BIQS Presentation Aug 2017
BIQS Presentation Aug 2017
BIQS Presentation Aug 2017
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What is BIQS ?
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BIQS Operating Guideline
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The BIQS has
30 elements in
the audit
Comprehensive
measurement
of the of your BIQS
quality system 30 Elements
and your ability
to mange the
manufacturing
and delivery of
product to the
Automotive
OEMs
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**Three Key GM BIQS Controls Every Organization Should Implement
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BIQS Operating Guideline
BIQS - 30 (Safety)
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Safety
**Select all safety concerns (below) that are observed during HAVS Response
The Organization is focused on safety. Work place audit. These concerns can be selected (all that apply) when 1. SPL 071 - Health & Safety Program
is safe. Safety rules are addressed in work uploading the audit into SCMS. 2. Safety Alert System, iQRQC
instructions, including PPE. Systems are in place to 3. iQRQC details safety actions and resolutions
reduce safety risks and communicate/address No Safety Process In Place? 4. SPL 071 - Health & Safety Program. Safety Alerts
safety concerns. Safety issues/concerns are Safety issues/concerns are not communicated? cascaded worldwide throughout Hutchinson, and are
tracked, reviewed, and addressed. Corrective actions are not taken to address safety concerns? assessed for applicability and pertinence at each site.
Safety knowledge and actions are not read across within site 5. GWI 0918 - Hazardous Energy Lock Out
*BIQS 30 is not used to calculate BIQS level and corporation? 6. As evidenced by observation of safety equipment
scoring. Lock out/ Tag out is not followed? an operations at the cell.
Machinery Safety guards are off and machine is running? 7. GEWI 403 - Spill Kit Usage & Maintenance, spill
Slip/Trip hazards (Oil/coolant in the floor)? drills
Air quality is poor (Mist/fog/odor)? 8. RTO and regular filter changes, monitoring and
BIQS-30
Vehicle traffic concerns? reduction of VOC's
Parking lot safety concerns (ice, trip hazards)? 9. PL 080 - Safe Driving
Personal protective equipment (PPE) is not available or not 10. As per observation during walkthrough
used? 11. Vests, steel-toe shoes, permanent side shielded
Fire hazards (weld flash/spark/molten metal)? eye protection, ear protection, bump caps, helmets,
Overhead hazard concerns? etc.
Crush hazard concerns? 12. Non-sparking tool requirement in cementing, fire
Pinch point hazards concerns? safety drills
No issues found? 13. Bump caps / helmets mandatory at Mixer
14. Like curtains and keys for entry into robotic cells
15. To be observed during work cell operations
review
16. To be observed during walk-through
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BIQS Operating Guideline
BIQS - 1 (Nonconforming Material/Material Identification)
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BIQS – 1
Nonconforming Material /Material Identification
Definition:
Nonconforming Material / Material Identification
• Standardized process of identification of all material Nonconforming Material / Material Identification Sample audit to verify that team members understand what to do
in the plant including traceability rule and Segregate with nonconforming / suspect material.
Team members have standardized work and
Nonconforming material from good material . understand what to do with non conforming / suspect Confirm that conforming material is handled, stored and identified
material. appropriately.
Conforming material is handled, stored and identified Confirm that nonconforming / suspect material is clearly identified
appropriately. and/or segregated. Red, Yellow, Green stoplight approach is
adhered to for foot printing, containerization, table marking and
Scope: Non conforming / suspect material is clearly identified tagging.
BIQS -1 and/or segregated for review/disposition (i.e.
• All Material inside the facility . appropriate color coding for foot printing – red, Audit that all parts removed from the process are identified,
Y
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BIQS – 1
Nonconforming Material /Material Identification
Standardized Work
A)Identification B)Segregation C)Traceability
• Identify Good and • Containment process • Follow Traceability
NC Material in all & Worksheet rules
steps • Segregation of NC
• WI for Identification material
process • Record NC
A) Identification
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BIQS – 1
Nonconforming Material /Material Identification
A) Identification
Good Material identified by green tag NC material identified and segregated
1st Hour 2nd Hour 3rd Hour 4th Hour 5th Hour 6th Hour 7th Hour 8th Hour
# Defects VS Alarm 6:00-7:00 Trigger
7:00-8:00 8:00-9:00
an Alarm! 9:00-10:00 10:00-11:00 12:00-1:00 1:00-2:00 2:00-3:00 Total
Trigger # 4:00-5:00 5:00-6:00 6:00-7:00 7:00-8:00 8:00-9:00 11:00-12:00 12:00-1:00 1:00-2:00
1 Scratches 6 ll l ll 5
2 Bolt Reject 1 l l 2nd Alarm is Escalated! 2
3 Lash Reject 4 ll l 3
4 Crank Torque 5 ll lll l 6
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BIQS – 1
Nonconforming Material/Material Identification
B) Containment
COMPLETE
841222(
10/12/1 O O O O O O
6)
Internal
Issue
O O O O O NA
(Jan5th -
16)
843867
Aud
( Oct 20, O O O O
2016)
Containment work sheet done at least for fast response issues - Break point is
identified .
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BIQS – 1
Nonconforming Material /Material Identification
300,000
244,892
250,000
count of vehicles
200,000 potentially affected
vehicle count using
150,000
available trace
100,000 vehicles with actual bad
36,754 parts (better trace)
50,000
2,000
0
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BIQS Operating Guideline
BIQS Element 8 – Fast Response Problem Solving
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BIQS - 8
Fast Response Problem Solving Process
Definition:
• Systematic approach to act fast for quality issues using
standardized exit criteria .
Scope:
• All customer issues ( Formal /informal ) and key internal
issues .
Purpose:
• Ensures that quality issues are immediately addressed and closed using standardized approach and
avoid reoccurrence .
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QUALITY ISSUE #
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DEPT CONTAINMENT
Input
WORKSHEET USED
internal issues .
external and key
CORRECTIVE ACTION
EFFECTIVENESS MONITORED
ERROR PROOFED
Process
*
ERROR PROOFING
VERIFICATION COMPLETE
criteria
FMEA UPDATED
BIQS –8
STANDARDIZED WORK
UPDATED
* Identify issue owner
Identify meeting time
TRAINING COMPLETED
Fast Response Process
PTR CONDUCTED
CHANCES OF
* All issues closed
internal issues are
RECURRENCE
against standardized
* All customer and key
ISSUE DESCRIPTION
BIQS - 8
Fast Response Problem Solving Process
• Confirm the Plant Management ensures the applicability and the timely completion of the items
being tracked.
• Confirm the plant staff level personnel actively participate in daily meeting and confirm that
natural owner is assigned for FR issues.
• Verify the required documents are reviewed and updated (e.g. Fast Response tracking sheet,
problem solving document, PFMEA, process control plan, standardized work, layered audits,
lessons learned, etc.)
• Confirm there is read across of corrective actions to like operations.
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BIQS - 8
Fast Response Problem Solving Process
Fast Response Daily Meetings:
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BIQS - 8
Fast Response Problem Solving Process
Minimum Criteria for Initiating Fast Response is Being Met:
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BIQS - 8
Fast Response Problem Solving Process
Plant manager ensures the applicability and the timely completion of the items being tracked:
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BIQS - 8
Fast Response Problem Solving Process
Fast Response Board Example:
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Containment -
Breakpoint -
24 H
Quality Alert
Root Cause
7D
Identified
Corrective Action
Implemented
Error
14 D
Proof/Detection
Layered Process
Audits
Corrective Action
BIQS - 8
34 D
Validated
PFMEA / CP
Updated
Exit Criteria with Appropriate Timing are Defined for Closing Issues.
