1. Click to edit
Master title
style
KBS1 Lowest Value Chain Cost
with High Reliability
KBS 2 Rapid Growth of Added
Value Independent Business
KBS 3 European Operations
Optimisation
Support Strategies HR, IT &
Technology
1. Think Safety; Act Safely
2. Embrace 5S
3. Foster Employee Development
4. Be Environmentally Responsible
5. Model Corporate Social
Responsibility
6. Deliver Quality
7. Breathe Fact-Based Decision-
Making
8. Show Visual Management
9. Deploy Standardisation
10.Live KAIZEN
11.Pursue Super Low Cost
12.Implement Synchronisation
S
E
Q
C
D
Title:
FMEA to Meet RPL’s Robust Manufacturing Constitution
Start Date: 2009
Project Sponsor: Tim James
Management Support: Colin Weaver, Darren Nutting
Project Lead Name: Robert Farr
Job Title: Product Recycling Engineer
Department: Recycling Engineering
Log Number: K000433
Project Team Members (Optional):
Robert Farr, David Newbrook, Rhona Davies, Tom Foster,
Deborah Figueiredo-Daniels
2. Step 1 Introduction of Problem
Problem Statement:
Inconsistent Approach to FMEA and Product Quality Defect Analysis / Countermeasure Techniques
Goal Statement:
To develop the FMEA Template & Methodology to meet RPL’s Robust Manufacturing Constitution
Brief History
< 2010
• Supplies Recycling has Inconsistent Finished Goods Quality
• No FMEA Conducted at New Model Introduction
• Quality Controlled by Reactive Defect Management
2010
• Decision for New Model Introductions to incorporate FMEA (No Template)
• Supplies Recycling Engineering develop basic 10 Scale FMEA
2011 > 2013
• SR Continue Evaluation of 10 Scale FMEA Definitions/Scaling Features
• December 2012: IMS Procedure updated to use 5 Scale RPL FMEA Template
QA Approve SR Engineering to Continue Trials of 10 Scale Method
PERSEUS
MIDAS
RINMEI
SINCERE
CASSIS /
ADAM
SCHMIDT
PANACHE
JUPITER
3. Step 2 Investigation of Facts
PROBLEM 1 - No FMEA Situation (Before 2010)
Through the years Supplies Recycling Right-First-Time (RFT) and IQ Sampling Quality has been inconsistent…
This is particularly noticeable at New Model Introduction (NMI) phase, where quality can be poor whilst production is stabilising.
Defects found at Final QC or QA Sampling were countermeasured reactively by Engineering/Manufacturing in Defect Meetings.
PERSEUS
NMI
SINCERE
NMI
CASSIS /
ADAM
SCHMIDT
PANACHE
NMI
JUPITER PCU
NMI
Current Product
JUPITER
FUSING
NMI RFT Results take a long time to
stabilise after NMI, and are
generally inconsistent
throughout Product-Life-Cycle
RFT%DefectsatProductionQC
4. Step 2 Investigation of Facts
Key Point: There was no Proactive Failure Mode Analysis in SR prior to 2010 for an FMEA to be incorporated in NMI.
PERSEUS
NMI
SINCERE
NMI
CASSIS /
ADAM
SCHMIDT
PANACHE
NMI
JUPITER PCU
NMI
Current Product
JUPITER
FUSING
NMI
PROBLEM 1 - No FMEA Situation (Before 2010)
IQ Results take a long time to
stabilise after NMI, and are
generally inconsistent
throughout Product-Life-Cycle
IQ%SamplingRate
5. Step 2 Investigation of Facts
PROBLEM 2 - 2012 IMS Update (5 Scale FMEA Template)
In December 2012 the QA Department updated the IMS Procedure to include an FMEA Procedure & Template.
A template was based on a 5 Scale System.
When reviewing this template in SR Engineering, there were issues found with 5 Scale FMEA as detailed below:
Rank Effect rate Criteria
No effect No effect.
P/O
Not to standard but does not affect overall appearance or
function
Slight effect
Fit & finish/Squeak & Rattle item does not conform. Defect
likely to be noticed by customers.
C
Functions but not to standard i.e. Scratch, misset or
damaged parts
Moderate
Item operable, but Comfort/ Convience item(s) inoperable.
Customer experiences discomfort.
B
Functions but not to RGS i.e. Not enough toner, print
defects
Major effect Item inoperable, w ith loss of primary function.
A Does not function i.e. Machine does not pow er up
Extreme
effect
Very high severity ranking w hen a potential failure mode
affects personal safety, safe item operation and/or
involves non-compliance w ith government regulation
AA
Cause major ill effects, serious malfunction, damage to
company image or lack of compliance to legislation
SEVERITY
5
4
1
2
3
Severity Rating
Severity Rank & Criteria Definitions are compressed into the
RPL QA Defect Ranking.
