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QMP – Quality Management Procedure Revision status: 1.

2
14. Dec.
EMEA 60 Date:
2005
100% Inspection of Critical Parts Page 1 of 5

Date Created: 14.12.2005 Inspected: Released:


Dept./ Func. QA GAD EMEA / Manager QA GAD EMEA / Director GAD EMEA / Vice President
Name Horst Teutschländer Christian Bauer Ulrich Baur
Signature

1. SCOPE

This QMP specifies the procedure and the responsibilities of 100% inspection of critical
production parts, as interim solution in order to protect the customer(s), until corrective and
preventive actions become effective.

2. APPLICABILITY

This QMP applies to the manufacturing plants of Tyco Electronics, Global Automotive Division -
Europe, Middle East and Africa (GAD-EMEA). The outside vendors (OV) belonging to GAD-
EMEA are also included, and are to be considered as one virtual plant.

The procedure is a generic guideline, to be considered as a minimum requirement. More severe


definition criteria and inspection activity shall be specified by local responsibility, every time this
appear to be necessary due to specific requirements of the different core processes (molding,
stamping, assembly, etc.).

3. DEFINITIONS

3.1 100% Inspection

100% inspection is defined as inspection of individual critical characteristics on all parts


produced within a certain time period. It is not the inspection of all specified characteristics of
representative parts.

3.2 Critical Parts

Produced parts are critical by means of this QMP if the involved production equipment (mold,
die, machine, ...) and / or the process (assembly, plating, ...) is categorized as critical.

3.3 Critical Equipment / Processes

An equipment or a process is critical by means of this QMP if at least one of the following
situation occurred in relation with the produced parts (all variations / mutants)

a. Failure reoccurrence - a certain defect reoccurred after implementation of improvement


actions dedicated to eliminate the defect causing error.
or
b. High number of complaints - more than 3 justified complaints (internal / external)
occurred within the last 6 months (L6M)
QMP – Quality Management Procedure Revision status: 1.2
14. Dec.
EMEA 60 Date:
2005
100% Inspection of Critical Parts Page 2 of 5

3.4 Performance Categories of Equipment / Processes

Category A

a. No failure reoccurrence - if occurred, sporadic defects have been efficiently


eliminated
and
b. No complaints (internal / external) within L6M

Category B

a. 1 failure reoccurrence within L6M


or
b. 1 to 3 internal and/or external complaints within L6M

Category C

a. more than 1 failure reoccurrence within L6M


or
b. more than 3 internal and/or external complaints within L6M

3.5 100% Inspection Categories

The performance category of equipment / processes (as per 3.4) determines the 100%
inspection mode, which shall be applied as following :

Category A

No 100% inspection required. The production is inspected according QIP, Control Plan, ...

Category B

100% inspection of all parts produced within min. 1 hour of regular production process, directly
after each

1. Tool and process transfer


2. Equipment / process modification
3. Set-up completion
4. Process parameter changes
5. Production restart
6. Detection of a defect (e.g. by line inspection, operator, 100% inspection)

Category C

100% inspection of all parts out of the critical production process.

3.6 Individual Defect Code

Each category B and C equipment / process has its own range of potential defects. The
Individual Defect Code is the range of different defects occurred on parts out of a critical
production process.
QMP – Quality Management Procedure Revision status: 1.2
14. Dec.
EMEA 60 Date:
2005
100% Inspection of Critical Parts Page 3 of 5

4. RESPONSIBILITIES

Determination of critical equipment / processes Quality-Manager,


Manufacturing-Manager
100% inspection of critical parts and process documentation Manufacturing-Manager

Decision for change of performance categories (as per 3.4) Manufacturing-Manager

5. DESCRIPTION

5.1 Determination of critical equipment / processes

By analysis of PN-related defect occurrence, and number of internal / external complaints, the
Quality Manager and / or the Manufacturing Manager shall detect critical equipment /
processes, and determine an initial Individual Defect Code. The used tools are the complaint
database (QICN / TECHS), line inspection documentation, scrap analysis, and other failure
documentation systems.

