Quality Complaint Alert Report: Product Information Customer Information

QUALITY COMPL
STEP 1 Enter Complaint into the VOC data base

Management Review Plant Manager, Quality Manager, Quality Supervisor, Operations Manager, Engineering M
Human Resource Manager
FRAM Plant & Dept: Complaint Date / Time: Revision Date(s)
Product information Customer Information

Filter Type: Customer
Cust PN: Complaint #
Fram PN(Long): Contact
Lot No.: Telephone
Qty. Reported: Email
DOM/date code:
D2) Description of Complaint (verbal, picts, etc.):

Template Rev: CAPA FRAM 8D.xls
Doc: CAPA FRAM 8D.xls Rev A 8/4/16
QUALITY COMPLAINT ALERT REPORT
e VOC Data Base #:
isor, Operations Manager, Engineering Manager,
Revision Date(s) Customer Location:
MRB Review / Customer Requirements

Requirements Input / Output
CA/8D Response? Input
Containment ? Input
3rd Party Sort? Input
Expedited Shipment? Output
Notify Other Locations? Output
Return Suspect filters? Output
Suspect Filter Returned? Date:
My signature belows confirms that I have read and been made aware of the customer complaint:
Department Date
Na Clock #
me
Template Rev: CAPA FRAM 8D.xls

Doc: CAPA FRAM 8D.xls Rev A 8/4/16
made aware of the customer complaint: 0
Trainer Shift
Name Clock #
Inventory Containment
Form
Reported Concern and Product Involved
Customer/Reported by: 0 Product Description: 0
Date Code: 0 Customer Concern Number: 0
Concern
Description 0
Containment/Sorting of Suspect Product at Customer Facil

Third Party Sorting Required: 0 Quan
Sorting Company:
Quantity in transit to Cu
Location: Quantity/Duration of So
Purchase Order Number:
In-house Containment of Suspect Product (Components or Finishe

Manufacturing Plants: Greenville Distribution Centers: Costa Rico
Vendor (CR) Hebron (HB) Illinois Whse (D
Location Part Number Hold Tag Quantity Location Part Number
Sorting Results of Contained Product

Part Number Qty Plt/Whse Date Code Qty Good Qty Bad Part Number
Refer to Certifiction/Sorting Instructions for Cerification Requirments for good product to

Defective Product Disposition Instructions
No containment required
Containment Tracking Number:
0
ern and Product Involved
0 End Item Number: 0
0 Line/Dept: 0
uspect Product at Customer Facility

Quantity on Hand at Customer Location (if available):

Quantity in transit to Customer Location (if available):
Quantity/Duration of Sorting by Third Party: 0
t Product (Components or Finished Filters)
Toronto
n (HB) Illinois Whse (DS) Fernley (FN) (TO)
Hold Tag Quantity Location Part Number Hold Tag Quantity
ts of Contained Product
Part Number Qty Plt/Whse Date Code Qty Good Qty Bad
Requirments for good product to be returned to useable inventory.

ct Disposition Instructions
tainment required
Certification/Sorting
Instructions
Part Number: 0 Customer: 0
Filter Type: 0 Customer Part #: 0
Non-Conforming Condition Reported: Required Tools/Devices/PPE
Wire brushes
Magnifier allowed
Glovesunles
0
Thread Gage Sleeves
Lock Box
1) Obtain product for inspection.

2) Review Individual part for non-conforming condition reported.
- if non-conforming condition found, place in designated area away from certified parts.
- if part does not have non-conforming condition proceed to step 3.
3) Conduct quick general review for obvious defects such as: no paint chips, no scratches, no dents, no dirt/contaminates,
no missing gaskets, no missing components, etc.
- if unacceptable condition is found, place in designated area away from certified parts.
4) Mark acceptable parts with certification mark if required.
5) Place certified part into required packaging. Verify stacking pattern & pallet height against Packaging Set up sheet in JDE.
- when handling/stacking open topped containers, insure top container does not drop into lower container. If it does,
inspect product in lower container to insure that no damage occurred.
- if damage product is found, place in designated area away from certified parts. Replace with good product as needed
6) Mark packaging with certification as required.
7) Document date codes and number of parts inspected
Pictures/Additional Information
For non-conforming filters found:

- Document all non-conformance(s) found (not just reported condition), date codes, and quantities.
- Obtain disposition instructions for non-conforming product and implement accordingly.
Certification Mark Requirements:
Filter Marks Case/Carton Marks
No Filter marks required No case/carton marks required No pallet marks re
Individual filter marks required: Case/carton marks required: Pallet marks requi
ng Instructions
Prepared by:
Tracking #: 0
(CC, CAPA, etc.) Date: 1/0/1900
ools/Devices/PPE
Wire brushes and knives not
allowed
Glovesunless specified.
Sleeves
Lock Box
d parts.
ches, no dents, no dirt/contaminates,
d parts.
t against Packaging Set up sheet in JDE.

t drop into lower container. If it does,
. Replace with good product as needed.

des, and quantities.
ordingly.
Pallet Marks
No pallet marks required
Pallet marks required:
CORRECTIVE AND
Management Review Plant Manager, Quality Manager, Quality Engineer

0 1/0/1900 1/0/1900
Product information Customer Information

Filter Type: 0 Customer 0
Cust PN: 0 Complaint # 0
Fram PN(Long): 0 Contact 0
Lot No.: 0 Telephone 0
Qty. Reported: 0 Email 0
DOM/date code: 0
D1) Team Members: D2) PROBLEM: Description of Co
D3) Interim Containment Action:

N0. Action Item Resp. Date issued
Revision: 1 2014 04 08
C:\Users\jcg0235\Documents\Quality\Appendix 1-CAPA FRAM 8D Blank
Page 5 of 17
CORRECTIVE AND PERMANENT ACTION REPORT

e VOC Data Base #:
ngineer 0

1/0/1900 0
Containment
Quantity Contained Defects Found
At Customer Location
In Transit To Customer
At Fram Filtration
Fram Filtration WIP
Total 0 0
PROBLEM: Description of Complaint (verbal, picts, etc.):
Date Due Date Completed List Similar Products or Processes Affected
k
Page 6 of 17
CORRECTIVE AND

0 1/0/1900 1/0/1900
D4) Root Cause(s) (use 5-why or fishbone to clearly determine)
D5) Permanent Corrective/Preventative Actions

Revision: 1 2014 04 08
e VOC Data Base #:
ngineer 0

1/0/1900 0
ne)
Page 7 of 17
CORRECTIVE AND

0 1/0/1900 1/0/1900
D6) VERIFICATION PLAN

D7) Policies or systems changed to prevent reoccurance

DOCUMENT REVIEW/UPDATE Resp. Date issued
PROCESS FLOW CHART

PFMEA
CONTROL PLAN
INSPECTIONS/ML
TRAINING
AUDIT SCHEDULE
OTHER:
D8) Closure Approval

Signature
Closed by:
Revision: 1 2014 04 08
e VOC Data Base #:
ngineer 0

1/0/1900 0
occurance
Date Due Date Completed NOTES/COMMENTS
Date Comment
Page 8 of 17
CORRECTIVE AND
FRAM Plant & Dept: Complaint Date / Time:

0 1/0/1900
Plant Manager Approval:
Revision: 1 2014 04 08
e VOC data base VOC Data Base #:
anager, Quality Engineer 0

1/0/1900 0
PA FRAM 8D Blank
PERMANENT ACTION REPORT
VOC Data Base #:
0
Location:
PSS # Pro
Date/Time List Machine Name
1 PROBLEM STATEMENT and RECOGNITION (Business Case)
6 5 WHY INVESTIGATION( The most probable root cause)
Why?: (Direct Cause)
Why?:
Why?:
Why?:
Why?:
7 ROOT CAUSE AND RECOMMENDATION(Target Condition)
People Involved Production Description