(x1 Severity Rank for x1 RPL QA Rank)
This means the degree of severity of the Defect cannot always
be accurately registered…
Example: The severity degree of Rank B Defects can vary…
RPL QA Ranking dictates a Copy Defect outside of specification is a
Rank B Defect and therefore registers as 3 on the FMEA Rating.
However, some Rank B Copy Defects, although out of standard, are
more obviously sever to the customer than others, meaning the
customer complaint severity will also vary.
Varying Rank B Defects:
x11 0.5mm Black Spots on a White Chart
Large Black Mark on a White Chart
6. Step 2 Investigation of Facts
Rank CPK Failure Rate Criteria
> 1.17
> 1.33
1 in 2000
1 in 15 000
Low
OCCURENCE
Failure is unlikely
1 in 150 000
< 1 in 1 500 000
> 1.50
> 1.67
4
5
< 0.33
> 0.33
Very high
< 1 in 3
1 in 3
> 0.51
> 0.67
1
2
3
> 0.83
> 1.00
Regular
1 in 80
1 in 400
1 in 8
1 in 20
High
Occurrence Rating
Defect Quantity or CPK Values are have large ranges for each rank.
This means it is difficult for the occurrence to be accurately registered due to large
quantity differences between each FMEA Rank Scale.
Also there is no probability rating which is helpful for New Model Introductions
where the final production capacity is only an estimate.
Example: “Probability on most units” - “…on a daily basis” - “…every week”
Rank Detection rate Criteria
Design Controls w ill almost certainly detect a potential cause/mechanism
and subsequent failure mode.
100% w ill be detected
High chance the Design Control w ill detect a potential cause/mechanism
and subsequent failure mode.
Likely to be detected during normal process
Moderate chance the Design Control w ill detect a potential
cause/mechanism and subsequent failure mode.
Unlikely to be detected during normal process
Very Low chance the Design Control w ill detect a potential cause/
mechanism and subsequent failure mode.
Ghost part present or failure mode not visible
Design Control w ill not and/or cannot detect a potential cause/
mechanism and subsequent failure mode; or there is no Design Control.
Not likely to be detected
4
5
DETECTION
1
2
3
Almost certain
High
Moderate
Absolute
uncertainty
Very low
Detection Rating
Criteria Definition has no clear distinction
between 2 fundamental detection factors:
1. Error Proofed Detection (e.g. Automation)
2. Subjective Detection (e.g. Manual Inspection)
Criteria Definitions are also very vague in
description.
Example:
“Likely” / “Unlikely” to be detected during normal
process… What is likely? Is likely automated
inspection or manual inspection method? How can we
define the effectiveness of a manual inspection?
PROBLEM 2 - 2012 IMS Update (5 Scale FMEA Template)
7. Step 2 Investigation of Facts
Similarities with the Likert Scale:
The Likert Scale is a 5 Scale Method normally adopted for questionnaire studies.
The RPL developed 5 Scale FMEA has clear similarities with this scaling.
This does cause a problematic issue with predictive Severity, Occurrence, Detection ratings
Key Point: Avoidance of extreme ratings for categories that are hard to predict… “Central Tendency Bias”
RPL FMEA Scaling Different to the “General Industry Standard”:
PROBLEM 2 - 2012 IMS Update (5 Scale FMEA Template)
COMPANIES
using 1-10
Scale
Methodology
EDUCATION
PROVIDERS
using 1-10
Scale
Methodology
Benchmarking the Industry Standard.
In general, both Education Providers and Manufacturing Companies use a 1-10 Scale FMEA Methodology
8. Step 2 Investigation of Facts
RPL FMEA Procedure Different to the “General Industry Standard”:
RPL FMEA IMS Procedure does not include the requirement for the FMEA to be conducted as a team.
It only requires the assignment of responsibility to an appropriate Engineer:
Key Point: The “Industry Standard” of conducting FMEA, is to incorporate a FMEA Team with select disciplines and
product/production knowledge. This is to maximise product quality defect predictions.
Quoted from Quality Associates International Inc:
FMEAs are conducted by a core team of three or four people with supporting Subject Matter Experts (SME). This group creates
the Cross Functional Team (CFT). Ideally, the CFT should be selected from disciplines that have a slightly different view
of the product or process under investigation. The synergy created by the CFT is what makes FMEA so powerful.
A single person will not be able to develop a comprehensive FMEA without input from the CFT. It is easy to tell when a
FMEA is created by one individual rather than the team. Such FMEAs are typically generated to satisfy customer
requirements but have very little value to the program or organization. FMEAs are a means to achieve better quality products and
processes. Many Original Equipment Manufacturers (OEMs) require the proper use of FMEA. Industry standards in diverse industries, such as
automotive, medical device manufacturing, aerospace, chemical processing and more, have been developed to utilize the power of FMEA.