35 D
Standard Work
Target Timing, Status, & Date Green
Operator Instructions
Lessons Learned
40 D
(Institutionalized)
Fast Response Problem Solving Process
BIQS - 8
Fast Response Problem Solving Process
DRILL WIDE MATRIX (Ref. GM 1927-69 Drill Wide Matrix)
SYMBOL & STATUS KEY:
SUPPLIER: O Original location
Name: X Location with similar process
Location: N/A Not Applicable
Duns: Completed & 3rd Party/GM verified
There is read Contact Name: Completed & Supplier verified only
Contact Phone: Not Completed
across of E-mail: P Pass Through
Classification
Product /
Process
Press 1
Press 2
Press 3
Line 1
Line 2
Line 3
Cell 1
Cell 2
Cell 3
Tier 2
Tier 3
Tier 4
Part Name & EFFECT OF FAILURE N/C or CS DDW Completion
GM Plant FAILURE MODE PRR Number / Issue
Number MODE CPV Status & Verification 1 Champion Symbols
Containment
Corrective Action
Cause of Failure Mode Corrective Action
Prevent Corrective Action
Protect Corrective Action
Predict Corrective Action
Key Findings Corrective Action
Documentation Updated
A Process Failure Alert must be used to “read across” to other facilities and
engineering for preventive measures when a product quality issue (mfg. controllable):
is missed by first line of error detection, a Preventive Action Letter (PAL) letter is
issued, a Process Control Plan not followed has escaped the control of the plant or a
significant process failure occurs(e.g. safety, regulatory, statutory, etc.). A PFA may
also be used to communicate a significant process improvement. The receiving
plant(s) must implement
| preventive measures communicated through the PFA.
BIQS - 8
Fast Response Problem Solving Process
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QUALITY ISSUE #
17)
834719
17-026(
Feb-10-
( Aug,26)
O
O
FAST RESPONSE PROCESS USED
DEPT CONTAINMENT
O
to add
WORKSHEET USED
in other
location
Storage
O (need
O
O
QUALITY ALERT POSTED
O
ADDED TO CARE / GP12
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PROBLEM SOLVING FORM
X
O
COMPLETE
X
X
ADDED TO LAYERED AUDIT
CORRECTIVE ACTION
X
X
EFFECTIVENESS MONITORED
X
ERROR PROOFED
NA
ERROR PROOFING
X
NA
VERIFICATION COMPLETE
FMEA UPDATED
X
O
X
O
TRAINING COMPLETED
MATL SEGREGATION
ENGINEERING CHANGE
X
REQUEST
X
PTR CONDUCTED
NA
/ PROCESSES
CHANCES OF
M
RECURRENCE
colling
shipped
Number
process
ISSUE DESCRIPTION
Deep line
during cold
around coil
Wrong Part
6)
QUALITY ISSUE #
16)
Issue
Internal
841222(
10/12/1
(Jan5th -
O
O
DEPT CONTAINMENT
O
O
WORKSHEET USED
O
O
COMPLETE
O
CORRECTIVE ACTION
O
O
EFFECTIVENESS MONITORED
ERROR PROOFED
NA
NA
ERROR PROOFING
NA
NA
VERIFICATION COMPLETE
FMEA UPDATED
O
O
O
O
STANDARDIZED WORK
O
O
UPDATED
TRAINING COMPLETED
Check
Check
MATL SEGREGATION
ENGINEERING CHANGE
O
O
PTR CONDUCTED
/ PROCESSES
CHANCES OF
L
L
RECURRENCE
Wrong
ISSUE DESCRIPTION
Oreientation
Missing Bracket
BIQS Operating Guideline
BIQS Element 9 – Team Problem Solving
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BIQS - 9
Team Problem Solving
Definition:
• Standardized problem solving method for problem
solving using cross function team include team
members in shop floor .
Scope:
• Used for quality spills and all fast response issues .
Purpose:
• To identify the root cause and implement countermeasure(s) that prevent recurrence and contributes to
continuous improvement.
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BIQS – 9
Team Problem Solving
Problem Solving Team Standardized process
• Team member and shop floor • Standard method and forms for
levels are involved in problem problem solving such as 6 steps
solving activities of problem solving
• Criteria to initiate a problem
solving
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BIQS - 9
Team Problem Solving
• A standardized problem solving process exists. A range of problem solving activities are conducted for
different problem types and complexities, including single (special) cause, common (repetitive) cause,
as well as more complex multiple-cause problems.
• Ask to talk through some problems with Team Leaders and Supervisors.
• Ask how many formal problem solving activities the team has worked on in recent months?
• Look for all teams that should be involved in problem solving activities.
• Look for a standardized processes that include: issue description and definition; containment, probable
cause analysis, root cause analysis (5 Whys), countermeasures, implementation plan, verification,
approval to close, and escalation or read across if needed.
• Look for Leadership involvement (reviews, coaching, escalation, support, read across, etc.)
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BIQS - 9
Team Problem Solving
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BIQS - 9
Team Problem Solving
Documentation Is A…:
Communication Tool:
Each Team Member involved in the process has the necessary information,
responses are ensured, and countermeasures are documented.
Control Check: on activities and responsibilities in the Problem Solving
Process. It states what must be done, by whom and when, and with what
expected results.
Documented Analysis: Leading to the problem solution and are generated
by following the logical steps of the Problem Solving Process.
Standard Report: For the entire organization that follows the Problem
Solving methodology.
Documentation: can be filed by a simple tracking number. This allows for
easy retrieval throughout the year in case the problem reoccurs, or a similar
situation arises.
Opportunity: Provides an opportunity to share ideas or lessons learned.
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BIQS - 9
Team Problem Solving
By including these simple, standard elements in the Problem Solving
process, we will be able to successfully determine the root cause of
any problem and prevent it from happening in the future.
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BIQS Operating Guideline
BIQS Element 10 – Quality Focused Checks
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BIQS - 10
Quality Focused Checks
Definition:
• Critical operation identified by customer ,
suppliers and past customer issues are in focus
to be reviewed each shift .
Scope:
• KPCs , PQCs ,( Sev 9,10 ) , supplier identified as
critical and past customer issues .
Purpose:
• Reduce risk of field actions and major disruption through keep focusing on critical operations each shift .
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BIQS – 10
Quality Focus Checks
QUALITY ISSUE #
or key internal issues
COMPLETE
• Done each shift
Critical Operations
• KPC or critical operations
• Done each shift
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BIQS - 10
Quality Focused Checks
What is required:
• High risk items from Critical (Delta) operations have a Quality Focused check performed
each shift.
• High risk quality focused items from customer feedback and problem solving are included in
the Quality Focused audit, or other suitable checklist, and checked each shift.
• Look for high risk quality focused items from Delta C operations to be included in a Quality
Focused audit OR the quality focused section of the layered audit and checked each shift.
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BIQS - 10
Quality Focused Checks
QUALITY FOCUSED - GROUP LEADER QPV SHEET 1C74 27-May-16
Complete all shift checks using O/X: O - no deviation found X - deviation found
R easo n U LO C D a t e I s s ue d Quality Check Description Mon Tue Wed Thu Fri Sat
O
GEN
GEN
N/A
N/A
18-Aug-06
18-Nov-06
Team leader checks compliant and completed for the 1st hour.
S
H
GEN
GEN
N/A
N/A
18-Aug-06
18-Aug-06
Ensure all Ergonomic assists are being used properly according to JES.
