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Minnesota Urology

Alex Ivanoff, Laboratory Manager


What is Quality Control?
When a diagnostic test is performed in the lab, the outcome is a result.
The result can be quantitative(a number) or qualitative (positive or
negative)
To assure that our tests results are correct, we run control materials.
Based on the control material , we decide whether our results are
acceptable.
Quality Control:
Lets assume we measured value of potassium in a patients serum and it
is 2.8 mmol/L ( 3.6 to 5.2 millimoles per liter (mmol/L)) This result is
abnormally low and indicates an inappropriate loss of potassium.
But how do you know that the test result is truly reliable? It is possible
that the instrument is out of calibration and the patients true potassium
value is 4.2 mmol/L a normal result.
The question of reliability for most testing can be resolved by regular use
of quality control materials and statistical process control.
Quality Control
Quality Control in the medical laboratory is a statistical process used to
monitor and evaluate the analytical process that produces patient result.
What are the Requirements for statistical process:
Regular Testing of Quality control products along with patient samples
Comparison of Quality control results to specific statistical limits (ranges)
QC
Control materials are all the materials which can be used for error detection in QC methods.
Control samples are pools of biological fluids (serum, whole blood, urine or other materials).
They contain analytes which are determined by the laboratory, in known concentrations/activities.
In internal and external QC, two or three different control samples which contain different quantities
of analytes e.g. low, normal, high concentrations/activities.
Control samples with the same analytes but different concentrations/activities are called levels.
Different levels check the performance of laboratory methods across all their measuring range.
control samples are assayed for QC reasons, each laboratory has to estimate their limits.
Control limits are an upper and lower limit between which the control values are allowed to fluctuate.
A normal control product contains normal levels for the analyte being tested.
An abnormal control product contains the analyte at a concentration above or below the normal range for
the analyte.
For example, the normal range for a potassium level is about 3.5 5.2 mmol/L. A normal control would
contain potassium at a level within this range. An abnormal control would contain potassium at a level
below 3.5 mmol/L or above 5.0 mmol/L. (called levels, 1 or 2 )
QC is required by law !
CLIA: Implement control procedures that monitor the accuracy and precision of the complete
analytic process, which includes establishing the number, type and frequency of testing control
materials; ensuring control procedures detect immediate errors that occur due to test system
failure, adverse environmental conditions and operator performance; and monitor, over time,
the accuracy and precision of test performance that may be influenced by changes in test system
performance, environmental conditions and variance of operation performance.
At least once each day, analyze or examine patient specimens, using the following controls:
For each quantitative procedure, include two control materials of different concentrations.
For each qualitative procedure, include a negative and positive control material.
Beckman Coulter recommends :
with each new calibration
with each new lot of reagents
after specific maintenance or troubleshooting activities
QC
Regular testing of quality control products creates a QC database that the
laboratory uses to validate the test system. Validation occurs by comparing
daily QC results to a laboratory-defined range of QC values. The
laboratory-defined range is calculated from QC data collected from
testing of normal and abnormal controls.
QC B. When the daily QC result for the abnormal control (high
potassium) is compared to the defined range for the abnormal
control, the analytical process is shown to be in control for
each day of testing except for the last day (11/7). On November
1 through November 6, both controls were in control and
patient values could be reliably reported.

C. However, the laboratory was out of control


for abnormal high potassiums on November 7
because the value obtained for the QC material
(8.0 mmol/L) was outside the acceptable range
(6.7 7.3 mmol/L). This means that some error
occurred which may have made some patient
A. Here there are two ranges reported. The acceptable range for the Level I results unreliable. The laboratory should not
(Normal Control) is 3.7 4.3 mmol/L. The range for Level II (Abnormal Control) is report any patient samples with an abnormally
6.7 7.3 mmol/L. When the daily QC result obtained for the normal control is high potassium result until the error is resolved
compared to the range calculated for the normal control, it becomes apparent
that each result lies somewhere within the expected range. This indicates that and the abnormally high sample(s) are re-tested
the analytical process is in control at the normal level on that day of testing.
Mean & Standard deviation
Mean= the average of the numbers: a calculated "central" value of a set of
numbers. To calculate: Just add up all the numbers, then divide by how many
numbers there are.

