There are many concerns when facing quality management within organizations and big companies. There are always high risks in the supply chain. Furthermore, there are risks with internal infrastructure and the value chains (from distribution to retail to the consumer).
2. Quality Challenges within an Organization
INTERNAL INFRASTRUCTURE
Brand Owner
MESERP
Manufacturing
& Packaging
Finance
& Sales
Quality
Management
EQMS
Regulatory
Bodies
Master CAPA
Master Change Control
Master Deviations
Master Investigation
SUPPLY CHAIN
Tier 1
Suppliers
Contract
Manufacturers &
Packagers
No Quality
Visibility
Tier 2, 3 Suppliers
& Supplier’s
Suppliers
Distribution
Retail
Consumers
VALUE CHAIN
3. Example:
Contract Spending Grouping and Rations
3
32%
DIRECT
25%
ENTERPRISE
22%
SALES & MKTG
21%
R&D MGT
Raw Materials
Packaging
Contract Mfg.
Transportation
Capital
9%
6%
8%
5%
4%
Services
Corp Svs
IT
Energy
Telecom
16%
4%
3%
1%
1%
Creative
Marketing
Promotion
Meetings
Travel
3K
2K
4K
5K
2K
18K
2K
3K
1K
1K
6%
6%
8%
5%
3%
5K
5K
15K
36K
20K
Services
Corp Svs
12%
9%
24K
11K
% of
Costs# Suppliers
% of
Costs# Suppliers
% of
Costs# Suppliers
% of
Costs# Suppliers
3 categories are under scrutiny by Regulatory Agencies
– Must be fully audited
Quality
Transaction
s
20K
10K
100K
Total 9K 23% 130K
4. The Challenge
4
Business
Impact
Overhead Costs
Out of Stock Costs
Organizational
Impact
Compliance &
Litigation
Market
Impact
Time = Money
Poor Quality =
Danger
Poor Quality
Affects Brand
Reputation
Raw Material Supplier
Product shipped late
Product damaged
Manufacturing delays
Scrap, delays in Mfg &
shipping
Issues
Manufacturing
Facility
Distribution
delays
Impact
Packaging
Product out of spec
Product mislabeled
Shipped wrong
product Manufacturing
Facility
Issues
Issue not captured
Dangerous
product
distributed
Impact
Contract Manufacturers
& Packagers
Issues Not Captured:
Poor quality product
delivered
Issue
Distributor
Issue not captured
Poor quality
product delivered
Impact
Poor
information+
No visibility
Inconsistent
processes
+
Reactive
Environment=
Pharmacy
(Out of Stock)
Consumers
Distributor
5. Supplier Quality
Management
Addressing the Challenge
5
Raw Material
Supplier
Packager
Contract
Manufacturers &
Packagers
Consistent
Quality
Manufacturing Quality
Few Manufacturing Delays
Fewer Shipping Delays
Less Product Quarantined
Less Waste/Rework
Protected
Supply Chain
Quality Processes
Interactive Supplier Scorecard
Real-Time
Consistent
Accurate
TrackWise
Analytics
On-Time Shipping
Fewer Damaged
Products
Product In Spec
Accurate Labeling
Right Product Shipped
Product In Spec
Accurate Labeling
Correct Product
Shipped
Fewer Damaged
Products
Better
Visibility
Efficiency
6. Meeting the Needs of the Organization
6
IT
Accuracy
Speed
QA Processes
Supplier
Nonconformance
Supplier Audits
Supplier Onboarding
Risk/ Compliance
Warning Letters/Decrees
(483s)
Recalls
Internal Teams Need to Increase Visibility
QA MANUFACTURINGPROCUREMENT
7. The Challenge
Technology Driving Efficiency & Accuracy
7
TrackWise
Analytics
Lost or incomplete data at
time of business decision
Days or
months to
receive data
Paper-based
Audits
Resulting in negative
monetary impact
Manufacturing Process
ISSUE VOLUME
Quality Processes
On
Premise
SQM
TIME
ACCURACY
8. Addressing the Challenge
Technology Driving Efficiency & Accuracy
8
Complete data at time of
business decision
Electronic Audits
One Click
Electronic Upload
Resulting in positive
monetary impact
Manufacturing Process
ISSUE VOLUME
Quality Processes
On
Premise
SQM
TIME
ACCURACY
Via
TrackWise
Analytics
9. The Challenge
Supplier Audits
9
Suppliers and CMOs to Be Audited
Critical
Suppliers
Important
Suppliers
General
Suppliers