PROBLEM 2 - 2012 IMS Update (5 Scale FMEA Procedure)
9. Both RPL 5 & Industry Standard 10 Scale FMEA incorporate the requirement to reduce residual risk as much as possible.
Residual Risk is the remaining RPN Risk to a Process after all available actions from the FMEA Group has been implemented
Observed RPL & Industry Standard Problem:
The tendency for the majority of FMEA approvers within RPL (particularly in NMI Gate Meetings), that high / medium residual
risks are deemed to “have to be low”, that it is not satisfactory to have remaining RPN Risks above Low Ratings.
This is an extremely difficult mandate to achieve for all design or production processes, especially those developed around the
following criteria limitations:
1. Small Investment for Design / Product / New Model Introduction
2. Product has a Low Volume of Production – Return On Investment (ROI) is High
3. Product has Low Gross Margin – Return On Investment (ROI) is High
4. Technology is not advanced enough to develop an Error Proofing Method (Automation or Mistake Proofing Gauge)
Examples of Residual Risk in Supplies Recycling:
Since the first use of 10 Scale FMEA within Supplies Recycling, NO Process FMEAs have ran live within production without
there being high or medium residual risks. See examples below:
Step 2 Investigation of Facts
PROBLEM 3 - FMEA Residual Risk Management (Monitoring)
MIDAS RINMEI
Note: Midas has a higher Production
Volume, higher Gross Margin and larger
NMI Investment than Rinmei, therefore
Midas had more investment for Residual
Risk Reduction Practices, due to its ROI
Quality Residual Risk
countermeasure is too High
Cost for Product Investment
Key Point:
Due to the nature of investment into products & ROI (the 4 limitations above), management of high residual risks are a problem
10. Step 3 Root Cause Analysis
Inconsistent
Approach to FMEA
and Product
Quality Defect
Analysis /
Countermeasure
Techniques
No FMEA Conducted
5 Scale System –
RPL FMEA Procedure
Industry Standard
10 Scale System –
No Residual Risk Monitoring
NG RFT % Level
NG IQ % Level
No Proactive Defect Management
High Customer
Complaint Probability
Poor Operator Awareness
of High Risk Processes
NG NMI Vertical Launch
Inconsistent Failure
Detection Ratings
Failure Severity Rating
Not Always Precise
Vague Understanding
of Detection Method
Effectiveness
(“How Subjective”)
No Requirement
for an FMEA Team
Emphasis is placed on Residual
Risk Reduction not Monitoring
No / Limited High / Medium
Residual Risk Monitoring
Low Investment / ROI have limited
Residual Risk Reduction Capability
4M Controls not always based on FMEA
Patrol Inspections not always based on FMEA
Hard to Predict Failures Suffer
“Central Tendency Bias”
Different to the General Industry Standard
(Difficult to Benchmark)
Technology Limitations can limit
Residual Risk Reduction Capability
No Standard for
Residual Risk
Monitoring
11. Improvement
Area
Quality:
Right-First-
Time Rate
Increase
Quality:
IQ Sampling %
Increase
Quality:
Reduce
Customer
Complaints
Quality:
Residual Risk
Understanding
& Monitoring
No FMEA
Use RPL 5 Scale
FMEA
Develop RPL
“Industry Standard”
10 Scale FMEA
10 Scale FMEA with
Residual Risk
Monitoring
Development
Step 4 Proposed Improvements
Measurable Items
12. Step 5 Implementation of Improvement
WHAT
• Development of an RPL Version 10 Scale FMEA Template & Definitions
• Development of a Residual Risk Management (Monitoring) Methodology
WHEN
• From 2010 - FMEA Requirement at NMI
WHY
1. Improve Production RFT & IQ Rates, particularly after NMI stage – “Achieve Vertical Launch”
2. Improve the current RPL 5 Scale Template which has weaknesses:
Severity Rating: Difficult to measure the “Degree of Severity” of a Defect
Occurrence Rating: Large Ranges (“Gaps”) between Ranks
No Probability Statements
Detection Rating: Definitions are Vague
No Distinction between Subjective & Error Proofing Methods
No Requirement for FMEA to be conducted in Groups
3. Improve Method & Control of Residual Risks which are still High / Medium
• Little Emphasis on Monitoring High/Medium Residual Risks that cannot be Reduced Further
• High / Medium Residual Risks are difficult to reduce with Low Investment or Low Production
Volume / Gross Margin Products
• Technology Limitation can mean some Residual Risk cannot be reduced from High/Medium
13. WHO
• Robert Farr, David Newbrook, Rhona Davies, Tom Foster, Deborah Figueiredo-Daniels
WHERE
• RPL Supplies Recycling Engineering & Production, with support from QA Department
HOW – 10 Scale Research
The general industry standard shows that there is a basic 5 Criteria Division, but of a 10 Scale Rating System:
1 – Remote Rating Measurement
2 ~ 5 – Low Rating Measurement
4 ~ 8 – Moderate Rating Measurement
7 ~ 9 – High Rating Measurement
9 ~ 10 – Very High Rating Measurement
Examples of this can be seen below…
Step 5 Implementation of Improvement
This information is available at Quality
Associates International Inc.