Standard deviation = quantity expressing by how much the members of a


group differ from the mean value for the group

Statistics
The mean (or average) is the laboratorys best estimate of the analytes true value for a specific level of control.
To calculate a mean for a specific level of control, first, add all the values collected for that control. Then divide the sum of these
values by the total number of values. For instance, to calculate the mean for the normal control (Level I) in Table 1, find the sum of
the data {4.0, 4.1, 4.0, 4.2, 4.1, 4.1, 4.2}. The sum [] is 28.7 mmol/L. The number of values is 7 (n = 7). Therefore, the mean for the
normal potassium control in Table 1 from November 17 is 4.1 mmol/L (or 28.7 mmol/L divided by 7).
Standard deviation is a statistic that quantifies how close numerical values (i.e., QC values) are in relation to each other.
The term precision is often used interchangeably with standard deviation.
Another term, imprecision, is used to express how far apart numerical values are from each other.
Standard deviation is calculated for control products from the same data used to calculate the mean. It provides the laboratory
an estimate of test consistency at specific concentrations.
A test may be consistent (low standard deviation, low imprecision) or inconsistent (high standard deviation, high
imprecision). Inconsistent repeatability may be due to the chemistry involved or to a malfunction. If it is a malfunction, the
laboratory must correct the problem
Statistics
The bell curve which represents a normal
distribution of data shows what standard
deviation represents.

One standard deviation away from


the mean in either direction on the
horizontal axis accounts for around
68 percent of the data. Two
standard deviations away from the
mean accounts for roughly 95
percent of the data with three
standard deviations representing
about 99 percent of the data.
Westgard rules
The formulation of Westgard rules were based on statistical methods. Westgard
rules are commonly used to analyze data in Levey-Jennings charts.
Westgard rules are used to define specific performance limits for a particular assay
and can be used to detect both random and systematic errors.

Westgard uses a combination of decision criteria, or control rules, to decide whether an


analytical run is in-control or out-of-control
In-control = acceptable
Out-of-control= unacceptable
12s Rule
1= one point
2S= position exceeds 2S
12s One control value lies between +2s/+3s or
between -2s/-3s. It is only a warning rule
13sRule
13s One control value lies over +3s or under -3s. This criterion is sensitive
to the detection of random errors. The results should be blocked and not
reported to the patients. The run is rejected.
13S
22s Rule
22s Two successive control values lie between +2s and +3s or between -
2s and -3s. It defines a systematic error. The results should be blocked
and not reported to the patients.
22S
41s Rule
41s - Four successive control values lie between +1s and +3s or between -1s
and -3s. It defines a systematic error. The results should be blocked and not
reported to the patients
R4s Rule
R4s - reject when 1 control measurement in a group exceeds the mean plus 2s and another
exceeds the mean minus 2s. (The distance of two successive control values, values, is over 4s)
The graphic below should really imply that points 5 and 6 are within the same run.
. It is a criterion sensitive to random errors. The results should be blocked and not reported to the
patients. (Normally this criterion is used with two different control levels/across runs when used
with one level, as in this example, is applied for two consecutive runs
8x ,10x , 12x Rule
8 , 10 or 12 successive control values lie between and +3s or between
and - 3s. It is a criterion that reveals systematic errors. The results should
be blocked and not reported to the patients.
10x
10X
10X
SUMMARY
Westgard rules are used to know whether to accept or reject the run.
If one point exceeds 2s control limit (12s) Look carefully but no stop require ( accept run)
Look carefully means is there any of the other rules in the graph
Stop required ( reject run) for 13s , 22s , R4s , 41s 8x ,10x , 12x Rules
Introductions

Lean knowledge or experience


No prior experience
Some experience
Able to discuss
Able to teach others
Lean expert
Standardized 5S /
Problem Work Visual
Solving Factory

Lean
Lean Manufacturing Kanban
Layout

Total
Error Productive Quick
Proofing Maintenance Changeover
Introduction

Lean Manufacturing:
least-waste way to manufacture high quality
products

TPS- Toyota Production System

Kaizen- Continuous Improvement


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Why
Personal Considerations
Continuous Improvement can affect you where you work and live
Job Security
Our job security depends on the long-term health of the company.
We must improve production efficiency, reliability, and leadtime if we are to continue to meet
competitive challenges and customer expectations.