No Quality
Visibility
Supplier qualification
Risk Assessment
Interim Check
Supplier qualification
Risk Assessment
Interim Check
Supplier qualification
Risk Assessment
Interim Check
No Quality
Visibility
1. Online Assessment
2. Audit Execution
3. Observations & CAPAs
Supplier Audit Checklist
Prioritize
Schedule
Manage
Cumbersome
Resource Intensive
Difficult to coordinate
Execute Inconsistent
Remediate Detached
Measure Inaccurate Decisions
No Quality
Visibility
10. Addressing the Challenge
Supplier Audits
10
Critical
Suppliers
Important
Suppliers
General
Suppliers
Prioritize
Schedule
Manage
Informed
Systematic
Efficient
Execute Consistent
Remediate Integrated
Measure Accurate
Decisions
Complete
Measure and Inform
Audit Management
Audit Execution
Audit Planning
Supplier Audit Checklist
1. Online Assessment
2. Audit Execution
3. Observations & CAPAs
Suppliers and CMOs to Be Audited
Supplier qualification
Risk Assessment
Interim Check
Supplier qualification
Risk Assessment
Interim Check
Supplier qualification
Risk Assessment
Interim Check
11. The Challenge
Product Non-Conformance
Paper based
Management
Slow Response Detached
Issue Identified
Notification
SCAR
Reviewed
Action Item
Extension Approved
Product Damaged
Notification Received
Supplier Response
Due Date Extension
Product Damaged
(Repeat Issue)
Quarantine
Days or months
to receive data
No Visibility
Quality Processes
Product
Manufactured
Product Shipped
Issue Missed
Poor Quality =
Danger
Poor Quality =
Brand Reputation
12. The Solution
Product Non-Conformance
Quarantine
SafeQuality
Visibility
Quality Processes
Issue Identified
Notification
SCAR
Reviewed
CAPA Approved
Action Item
Reminders
Product Damaged
Notification Received
Supplier Identification
Root Cause
CAPA Plan
Effectiveness Check
Electronic Record
Management
Efficient Response Connected
e
On time
TrackWise
Analytics
Efficient Response
Product Manufactured
Product Shipped
Electronic Record
Management
13. The Challenge
Supplier Onboarding
13
Supplier A
Inconsistent Processes
Inefficient Management
Poor Recordkeeping
Onboarding x Supplier x Material
o Raw Material x 1,000’s
Poor Onboarding and subsequent management leading to:
Less Compliance
More Risk
Higher Costs
Material #1 Cert
Material #2 Cert
Product
Manufactured
Non-Compliant Certs.
= Danger
Poor Recordkeeping =
Brand Risk
Manufacturing
Facility 2
Material Certification
Material #1
Received – Improperly Filed
PLM – Cert Flagged - Out of
Date
Material Certification
Material #2
No Cert Received
PLM – Supplier Flagged w/
Cert
14. The Solution
Supplier Onboarding
14
Supplier A
Consistent Processes
Efficient Management
Electronic Recordkeeping
Onboarding x Supplier x Material
Raw Material x 1,000’s
Automated onboarding and subsequent management leading to:
Material #1 Cert
Material #2 Cert
Product
Manufactured
Compliant Certs.
= Quality
Sound Recordkeeping =
Brand Protection
Manufacturing
Facility 2
Certification
Doc Posted
Business Rules
Safe Material
Material #1
Supplier Onboarding
Received
Systematic
Efficient
Delivered
Material #2
Certification
Doc Posted
Business Rules
Safe Material
Received
Systematic
Efficient
Delivered
AutomatedProcessing
SQM
15. VP Procurement VP of QA
VP
Manufacturing
Stratas – Supplier Scorecard
Accurate Data When you need it
15
Manufacturing Metrics
Greater Transparency
Better Accountability
More Efficiencies
Net Effects
PROCESS FLOW METRICS
8 Materials Waiting Time
Quotient
MWTQ Percent (%)
Ratio of waiting time for materials to total
manufacturing lead time (TML)
9 Line Efficiency LE Percent (%)
Ratio of actual process throughput to the
theoretical idea throughput based on the pace
and cycle time at the bottleneck station.
