LEAN ISO

ASQ North Central PA Section

January 14, 2013

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Todays Objectives
View Quality Management System (QMS)
and Lean practices as complementary
forces.
1. Integrate Lean practices and the QMS.
2. Use Lean tools to lean out the
documentation.
3. Show how to lean out QMS processes.

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OBJECTIVES OF AN ORGANIZATION

To:
- Do Everything Right the First Time
- Deliver Every Product/Service Within Spec, as
Documented and on Schedule

Thereby:
- Satisfying Customers
- Providing Consistent Top Quality
- Reducing Cost and Increasing Profitability

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KEYS TO ANY EFFORT

1.

2.

3.

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Management commitment, responsibility

- Strategic planning
- New ways of thinking
- Leadership
- Follow through
Understand processes
- Flow
- Interactions
- Effectiveness and efficiency
Measure and analyze
- Facts
- Improvement
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INTEGRATING
LEAN AND QMS
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Todays Objective 1 Part 1

Integrate the QMS with lean practices

8 wastes in the QMS

Lean tools applied to the QMS

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8 FORMS OF WASTE

Over production

Motion

Over processing

Waiting

Defects

Inventory

Transportation

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Under utilization of
people
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ISO AND THE 8 WASTES

LEAN

ISO

Overproduction

Over processing

Defects

Transportation

Motion

June '11

Too many documents,

NVA documents
Review & control,
multiple approvals
Inaccurate documents,
uncontrolled documents
Distribution, multiple
copies
Looking for documents

Lean ISO

ISO AND THE 8 WASTES

LEAN

ISO

Waiting

Inventory

Underutilize people

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For revisions, approvals,

locating documents
Keeping lists and
controlled copies, multiple
locations for same
document
Not letting people
determine the need for,
content, and use of info

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ISO AND THE LEAN TOOLS

LEAN

5S

ISO

Standardized work
POUS

Quality at source
Value stream mapping
Quick changeover (SMED)

Teams

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Lean out documentation & ISO

processes
Document and process control
Information available where
used
Process control
4.1 General requirements
Document control (SMED)
Single Minute Exchange of
Documents
Interaction

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ISO AND THE LEAN TOOLS

LEAN

Layout
Visual

ISO

Batch reduction
Pull /Kanban

Cellular/flow

TPM

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Document storage
Document and process
control
Process flow
Create only what is
needed
Write documents as flow,
store by process
Perform maintenance on
QMS

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Todays Objective 1 Part 2

Integrate lean practices with the QMS

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Processes & documents

Objectives & measures
System planning
Management review
Competency & infrastructure
Production planning & control
Internal audits
Preventive actions
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4.1 GENERAL REQUIREMENTS

Determine processes,
Determine sequence and interaction,
Determine effectiveness and ensure control,
Ensure availability of resources and
information,
Monitor, measure and analyze processes,
Continually improve.

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4.1 GENERAL REQUIREMENTS

Make value steam mapping (VSM) a work

instruction. Link to

Quality planning
CAPA
Management review

Make 5S a work instruction. Link to

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Process control
Quality planning
Internal auditing
CAPA
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4.2.1.d DOCUMENTATION

Include lean documents

Standard worksheets
Kanbans
5S assessment forms
Job breakdown sheets

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5.4.1 QUALITY OBJECTIVES

Develop targets for future state value

streams such as

Space required
Walking distance
Cycle time
Changeover time
First pass yield
Units per labor hour

Avoid conflicts with other quality objectives.

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5.4.2.b SYSTEM PLANNING

Lean tools are valuable in planning

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Value stream map

Kaizen event
Visual management
Gemba walks

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5.5.1 RESPONSIBILITY AND

AUTHORITY

Define for

Kaizen team leader

Lean Champion
Value stream manager

Include job descriptions

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5.6.1 MANAGEMENT REVIEW

Include in management review

Daily accountability meetings review parts

of the system
Gemba walks by top management.

Include

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Lean metrics
Preventive action plans to eliminate waste
Review lean changes to sustain actions
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6.2 COMPETENCY,TRAINING

Audit lean training process for

effectiveness.
Integrate lean job breakdown (JB)
sheets.
Use standard work /work instructions.