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Improvement means Change

Lean is a steady platform for change


that empowers people to continuously
look for ways to make work better
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5S Work Place Organization

2S 1S
5S
3S 4S

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5S What is it?
A Management philosophy devoted to the proper arrangement and
orderliness of the workplace.

5S lays the foundation for continuous improvement (Kaizen, Lean


Manufacturing).

A tool used to eliminate waste. (MUDA)

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Waste
Anything other than the minimum amount of equipment, materials, parts, space, and workers
time which are absolutely essential in adding value to the product.

Eight Deadly Wastes


Over Production Transportation
Product Defects Excess Motion
Inventory Waiting
Excess Process Under-utilizing People

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Over
Production
Waiting

Transportation
Correction

MUDA
Unused Over
Creativity Processing

Inventory
Motion
5S
The Foundation for Everything

Good factories develop beginning with the 5Ss;


bad factories fall apart beginning with the 5Ss.
Hiroyuki Hirano, Chairman JIT Management Laboratory, Co.,
5S
The Foundation for Everything
The underlining principal of 5S:

A place for everything and everything in its place.

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Management Support
5S starts from the top
Without the support of:
- Upper management
- Middle management
- Front line supervision

YOU WILL SURELY FAIL !!!!!!

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5S Sort

Set In Order

Shine

Standardize 2S 1S
Sustain
5S
3S 4S

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Meaning of the 5Ss
Sort -
Clearly distinguishing between what is necessary and what is unnecessary, while disposing of
the latter.
Evaluate all items in the workplace and determine which items are really needed.
Understand why items are needed.
Keep only whats needed.
Throw out whats not needed.
Include desk drawers and filing cabinets

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Sort
Where? What?
Walkways, Floors Excess materials
Storage shelves Tools, fixtures, gauges
Cabinets Spare parts
Drawers, Desks Documents
Walls, Bulletin Boards Brushes
Between Dock Doors Cloths
Around poles Furniture
On and around machines Seldom used equipment
EVERYWHERE!!!!! EVERYTHING!!!!!
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Sort and JIT
Corresponds to the Just-In-Time principle:
Keep only what is needed.
Only in the amounts needed.
Only when its needed.

Remove all items not needed for current production.

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Sort Problem Avoidance
The plant becomes crowded and hard to work in.
Cabinets, lockers and shelves required for unneeded items get in the
way of communication and place unwanted walls between
employees.
Time is wasted searching for parts, tools and fixtures.
Unneeded inventory and machinery are costly to maintain.
Excess stock on hand hides problems on the production floor.
Unneeded items and equipment make it harder to improve the
process flow.

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Sort

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Sort

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Meaning of the 5Ss
Set In Order
Organize the necessary items so that they can be used and returned easily.
Sort first so we dont waste time straightening things we dont need.
Organize all needed items - Locate items where
they most needed. - Identify where to return items when not in use.
- Identify items and their storage locations.
Make the order of things clearly understood at first glance.
Eliminate all wasted time and motion.

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Set In Order

Provide a convenient, orderly and safe place for


everythingand keep it there!
Set In Order

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Set In Order Can we achieve
requirements more simply?
incorporate tools

Keep tools close to where they


are needed
Set In Order
Make locations
obvious

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Label names and addresses


121 122 123
121 122 123
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Marking Color Code
Work Area - White

Aisles - Yellow

WIP - Blue

Scrap/Non-Conforming - Red

Finished Parts - Green


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Meaning of the 5Ss
Shine
Clean floors, equipment, and furniture in all areas of the workplace.
During and after the straightening process, the work place must be scrubbed.
Make things clean , neat and orderly. - Sweeping floors.
- Wiping off machinery, tools, computers and
furniture. - Use the cleaning process to inspect for sources of dirt, oil,
trash, etc.

