Not having the ability to identify and rapidly respond to an abnormality means risking potential line shutdown, re-work, or maybe even a recall. Learn the steps needed to formalize and implement a proactive abnormality management program - including methods to error-proof your operations.
Hybridoma Technology ( Production , Purification , and Application )
Proven Methods to Abnormality Management and Error Proofing
1. Beyond Compliance
Webinar & Podcast Series for Process Manufacturers
Proven Methods to
Abnormality Management & Error Proofing
Dan Hicks
Management Consultant
Tim Nickerson
Client Manager
3. ✔Ask questions! (Q&A at end)
✔Only panelists are displayed
✔Recording link will be shared
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BEYOND COMPLIANCE
// Before We Get Started
4. BEYOND COMPLIANCE
Tim Nickerson
Client Manager and
Management System SME
• Former Chief Operations Manager, Plant
Manager, Business Unit Manager, and
Director of Lean Manufacturing
• Designs, implements and installs
management systems at large, multi-site
organizations
• Regularly conducts operational
diagnostics, implements go-forward
plans, and leads turnarounds
Dan Hicks
Management Consultant
• Former Production Leader and
Production Technician
Today’s Speakers
5. BEYOND COMPLIANCE
Our Fundamental Belief: Speed Wins Every Time
Contenders
Challengers
Leaders
Depth
of
Consulting
Capabilities
Breadth of Consulting Capabilities
High
Low
TBM
Consulting
R&G Global
Consultants
EFESO
A.T. Kearney
PWC
BCG
EY
McKinsey & Co.
Deloitte
Note: Challenger and Contender names omitted for improved
readability.
High
TBM recognized as a Production Operations Consulting
leader for client impact & depth of expertise.
Global Operations
Management
Consulting Firm
150+ operations consultants globally positioned,
delivering services in nine different languages
LATIN AMERICA OFFICE
(Mexico City)
NORTH AMERICA OFFICE
(Raleigh, NC)
EUROPE OFFICE
(Nottingham, UK)
ASIA PACIFIC
OFFICE
(Shanghai)
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OFFICE
(Santiago)
Proven Results Track Record
with thousands of case studies delivering
a minimum 3X annualized ROI within
12 months
Seasoned Consultants
who have a minimum of 25+ years
of senior operations management
and lean implementation experience
Global Footprint
serving hundreds of clients on four continents,
in nine languages
Recognized Leader
driving business excellence and end-to-end business
process transformation since 1991. Work with
Shingijutsu documented in book ‘Lean Thinking’.
Comprehensive Management System
to align strategy through execution & sustain
improvements
| The Global Lean Transformation Leader Since 1991
6. BEYOND COMPLIANCE
● Quick Recap: Tiered Management System
● Quick Recap: Layered Audits, Gemba Walks, & Leader Standard Work
Abnormality Management & Error Proofing: Session Overview
BEYOND COMPLIANCE
● Approaches to Abnormality Management
● Auditing Countermeasure Effectiveness
● Hierarchy Model of Error-Proofing
Sustaining Lean Improvements
8. BEYOND COMPLIANCE
Three Critical
Components of a
Management
System
Daily
Management
System
Framework
& Tools
Metrics Capability
Tier System Hour by Hour
• Abnormality
Management
• Error-Proofing
• Leader Standard Work
• Layered Audits
• Gemba Walks
• Problem Solving
• 8D, A3
Safety, Quality
Delivery, Cost
(SQDC)
9. Strategy Deployment
Corporate Vision and Direction - Long
term horizon to annual objectives with
monthly status checks.
Top Down
Tactical Execution
Plant level pursuit of the Strategy – real time, front
line pulse checks and course correction.
Bottom Up
Strategic Planning
Level III Review
Who: Operating Units’
Leadership Team
What: Review Plants’/Site Performance
on SQDC
(Monthly-On Site)
Level II Review
Who: Business Unit/Division
Leadership Team
What: Review Plants/Site
Performance on SQDC
(Yearly – On Site)
Level I Review
Who: Executive Team
What: Review Company Performance
on Safety, Quality, Delivery, & Cost
(Monthly)
Strategy
Deployment
Tactical Execution
Tier 1 Meetings (10-15 min.)
Who: Outgoing & Incoming Shift Supervisors and
TLs
What: Review Safety/Quality and Unresolved
Abnormalities of orders (each Shift Change)
Tier 1A Meeting (5 min.)
Who: Shift Supervisor and Hourly
What: Review Safety/Quality and Assignments
(each Shift Change)
Tier 2 Meetings (30 min.)
Who: Site Leadership Team
What: Review SQDC, open actions items from
previous meetings (using Accountability and A3
boards ( ~2 hrs. into shift on weekdays)
Tier 3 Meetings (30-60 min.)