14. Step 5 Implementation of Improvement
HOW – FMEA Scale Definitions Research
Severity:
This information is available at Quality
Associates International Inc.
The Severity Measurement is a rating for when a
Potential Failure Mode results in a Customer or Final
QC Manufacturing Defect.
The severity definition shown is a general industry
standard for the training of the FMEA Tool.
Improvement Area:
Severity Definition Scaling still
compares well to the RPL QA
Defect Ranking Policy.
However, it also expands on this
by having a severity degree.
Example:
Degree of Rank B Defects:
High = Customer Very Dissatisfied
Moderate = Customer Dissatisfied
Low = Customer Somewhat
Dissatisfied
QA RANK AA
QA RANK A
QA RANK B
QA RANK C
QA RANK PO
15. Occurence:
The Occurrence Measurement is a rating given for
the amount of times the Potential Failure Mode
Defect happens within Production.
The occurrence definition shown is an example used
in industry.
Improvement Area:
The Failure Rate Criteria can be
adjusted to match any
Production Quantities per Period
(day, month, year etc), or can be
measured by Process CPK
Values if known.
The ranges between quantity
values are smaller meaning
scoring can be more accurate.
Also most industry models
show a probability estimate
description.
Step 5 Implementation of Improvement
HOW – FMEA Scale Definitions Research
This information is available at Quality
Associates International Inc.
16. Detection:
The Detection Measurement is a rating given for the
ability the production process has to detect a
Potential Failure Mode Defect.
An example of a general industry standard definition
is shown.
Inspection Types:
A = Error Proofed
B = Gauging or Mistake Proofing (Poka Yoke)
C = Manual Inspection
Improvement Area:
The Detection Rating is based
on how Subjective the
Detection Method is.
Example:
There is a clear distinction that
Manual / Visual Inspections
score worse than Mistake
Proofing or Automation
Inspections which are more
Error Proofed.
The Criteria Definition is also
very precise in description.
Step 5 Implementation of Improvement
HOW – FMEA Scale Definitions Research
This information is available at Quality
Associates International Inc.
17. HOW – Testing SR Developed 10 Scale vs RPL 5 Scale
Step 5 Implementation of Improvement
Using the Research Findings SR Engineering created an RPL 10 Scale Template & Definitions Scaling.
This was then tested in some production process scenarios to compare risk results and precision of the risk rating:
Copy Check Inspection:
Potential Failure Mode Effects of Failure S Class Causes of Failure O Current Prevention Current Detection D RPN Recommended Action S O D RPN
A defective print image is
missed by the inspection
operator
Defective print image:
any print defect.
7 B Operator Inspection Error. 8
Keypoints in WSPB.
Operator Training.
Visual Check of Unit
Prints. Sampled QA
Inspection.
5
280
1) Production Monitor Copy Defect Mis-
Judgements.
2) 4M QA Check of Operator checking Copy
Samples.
3) Process Confirmation in Training Document.
7 7 5
245
Defective Print Image
missed by inspection
operator
Defective Print Image 3
Operator Inspection Error.
Poor assembly of product.
3
Visual Check.
QA Sampled Check.
2 18
1) Production Monitor Copy Defect Mis-
Judgements.
2) 4M QA Check of Operator checking Copy
Samples.
3) Process Confirmation in Training Document.
3 2 2 12
Copy Check Inspection for a Recycling Process is one of the most important Quality Check Processes. It is extremely subjective in that it is
totally reliant on manual inspection, and because of this operators used to conduct Copy Inspection are highly trained and highly critical with
their judgements based on strict Ricoh Japan Copy Standards. Automation of this process is extremely difficult with high cost implications
which most (if not all) recycling products cannot invest against.
Result:
• 5 Scale shows a Medium Risk rating before / after countermeasures. Final residual risk is the lowest medium rating.
• 10 Scale shows a High Risk rating before / after countermeasures. Final residual risk is a mid-level high rating.
10 Scale:
5 Scale:
18. Development unit
over/under filled with toner.
Defective print yield: The
unit does not complete
its designed print yield.
5 B
The Toner Filling Jig might
fail due to any number of
running conditions moving
out of specification.
5
Every unit is 100%
checked by an integral
load cell on the filling jig.
Units are weighed. 4
100
5 5 4
100
Under Weight Development
Unit
Defective Print Yield as
rans out of Toner
3
Filling Jig running out of
specifications
2 Weight Check. 1 6 3 2 1 6
Damage to OPC during the
fitting of the LEFT/RIGHT
CUSHION
Copy quality problems. 7 B
Poor holding and assembly
process or process
adherence.
6
Keypoints in WSPB.
Operator Training.