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6.3 INFRASTRUCTURE

Use to sustain

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5S improvements
TPM efforts

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7.1 PRODUCT REALIZATION

(QUALITY PLANNING)

Lean layout
Value stream map
Cellular/ flow
Use the automotive APQP Advanced
Product Quality Planning
Consider A3

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7.5.1.a,b PRODUCTION
CONTROL

Include

Kanban cards
Standard worksheets
Visual instructions
Job breakdown sheets

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7.5.5 PRESERVATION
OF PRODUCT

Include

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Kanban levels
Continuous flow
U-shaped cells

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8.2.2.b INTERNAL AUDIT

Schedule audits of lean processes and

their improvements for effectiveness.
Use to sustain improvements from
lean actions.
Train auditors to look for waste. Waste
is not effective.

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8.2.3 MONITORING AND

MEASURING OF PROCESSES

Monitor and measure waste.

Supports visual management and lean
culture.
Helps sustain improvements.

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8.5.3 PREVENTIVE ACTION

PA forces root cause analysis (RCA)

RCA not often done prior to lean
activities.
PA process requires verification of
action taken to eliminate root causes of
problems.

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8.5.3 PREVENTIVE ACTION

7 of the 8 wastes are causes of

potential nonconformances.
Which one is not a potential cause of
preventive action?

June '11

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LEANING OUT ISO

DOCUMENTATION

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Todays Objective 2

Use lean tools to lean out

documentation

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8 wastes
5S
Value Stream Maps (VSM)
Single Minute Exchange of Die (SMED)

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KISS

10 Commandments: 297 words

Bill of Rights:
463 words
Gettysburg Address 266 words
Federal Directive to
Regulate the price of
cabbage:
26,911 words
ISO 9001 QMS documentation??????
See ISO section 4.2.1

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ENTROPY PROBLEM

Everything proceeds in the direction of

disorder.
ISO documentation has a tendency to
grow more and more.
Our ISO system becomes complex,
lengthy, and un-user friendly.

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Root Cause Analysis

Old procedures no longer required.

Redundancy in many documents.
Procedures written in batch form.
External auditor recommendations in the
form of OPIs.
Over interpretation of the requirements.
Paragraphs instead of bullets or flowcharts.
Procedures written in detailed ISO-ese to
impress the external auditor.

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ROOT CAUSE

No control system to keep the QMS

from getting out of hand.

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USE 5S TO LEAN OUT THE

DOCUMENTATION

Sort
Set in order
Shine
Standardize
Sustain

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GENERAL GUIDELINES

Never repeat any requirement, procedure,

specification, etc. Use references and links.
Let process operators write
procedures/instructions as they actually do
them in process flow. Not for external
auditors.
Reduce the number of procedures. Create
only useful documents.

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SORT ELIMINATE WHAT IS

NOT NEEDED

Identify documents or parts of

documents that are not used.
Red tag the documents create
temporary folder.
Red line the document contents.
Start with the quality manual and
procedures.

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SORT - QUALITY MANUAL

Most manuals duplicate the ISO 9001

standard.
Does anyone read it?
Is it value added?
How does it meet the requirements of
ISO section 4.2.2?

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TWO PAGE QUALITY MANUAL?

4.2.2.a Page 1 In 4-5 paragraphs

4.2.2b,c Page 2 In a flowchart

Introduction to the company

Scope
Justification for exclusions
Quality policy
Reference to documented procedures
Interaction of procedures of the QMS.

Page 3 ?

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SORT - PROCEDURES

Check revision records. Procedures not

revised for a long time may not be used.
Documents that do not affect the quality of
product, service, or process.
Contain information only.
Content is repeated in another document.
Are left over from ISO 1994 and no longer
required.

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SORT-DOCUMENT SECTIONS

Redundant paragraphs in the same or

other documents.
How to complete a form.
Batched info rather than process flow,
references, responsibilities, definitions.
Sections not read.
Info only or philosophy statements.

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SORTING FORMS

Multiple forms for the same process

Similar forms with different titles
Multiple forms with the same
information.

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SORT - ACTIONS TO TAKE

Eliminate
Combine with another document
Rewrite for .. (reason)
Change format to work instruction,
form, log, etc.
Delete sections ..

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SET IN ORDER A PLACE

FOR EVERYTHING

Documents accessible in 2-3 mouse

clicks
Group documents by process rather
than type. Link horizontally.
Documents must be referred to in at
least 1 other document.
Use a logical numbering system.
(Numbers are not required.)