Who: Ops Manager, Wave Planner,
Reg. CI & Project Leaders
What: Review Key Initiatives, Projects, Financials,
People & A3
Tier 4 Meetings (45-60 min)
Who: Site leadership
What: Review Safety, One Pager, Ops Plan, Projects,
A3, & Priorities for the month
SQDC
Strategy Deployment Meets Daily Management
10. BEYOND COMPLIANCE
Developing Leader Standard Work
Similar to Operator Standard Work, Leader Standard Work:
• Identifies activities to be performed
• Specifies when the task should be completed
• Reduces variation, increases consistency
• Sustains the process
• Highlights opportunities
• Leads to new standard work - process improvement
11. BEYOND COMPLIANCE
Developing Leader Standard Work
• An organized group of questions designed to examine an operation, equipment or process
• Should start by focusing on areas of high risk to the process
• An ongoing system of process checks that verify:
• Proper methods
• Settings
• Operator craftsmanship
• Error proofing devices
• That other inputs are in place to ensure a
defect-free product/process
13. BEYOND COMPLIANCE
Abnormality Management:
Defined
• Abnormality: A violation of a standard
operation, process or procedure
• Abnormality Management: The ability
to identify and rapidly respond to an
abnormality
14. BEYOND COMPLIANCE
Abnormality Response & Andon
• Abnormality: Any condition (i.e. interrupters) that negatively impacts the process and
prevents us from meeting hourly and SQDC targets
• Andon: Any signal generally involving sight or sound that alerts the user that an abnormality is
occurring or about to occur.
• The purpose of the abnormality response system is to identify trends
below target on area Performance Boards & Hour by Hour boards that
require immediate action (Andon Response)
• The rapid response to the identified abnormalities will ensure that the
Managing for Daily Improvement activities are taking place and are
effective in solving problems and driving improvement
15. BEYOND COMPLIANCE
Two Approaches: Dealing with Abnormalities
Quick fix approach – “Just Do It”
• Cause is known and easy to address
or…
• Cause is not known but interim fixes
are put into place to maintain
operations and/or processes – AND
THEN move to #2
Investigative approach – Root Cause Analysis
• Problems difficult to resolve & tend to recur
• Requires more formal data collection and
analysis
16. BEYOND COMPLIANCE
Response Strategies: Countermeasures
Countermeasures can be short term and/or long term
• Short term example: place container under leaking machine to contain spillage
• Long term example: find source of leak and repair
Must be based on a formalized problem solving process appropriate for the issue
• Pareto Analysis (multiple levels where needed)
• 5 Whys
• Cause & Effect (Fishbone or Ishikawa diagram)
• A3 methodology
Must be specific
• “What, Who, When” accountability
Must be audited for sustainment
17. BEYOND COMPLIANCE
Step 5
Step 4
Step 3
Step 2
Abnormality Management: Steps to Implementation
Establish the
standard (i.e. task,
operator or process)
Implement visual
controls to
distinguish normal
from abnormal
Establish a rapid
response system
(Andon) to address
abnormalities
Implement
Countermeasure
Strategies (i.e.
response protocol)
Audit the
effectiveness
of the system
Step 1
18. BEYOND COMPLIANCE
Visual Controls:
Drives Improvement
Through Awareness
• What would bowling be like if there was a
curtain blocking your view of the pins?
• Who would know the score?
• What if you were only told your score once
per day/week/month?
• How would we know if we were winning?
• How motivated would we be to play
or improve?
Visual controls creates an awareness
➜ everyone knows the score
19. BEYOND COMPLIANCE
Visual Control
• Hour x Hour Board
• Area Performance Boards
• Plant Performance Boards
• Problem Solving Boards
• Andon Lights depicting status
of equipment operation
• Colors and Lines depicting
line side inventory,
on-line defects, staffing
• Safety Man – safety occurrences etc.
23. BEYOND COMPLIANCE
Tracking Abnormalities
• Information is recorded
• KPI board
• Countermeasure sheets (What, Who, When)
• Assign ownership
• Create Pareto charts based on targets not achieved
• Use problem solving tools (e.g. 5 Whys, Cause & Effect, Root Cause Analysis)
• Track trends
• Continue to improve through countermeasure implementation
24. BEYOND COMPLIANCE
Countermeasure Effectiveness
Auditing Countermeasures is essential to ensure effectiveness
• Did the plan happen as scheduled?
• Did the countermeasure work?
• If not, what is the new plan?
