and after obtaining approval from the SQE (or Quality designee).

Nonconforming material may not be sent to any Great Dane facility or customer without a written deviation.

3.15
Part Qualification
Qualification Process

The Part Qualification process is as follows:

  1. The SQE (or Quality designee) notifies the Supplier of the data required in the data package, the number of samples, and the shipping instructions.
  2. The Supplier submits a data package and part samples to Great Dane for approval.
  3. All documents sent to Great Dane must contain the Great Dane part number and revision.