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SET IN ORDER

Link procedures, work instructions, and

forms and make it easy to trace back to
each referencing document. Link
vertically.
Make it easy to find documents. Use
titles, numbers can be confusing.

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SHINE KEEP IT CLEAN AND

ORDERLY

Make clearly legible even in dirty

areas and in readable locations.
Apply document control to lean
documents.
Use visual standards.
Ensure documents tell what people
really do.

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SHINE KEEP IT CLEAN AND

ORDERLY

Update processes as changes or

improvements are made.
Look for documents being used that are
not controlled.

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STANDARDIZE MAINTAIN
AND MONITOR

Maintain the first 3 Ss.

Make clear definition of

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Procedure tells who, what, when, where;

involves many people and/or departments.
Work instruction tells how; procedural steps;
one person, one task. to do the job.
Training material Used for training or reference,
but not everyday use.

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STANDARDIZE MAINTAIN
AND MONITOR

Keep documents lean

Procedures format

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Purpose why process exists, not why

document exists
Scope applies to, or does not apply to
Procedure tell who with a verb; use if or
when
Revision - latest revision only

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STANDARDIZE MAINTAIN
AND MONITOR

Keep documents lean

Avoid batches

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Responsibilities
References
Definitions

Put these in the defined steps

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STANDARDIZE MAINTAIN
AND MONITOR

Keep documents lean (cont)

Procedure guidelines

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Three pages or less

Avoid redundancy within or between docs
Do not attach forms
Make forms self-explanatory
Refer to other docs at point of use
Electronically link
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STANDARDIZE MAINTAIN
AND MONITOR

Keep documents lean (cont)

Work instructions

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One task, one person, one page steps only

Procedural steps only start with a verb
Latest revision only
Avoid redundancy within or between docs
Refer to other docs at point of use
Electronically link
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STANDARDIZE MAINTAIN
AND MONITOR

Use Microsoft Office capabilities.

Do not duplicate in other lean documents, e.g.,
combination work sheets (CWS) or job breakdown
sheets (JBS.)
Limit access to make changes.
If using hard copies, standardize their organization.
Simplify user access to documents. Titles are easier
than numbers.
Standardize desk top access.

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SUSTAIN - DISCIPLINE

Quality and lean must work together to

sustain the lean documentation.
When adding a new document, check for
redundancy in existing ones.
Conduct 5S repeatedly part of internal
audits or process control.
Make 5S a work instruction. Link to CAPA,
internal audits, process control, management
review.

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REMOVING WASTE FROM

THE QUALITY
MANAGEMENT SYSTEM

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Todays Objective 3

Show how to lean out QMS processes

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Continual improvement
Document change control
Document structure files and folders
Records control
Management review
Corrective & preventive action (CAPA)
Internal auditing
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REMOVE WASTE IN CONTINUAL

IMPROVEMENT PROCESSES

Many processes with separate

leaders/managers, separate departments,
and separate goals.

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Six Sigma
Lean
ISO
Theory of Constraints
Balanced Scorecard
TQM
Innovation Engineering
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REMOVE WASTE IN CONTINUAL

IMPROVEMENT PROCESSES

All trying to do the same thing, improve

processes and products.
Competition or collaboration?
Who gets the credit?
Processes and measures not aligned.
Causes waste and confusion.
Increases costs.

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REMOVE WASTE IN
DOCUMENT CHANGE CONTROL

As a result of lengthy approval process

System is circumvented
System is seen as bureaucratic
State of limbo exists
People look for reasons to not control
documents

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For reference only

Training document
Lean document
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REMOVE WASTE IN
DOCUMENT CHANGE CONTROL

Why does it take so long? RCA

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Many approvals take time

No measure of how long it takes
No goal set for time spent
Not a priority
Paper trail approvals

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DOCUMENT APPROVAL

Process owner or value stream manager

Management representative

Thats it!

Multiple approvals create waste

Risk rubber stamping

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REMOVE WASTE IN
DOCUMENT CHANGE CONTROL

Improve the process

Value stream map and identify

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Value-added steps
Non-value-added steps

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REMOVE WASTE IN
DOCUMENT CHANGE CONTROL

SMED

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Preparation, after approval changes, check

existing docs.
Changing words, paragraphs, revision
record, etc.
Review and approval
Post training modifications to docs.