Track results and look for trends
• Results should be visible on the SQDC board in terms of stated targets – Recurring issues are
highlighted in War Room (Visual Management Center)
Track results and look for trends
• Results should be visible on the SQDC board in terms of stated targets – Recurring issues are
highlighted in War Room (Visual Management Center)
Formalize the improvement
• Train everyone involved
• Update standard work
• Audit the new standard work to ensure compliance
27. BEYOND COMPLIANCE
Countermeasure Effectiveness
● If the process is not documented and visual, it cannot be effectively audited
● Auditing ensures effectiveness and sustainment
• Response time to react to an abnormality must be clearly established
• Consistency in response times lead to sustainment
• Effective Problem solving results in effectiveness and continuous improvement
● Establish accountability and management credibility
28. BEYOND COMPLIANCE
Countermeasure Effectiveness
Leader’s job regarding abnormality management:
• Ensure everyone knows their role in Abnormality Management
• Ensure abnormalities are quickly identified at the source
• Ensure both manufacturing and support groups are held accountable to
rapid response times (Andon)
• Verify tracking of trends through audits
• Ensure abnormalities are clearly documented
• Ensure appropriate countermeasures are in place
• Verify timely execution of countermeasures (accountability)
Become more proactive and less reactive
29. BEYOND COMPLIANCE
Summary: Visual Controls & Abnormality Management
• Visual Controls are a prerequisite to establishing Abnormality Management
• The norm or standard must be established and understood by all
• Implement a disciplined rapid response system (Andon)
• Rapid response must be clearly defined…
…expectations must be communicated
• Leadership must be consistent in follow up and audit to ensure an effective
Abnormality Management System
• There must be consequences for failing to do what has been agreed by all
• Effective countermeasures improve results and creates a culture of
continuous improvement
31. BEYOND COMPLIANCE
Error Detection vs. Cost
Customer
Cost
of
Non-
Conformance
Mistake
Proofing
Source
Self
Successive
SPC
Inspection
Source, Self, and Successive checks
make Mistake Proofing much more
effective than other detection methods!
32. BEYOND COMPLIANCE
Zero Quality Control
Customer
Feedback
Time
Mistake
Proofing
Source
Self
Successive
SPC
Inspection
It’s All About Feedback Time!
100% “inspection” built into the process
with as short of feedback and corrective
action cycle time as possible.
33. BEYOND COMPLIANCE
Implement Mistake Proofing
Goals and reasons for
installation are clear
Effective against
recurrence—never
malfunctions
Will not make or pass
on a defective part
Costs very little
Made with shop floor
wisdom and ingenuity
Simple, durable, and
easy to maintain
Usable in
other processes
Doesn’t impair
operability
Understood by
the operator
Poka: means that which anyone could make
Yoke: prevention or error proof
Characteristics of an Effective Poka Yoke
34. BEYOND COMPLIANCE
Sensory
Warning
Shutdown
Four Methods to achieve Poka yoke
Eliminate the opportunity
for errors to occur
Stops the process
when the error occurs
(Jidoka)
Use active visual or
audio signals to notify
operators or users that
an error has occurred
Alert methods make
errors obvious, but
depends on the operator
or user to actually
perform the check
Control
Even the simplest mistake-proofing devices must not result in worker detachment from the process.
Rather, workers need to be involved in the design and enhancement of the process and its
mistake proofing mechanisms……
35. BEYOND COMPLIANCE
Control Poka yoke
• Regulatory functions (warning and control method)
• 2-sided car key no wrong insertion
• Tank Connections for Grilles
CONTROL
Everyone has a photographic memory.
Some, just don't have any film.
36. BEYOND COMPLIANCE
Jidoka Elements
• Abnormality Response/Reaction
• Roles and responsibilities
• Line stop guidelines React to problem
S Q D C
Measure impact
Alert team
Train affected associates in
new standard operations
MAN
EFFECT
MACHINE
MATERIAL
METHOD
Find root cause
Develop and test
improvement
Update standard operations
with tested improvement
37. BEYOND COMPLIANCE
Mistake Proofing
Detection
In cases where physical “inspection” is
possible, mistake proofing devices can be
installed within the process boundaries so
when errors occur during the operation the
information is immediately fed back to the
operator. This allows the operator to take
quick corrective action.
Source: Dr. Shingo: Zero Quality Control book
38. BEYOND COMPLIANCE
Sensory
The Smart Gate is a mistake proofing system with infrared
sensing devices.
Primarily for large parts (castings, cartons, boxes or literature)
or single bin applications.
The aluminum extrusion has the electronics
and power supply integrated.
Control can be provided via Smart Product Controllers,
PC's or PLC's for detection of parts picking.
Low cost- sensor systems
39. BEYOND COMPLIANCE
Sensory Poka Yoke
“Smart Frame has reduced errors in our control
box assembly area by 66%. I recommend all of
our plants look into this product to improve our
assembly quality.”
Stan Crockett
Black Belt Engineer | The Trane Co.
43. White Papers & Surveys
Webinars & Videos
Product & Partner Info
Solution Consultation
BEYOND COMPLIANCE
More Resources
safetychain.com/resources/webinar-replays
• Part 1: How to Use a Tiered Management System for
Effective Daily Execution
• Part 2: Transition from Fire Fighting Mode Using
Leader Standard Work and Layered Audits
• Part 3: Proven Methods to Abnormality Management
and Error Proofing
Replay the Series
Part 4: Lean Problem Solving Methods
Coming Soon