GEN
N/A
A22L
25-Oct-10
4-Apr-11
Validate that housekeeping is acceptable and no stock on floor
Ensure you are using a new blue seal protector (Validate the correct
area/group for each shift
date/shift is on the blue tool)
Complete all Quality Checks by recording PVIs or CSNs (If * next to reason = Part of Team Leader verifications)
Ensure the operator is using the blue seal protector tool correctly
See next 2 pages for
TL
#1 GEN A21L 4-Apr-11
Ensure Operator is performing 'TUG CHECK' on propshaft to verify it is
fully seated close-up of details
GEN A28R 15-Jul-15 Verify no damage to AWD clamp
GEN A30L/R 17-Mar-09 Verify team member clamps rad hose in correct location
GEN A65 7-Mar-16 Verify all 3 Turbo snorkel connections are fully seated on LTG
TL
#2 GEN A66 7-Mar-16 Verify all 7 CAM connections are fully seated and locked on LFX
Complete all GMS checks using O/X: O - no deviation found X - deviation found
LA All 11-Dec-07 Ensure PMP's at each station are complete and up-to-date
LA All 11-Dec-07 Ensure rotation logs are being signed and Flex Charts are accurate
Sign-off the Team Leader QPV's are completed daily, (including the LA
LA n/a 11-Dec-07
questions) with appropriate corrective actions - when required.
G
M GEN N/A 18-Aug-06 Review, initial, and file Team Leader QPV and Yellow cards.
S
Ensure all alarms have been reviewed with containment strategy and
GEN N/A 18-Aug-06
signed-off.
Reason Legend: W :W arranty; JDP : JD P ower; QCL: Quality Check List; M S : M andatory S equence; P CC: P rocess Control Check; P AD: P roduction Assembly Document; eBOP : Bill of
P rocess, AUD: Audit Call; OS O: T eam M ember S ensitive Operation; KP C: Key P roduct Character,GE N= General, M UT = M utilation LA: Layered Audit requirement
Complete all shift checks using O/X: O - no deviation found X - deviation found
Reason ULOC Date Issued Quality Check Description Mon Tue Wed Thu Fri Sat
Quality Checks are to be performed during the 1st 4.0 hours of shift and the last 4.0 hours of shift
Ensure the operator is using the blue seal protector tool
GEN A21L 4-Apr-11
TL correctly
#1 Ensure Operator is performing 'TUG CHECK' on propshaft to
GEN A21L 4-Apr-11
verify it is fully seated
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BIQS - 10
Quality Focused Checks
Complete all GMS checks using O/X: O - no deviation found X - deviation found
LA All 11-Dec-07 Ensure PMP's at each station are complete and up-to-date
LA All 11-Dec-07 Ensure rotation logs are being signed and Flex Charts are accurate
Sign-off the Team Leader QPV's are completed daily, (including the LA
LA n/a 11-Dec-07
questions) with appropriate corrective actions - when required.
G
M
Suggested Practice
GEN N/A 18-Aug-06 Review, initial, and file Team Leader QPV and Yellow cards.
S Daily: BIQ discipline
GEN N/A 18-Aug-06
Ensure all alarms have been reviewed with containment strategy and
signed-off.
review
Ensure that scrap is reviewed and written up on salvage table by end of
GEN N/A 18-Aug-06
shift.
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Detailed Process Description Nr.: F-CXXXFO-PABWELD
Initial Process Description Nr./Revision: Issued by: Review Nr.:1
CXXX Instrument Panel PAB Chute Weld First Off Inspection John Doe 10/10/2016
Product Name: Product Number: Eng. Level / Date: Process:
CXXX Instrument Panel PAB Chute Weld First Off
123456B, 123457B, 123458B, 123459B NA Verification of PAB Chute weld install
Inspection
Nr. Detailed Operation Description Time Main Stage Key Point Reason of the Key Point. Explanatory Sketch. Operating Rules and other.
Defined Reaction NOTE: NOTIFY PROCESS TECHNICIAN TO ADJUST IF ANY FAIL ITEMS ARE DISCOVERED. Contact quality manager, quality engineer, manufacturing engineer, engineer manager, and plant manager.
Plan Production will set aside a first off part First off shall be 4
1 with tag identification for testing to be completed within 2 hours
complete. of production run.
Verify PAB Chute position. PAB Chute Scribe line must be visible all four
5
should be centered within scribe lines sides.
Reference PFMEA/CP 6
Check back side laser score position in
relation to PAB Chute
! anywhere except hinge. Hinge is
located in area circled in green
Photo 6.
Record dimesnion.
Measure distance of the PAB Wall to the !
10 PAB wall visible around perimeter. Dimension must be
laser score scribe line.
between 0.5 - 5.5 mm.
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BIQS - 11
Standardized Work
Definition:
• Standardized work is documented for all operations .
Work is performed as standardized work . Work place
organization is followed .
Scope:
• All operations such as manufacturing , handling ,
shipping ,….etc .
Purpose:
• To establish a repeatable, predictable baseline for continuous improvement and to involve the Team Member
in both the initial and ongoing improvements to achieve the highest levels of safety, quality, and productivity.
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BIQS – 11
Standardized work
Work Place
Organization (5S)
Work Instructions
• 5S principles are applied
• Support delivering NC
• Include what & How to do parts , incomplete parts to
• Used to perform work customer .
• Used for training • Support in following WI
• Avoid waste time
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BIQS - 11
Standardized Work
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BIQS - 11
Standardized Work
STANDARDIZED WORK BENEFITS
To the Team Member:
:
•Identifies the safest, highest quality, most efficient & most ergonomically friendly approach to completing the task.
•Provides a method for the Team Member to have input into the improvement of their jobs.
•Provides the tool for proper training & problem solving.
To External Customers (People buying our vehicles):
•Provides great quality and lowest possible cost through the continued execution of the best known method of production.
To Internal Customers (Downstream Operation):
•Provides an error-free component to the customer down the line.
•Provides a baseline for problem identification and resolution.
Internal Suppliers (Upstream Operations):
•Allows for level schedules to Internal Suppliers.
•Allows for quick identification & feedback of problems to Internal Suppliers.
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BIQS - 11
Standardized Work
What?
•Standardized Work (SW) is the documented and current best method to safely and efficiently organize
work that can meet required quality standards.
•SW at a minimum answers: What to do on a job or task (major step), How to do it (key point), and Why
it needs to be done (reason).
Why?
•SW, like all standardization, is done to help Identify and Eliminate Waste and to improve business results
as measured by the organizational goals.
•SW acts as a controlled continuous improvement process (CIP). Following SW will demonstrate if actual
results match expected results. If not, the process can be improved by changing controlled inputs. SW is
therefore your basis for continuous improvement (CIP).
When and Where?
•When errors (waste of correction) occur, it is either a problem with the way the SW is designed, inputs to
the work, or SW was not followed.
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BIQS Operating Guideline
BIQS Element 2 – Layered Audit
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BIQS – 2 Layered Audit
Definition:
• Standardized layered audit to check
compliance to processes
Scope:
• All Processes , Multiple layers
Purpose:
• Ensure Compliance to processes , Identify areas for
improvement , and used by leadership in teaching and
coaching .
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BIQS – 2
Layered Process Audit
Develop Execute Audit Continuous
Process Improvement
|
BIQS – 2 Layered
Process Audit
Key Point:
• LPA process is owned by management who assure effective
implementation of LPA on all levels and use the LPA process for
Continuous Improvement
• LPA should include daily activity by team members/leaders
• Management should participate with audit activity and visit the shop
floor, frequently (i.e: monthly basis)
• Customer specific and quality focus checks from FR issues should be
reviewed by all layers including management
• Top Management should ensure effective corrective actions and counter
measures
|
BIQS – 2 Layered Audit
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BIQS – 2 Layered Audit
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BIQS – 2 LAYERED AUDIT
DEPT._________________ LAYERED PROCESS AUDIT RESULTS
100% 47 50
90% 43 43 45
80% 40
70% 35
60% 27 30
24
50% 23 22 25
20 19
40% 20
16 16
14
30% 15
20% 10
10% 5
0% 0
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
% IN COMPLIANCE: 88% 68% 95% 96% 97% 84% 95% 95% 94% 95% 95% 89%
# OF ITEMS ON ASSESSMENT: 20 15 20 30 20 10 20 25 20 20 20 20
# OF ASSESSMENTS 20 9 28 15 20 10 20 20 20 20 20 20
TOTAL # OF ITEMS ASSESSED: 400 135 560 450 400 100 400 500 400 400 400 400
# OF ITEMS IN COMPLIANCE: 353 92 533 434 386 84 380 477 376 381 378 357
NON CONFORMANCES 47 43 27 16 14 16 20 23 24 19 22 43
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BIQS Operating Guideline
BIQS - 3 (PFMEAs)
|
BIQS–3
PFMEAs
Definition:
• Based on product requirements, risk for each
operation should be studied , preventive & Detection
controls should be taken based on Sev of risk and
occ of each cause .