Sampled QA Inspection. 9
378
1) 4M QA Check of Operator correctly holding
PCU whilst inserting into Packaging Cushions/
2) Process Confirmation in Training Document.
7 5 9
315
Damage to OPC during
fitting of the Left/Right
Cushion
Copy quality problems 3
Poor handling and assembly
of product into packaging
2 QA Sampled Inspection 4 24
1) 4M QA Check of Operator correctly holding
PCU whilst inserting into Packaging Cushions/
2) Process Confirmation in Training Document.
3 1 4 12
Step 5 Implementation of Improvement
Manual Packing of Exposed / Sensitive OPC Unit:
Potential Failure Mode Effects of Failure S Class Causes of Failure O Current Prevention Current Detection D RPN Recommended Action S O D RPN
Packing of exposed or sensitive products (like OPC Units) are inherently risky processes. This is because there is no way to Quality Check
that the unit has not been damaged in some way after the packing process. Automation of this process is extremely difficult with high cost
implications which most (if not all) recycling products cannot invest against.
Result:
• 5 Scale shows a Medium Risk rating before / after countermeasures. Final residual risk is the lowest medium rating.
• 10 Scale shows a High Risk rating before / after countermeasures. Final residual risk is a mid-level high rating.
10 Scale:
5 Scale:
Toner Filling a Unit:
Potential Failure Mode Effects of Failure S Class Causes of Failure O Current Prevention Current Detection D RPN Recommended Action S O D RPN
Automation process with automatic weight check. Process still has a subjective possibility if operator ignores fill-weight result.
Result:
• 5 Scale shows a Low Risk rating before / after countermeasures. Final residual risk is a very low, low rating.
• 10 Scale shows a Medium Risk rating before / after countermeasures. Final residual risk is a low-level medium rating.
10 Scale:
5 Scale:
HOW – Testing SR Developed 10 Scale vs RPL 5 Scale
19. HOW – FMEA Methodology Research - “Industry Standard”
From various FMEA Education outlets (Websites, Textbooks, University) an FMEA Study is generally conducted as follows:
Establish FMEA
Group
• Engineering Control of
FMEA
• Group consists of
Product Designer,
Production Design
Engineer, Production
Staff (including Key
Operators), Offline
Support Staff
(Warehouse), Process
Book Author
Conduct FMEA
• Estimate Potential
Failures
• Investigate Potential
Failure Effect
• Detail Root Cause of
Failure
• Score the Severity of
the Failure to the
Customer
Identify Current
Controls
• Identify any Current
Prevention Methods
to stop the failure from
happening
• Identify any Current
Detection Methods to
detect the failure has
happened within the
process.
Score FMEA
• Score Occurrence
Rate Potential of the
Failure Happening
based on current
Prevention Methods
• Score Detection Rate
for finding the failure in
the process based on
current Detection
Methods
Identify
Corrective
Actions
• Identify
Recommended /
Corrective Actions to
further reduce Risk
Rating Score (RPN)
Implement
Corrective
Actions
• Assign Responsibility
• Assign Completion
Date
• Change Process
Approve
Residual Risks
• Score Implemented
Corrective Actions to
provide Residual Risk
(RPN)
• Create Priority List of
Residual Risks for
future RPN risk
reduction exercises
Note: Risk Rating (RPN) is
produced by the
multiplying of Severity /
Occurrence / Detection
Rating Scores (S x O x D)
Step 5 Implementation of Improvement
20. HOW – FMEA Methodology Improvement
Establish FMEA
Group
Conduct FMEA
Identify Current
Controls
Score FMEA
Identify
Corrective
Actions
Implement
Corrective
Actions
Prioritise
Residual Risks
• Score Implemented
Corrective Actions to
provide Residual Risk
(RPN)
• Create Priority List of
Residual Risks for
future RPN risk
reduction exercises
• Identify any Process
Monitoring
Techniques for High /
Moderate Residual
Risks that cannot be
immediately reduced
or reduced cost
effectively
Implement
Residual Risk
Actions
• Action RPN Risk
Reduction Exercise
• Create High /
Moderate Residual
Risk Monitoring
Documentation
(i.e. Process
Confirmation, 4M,
Patrol Inspections)
Improvement Area:
This feature is being conducted in
Supplies Recycling FMEA but is
missing from RPL IMS 2012 ENG
027 Procedure
Step 5 Implementation of Improvement
SR Engineering reviewed the FMEA methodology, but expanded the Residual Risk Management at the end of the process
flow. This enabled an understanding of how high / medium residual risks that can no longer be reduced in a cost effective
way can be monitored and managed. This alternative flow is as follows:
Improvement Area
21. Step 6 Confirmation of Effect
RFT Results since 10 Scale FMEA Implementation
MIDAS
NMI
RINMEI
NMI
APOLLON
ATHENA
NMI
RINMEI
LBG
NMI
TAURUS
TCRU
NMI
RFT Results are within Good
Ratings 1~2 Months after NMI
Note: Residual Risk Monitoring
Methodology was completely incorporated
into Apollon/Athena NMI and onwards.
