Manufacturing companies today are challenged by mounting pressures to meet extreme demands such as market demand, cost and recall reduction and coordinating communication across a complex supply chain to ensure quality and compliance.
In this presentation, Sparta Systems displays the quality issues faced today, and the best practices leading manufacturers are leveraging to manage quality across the enterprise, standardizing processes to improve efficiencies, reduce costs and ensure better business outcomes.
2. 2
Why Is Quality Important to Your
Business Ecosystem?
R&D
PRODUCT INTROEXPANDING MARKETS
GROWTH & MATURITY
LIFE SCIENCE INDUSTRY
Brand protection
Globalization
$ Cost, Price & Margins
Vendor Network
Speed to Market
Consistent Delivery
Compliance
Sparta Systems Proprietary
3. The Challenge
3
Company
Develops products to satisfy the
needs of consumers
Finance & Purchasing
Focused on performance management
and reducing costs
Suppliers
Supplies safety and high quality
raw materials and packaging
NO QUALITY
VISIBILITY
Issue Resolution Cost:
CAPA 2
Change Control 2
Deviations 2
CAPA 3
Change Control 3
Deviations 3
DISPARATE
PROCESSES
CAPA 1
Change Control 1
Deviations 1
ConsumerDistributor
WALL ST
1x 10x 100x 1000x…
Contract Manufacturers
& Packagers
Handles outsourced manufacturing
and packaging for brand owner
NO QUALITY
VISIBILITY
Sparta Systems Proprietary
4. Addressing the Challenge
4
Path to
Success
ERP $
End-to-End Quality Management
Internal Facility Worldwide Facilities Vendor Facilities
Functional Area
Internal
Manufacturing
External
Manufacturing
R&D
Supplier
Management
Geography
Country
Region
Business Unit
Quality Process
CAPA
Deviation/ Incident
Auditing
Complaint Handling
Change Control
OOS/OOT
Sparta Systems Proprietary
5. The Proven Quality Solution
5
Company
Finance & Purchasing
ConsumerDistributor
WALL ST
EQMS: Harmonized Global
Processes
Contract Manufacturers
& Packagers
Suppliers
500k Global Users
700 (+) Implementations
Best Practice EQMS Workflows
Top 35 Pharmaceutical companies
Top 13 out of 15 Med Device
Companies
Meets FDA & global regulatory
requirements
Sparta Systems Proprietary
9. 9
SPEED
QUALITY INTELLIGENCE
Addressing the Visibility Challenge:
What’s Broken?
Role Business Questions Today
Executive
What quality events are happening
across the global business
environment by product, process,
region and function?
Quarterly
Consumer:
Senior Manager
What’s preventing us from
shipping product/filling orders?
Monthly
Consumer:
QA Manager
What is the origination of our
problems?
How deep are our problems?
Weekly/
Monthly
Consumer:
Auditor
What is the root cause of our
issues and how deep is the issue?
How can we be more proactive in
managing our product quality? (i.e.
SOPs, training, change
management)
Days/
Weeks
Monthly/
Quarterly
Analyst
Are there any positive or negative
trends that impact product quality
(i.e. waste, warranty, recall costs,
etc.)
Weekly/
Monthly
Business
Needs
Insights
needed for
fact-based
decisions
Current
Reporting
Paradigm
Current
Output
Self-service analytics users were 85% more
effective in finding the information in the
required amount of time. (Aberdeen Group, April 2012)
Companies that inject analytics into their
operations show productivity rate and
profitability that are 5-6% higher than their peers.
(Harvard Business Review, October 2012)
VOLUME
Role Business Questions TWA
Executive
What quality events are
happening across the global
business environment by product,
process, region and function?
Minutes /
Hours
Consumer:
Senior Manager
What’s preventing us from
shipping product/filling orders?
Minutes /
Hours
Consumer:
QA Manager
What is the origination of our
problems?
How deep are our problems?
Minutes /
Hours
Consumer:
Auditor
What is the root cause of our
issues and how deep is the issue?
How can we be more proactive in
managing our product quality?
(i.e. SOPs, training, change
management)
Minutes /
Hours
Analyst
Are there any positive or negative
trends that impact product quality
(i.e. waste, warranty, recall costs,
etc.)
Minutes /
Hours
Speed to Insights and Volume of Insights
Business
Needs
TWA
Enabled
Insights
needed for
fact-based
decisions
Sparta Systems Proprietary
11. 11
From multiple project solutions/data to a single platform
All processes connected to a single data source
EFFICIENCIES GAINED FROM…..