1 6
2 7 Equipment
3 8
4 9 Downtime Minutes:
5 10
Basic Problem Area: Scrap in Pounds
Total Cost in $
Problem Description:(when and what, Current Conditions)
Trigger Type: (circle one or more and qua
Downtime Changeover
Material Other
2 IS THE PRODUCT ON HOLD? ( YES or NO)
3 BEST GUESS/OBSERVATION/ NOTES/POC(POINT OF CAUSE)
8 CORRECTIVE AND PREVENTATIVE ACTIONS
Who: When: Date Action was Completed

What?
Who: When:
What?
Who: When:
What?
Who: When:
What?
Was a mistake proof method added? Yes

Was there any immediate detection devices added? Yes
Do any of these actions create new standards and require documentation chang Yes
Are there any training issues? Yes
Are there any preventative maintenance changes? Yes
Where audits added for any mistake proof, detection or standards ? Yes
What: Who:
What: Who:
What: Who:
5 CAUSE INVESTIGATION(Brain storming)
People Methods/Procedure
Environment
Materials
Machine/Maintenance
Measurement
Problem Solving Sheet (PSS) - Problem Solving A3 format
REVIEWED BY: DATE / /
ess Case)
ost probable root cause)
Date/Time:
(circle one or more and quantify) Rework

Downtime Changeover Scrap
Material Other
USE)
Date Action was Completed

No
No
No
No
No
No
Who:
Who:
Who:
Problem
Sheet (PSS) - Problem Solving A3 format
REVIEWED BY: DATE / /
Date/Time:
Are all actions closed? Yes No
Have there been additional in
What and how much was the business imp
root cause
Sign off as needed in the last 30 days?
(1 Minimum)
Should there If
beYes
continued
What? monitoring? Ye
EHS Qua
A3 PS
Production
5W and 2H Problem Description
Determine is……..
What
Who
Where
When
Why
How Many
How Much/Often
is not………
1. PROBLEM STATEMENT:
(WHAT IS WRONG WITH WHAT)
2. PROBLEM IS IS NOT
DESCRIPTION
OBJECT
W
H
DEFECT
A
T
OBJECT
W
H
E
GEOGRAPHICALLY
R
E
FIRST SEEN
W
WHEN ELSE SEEN
H
E
N
WHEN SEEN IN PROCESS (LIFE CYCLE)
HOW MANY OBJECTS
H HAVE THE DEFECT?
W HOW MANY DEFECTS
PER OBJECT?
I WHAT IS THE TREND?
G
Updated:
GET INFORMATION
5 Whys
Repeated 5 Whys
State what is the problem and then ask why does it exist.
Bezel on LED light did not seat completely after machine cycled creating need to
manually snap bezel into light
WHY ?
Alignment of the punched hole station and the bezel/light assembly station was out of adjustment.
WHY ?
Part clamping is designed for a hard stop on the right side of nest, and only has a c-clamp on the left side t
hold the part from moving left to right and up, but not down.
WHY ?
Left clamp only designed to hold part from moving up, right and left. Fixture not designed with enough pos
clamping down to hold part down in place during the assembly operation.
WHY ?
During the design of the fixture/nest, didn't take into consideration the need for downward clamping to hold
in position.
WHY ?
Ref. No.:
Date:
d creating need to
out of adjustment.
s a c-clamp on the left side to
t designed with enough positive
downward clamping to hold part

CAUSE & EFFECT DIAGRAM
FISHBONE
DATE:
COMPONENT:
E METHOD
N
VI
R
O
M
PROBLEM DESCRIPTION E
N
T
O
T
H
E
R MATERIAL
FECT DIAGRAM
MEN POWER
ROOT CAUSE(s)
MACHINERY
Define Problem
Root Causes
Use this path for why the
specific nonconformance occurred
WHY?
WHY?
Use this path to
investigate why the problem was not detected.
WHY?
WHY? WHY?
A
WHY?
Use this path to investigate the systemic root cause
WHY?
WHY? WHY?
B
CAR Number WHY?
Date of Incident WHY?
Product / Process
Problem Resolution Complete Date: Communicate to Customer Date:
Lessons Learned: .
Corrective Action Resp. Date
WHY?
WHY?
Process Change Break Point Date: Implement System Change Date:

Fault Tree Analysis
This sheet is used to determine which potential root cause(s) are investigated on the 5-Why Root Cause Analysis format.
FACTOR CONTROL POINT STANDARD ACTUAL JUDGEMENT
Standard Quality
MATERIAL
METHOD
MOLD
MAN
MACHINE
MEASUREMENTS
SYSTEMS
DECISION
Action Item or Transfer to 5-Y

3/25/2014 Added Greg Noetlich's Problem Solving Tools
4/8/2014 Added Status and approval, Added section for quanities suspect/actual
7/15/2014 sre: removed plant reference to enable use by all locations as off-line alternative
YES
NO

Quality Complaint Alert Report: Product Information Customer Information

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Quality Complaint Alert Report: Product Information Customer Information

Uploaded by

Copyright:

Available Formats

QUALITY COMPL

STEP 1 Enter Complaint into the VOC data base

FRAM Plant & Dept: Complaint Date / Time: Revision Date(s)

Product information Customer Information

D2) Description of Complaint (verbal, picts, etc.):

Revision Date(s) Customer Location:

MRB Review / Customer Requirements

Template Rev: CAPA FRAM 8D.xls

Containment/Sorting of Suspect Product at Customer Facil

In-house Containment of Suspect Product (Components or Finishe

Location Part Number Hold Tag Quantity Location Part Number

Sorting Results of Contained Product

Refer to Certifiction/Sorting Instructions for Cerification Requirments for good product to

uspect Product at Customer Facility

t Product (Components or Finished Filters)

Requirments for good product to be returned to useable inventory.

1) Obtain product for inspection.

For non-conforming filters found:

ches, no dents, no dirt/contaminates,

t against Packaging Set up sheet in JDE.

. Replace with good product as needed.

Management Review Plant Manager, Quality Manager, Quality Engineer

FRAM Plant & Dept: Complaint Date / Time: Revision Date(s)

Product information Customer Information

D1) Team Members: D2) PROBLEM: Description of Co

D3) Interim Containment Action:

CORRECTIVE AND PERMANENT ACTION REPORT

Revision Date(s) Customer Location:

PROBLEM: Description of Complaint (verbal, picts, etc.):

Date Due Date Completed List Similar Products or Processes Affected

Management Review Plant Manager, Quality Manager, Quality Engineer

FRAM Plant & Dept: Complaint Date / Time: Revision Date(s)

D4) Root Cause(s) (use 5-why or fishbone to clearly determine)

D5) Permanent Corrective/Preventative Actions

Revision Date(s) Customer Location:

Date Due Date Completed List Similar Products or Processes Affected

Management Review Plant Manager, Quality Manager, Quality Engineer

FRAM Plant & Dept: Complaint Date / Time: Revision Date(s)

D6) VERIFICATION PLAN

D7) Policies or systems changed to prevent reoccurance

PROCESS FLOW CHART

D8) Closure Approval

Revision Date(s) Customer Location:

Date Due Date Completed List Similar Products or Processes Affected

Management Review Plant Manager, Quality Manager, Quality Engineer

FRAM Plant & Dept: Complaint Date / Time:

Plant Manager Approval:

Revision Date(s) Customer Location:

1 PROBLEM STATEMENT and RECOGNITION (Business Case)

6 5 WHY INVESTIGATION( The most probable root cause)

Why?: (Direct Cause)

7 ROOT CAUSE AND RECOMMENDATION(Target Condition)

People Involved Production Description

2 IS THE PRODUCT ON HOLD? ( YES or NO)

3 BEST GUESS/OBSERVATION/ NOTES/POC(POINT OF CAUSE)

8 CORRECTIVE AND PREVENTATIVE ACTIONS

Who: When: Date Action was Completed

Was a mistake proof method added? Yes

5 CAUSE INVESTIGATION(Brain storming)

ost probable root cause)

(circle one or more and quantify) Rework

Date Action was Completed