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Shine
Monitor and restore the
condition of equipment and
the workplace during
cleaning
Meaning of the 5Ss
Standardize Maintaining and
improving the standards of the first three Ss
The first three Ss have been done - Sort
- Set In Order - Shine
Maintain and improve the first three Ss. -Eliminate
causes of dirt leaks and spills.
-Create systems to keep things neat and organized.

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Standardize

Establish standards of cleanliness and procedures for


routinely maintaining workplace condition
Problems when Standardize is not
implemented well
Conditions go back to the old and undesirable levels
At the end of the day piles of unneeded materials are left over.
Tool storage areas become disorganized

The purpose of Standardize is to prevent setbacks in the first three. To make implementing them a daily
habit.

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Standardize Everything
Beyond the Cleaning
Work methods
Data processing
Reports
Cleaning
Forms
Training
Tools

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Meaning of the 5Ss
Sustain Achieving the discipline or habit
of properly maintaining the correct 5S procedure.
Develop a habit of practicing the first four Ss
Make 5S a way of life.

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Definitions
Sort - Clearly distinguishing between whats necessary and whats
unnecessary, while disposing of the latter.
Set In Order - Organize the necessary items so that they can be used
and returned easily.
Shine - Clean floors, equipment, and furniture in all areas of the
workplace
Standardize - Maintaining and improving the standards of the first
three Ss
Sustain - Achieving the discipline or habit for properly
maintaining the correct 5S procedure.

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Benefits of 5Ss
How will we, as a group, benefit from 5S?
Reduced Waste
Improved Safety
Easier Maintenance
Higher Quality
Improved Profitability

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Benefits of 5Ss Cont
How will you, as an individual, benefit?
You can take pride in a 5S workplace
Your co-workers will respect you and your work space.
You can also keep a positive mental attitude

5S CREATES A BETTER PLACE TO WORK

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RED TAG STRATEGY
Initiate first round of Red Tagging
Select members from various areas
Select a manager to lead the team
First session should be plant wide

Identify Red Tag Targets


Inventory, equipment, supplies, tooling
Office areas are not exempt from red tagging

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RED TAG STRATEGY
Hillman

B.S.A.

ARMSTRONG

Sopwith Ltd..
RED TAG STRATEGY
Define Red Tag criteria
Determine what criteria will be used to distinguish a needed item
from an unneeded item
Example: Save only the items needed to make the next day, next
weeks or next months production schedule.

Make Red Tags


Determine information to be recorded on tags
Determine material to be used for red tags

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RED TAG STRATEGY
Conduct Red Tag Session
Explain the red tag criteria to all teams
Make sure you have a good cross-section of people tagging items in order to
prevent the I MIGHT NEED THAT Syndrome
Red tag the entire plant as rapidly as possible
Evaluate the red tag items
Review the material that has been tagged
Dispose of the truly unnecessary inventory, equipment and other items
Discard any material which is still tagged after a predetermined amount of time
All tags must be completed and returned

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RED TAGGING HINTS
Record information about all tags used on a Red Tag Log where you can
track disposition easily
Make sure everyone understands what is to be tagged and why
Discourage people from being defensive
Be fair all areas get tagged
Dont compromise; IF IN DOUBT, THROW IT OUT!
Necessary items can be tagged if improvements are known or suggested
Do not put multiple tags on any one object
Make reasonable allowances for decorative items such as plants or family
photos

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Forms

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CELL/AREA TAG NUMBER
RED TAG
CATEGORY
1. RAW MATERIAL 5. SUPPLIES 9. BOOKS/MAGAZINES
2. WIP 6. EQUIPMENT 10. OTHER
3. FINISHED MAT'L 7. FURNITURE
4. TOOLS 8. OFFICE MAT'L
TAG DATE:
ITEM NAME:
QUANTITY:
REASON TAGGED:

DISPOSITION REQUIRED
1. DISCARD 4. REDUCE INVENTORY
2. IN CELL STORAGE 5. SELL/TRANSFER
3. LONG TERM STORAGE 6. OTHER__________________

ACTION TAKEN DATE

---------------------------------------------------------------------------------------------------------------

CELL/AREA TAG NUMBER


RED TAG LOCATOR
LOCATION
DESCRIPTION
Item Disposition Guidance
Determine the category each tagged item belongs
Directions Determine required action, record on tag and Unneeded Items Log
Take action
Category Action
Obsolete Sell
Hold for depreciation
Give away
Throw away

Return to supplier
Defective
Throw away
Repair

Scrap Remove to proper location

Throw away
Trash / garbage
Recycle

Unneeded in this area Remove to proper location

Used at least once per day Carry with you


Keep at place of use
Store in area
Used about once per week
Store where accessible in plant
Used less than once per month
Store in distance place
Seldom used
Sell
Give away
Throw away

Use unknown Find out use


Remove to proper location
Red Tag Checklist
Examine all items in each category
Directions Red tag every item that may not be needed
Enter a when a category is inspected
Search these spaces Search these storage places
Floors Shelves
Aisles Racks
Operation areas
Closets
Work Stations
Sheds
Corners, behind/under equipment
Other storage areas
Stairs
Small rooms
Offices Search the walls, boards, etc.
Loading docks Items hung on walls
Inside cabinets and drawers Bulletin boards
Signboards
Other
Look for unneeded equipment
Machines
Small tools
Dies Look for unneeded material / supplies
Jigs Raw materials
Bits Supplies
Conveyance equipment Parts
Work in process
Plumbing, pipes, etc.
Finished products
Electrical equipment
Shipping materials
Wire, fixtures, junction boxes

Look for unneeded furniture Look for other unneeded items


Cabinets Work clothes
Benches and tables Helmets
Chairs Work shoes
Carts Trash cans
Other Other
Unneeded Items Log
Unneeded Item # Date Reason for Tagging Notes / Disposition
Workplace Scan

To identify workers, processes, and functions of the area. To plan the Workplace Scan.

Target Area Name:


Directions:
Define the boundaries of the target area and tape it off.

State the primary purpose of the target area.

Record the functions of the target area.

Plan the Workplace Scan by identifying who is responsible for each step and when completion is expected

Scan Step Who When


Draw an area layout
Draw a material spaghetti chart
Complete 5-S & Safety audits
Take photos
Create a workplace scan display
Workplace Audit Checklist

BEFORE AFTER
Distinguish between what is needed and not needed
Unneeded equipment, tools, furniture, etc. are present
Unneeded items are on walls, bulletin boards, etc.
Sort Items are in aisles, stairways, corners, etc.
Unneeded inventory, supplies, parts, or materials are present
Safety hazards (water, oil, chemical, machines) exist

A place for everything and everything in its place


Correct places for items are not obvious
Items are not in their correct places
Set in Order Aisles, workstations, equipment locations are not identified
Items are not put away immediately after use
Height and quantity limits are not obvious

Cleaning, and looking for ways to keep it clean and organized


Floors, walls, stairs, and surfaces are not free of dirt, oil, and grease
Equipment is not kept clean and free of dirt, oil, and grease
Cleaning materials are not easily accessible
Shine Lines, labels, signs, etc. are not clean and unbroken
Other cleaning problems of any kind exist

Maintain and monitor the first three Ss


Necessary information is not visible
All standards are not known and visible
Standard Work doesnt exists for all cleaning and maintenance jobs
Standardize All quantities and limits are not easily recognizable
Items cannot be located in 5 seconds

Stick to the rules


Area workers have not had 5-S training
5-S is not performed routinely
Sustain Personal belongings are not stored neatly
Standard Work is not available or up to date
Daily 5-S audits are not performed

Note: Check all that apply, plan countermeasures.