Scope:
• All part numbers and operations including non-
manufacturing (such as labeling, handling, and
transportation)
Purpose:
• Build standardized process of developing PFMEAs using cross functional teams to address each potential failure effect
and set appropriate controls for each failure mode causes using standardized guidelines such as AIAG
|
BIQS – 3
PFMEAs
PFMEA Development Process
PFD Product Requirements Preventive Controls
Input
Process
Output
DFMEA Failure Modes Detection Controls
Drawing & Customer Highest Effect of (Det)
requirements Failure modes (Sev) RPN for each cause
PFMEA Ranking Potential Causes of Ready to link with PCP
Guide Lines Failure mode
FTQ, PPM,… Occurrence Rate for
(Historical Records) Each Cause
|
BIQS – 3
PFMEAs
AIAG Severity Occurrence Detection (S.O.D) Guideline Tables:
|
BIQS – 3
PFMEAs
Examples 1 : Suspected parts potential
Handling Risks: (Mirror Noise) to fill into Ok box
• Bad Part shipped to customer .
• Root cause identified that short length part is shipped to customer .
• Part supposed to be 100% inspected with green mark Detection .
• System root cause reported : Uninspected defected part fall into
OK box ( handling risks are not analyzed in PFMEA) The Ok
Box
Occurrence
Current Current
Detection
Potential s Potential
Process Requirem Potential Process Process
RPN
Effect(s) e Cause(s) of Recommened action
Step ents failure mode
of v Failure
Controls
prevention
Controls
detection
Handling Risks are not studied
Failure
* MP:
Rework Suspected Parts
off line
* Standardize
P04 Suspected Mixed Customer Green Box location of
Visual Standardize areas in WI for
Flange parts not suspected : close to suspected
6 5 Inspection 7 210 suspected material and ok bin
Machinin mixed with parts into Ok Rework suspected material
during LPA away from each other
g good parts parts off line material away from
* End Ok bins
User:
Noise
Ok bin without
• Lack of studying handling risks might cause quality issues . potential for mix
Handling Risks considered
|
BIQS – 3
PFMEAs
Examples 2: • Failure Modes Captured after studying
Requirements : (Part Subassembly) Requirements for each step:
• Failure Modes Captured without Process Step Requirements Potential failure mode
studying requirements:
Wrong Screw Used
• Lack of studying product requirement will lead to miss many failure modes that might cause quality issues
|
BIQS – 3
PFMEAs
Examples 2 : • Effect is studied based on manufacturing
Effect Study: (Glass Scratch) process, customer and end user.
• Effect Study is based on End
User point of view. Potential s
Potential failure
Effect(s) of e
mode
Failure v
Potential s
Potential failure
Effect(s) of e
mode
Failure v * MP : Might
Scrap based
on size (7)
Scratch in * Customer :
7
Windshield Rework off
Scratch in Apperance
4 line (6)
Windshield defect
End User :
Apperance
defect (4)
• Study Effect from one point of view might lead to wrong or unestimated severity ranking.
• If Sev. is underestimated, real risk will be hidden and proper controls might not be taken.
• Risk reduction priorities will not be accurate.
|
BIQS –4
PFMEA Risk Reduction & Annual Review
|
BIQS –4
PFMEA Risk Reduction & Annual Review
PFMEAs - Risk Reduction & Annual Review Look for evidence of monthly cross functional risk reduction reviews focused
Definition: on preventing defects from leaving the work station.
• Cross Function teams work in a systematic Monthly RPN risk reduction reviews by product focused on Confirm action plans for top issues include: 1) Recommended actions, 2)
approach to reduce risk proactively . preventing defects from leaving the work station are held to drive Responsibility, 3) Timing.
continuous improvement. Action plans for top issues must Check if there is a process of prioritizing high risk items such as Risk limiting
include: 1. Recommended actions, 2. Responsibility, 3. Timing. method or equivalent.
BIQS -4 Plant Management shall be included in top risk reporting and approval of
Scope: Reverse PFMEA process is in place to identify new potential countermeasures.
• All Operation , using PFMEA periodic risk failure mode in the shop floor Verify if Reverse PFMEA (On-station reviews) findings are driven back into the
reduction and reverse PFMEA activities . Process Flow, PFMEA, Control Plan, and Work Instructions as applicable.
Purpose:
• To reduce risk on proactive approach to reduce BIQS Red + Yellow Elements
highest risks first .
BIQS-4: PFMEAs - Risk Reduction & Annual Review 1088
BIQS-1: Nonconforming Material/Material Identification 886
BIQS-2: Layered Audit 858
BIQS-26: Maintenance 817
2016 BIQS audit analysis shows 77% of BIQS - 4 has not
BIQS-9: Team Problem Solving Process 743
achieved Green status.
BIQS-8: Fast Response Problem Solving Process 693
BIQS-23: Feedback/Feedforward 630
|
BIQS-3: PFMEAs 621
BIQS-11: Standardized Work 621
BIQS –4
Risk Reduction & Annual Review PFMEA Risk Reduction & Annual Review
PFMEA Team monthly Reverse PFMEA
Process
Output
Input FTQ , PPM
Meeting Agenda outcome ( New Failure
Modes, New Causes,
,…customer Shop floor reverse
PFMEA review. New Controls, Revised
records).
Occ., Det Numbers).
Annual Review Team deep dive to
reduce to risky items Top risky items new
Plan.
as per prioritizing preventive, detection
Criteria for criteria controls or both.
prioritizing risk
(EX : Risk limiting
method ).
|
BIQS –4
PFMEA Risk Reduction & Annual
A) Update PFMEA for
Review
customer & Internal Big B) Reverse PFMEA &
Issues Monthly RPN reduction
* Review PFMEA to add new
Failure Modes, causes, and
* It is required in Fast
Response Process
VS controls .
* Monthly Reduce top risky
potential risk
|
BIQS –4
PFMEA Risk Reduction & Annual Review
Priority Level
Risk Limiting Method: Based on Severity Zone (Severity vs. Occurrence) and Detection Level (Severity vs.
Detection)
10 3 1 1 1 1 1 1 1 1 1
Priority Level 1: Highest level of risk, should review for potential risk reduction
Occurrence
9 3 1 1 1 1 1 1 1 1 1
8 3 2 1 1 1 1 1 1 1 1 activity
7 3 2 2 2 1 1 1 1 1 1
6 3 2 2 2 1 1 1 1 1 1
Priority Level 2: Medium level of risk, next group to review for potential risk
5 3 3 2 2 2 2 1 1 1 1 reduction activity
4 3 3 3 3 2 2 1 1 1 1
Priority Level 3: Lowest level of risk, risk reduction activity not necessary.