QUALITY METRICS
10 Scrap Rates SR Percent (%)
Percentage of units starting as raw material that
are lost as scrap from all steps in the process.
11 Rework Rates RR Percent (%)
Percentage of units starting as raw material that
have to be reworked at least once in the
process.
FINANCIAL METRICS
12 Cost per Part CPP $/unit
Total cost per unit for raw materials, processing
and indirect overhead.
16. Stratas
Protecting the Supply Chain from Supplier Issues
16
Manufacturer 1
Manufacturer 2
Manufacturer 3
Contract
Manufacturers
Suppliers
Packagers
Certified
Trending
Negative
Certified
Not
Certified
Certified
Remediate
SQM by
Manufacturing
Facility
Corporate
Distributors
Retail
Industrial
Internet
Consumer
Can you get to the data you need to
protect your entire supply chain?
17. Risk Scorecard Integration Sources
17
Supplier
Audits
CARs
Incoming
Inspections
Contracts /
POs
Inventory
Management
Bill of
Materials
Supplier
Questionnaire
TrackWise
EQMS
MES
ERP
PLM
Notes de l'éditeur
“Rules of engagement” for the Value Messaging meeting. (16-17 slide per vertical – after breakout)
Meeting Agenda & Approach
Each person (KR, Kelly and Mohan) will be given 30-35 minutes to present their deck to the team
Each person will receive anonymous feedback from their teammates using the attached form
Note: I will be abstaining from providing feedback (verbal or written) and will simply play a time moderator role
You may choose to accept the feedback and incorporate it into your final product, or you may decline the feedback
Meeting Outcome
Coming out of the meeting, the desired outcome is as follows:
A polished deck that is ready to present to John McNeill within 1 week of the meeting on the 24th (including peer feedback if you so choose)
A polished deck script (i.e., written voice over) that is ready to present to John McNeill within 1 week of the meeting on the 24th (including peer feedback if you so choose)
I will look to reserve some time with John in late July or early August to allow each of you to present to John. At that point in time, I would expect the team to be prepared to take the best ideas from the 3 verticalized decks and work toward a standard deck (where it makes sense) with minor mods based on each vert.
Notes:
We are setting a new standard for Sparta, so please feel free to take liberties with the following if you feel it bolsters your story:
Existing Business Drivers
The Problem & The Solution
Chalk Talk – Off Limits – No liberties permitted
Existing Value Pillars
Look, feel and graphics – We’ll calibrate with Marketing at the appropriate time
KEY TAKEAWAYS: Current EQMS solves internal problems, but externally you have no visibility.
POINTS:
You have harmonized on your internal systems. Protect supply chain and consumer. Show quality processes.
A disconnected supply chain presents an issue for quality management, because historically this used to be a very orderly, within the four walls type of business process when manufacturing and supply businesses were highly verticalized.
A firm may have strong supplier quality management system that include vendor qualification and management of the lifecycle of issues and changes, regular audits of suppliers and external manufacturers and a series of quality related activities such as deviations and non-conformances, change controls that go back and forth, and supplier corrective actions.
But these same firms might still support supplier quality in the same, manual, error prone fashion. And over the course of time, the network of suppliers and contract manufacturers just gets more complicated, and the communication with these becomes a bigger issue.
The risk here is the lack of visibility into what suppliers are doing.
Prioritize – No ASL, no risk measure
Schedule – Sourcing Limited Availability
Manage – Historical Reseach (TW)
Execute – All Manual (AEP)
Remediate – Phone, fax, email, No Visibility
Measure – No Scorecard or risk measure
Prioritize – No ASL, no risk measure
Schedule – Sourcing Limited Availability
Manage – Historical Reseach (TW)
Execute – All Manual (AEP)
Remediate – Phone, fax, email, No Visibility
Measure – No Scorecard or risk measure
Process flow to Driving process
Biz engine – when last step (certify recd) – add expir date for recertify reminder
Integr with Doc Mgt
Visio – Business Decisions