Results further improved from this point…
RFT%DefectsatProductionQC
22. Step 6 Confirmation of Effect
IQ Results since 10 Scale FMEA Implementation
MIDAS
NMI
RINMEI
NMI
APOLLON
ATHENA
NMI
RINMEI
LBG
NMI
TAURUS
TCRU
NMI
IQ Results are within Good
Ratings 0~1 Month after NMI
IQ%SamplingRate
23. Step 7 System Improvement
SR FMEA Final 10 Scale Definition Documentation
After 10 Scale FMEA Trials on Midas, Rinmei, Apollon/Athena and Taurus NMI, Supplies Recycling have compiled a complete
FMEA Template Spreadsheet including Definition Rating Scale Template.
(See Kaizen Presentation Attachment – SR FMEA Template v2.0)
SR FMEA Residual Risk Management Supporting Documentation
High / Medium Residual Risk Items found on the FMEA RPN after all countermeasures are implemented are recorded as
requiring Residual Risk Monitoring techniques within the “Recommended Action” column.
Potential Failure Mode
Charge Frame is C1, C2 or C3 type.
RPN
Recommended Action
Responsibility
and Target
Completion
Date
Action Taken
Severity
Occurrence
Detection
RPN
392
1) Process Book Page 25319 / 25437 - Add Visual Inspection
for Charge Frame Types (James Radnor to confirm visual
differences)
2) Create Keypoint Memo for Frame Variations.
3) Process Confirmation in Training Document.
4) 4M QA Check of Charge Frames in Buffer Trolleys.
Ian Collins/
James Radnor
(15/08/14)
Carlton Everett
(29/08/14)
John Pountney
(29/08/14)
1) Process Book Addition
2) SRO raised by James Radnor
3) Added to Training Documents
4) 4M Check Added
7 6 5
210
Apollon / Athena C2.5 PCU Recycling Process Confirmation - Strip 1
Operator Name:
Ref: Item Result Comment
N/A Why is there a Downdraft Bench on the Station
25305 Explain / Demonstrate remove charge cleaner
roller (to not damage unit lugs)
25316 &
19
Explain / Demonstrate the method checking
Charge Frame to appearance standards
25319 Explain / Demonstrate the method checking
Charge Frame type is a C2.5 (Keypoint Memo
to be created)
25128 &
25130
Explain / Demonstrate the method checking
Coating Bar Spring to appearance standards
PROCESS
SR Invented Process Confirmation Documents –
Operator Examination of Process Understanding of Risk Areas
4M QA Operator Patrol Inspection –
Process Surveillance
Item No Photograph STN Check Contents MON TUE WED THR FRI
8
Strip
Stn 1
Visually check x2 harness lugs
HARNESS LUGS MUST NOT BE DAMAGED OR MISSING
FRAME STDS REFSRO 14-SR017
CLEANLINESS STDS REFSRO 14-SR015
Ref Control No. 25278
9
Strip
Stn 1
Visually check correct Charge Frame Type
COVER STDS REFSRO 14-SR016
GENERIC CLEANLINESS COVER STDS REFSRO 14-SR015
UNIT CONDITION STDS SRO 15-SR020
Ref Control No. 25319
10
Strip
Stn 1
Visually check x9 harness lugs on side of frame &
harness routing.
HARNESS MUST BE ROUTED CORRECTLY
FRAME STDS REFSRO 14-SR017, CLEANLINESS SRO 14-SR015
Ref Control No. 25281
Production Line
4M Control Check (Apollon / ATHENA PCU - STRIP)
mm/WK
Check by
4M CONTROL
Patrol Inspection Check
ProcessKey
Point
ProcessKeyPointProcessKey
Point
ProcessKeyPointProcessKey
Point
ProcessKeyPointProcessKeyPointProcessKeyPointProcessKeyPoint
Assembly
Condition
AssemblyConditionReturnedPart
Condition
ReturnedPart
Condition
ProcessKey
Point
Assembly
Condition
ReturnedPart
Condition
ReturnedPart
Condition
ReturnedPart
Condition
ReturnedPart
Condition
Manufacturing
Condition
24. Step 8 Horizontal Deployment
RPL ENGINEERING
All other Engineering Departments are currently using 5 Scale RPL Template
(This potentially includes not using a Residual Risk Management / Monitoring Techniques)
• QA Department create a FMEA Focus Group for 10 Scale Development Findings
• RPL Engineering to be trained to FMEA Focus Group Conclusions
RPL POLICY
• IMS Procedure and Flow to be adjusted with FMEA Group Conclusion
RICOH MANUFACTURING GROUP
• FMEA Focus Group Findings to be shared with Ricoh Japan (RCL) – Ricoh Academy
25. Step 9 Summary of Improvement
QUALITY
IQ Increase
IQ Stable at > 99.5% quickly after NMI
COST
Product
Rework
Reduction
QUALITY
Higher Operator
Risk Awareness
QUALITY
Right-First-
Time Increase
COST
QC
Rectification
Reduction
DELIVERY
Lower Chance of
Finished Goods
Shortage
ENVIRONMENT
Product Rework
Part Usage
Reduction
RFT Stable at > 95% quickly after NMI
QUALITY
Customer
Complaint
Reduction
QUALITY
IMS Procedure
Improvement
DELIVERY
Lower Chance of
Parts Shortage
from Rework
26. Step 10 Remaining Issues & Future Plans
Future Plans Time Frame
FMEA Focus Group (Engineering & QA Departments) June – Dec 2015
Create new FMEA Template & Definitions June – Sept 2015
Develop FMEA Course June – Sept 2015
Pilot Training for FMEA Course Oct – Dec 2015
Update IMS Procedure Eng-027 Dec 2015
Start-Up of RPL Academy Training for FMEA Course Jan – Mar 2016
All the above form part of this years SMO.