3 3 3 3 3 3 3 2 2 1 1
2 3 3 3 3 3 3 3 3 2 2
1 3 3 3 3 3 3 3 3 3 3 Priority Level
1 2 3 4 5 6 7 8 9 10 Detection
Severity
• Severity Zone: comparing the severity and occurrence
(Sev over Det)
Detection Zone
3 2 2 3
Detection
10 3 2 1 1 1 1 1 1 1 1
2 1 2 3 numbers.
9 3 2 1 1 1 1 1 1 1 1
8 3 2 2 2 2 2 1 1 1 1 1 1 1 2 • Detection Zone: comparing the severity and detection
7 3 3 3 3 2 2 2 2 1 1 numbers.
6 3 3 3 3 3 3 2 2 1 1 1 2 3
5 3 3 3 3 3 3 3 3 2 2
Severity Zone
4 3 3 3 3 3 3 3 3 2 2
(Sev over Occ)
3 3 3 3 3 3 3 3 3 3 3
2 3 3 3 3 3 3 3 3 3 3
1 3 3 3 3 3 3 3 3 3 3
1 2 3 4 5 6 7 8 9 10
Severity |
BIQS –4
PFMEA Risk Reduction & Annual Review
Standardized Risk Prioritizing Methods
Ex:
|
BIQS –4
PFMEA Risk Reduction & Annual Review
Ex: Risk Reduction Risk
Criteria
Proactive Approach
Risk Reduced
|
BIQS –4
PFMEA Risk Reduction & Annual Review
Ex Reverse PFMEA
Reverse PFMEA Check List Outcome
Proactive Approach
|
BIQS Operating Guideline
BIQS Element 19 – Process Control
|
BIQS - 19
Process Controls
Definition:
• PFMEA is used to build PCP which is used to develop WI .
All of them are updated with each other using same logic
order .
• Critical operations are communicated in the PCP & WI
Scope:
• All Operations .
• PQC , KPC , supplier identified critical operations .
Purpose:
• WI for team member is taken from PFMEA & PCP .
• Critical Operation are communicated to team member in the WI
|
BIQS - 19
Process Controls
Review critical operations to ensure they are identified with a delta at the operation and in the
standardized work.
|
|
identified in WI
• KPC , PQC , Supplier critical are
Critical Operations Identified
BIQS – 19
of WI .
6)
QUALITY ISSUE #
841222(
10/12/1
O
DEPT CONTAINMENT
O
WORKSHEET USED
O
COMPLETE
Development of Process Control (PFMEA - PCP – WI)
CORRECTIVE ACTION
O
EFFECTIVENESS MONITORED
ERROR PROOFED
NA
ERROR PROOFING
NA
VERIFICATION COMPLETE
FMEA UPDATED
O
O
STANDARDIZED WORK
O
UPDATED
BIQS - 19
Process Controls
|
BIQS - 20
Process Control Plan Implemented
Definition:
• PCP should be followed . Sample size and time should
be respected .Reaction plan is standardized and
followed in case of poor results.
Scope:
• All operations .
Purpose:
• To ensure that approved control plan designed to reduce risk is followed and reaction plan is followed if needed .
|
BIQS - 20
Process Control Plan Implemented
Sample process control plans and ensure checks are performed at the correct frequency and
sample size.
• Confirm that checks are documented using the proper control method (i.e. control charts,
check sheets).
• Check that reaction plans from the process control plan are present, followed and effective.
• Check how sample size is determined and how it is linked with occurrence number.
• Check that sample size is reviewed on a regular basis.
• Check that testing sample size is according to customer requirement/testing standard as
minimum.
• Check that process specific requirements are met, audit records are kept, and action plans in
case of gaps are followed.
|
BIQS - 20
Process Control Plan Implemented
|
BIQS - 20
Process Control Plan Implemented
|
BIQS - 20
Process Control Plan Implemented
|
BIQS Operating Guideline
BIQS - 21 ( Process Capability review)
|
BIQS – 21
Process Capability Review
Definition: Process Capability Review Look for capability studies on KPC's and PQC's and confirm that action plans are
• Capability study should be done annually . documented to address characteristics with low capability.
Process stability is checked . Reaction plan Capability reviews of process equipment with high risk/impact
(e.g. minimum Key Characteristic Designation System) are held Annual capability studies are required on all critical equipment at a minimum,
should be followed incase of poor results . BIQS -21 to identify process capability and required corrective actions. A verify this is taking place
reaction plan for non-capable process is present. Corrective Check that capability study is done after process stability. Check that safety and
action is documented. Process stability is monitored and used for critical features are included in the capability study.
process capability reviews.
Scope:
• All KPCs , PQCs or any other critical features identified by supplier
Purpose:
• All special causes are eliminated.
• Process is capable to meet customer requirements and predictable.
|
BIQS – 21
Process Capability Reviews
KPC #1
|
BIQS – 21
Process Capability Review
A) B)
Measure VS Capability
100% only Study
|
BIQS – 21
Process Capability Review
* Study Process * All Process are stable
Output
Process
*Drawing
Input *PQC , KPC
stability ( action plan for special
Process Capability Reviews
|
BIQS Operating Guideline
BIQS Element 5 – Bypass Management
|
BIQS – 5 Bypass
Management
Definition:
• Current controls should be studied based on risk ,
alternative process should be standardized . Standardized
Communication method need to be done when bypass
occurred . Standardized audit need to be done .
Scope:
• At least study should be done for error proofing /detection
devices .
Purpose:
• Avoid stopping customer production for less risky controls but at the same time reduce risk of sending Nonconformities when
applied .
• Avoid bypass high risky controls .
|
BIQS – 5
Bypass /Deviation Management
Identification Prepare Communicate
|
BIQS – 5
Bypass Management
What to look for:
• Ask appropriate plant personnel to show you the plant list of manufacturing processes and/or error proofing devices
which can be bypassed. This is a master list indicating which stations can or can not be put in bypass. A Verification
Method is needed if a station is being placed in bypass.
• Ask to see evidence of how the Risk Priority Number (RPN) for all approved bypass processes is evaluated.
Note: Check if PFMEA is being used for this.
• Ask to see the standardized work available for bypass processes selected above.
• Ask to see evidence of their written and approved bypass procedure. Note: Bypass procedure should include customer
notification.
• Ask to see evidence of when implemented bypasses are reviewed by leadership. Note: Should be reviewed in the next
upcoming leadership meeting.
• Ask to see evidence of the quality focused audit/LPA performed for processes/devices in bypass.
• Ask to see evidence of restart verification being documented for a defined period. Note: Should be 100% checked for
all features.
|
BIQS – 5
Bypass /Deviation Management
Bypass Planning
Selected ( Yes) for bypass by Study PCP for by pass
PFMEA Risk Assessments yellow color process
|
BIQS – 5 Bypass
Management
Key Point:
|
BIQS – 5 Bypass
Management
Bypass
Master
List
Bypass / Backup allowed with GQP-067, JES / PPCR
1-020 ROLLOVER
1-040 PLACE EUN LABEL TO BLOCK LABEL CORRECT HAND SCANNER -EUN LABEL MATCHES RFID bad 2d on checksheet
1-040 REMOVE MBC VACUUM FOR DEBRIS INTERLOCK SWITCH FOR VACUUM REMOVED/USED ball on string
1-070 PISTON SQUIRTER TORQUE VERIFY TORQUE static torque check
1-080 MBC CAMERA VERIFY BEARING PRESENCE
SCAN 2D MATRIX ON CRANK & RECORD FOR
1-090 CRANKSHAFT LOAD WRONG CRANK
TRACEABILITY
bad 2d on checksheet
1-090 CRANKSHAFT LOAD LUBRICATION APPLIED TO CRANK FLOW/PRESSURE SENSOR ON 50W OIL IN CABINET verify visual that oil is on part
|
BIQS – 5 BYPASS
MANAGEMENT
|
BIQS – 5 Bypass
Management BYPASS CHECKLIST AND LAYERED AUDIT
Advisor Name:____________________________________________________ Shift:_________
1st Hour
Directions: After each step has been completed, please initial. Post form at bypass station. Time
Step BYPASS PREPARATION Initial
1 Verify BYPASS JES approved and posted. (Note: Verify torque is confirmed for all spindles in a bypassed station) Initial
If station is still in bypass at end of shift, next shift M UST initiate new " BYPASS CHECKLIST AND LAYERED AUDIT " form.