Set in Order Inspection Sheet

Inspect all items in entire area


Directions Move items to proper place
Enter a when a category is inspected

Equipment Materials / supplies / inventory


Machines Raw material
Small tools Supplies
Dies Parts
Jigs Work in process
Bits Finished product
Conveyance equipment Shipping materials
Cleaning equipment Cleaning supplies
Electrical equipment
Fixtures, junction boxes, etc.
Computer equipment
Other items
Charts, graphs, etc.
Books, checklists, etc.
Furniture Bulletin boards
Signboards
Cabinets Pens, pencils, rulers, etc.
Benches and tables Work clothes
Chairs
Helmets
Carts
Work shoes
Shelves
Trash cans
Racks
Personal items
Shine Inspection Sheet

Search all items in the area for cleaning needs


Directions Use this with the Initial Cleaning Plan
Enter a when a category is completed
Large Surfaces Carts

Ceilings Shelves
Aisles Racks
Work Stations
Corners, behind/under equipment Inside equipment / furniture
Stairs
Loading docks Machines
Walls Conveyance equipment
Doors Closets
Pillars and posts Drawers
Floors Cabinets
Other Sheds
Tool boxes
Storage bins

Surfaces of equipment and furniture Other items


Machines Materials and supplies
Conveyance equipment Trash cans
Plumbing, pipes, sinks Bulletin boards
Electrical equipment Labels and signs
Fixtures, junction boxes Small tools
Chairs Hoses, cords, tubing, etc.
Other
Initial Cleaning Plan

Directions List tasks and complete the columns below

Target Area
Task Location Who When Materials and Tools Needed
Current Score: Scored By:
Area Name:
Previous Score: Date:
Score
5S # Check Item Description
1 2 3 4
Does the inventory or in-process inventory
1 Unneded materials or parts.
include any unneeded materials or parts?
S Unneded machines or other Are there any unused machines or other
2 equipment. equipment around?
o Are there any unused jigs, tools, dies or
r 3 Unneeded jigs, tools or dies?
similar items around?
t Have unneeded items been Is it obvious which items have been marked
4 marked? as unnecessary?
Are display boards well
5 organized?
Are notices kept clean and orderly?
S Are shelves and other storage area marked
6 Are there location indicators?
with indicators and addresses?
e
t Do the shelves have labels showing which
7 Are there item indicators?
items go where?
I Are the minimum and maximum allowable
8 Are there quantity indicators?
quantities indicated?
n
Are white/yellow lines or other markers used
Are walkways and in-process
O 9 inventory identified?
to clearly indicate walkways and storage
r area?
d Are jigs and tools arranged more rationally to
Have improvements been made
e 10 to facilitate jig and tool handling?
facilitate picking them up and returning
r them?
Are the floors ket shiny, clean and free of
11 Trash, water or oil on floors?
debris?
Are machines covered with
S 12 shaving and oil?
Are the machines wiped clean?
h Is equipment inspection
Do operators clean their machines while
i 13 combined with equipment
checking them?
n maintenance?
Have specific cleaning task been Is there a person responsible for overseeing
e 14 assigned? cleaning operations?
Do operators routinely sweep floors and wipe
15 Has clealiness become a habit?
equipment without being told?
S Is the room/are ventilated well enough to be
16 Is there proper ventilation?
clear of heavy dust?
t
Is the angle and intensity of lighting adequate
a 17 Is there proper lighting?
for the work being performed?
b
Are workers wearing dirty or oil stained work
i 18 Are work clothes clean?
clothes?
l
Have improvements been made Instead of cleaning up the messes, have
i 19 to prevent things from getting people found ways toavoid making messes?
z Have rules been established for
e
20 maintaining the first three of Are the first three of 5S's being maintained?
d 5S's?
S 21 Are safety signs posted? Are all safety signs easily readable?
u
22 Are safety guards in place? Are safety guards being used properly?
s
t 23 Time and Structure Has time been set aside for sustaining?
Has management and maintenance provided
a 24 Is there an support?
all of the needed support to sustain?
i Have the workers developed the diciplines
n 25 Has 5S become a way of life?
required for maintaing the first four of 5S's?
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