Editor's Notes
Background to FMEA Risk Assessment of Design / Product
An FMEA (Failure Mode Effect Analysis), is “Pro-Active” a study of potential failures in the design or processing of a product and the Effect the failure has on the product.
It is produced by analyzing, measuring, estimating potential failures in the design or production process.
Then assessing / measuring 3 factors to that Design of a Product / Production of a Product.
Severity = This is a rating for when a Potential Design / Production Failure Mode results in a Customer End or Final QC Manufacturing Defect.
Occurrence = This is a rating given for the amount of times the Potential Failure Mode Defect happens within Production of the Product.
Detection = This is a rating given for the ability the Design / Production process has to detect a Potential Failure Mode Defect when it happens.
These 3 factors are multiplied together S x O x D = RPN – Risk Priority Number
Then the FMEA team looks at methods to reduce this RPN Risk down in order to make the Design or Production Process more robust and quality right-first-time.
(Similar method to those familiar with Health/Safety Risk Assessments – but this is a “Quality Risk Assessment” for the Product).
SHOW A3 Sheet of Methodology…
PROBLEM 1
Here is a history of Supplies Recycling Products prior to any FMEA activity being conducted.
Perseus AIO was the first time an FMEA template was tested but not fully implemented.
This graph shows the “end of line” QC Data. RIGHT FIRST TIME.
[READ: Red Cross Section]
During this historic period of Supplies Recycling, all defects found were managed by Defect Meetings with Engineering, Manufacturing and the QA Inspector. The results of this reactive meeting and root cause study would affect changes to the process.
This graph shows the “sampling” Final QC (QA) Data. IQ SAMPLING – Similar results to RFT Data.
[READ: Key Point]
As of 2010 Supplies Recycling started testing FMEA methods based around the 10 Scale System…
A 10 Scale System is an FMEA Method that means the rating scale (scoring) given to Severity / Occurrence / Detection is in 10 levels.
This was prompted by the an upper level Engineering request that FMEA are to be conducted as part of the NMI even though a template / method wasn’t specified.
In 2012 a BSi audit found that there was no standardization of FMEA through RPL NMIs…
Therefore the NMI IMS Procedure was updated, and a new procedure created for FMEA within Engineering (ENG-027) by the QA Dept.
The method and template that was decided was based on a 5 Scale System.
When reviewed in SR Engineering, there were issues for with this format, and QA Dept allowed the trial of 10 Scale to still be used within SR Production.
PROBLEM 2
Severity
Severity Rating where compressed to fit into the RPL QA Defect Ranking.
Severity Degree is not realized.
Discuss Example – SHOW Copy Charts of Minor / Major Copy Defects…
Occurrence
Occurrence Rating is not really a problem entirely.
It only suffers from compressed ratings again, which means there is large variation in Failure Rates all being located under one rating score.
This means accuracy can become somewhat reduced.
One thing that is missing is estimate probabilities.
This is particularly required for early versions of the FMEA when final production design or capacity is unknown.
Detection
Detection criteria and scaling is the largest problem found with the RPL 5 Scale Template.
No Clear Distinction for Subjective or Non-Subjective Detection Processes.
Discuss Example
The main issue just mentioned with Detection Rating (definitions being unclear), means it can suffer from issues surrounding the Likert Scale.
Note: FMEA is a “Pro-Active” Study, therefore we will be estimating a lot of the S/O/D Ratings.
[READ: Key Point]
RPL IMS Procedure does not incorporate the need for FMEA to be conducted as a team, even though in most educational institutions it is a minimum necessity.
PROBLEM 3
Residual Risk is – READ []
This “problem” is with either FMEA Scaling Methods 5 or 10 Scale. – READ Observed RPL Problem, particular Red Text.