Restart Verification
11 For intermittent failure: Verify proper operation of bypassed station. Amount: 100 + _______ part check
7th Hour
b Time
Signiture:_________________________________ Title:_________________________
Initial
12 Verify station placed back into full automatic. Re-evaluated RPN: ______
8th Hour
13 Record LAST unit processed in bypass/backup: Time
Trace#:_____________________________________ Time:______________________
14 Verify tools returned to cabinet: Initial
Who:________________________________________ Title:_________________________
Signature:____________________________________ Time:________________________
9th Hour
15 Approval of Restart of original process Time
|
BIQS – 5 BYPASS MANAGEMENT
|
BIQS Operating Guideline
BIQS Element 6 – Error Proofing Verification
|
BIQS - 6
Error Proofing Verification
Definition:
• Standardized method to verify error proofing /detection
devices by simulating their failure modes . Reaction
plan is identified in case of verification failed .
Scope:
• All Error Proofing /detection devices , should be
verified each shift .
Purpose:
• To verify error proofing devices are working as intended and reduce risk of sending bad parts when failed .
|
BIQS – 6
Error Proofing /Detection Verification
Plan Execute React
|
BIQS – 6
Error Proofing /Detection Verification
WI
Verification Records
|
BIQS - 6
Error Proofing Verification
• Verify all error proofing devices are checked for function (failure or simulated failure)
at the beginning of the shift. Otherwise according to the process control plan.
• Look to see error proofing masters (when used) are clearly identified. Confirm
records of verification are available.
• Verify a reaction plan is available and make sure it includes containment in the event
of error proofing device failure and is understood by a team member.
|
BIQS - 6
Error Proofing Verification
Regularly Verify All Error Proofing Devices to Ensure:
• Functioning according to design intent (i.e. when faulted station light
flashes, line stops, Andon board lights and melody plays).
• Error proofing
device used by
team as per
standardized
work.
• Audit functionality
and utilization to a
set schedule and
document results
(recommend at
shift start up).
|
BIQS Operating Guideline
BIQS Element 14 – Change Control –
Production Trial Run (PTR)
|
BIQS - 14
Change Control – Production Trial Run
Definition:
• The method by which changes in processes and (PTR)
products are validated immediately after change
implementation .
Scope:
• For all changes , if needed PTR .
Purpose:
• To ensure that each process and product changes are capable of meeting defined requirements.
|
BIQS - 14
Change Control – Production Trial Run
(PTR)
|
BIQS - 14
Change Control – Production Trial Run (PTR)
WHEN IS A PTR REQUIRED?
• EWO releases the parts produced on permanent tools.
• Raw material source change, tier supplier change, or change in tier supplier process.
• Only one PTR is required when the same change affects multiple part numbers (i.e., a hole
• change on many different color bumpers only requires one PTR at each affected plant).
• When the plant is notified of a part or process change that requires a supplier to complete the
Production Part Approval Process (PPAP).
• A PTR is conducted at each plant, even when multiple plants use the same part(s).
|
BIQS - 14
Change Control – Production Trial Run (PTR)
BIQS Requirement
The plant has regular meetings, including all departments, to discuss upcoming changes (product engineering changes, plant process changes,
supplier process changes) and coordinate PTR's. A reasonable sample size is used for Production Trial Run, based on risk.
AGENDA
PTR Date
Standardized Communication and Documentation (PTR form)
Build Readiness Reviews
Quality Reviews before and after the change
Reasonable sample size
Identification
Containment and traceability
Resources needed
Assistance needed (areas)
|
BIQS - 14
Change Control – Production Trial Run (PTR)
BIQS Requirement BIQS Requirement
Changes are clearly communicated and understood at all levels Parts are contained, stored and clearly identified prior to and
(e.g. team level). after the PTR build and PPAP approval.
Communication: PTR form (Example)
Top half of form Bottom half of form
(Example)
Responsibility - Basic
|
BIQS Operating Guideline
BIQS Element 22 – Rework / Repair
|
BIQS - 22
Rework / Repair
Definition:
• Rework/Repair process should be standardized ,
approved , verified .
Scope:
• All Rework/Repair processes
Purpose:
• Assure that rework/Repair is well done and avoid potential failure modes from Rework/Repair Process
|
BIQS - 22
Rework / Repair
|
BIQS - 22
Rework / Repair
|
BIQS Operating Guideline
BIQS Element 24 – Training
|
BIQS – 24 Training
Definition:
• Training plan is identified – Training process is
standardized – Team capabilities are documented ,
and standardized .
Scope:
• Shop floor and supported functions/system /management
activates . All types of training .
Purpose:
• Assure effective process of training to make sure that objectives , standardized work ,…etc are done through qualified
personal
|
BIQS – 24 TRAINING
|
BIQS – 24 Training
Key Point:
• Training plan and timetable exists for each employee aligned to the
business plan based upon job requirements and evaluations. Training
process is standardized and effective. Flexibility chart is updated for all
operation.
|
BIQS – 24 TRAINING
|
BIQS – 24 TRAINING
Flexibility Chart
|
BIQS – 24 TRAINING
|
BIQS Operating Guideline
BIQS Element 26 - Maintenance
|
BIQS - 26
Maintenance
Definition:
• Maintenance process is planned and standardized , Critical
spare parts are managed . Effectiveness is measured and
tracked for continuous improvement .
Scope:
• All Machines and equipment
Purpose:
• To reduce costs, improve plant throughput, quality and safety through ownership, accountability, and the development
of multi-functional employees.
|
BIQS – 26
Maintenance
Measure
Critical Spare Parts
PM Plan & Status Performance
( Min Qty Vs Actual)
(MTBF-MTTR)
|
BIQS - 26
Maintenance
• Equipment and tools maintained to the required standard, achieved business results, and
availability for production ensured.
• List of critical spare parts.
• Stock of spare parts: reception / organization / consumption.
• Conditions of storage.
• Computer aided system.
• Inventory (take an example of a critical part and verify the robustness of the inventory).
• MTTR & MTBF
• Look for evidence that PM schedule generates work orders and that these are closed as
scheduled. Must cover machine, tooling and gages.
• Look for use of predictive and preventive maintenance, (check some examples).
• Look for PM frequencies appropriate to needs.
|
BIQS - 26
Maintenance
|
BIQS - 26
Maintenance
Example of annual schedule
|
BIQS - 26
Maintenance
What Is…? :
Mean time to repair (MTTR) is the average time required to
troubleshoot and repair failed equipment and return it to normal
operating conditions. It is a basic technical measure of the
maintainability of equipment and repairable parts.
|
BIQS - 26
Maintenance
|
BIQS - 26
Maintenance
1) Visual controls are established to quickly identify inspection points and operating conditions
to reduce the time and increase the effectiveness of maintenance tasks.
2) Inspection points are grouped into inspection locations to improve efficiency.
3) A visual control grabs one or more of our senses in order to; alert us to an abnormality, help
us recover quickly, promote adherence and prevention.
4) Visual controls reduce error and waste by making problem visible. It identifies the gap
between the standard and the actual condition.
5) When visual controls are easy to see and understand, operators can respond as soon as
problems occur. Promoting a quick recovery.