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REMOVE WASTE IN DOCUMENT &

RECORDS CONTROL

Wall Street Journal

New York Enterprise Report

People spend 18-36 days a year looking for

correct information to do their jobs

Executives spend six weeks per year looking for

misplaced information

New York Times

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people spend 10 weeks per year rifling through

messy desks.
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REMOVE WASTE IN
RECORDS CONTROL

Why? Excess inventory of records

Maintain both paper and electronic copies

Double entry of data

Records not destroyed as indicated minimum retention

Confidential, classified, just information

No one is responsible or accountable for deleting them

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Find out why

All records treated equally

Delete/destroy records - 5S?

Employees keep additional copies

Use electronic storage if possible

5S or audit storage areas and file cabinets

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REMOVE WASTE IN
RECORDS CONTROL

Separate files into

Working
Reference
Archive

Disposition items in the in box once you

read it
Empty the out box every day

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REMOVE WASTE IN
RECORDS CONTROL

Master lists

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Combine master list of forms and records

into one spreadsheet list.
Spreadsheet can also serve as the required
procedure.

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REMOVE WASTE IN
MANAGEMENT REVIEW

Often done as one big batch see 5.6.2

Misconceptions

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Inputs have to be addressed at the same time

Inputs have to be addressed at the same
frequency
The review must be a meeting
No other topics should be covered
Some topics may have to be covered elsewhere
and at the review.
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REMOVE WASTE IN
MANAGEMENT REVIEW

An effective management review (MR)

process should ensure effectiveness of CAPA
and internal audits.
Review other meetings for MR items covered.
Lean daily accountability meetings may
address MR topics.
Record minutes, avoid double entry.
Record decisions and actions.
Use the same minute form for all meetings.

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REMOVE WASTE IN (CAPA)

CORRECTIVE/PREVENTIVE ACTIONS

The most important process

Results may not provide real
improvements
Often seen as a pain in the neck

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Forms hastily completed

Actions not effective

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REMOVE WASTE IN (CAPA)

CORRECTIVE/PREVENTIVE ACTIONS

Use the same procedure and forms for

both corrective and preventive action.
Combine ISO and lean forms e.g.,
Waste Walk and CAPA.
Combine CAPA and six sigma forms,
Continual Improvement Request?
Remove old forms

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REMOVE WASTE IN (CAPA)

CORRECTIVE/PREVENTIVE ACTIONS

Standardize terms.

Observation

Opportunity for improvement

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Avoid term
Requires no action
A preventive action
Requires action

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REMOVE WASTE IN (CAPA)

CORRECTIVE/PREVENTIVE ACTIONS

Use preventive action to eliminate waste.

Forces RCA
Effectiveness of action is verified.

Manage timely completion of CAPA

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Provide visibility for time lines

Send e-mail reminders and overdue notices to
assignee and supervisor/manager.
Discuss in meetings.

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REMOVE WASTE IN (CAPA)

CORRECTIVE/PREVENTIVE ACTIONS

Downsize paperwork.

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Consider access database

Database can serve as procedure and walk
the user through the process.

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8.2.2.b INTERNAL AUDIT

Integrate with gemba walks

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Seeing waste
Following the process
Becoming coaches ask questions
Walking regularly (weekly)
Follow up on assigned actions
Include all levels of management
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8.2.2.b INTERNAL AUDIT

Integrate layered process audits (LPA,)

gemba walks and internal auditing.

Charts
Action lists
Communications
Lean workplace organization

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6.3 infrastructure
6.4 work environment
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REMOVE WASTE IN
INTERNAL AUDITING

Do process auditing follow the

process steps.
Avoid batch auditing.
Refer to the CAPA procedure and use
CAPA form for findings.
Avoid double entry of info use 1 form.

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REMOVE WASTE IN
INTERNAL AUDITING

Provide competent auditors

Set auditing objectives and measure
effectiveness.

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Train
Retrain
Evaluate competence

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Todays Objectives
View Quality Management System (QMS)
and Lean practices as complementary
forces.
1. Integrate Lean practices and the QMS.
2. Use Lean tools to lean out the
documentation.
3. Show how to lean out QMS processes.

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Make More Money!!

Capitalize on the strengths and

counteract the weaknesses of both
Lean and QMS initiatives.
Recognize the synergy of combining
both.
Control operations and ensure discipline
to adhere to improved processes.

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