Points 1-3 are discussing design or production processes that have limitations with Cost.
In all 3 criteria there is not the available investment to apply complete Residual Risk Countermeasures to reduce that residual risk to a low (safe) rating.
Cost implications become higher importance than Quality.
Discuss Example.
READ: Key Point
This fishbone diagram highlights the main 3 Problems Supplies Recycling Engineering have found during this FMEA investigation process.
Highlight main points in bold.
No FMEA = Poor Design / Production Quality Control
RPL 5 Scale = Greater Design / Production Control, but 5 scale method means it is a less accurate measurement and the residual risk only requirement is a reduction activity not monitoring of remaining high / medium risks
Developed 10 Scale = Greater Design / Production Control over 5 Scale as measurement of risk is more accurate, but still no residual risk monitoring technique
Developing 10 Scale System with Residual Risk Monitoring = Complete Design / Production Quality Control and management of all Residual Risks
Why:
Highlights the 3 Main Problems set out in Step 2:
No FMEA Scenario was NG for RFT or IQ, therefore we are doing this activity to initially improve this item.
After investigation it was found that the current 5 Scale RPN Procedure, Template and Scaling has weaknesses that need to be improved.
A methodology of how to deal with High / Medium Residual Risk is not obvious, so we wish to create supporting documents for this feature of the FMEA.
How:
Engineering did research into the general industry standard used for Scaling of FMEA.
It showed that the most used variety of FMEA was a 5 Criteria Division scaled in 10 Ratings.
2) The 10 Scale Definitions were then researched –
Severity Evaluation Criteria - READ Improvement Area.
Occurrence Evaluation Criteria – Stated in Step 2, this measurement rating scale wasn’t a main issue.
However there are improvements in still using a 10 Scale Rating.
READ Improvement Area.
Detection Evaluation Criteria – This was a key issue in Step 2.
READ Improvement Area.
Criteria is very precise in description. It is logical…
Discuss example of Two Visual Checks over One… And the consistent thought of adding several visual checks will solve a defect issue.
This FMEA definition clearly shows that reliance of multiple human visual inspections is not a error-proofed methodology to assure quality.
Use of mistake proofing methods (Poka Yoke), gauges or complete automation only accomplishes this.
Examples of this are automated processes with automated inspections, but then processes being designed with addition manual visual inspections on top of this… According to the FMEA this would not improve the score rating, so therefore does not improve overall quality assurance of the product.
3) Once the scaling and definitions were established, SR conducted this method on SR Product Introductions since Midas AIO.
However, the RPL 5 Scale FMEA has been referenced in key process areas throughout the SR NMI since Midas AIO.
Examples can be seen on this and the next slide.
READ – Red box.
READ – Red box.
This is the FMEA Methodology Process according to most educational outlets and industry using FMEA.
The are minor variations of this format, but this is generally how FMEA works.
As seen, SR what to improve on this methodology further.
Establish FMEA Teams to conduct FMEAs, not done by individuals. SR have been doing this since FMEA introduction.
Key Improvement Area is the monitoring of High / Medium Residual Risks that cannot be reduced further due to Cost constraints or technological difficulties.
We can do this by incorporating the use of 4M Control Sheets directly linked with the FMEA to Surveillance the Process and also ensure Operator Training of high risks are well controlled.
The incorporation of FMEA into Supplies Recycling has been extremely beneficial with Quality Results showing that fact.
After NMI Quality does tend to stabilize after 1-2 Months with RFT values (only Rinmei AIO showing so further difficults that were not predicted within the FMEA).
Key Point: Quality was further improved when Residual High / Medium Risks that could not be reduced or countermeasured further were incorporated into a monitoring activity and operator training was improved with Process Confirmation Documents – as seen from Apollon / Athena C2.5 PCU NMI.
IQ Results show a similar positive impact much like RFT on the previous slide.
Hand out and review SR FMEA Template v2.0 – Show Definitions Scaling. Scaling is similar to that investigated in Step 5.
Supporting Documentation:
After all countermeasures to high / medium risk processes are implemented, it is reviewed in the FMEA whether they require monitoring activities of the residual risk.
SR use the 4M document to create a Process Surveillance Sheet that an inspector monitors (observes) the process at set intervals.
SR also re-invented the Process Confirmation Documents, so that it is not just a formal knowledge of the Process Book / Order, but an examination of the operators knowledge and UNDERSTANDING of the high risk processes and what the standards are to achieve those processes correctly.
Process Confirmation with the operator is reviewed at set intervals and after all major production shut-downs.
Both of these documents are created based on the FMEA (directly linked to it).
Therefore we are not just creating an overview of the process with these documents.
And we are not asking the operator to read and understand the direct results from the FMEA either.
BUT we are directly educating our operators in what is high risk within their process and why
Couple that with 4M Surveillance Checks, the operator is always reminded of the key / critical areas – “Constant Training Approach”