6) Visual controls should be built into engineering specifications and designs.
|
BIQS - 26
Maintenance
|
BIQS - 26
Maintenance
Preventative Maintenance
1) Preventive maintenance is a maintenance activity designed to retain the healthy condition of the
equipment and prevent sudden failure through inspections, parts replacements, servicing, etc.
2) Preventive maintenance tasks are typically time or cycle based and consists of periodically
inspecting, servicing and cleaning equipment and replacing parts to prevent sudden failure and
process problems (e.g. Replacement of oil or coolant every 15 days).
3) Tasks are repetitive and routine like operator maintenance, but normally at lower frequencies,
such as monthly, quarterly, or annually.
4) Tasks are usually related to a machine and contains a list of tasks, time required and a bill of
materials. This may require planning to coordinate the parts, materials, and schedule the work.
|
BIQS - 26
Maintenance
Predictive Maintenance
• Predictive maintenance is a method in which the service life of critical parts are predicted based on
inspection or diagnosis, in order to use the parts to the limit of their service life. Compared to
Preventive maintenance, Predictive maintenance is condition based maintenance. It measures and
analyzes data about deterioration through a surveillance system of some sort, designed to monitor
conditions (e.g. a shift in frequency discovered during a routine check of a bearing -with vibration analysis
equipment- may indicate imminent bearing failure that could not be diagnosed by a visual inspection).
• Predictive maintenance can be applied to critical parts/equipment to further improve the
effectiveness and cost of the maintenance activities. It serves the same purpose as
Preventive maintenance: to prevent equipment breakdowns, but by predicting when certain
components, such as bearings, gear boxes or motors are going to fail.
• Simple measuring methods of ‘prediction’ such as conveyor chain wear, or the resistance in
a circuit, can also be used as a guide to the equipment life time remaining before failure.
Work to identify low cost and simple tools for ‘prediction’ on critical equipment.
|
BIQS - 26
Maintenance
|
BIQS Operating Guideline
BIQS Element 12 - Process Change Control
|
BIQS - 12
Process Change Control
Definition:
• Systematic approach to communicate and
document all changes .
Scope:
• All customer changes and internal changes including
process changes .
Purpose:
• To ensure that all key stake holders are aware of changes, and all required information is submitted on time .
|
BIQS –12,14
Process Change Control & PTR
* Procedure . * * Modify PFMEA , PCP,
Output
Process
Input
Regular Meeting
* Frequent Change to review changes WI .
meeting. status . * Create PTR if needed.
* Communicate to all * Customer approval
team ( Internal &
External) using
change form
* Define reasonable
sample size
|
BIQS - 12
Process Change Control
|
BIQS - 12
Process Change
Control
• All changes should be processed through a cross
functional team.
• A sample build should be included in the process when
applicable.
• Customer notification/approval should be included.
|
BIQS Operating Guideline
BIQS Element 13 – Verification Stations
|
BIQS - 13
Verification Stations
Definition:
• Inspection processes are standardized , records
kept and updated on time .
Scope:
• All inspection gates such as in process gates , final gates ,
GP12 , SC1&2 , verification stations ,….etc .
Purpose:
• Make sure that Inspection gates are effective , get expected outcome in all shifts , and live records are used to take
actions on time when needed .
|
BIQS – 13
Inspection Gates
Records
Standardized Work
• Check sheet reference with
• WI defects .
• Visual Aids • Live document
• Findings recorded
• If Final gate ( checks should
be reviewed before)
|
BIQS - 13
Verification Stations
• Look for point, touch, listen and count inspection methods incorporated into quality
checks. Look for increased quality checks for launch, shut down or based on customer
feedback (eg. Fast Response).
• Findings must provide clear data to support Alarm Reactions and Problem Solving.
|
BIQS - 13
Verification Stations
Traditional
Approach
|
BIQS - 13
Verification Stations
|
BIQS - 13
Verification Stations
|
BIQS - 13
Verification Stations
|
BIQS Operating Guideline
BIQS Element 25 - Contamination
|
BIQS - 25
Contamination
Definition:
• Contamination Requirements Should be followed and
controlled .
Scope:
• When required by customer and when needed by process .
Purpose:
• To make sure that product , process meet customer requirement and make sure that contaminations are controlled .
|
BIQS - 25
Contamination
• When customer requires sediment control, verify that the supplier adheres to stated
frequencies, maintains trend charting and corrective actions for out-of-control and out-of-spec
points.
|
BIQS - 25
Contamination
Sources of Contamination:
• Original material/fluid from the supplier
• Transfer from upstream supplier container
• Material/Fluid handling at the station
• Dirt/oil or foreign material on parts/fluids/sealers or dunnage
• Incorrect PPE. e.g. cotton gloves instead of lint free
• System cleaning not completed correctly, sediment still in the system, metal in the
vehicle from body shop, or final wash effectiveness insufficient Powertrain
• Incorrect abrasive material, backing or particle size as well as forbidden materials
being used (Silicon, lubricating oil)
|
BIQS - 25
Contamination
|
BIQS - 25
Contamination
Prevention (Powertrain):
Sediment Reduction
• Sediment is any foreign material found in any assembly that is not part of the blue print requirements.
• Sediment negatively impacts our assemblies by:
a) Causing valves to stick thus not allowing the unit to shift properly.
b) Causing seals to be cut or lays on the seal thus causing internal pressure loss and/or external
leakage causing slippage and loss of performance
c) Mating parts may not seat, assemble easily or completely cause forced installation. Incomplete
installation may result in leakage, scoring, breakage and functional failure.
|
BIQS Operating Guideline
BIQS Element 27 - FIFO
|
BIQS – 27
FIFO
Definition:
• A process that incorporates a constant drive to attain
a simple sequential process flow of material. Material
handling racks in a good condition and maintained .
Scope:
• All Material – All in process racks .
Purpose:
• Allow traceability, reduce lead time, and easily detect problems while optimizing cost, and reducing inventory and
work- in- process.
• Make sure that handling rack is protecting parts from being damages .
|
BIQS – 27
FIFO
|
BIQS – 27
FIFO
|
BIQS – 27
FIFO
|
BIQS – 27
FIFO
1)Repacking
2)Kitting, buffers
3)WIP
4)And any staging areas)
|
BIQS Operating Guideline
BIQS Element 28 – Shipping Approved Packaging
|
BIQS - 28
Shipping Approved Packaging
Definition:
• Shipping is done according to customer requirements .
Scope:
• All Shipped material
Purpose:
• To meet customer requirements for shipping .
|
BIQS - 28
Shipping Approved Packaging
|
BIQS - 28
Shipping Approved Packaging
Requirement Sources:
1. Packaging requirements are located in GM1738.
2. Label requirements are located in GM1724 A/B/C.
Approval Documents:
1. Packaging approval form NA GM1738 Form for both standard and expendable packaging.
|
BIQS Operating Guideline
BIQS Element 29 – Supply Chain Management
|
BIQS - 29
Supply Chain Management
Definition:
• Supply base are managed , monitored . Supplier base is audited regularly . Quality issues are communicated and solved .
Scope:
• Tiered supply base .
Purpose:
• To reduce the risk of the sub-tier supply base to customer
activities and make sure that they are controlled .
|
BIQS - 29
Supply Chain Management
|
BIQS - 29
Supply Chain Management
Requirement Sources:
1. Supply chain statement of requirements are located in GM1927-03 SOR.
2. Risk assessment through GM 1927-07 APQP Assessment Subtier worksheet or similar
3. Sub tier audit through GM 1927-30 BIQS Subtier or similar
|
BIQS Operating Guideline
BIQS Element 7 – Gage Calibration/
Measurement System Analysis
|
BIQS - 7
Gage Calibration / MSA
Definition:
• System in place to make sure that all equipment and
gauges are calibrated regularly as per their standard .