The Quality-Manager and / or the Manufacturing Manager will define the performance category
of all equipment / processes as per 3.4.

5.2 Marking of critical equipment / processes

The performance category (as per 3.4) should be visibly applied to the equipment / working
place, supported by signal colours:

Category A : GREEN (or WHITE) Category B : YELLOW Category C : RED

5.3 100% Inspection

100% inspection as per 3.5 shall be performed on the regular production output of category B
and C equipment / processes, according to the Individual Defect Code. The MF-Supervisor /
Manager will update the Individual Defect Code, if additional defects are detected during the
100% inspection process. Sorting regulations (e.g. related to slippage), defect visualization, etc.
shall apply accordingly.

5.3.1 Documentation of 100% Inspection Activity

The enclosed template (excel file) shall be used for documentation of the 100% inspection
activity. All data required by the template shall be documented. The 100% inspection activity of
only one part number shall be documented on a sheet.

Part Number In 1-7-1 format


Revision Valid part revision
E/P Category Equipment / process category B or C, as per 3.4
E/P Number e.g. mold - number, die - number, ...
Cavities Number of mold cavities, as total / active
Machine Number Machine identification number
Location Plant location
QMP – Quality Management Procedure Revision status: 1.2
14. Dec.
EMEA 60 Date:
2005
100% Inspection of Critical Parts Page 4 of 5

Department e.g. Molding / Assembly / Plating


Fabrication Order FO - number
Date of Production In YY.MM.DD. format
Production Period Start - End of production time for inspected parts (hh.mm format)
Quantity Produced Number of produced units during Production Period
Individual Defect Code Detected defects in Pareto-order
Defect Quantity Number of detected defects per Individual Defect Code
In Cav. # Indication of defect generating mold cavity
PPM Defect rate of inspected quantity in ppm
Occ. Time Last Defect Best estimated occurrence time of last defect

5.4 100% Inspection Decisions

Depending on the result of the performed 100% inspection, taking into account the status of the
quality improvement process (e.g. corrective / preventive actions), the Manufacturing-Supervisor
/ Manager will decide on further processing of the 100% inspection :

DECISION
Initial
E/P Situation / Result of 100% Inspection 100% New
Category Inspection E/P
CONT. STOP Category
Equipment / process improvement completed,
1 C efficiency successfully verified, zero defects detected X B
during last 100% inspection
Zero defects detected during last 100% inspection,
2 C but no corrective / preventive action implemented X C
since last failure occurrence
3 C Defect(s) detected during last 100% inspection X C
Equipment / process improvement completed, and
4 B efficiency successfully verified ; X A
zero defects detected during last 100% inspection
Zero defects detected during 100% inspection of
5 B X B
minimum 1 hour of regular production
At least one defect detected by 100% inspection of
6 B X B
parts produced during one hour of regular production
No defect free one-hour-production possible.
7 B X C
Sporadic defect occurrence

5.5 Process Control

The Quality-Manager is responsible for roll-out and conformity control of the 100% inspection
process.

The 100% inspection records shall be filed together with the other equipment / process
documentation, and must be always readily available for audit / control.
QMP – Quality Management Procedure Revision status: 1.2
14. Dec.
EMEA 60 Date:
2005
100% Inspection of Critical Parts Page 5 of 5

5.5.1 Process Inputs/Process Outputs

Inputs Outputs

Suspect production parts Defect free products


Equipment / process categories

5.5.2 Process Owner/Interfaces

Process owner Manufacturing Departments


Quality Assurance
Interfaces
Plant Manager (QEP - Listing)

Category B equipment / processes can be subject to QEP-Listing


Category C equipment / processes must be subject to QEP-Listing

6. REVISION SERVICE

This QMP is owned by the Quality Director, GAD-EMEA.

7. ENCLOSURES

"100% Inspection of
Critical Parts.xls"

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