Platform
Consolidation
Infrastructure/Hardware
Integration
Development and Support
Organizational
Efficiencies
Process effectiveness
Reporting effectiveness
Aggregated KPIs
Distribution
NVA efforts
Maintenance
& Support
Hardware
Software
Data backup
Upgrades
+ +
Key Reasons to Implement an EQMS
IT Efficiency
ERP $Fragmented Pillar Systems
Q Q Q
Q Q
=
VALUE
Point
Solution
# Quality
ProcessesX XSites
Sparta Systems Proprietary
Sparta Systems Proprietary
12. 12
Key Reasons to Implement an EQMS
Operational Efficiencies
Role Key Responsibilities EQMS Benefit
Executive • KPI
• Critical information
• Real-time Info
• Push Report Visibility
Regulatory Affairs • Regulatory filing
• Risk assessment
• Safety/Compliance
• Visibility
• Signaling
• Timely reporting to Regulatory
Bodies
QA Manager • Task prioritization
• Problem areas
• Audit management
• Continuous improvement
• Resource efficiency
• Holistic Quality management
Manufacturing/
Operations
• Tasks list, completion, and
priorities
• Ops reporting
• Critical Issues detection
• Business rules based workflow
• Visibility
35%
− Cost of Managing a growing
number of Records
Cost of Managing
Records Today
Cost of Managing
Records Today
Reducing Number of Records
Given 35% Efficiency Gains−
VS
Sparta Systems Proprietary
13. Product Quality and Value directly
correlates to Brand
- Affects brand integrity
- Corporate Reputation
- Profitability (market share)
- Depends on the recall management
Key Reasons to Implement an EQMS
Brand Image Protection
RECENT EVENTS AND BRAND IMAGE
13
iPhone antenna
issues/ Foxconn
Labor Issues
B787 Li-Ion
Battery Fires
ICD
(defibrillator)
recalls
Microscopic
design error
(Sandy Bridge)
83%
78%
59%
70%
17% 22% 41% 30%
Pre-Recall Recall 1 Recall 2 Post-Recall
Positive Perception Negative Perception
Brand Sentiment
Sparta Systems Proprietary
Sparta Systems Proprietary
14. RECALL COST ELEMENTS
Recalls due to quality issues, product safety,
regulatory bodies
• Undermines trust and customer confidence
• Long time to recover reputation, goodwill
and equity
• Proactive recall – minimal negative impact
Key Reasons to Implement an EQMS
Recall Costs
Costs of
Customer
Dissatisfaction
Operational
Costs
Regulatory Fines
& Penalties
Litigation
Costs
Long-Term
Impact on Brand
Sparta Systems Proprietary14
Sparta Systems Proprietary
15. Product Recalls
A Threat to Brand Protection and Consumer Safety
15
Senior Team members manage recall
risk through supplier indemnification 2
58%
RECALL RISK MANAGEMENT
1 FDA Enforcement Statistics Summary, Fiscal Year 2012
2 Recall Execution Effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010
3 Capturing Recall Costs: Measuring and Recovering Losses. Ernst & Young, GMI, Oct. 2011
Recalls: Class I, II and III
5,585
5,778
8,065
9,361
9,288
9,469
07
08
09
10
11
12
Recalled Products
2007-20121
10.7
7.8
8.4
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
ImpactofRecall
onSharePrice2
Days from Recall Announcement
21%
52%
of Recalls were due to
supplier and contract
manufacturer issues2
High
Medium
Low
Recall Costs Scale X
$90,000,000
$35,000,000
$10,000,000
Sparta Systems Proprietary
16. 16
For additional information on Sparta Systems, please visit:
www.spartasystems.com
Or contact us at: marketing@spartasystems.com
Notas del editor
Reduce Time to Market
Existing Customer View
Overlay this EQMS system with TrackWise Analytics to provide management with real time quality information and metrics, to allow for faster decision making for remediation of problems and bringing cost saving efficiencies to you entire manufacturing process across the supply chain. Potential problems will be identified earlier in the process, and less costly adjustments can be made. Actions to correct an issue where it is discovered can now be applied globally to prevent it from happening elsewhere in your organization where similar conditions may exist. TrackWise Analytics allow a company to make fact based decisions about production and release of product, saving companies time and money.
The value this system provides (Value Pillars) :
IT Efficiency: IT can now consolidate the support of multiple systems and supporting infrastructure into a handful of core strategic systems, of which EQMS is one of. Knowing that ERP is the foundational system for business decisions, TrackWise easily integrates with ERP and other core systems to produce or consume master data, and to provide fact based information and data that can automate processes between these systems.
Operational Efficiency: Consolidating critical processes into a single set of standards means that companies put in place global standard operating procedures (SOPs). This means that everyone in the supply chain is speaking the same language, following proven and repeatable processes when events occur, and actions taken are applied anywhere the same conditions apply. Following a single set of processes eliminates duplication of efforts and different ways of doing things. Results are easily understood by everyone in the organization and decisions are made based on the same set of rules.
Supply Chain: TrackWise allows you to apply the same standards from raw material supplier through distribution of product. Quality events, audits, actions, CAPA’s, complaints and changes can now apply collaboration, investigation and actions across the many organizations and divisions involved with your products. Visibility and transparency can now be applied across your supply chain, and the necessary parties can make fact based decisions when event happen.
Risk Analysis: When you have a single quality system, it becomes the single source of truth. With TrackWise Analytics you can now visualize and analyze metrics which will identify trends and areas of risk for your company. Being able to quickly identify the root cause of a problem allows you to not only correct it where it happened, but to evaluate where similar conditions may exist and take action from preventing the problem from happening elsewhere in your organization. The future holds the ability to use predictive analysis to anticipate areas of risk, prior to issues occurring.