System in Place to make sure that MSA is done
regularly when needed (New launch,....etc .)
Scope:
• All Gauges
Purpose:
• Calibrated equipment assures proper decisions are made relative to product quality standards .
• MSA assure that variation of measuring process is accepted .
|
BIQS - 7
Gage Calibration / MSA
|
BIQS - 7
Gage Calibration / MSA
|
BIQS - 7
Gage Calibration / MSA
|
BIQS Operating Guideline
BIQS Element 15 – Andon System Implementation
|
BIQS - 15
Andon System Implementation
Definition:
• An operational floor process control system (that can be
activated manually or automatically) to communicate the
need for assistance when abnormal conditions occur.
Scope:
• To all team members .
Purpose:
• To empower operations to prevent the occurrence of passing on defects to the next process to support concept of
|
BIQS - 15
Andon System Implementation
• Check the requirements of an effective Andon system are present in all production areas.
• Take a few operator stations in different areas as an example. Ask Team Members and Team
Leaders how the Andon is working and validate the effectiveness.
|
BIQS - 15
Andon System Implementation
BIQS Requirement
A well functioning Andon system is implemented in all production areas to support the Team Member when abnormal conditions
occur and communicate relevant information.
All operational areas of the organization are using the Andon process as intended and this shows tangible results on the shop floor.
The Andon system enables the Team Member to call for help and supports the concept of "Do Not Accept, Build or Ship a Defect". Andon calls can be
radio, pager, stack lights, andon boards, etc.
|
BIQS - 15
Andon System Implementation
BIQS Requirement
All operational areas of the organization are using the Andon process as intended and this shows tangible results on the shop floor.
|
BIQS - 16
Alarm and Escalation
Definition:
• Alarm limits are identified based on risk and occurrence
, standardized and followed , also if reached escalation
path is clear and reachable
Scope:
• All Manufacturing operations at least .
Purpose:
• Avoid building NC material – feel special causes when happened on time – Empower team member – standardize
process of escalation
|
BIQS - 16
Alarm and Escalation
|
BIQS - 16
Alarm and Escalation
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BIQS - 16
Alarm and Escalation
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BIQS - 16
Alarm and Escalation
Verification Station Escalation Process
Alarm Trigger 1st Alarm 2nd Alarm 3rd Alarm
Alarm Notifier Gate Keeper Gate Keeper Gate Keeper
Alarm Notifier 1. Notify Alarm Responder over Radio 1. Notify Alarm Responder over Radio 1. Notify Alarm Responder over Radio
Responsibilities
Clear Alarm
2. Properly Document Alarm. 2. Properly Document Alarm. 2. Properly Document Alarm. Process
Instructions
Alarm Responder Team Leader Group Leader Shift Leader
(OR) Group Leader Shift Leader Area Mgr/Senior Shift Leader
Alarm Responder 1. Document acknowledgement within 1. Initial Alarm Sheet at V/S. 1. Initial Alarm Sheet at V/S.
Responsibilities 15 minutes of alarm time at internal
gates and within 30 minutes at
downstream gates.
4. Notify Supplier Action Center if root 4. Make decision concerning next 4. Make decision concerning next
cause is supplier based. step. step.
Process drives
Production and Quality
accountability:
review and understand
actions taken
Gatekeeper Responder
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BIQS - 16
Alarm and Escalation
Alarm Trigger of 1:
• Past customer issues relying on any visual inspection
• Higher customer severity failure modes relying on any visual inspection
• GP-12 failures
• CS failures
• Abnormal and unexpected findings
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BIQS Operating Guideline
BIQS Element 17 – Visual Controls
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BIQS - 17
Visual Controls
Definition:
• Visual standards should be standardized , controlled , and
updated regularly based on new issues and new risks .
Scope:
• All visual standards .
Purpose:
• To standardize process to identify difference of what is considered good Vs what is considered nonconforming as per
customer requirements .
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BIQS - 17
Visual Controls
• Look for engineering changes (Product Engineering) and if they are reflected in the Visual
Standards.
• Confirm Visual Standards are updated as a result for the Fast Response process where
required.
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BIQS - 17
Visual Controls
Key Points:
• Visual controls are established to quickly identify inspection points and operating
conditions to reduce the time and increase the effectiveness of maintenance
tasks.
• Inspection points are grouped into inspection locations to improve efficiency.
• A visual control grabs one or more of our senses in order to; alert us to an
abnormality, help us recover quickly, promote adherence and prevention.
• Visual controls reduce error and waste by making problem visible. It identifies
the gap between the standard and the actual condition.
• When visual controls are easy to see and understand, operators can respond as
soon as problems occur. Promoting a quick recovery.
• Visual controls should be built into engineering specifications and designs.
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BIQS - 17
Visual Controls
Gauge Range Marked
Visual controls are important for operators, maintenance and other plant personnel
making quick determinations on “normal” or “abnormal” conditions. Abnormal
conditions can be returned to a normal condition in a timely and efficient manner.
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BIQS – 17
Visual Controls
Inspection Points
Operators can quickly determine machinery and equipment status at a glance, and are
responsible for reporting its condition.
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BIQS - 17
Visual Controls
Floor Marking
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BIQS Operating Guideline
BIQS Element 18 - Visual Standards –
Communicated and Understood
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BIQS - 18
Visual Standards–Communicated &
Definition:
• Visual standards are understood and used when
Understood
needed by team member level
Scope:
• All team members assigned to use the visual standards .
Purpose:
• Support team member in understanding customer & process visual standard
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BIQS - 18
Visual Standards–Communicated & Understood
Confirm Visual Standards are clearly differentiated from good to bad; are clearly identified as a
Product Quality Standard document and are clearly referenced in the standardized work.
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BIQS - 18
Visual Standards–Communicated & Understood
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BIQS - 18
Visual Standards–Communicated & Understood
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BIQS Operating Guideline
BIQS Element 23 – Feedback / Feedforward
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BIQS - 23
Feedback / Feedforward
Definition:
• The communication of expectations and results
between internal /external customers through
standardized communication pathways.
Scope:
• At least Fast Response issues – issues occurred in floor
such as exceeding alarm limits , results from inspection
gates .
Purpose:
• To ensure that information reaches those who need it on the right time .
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BIQS – 23
Feedback /Feedforward
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BIQS - 23
Feedback / Feedforward
• Confirm quality alerts are posted at the operation for issues detected
downstream (e.g. Fast Response, Verification Station (Final Inspection
/CARE / GP12)).
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BIQS - 23
Feedback / Feedforward
Benefits:
Customer/Supplier relationship
• Expectations are clearly understood (product quality standards).
• Correct and accurate information flows in a timely manner.
• Problem resolution is expedited.
Integrity of Data
• Focus resources based on customer feedback.
• Data-driven problem solving.
Improved response time
• Unresolved issues are escalated.
• Actions are implemented in a timely manner to prevent the flow of defects.
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BIQS - 23
Feedback / Feedforward
Ability to Discover
Number of Defective
Time to Discover Defect
Root Cause Units Built
Inspection
Finished Product
Audit etc.)
J.D. Power
Month of Build
Early Quality
Feedback
Warranty
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BIQS Operating Guideline
Closing Comments
•The Presentation and the BIQS 30 Element Audit will be available on the Hutchinson Web Site
•http://www.hutchinsonna-antivibration-purchasing.com/ “Training Documents”
•We are requesting that you completyttyyyyyyyyyyyyyyytyyyyytyyyyytyyte a self audit using the
BIQS Audit
•Return the Audit and your improvement plans to HAVS not later than September 28, 2017
•The HAVS Supplier Quality Engineer will contact you to develop a plan for an audit at you facility
•QUESTIONS????????