Four Best Practices To Improve Quality In the Supply Chain. Lower supply chain risks and cost of quality

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Four Best Practices To Improve Quality In the Supply Chain Lower supply chain risks and cost of quality 1

Table of Contents 3 Introduction 7 Quality Risks in the Supply Chain 10 The Big Challenge 16 Best Practices to Improve Quality 17 Conclusion 2

Introduction Markets and manufacturing practices have evolved and companies now work with an increasing number of global manufacturing and supply partners. As companies have pursued this broadened supply chain strategy, the ability to manage quality risk has become more challenging. When working with external suppliers, companies lack the same quality management capabilities found internally and therefore are often faced with manual and ad hoc communication that can lead to miscommunication, delays and ultimately product issues in the market. At the same time, pressures in regulated industries and overall customer expectations have increased scrutiny of quality and accountability in the supply chain. All of this can lead to a high risk of brand devaluation, a loss of reputation when something does go wrong, and high overhead cost of managing the quality process. In this new paradigm, quality management does not end at traditional corporate boundaries. Leading companies are able to better manage risk and gain competitive advantage by investing in extending the quality enterprise to include suppliers and contract manufacturers. 3

Quality Risks in the Supply Chain It is estimated that manufacturers spend an average 50-80%1 of the total product cost on raw materials and parts procured from multiple suppliers across different parts of the globe. To continually manage costs and improve performance, a company must be able to not only select the right supply chain partner but more importantly monitor and proactively manage quality in the supply chain. Yet, the majority of companies only establish quality performance and measurement programs with less than 1/3 2 of the total supply base. By failing to establish more comprehensive supply chain quality programs, companies are exposing themselves to large scale quality issues, service deficiencies, and increased costs that can impact profits and damage brand reputation. Companies are becoming highly dependent on supplier and must assess and manage quality in the supply chain to reduce business risk and prevent revenue losses. 4

Proactive Approach to Recalls At the same time companies have expanded the supply chain network, product recalls continue to be an top concern. Product recalls have a severe negative impact on a company s profit and brand reputation. According to a Deloitte Consulting research report, 52% of recalls result from supplier and contract manufacturing issues*. That said, 58%** of executives manage recall risk through supplier indemnification. However, relying solely on supplier indemnification is not a long term solution that addresses the real issues. Proper planning and technology solutions to identify issues in real-time, can help manage a recall event to mitigate financial and legal risk, increase customer loyalty, and prevent brand damage. FDA Enforcement Statistics 2016 *Recall Execution effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010 Fda.gov ** Rapid Alert System for Food and Feed. FASFF. 2012 5

Financial Impact of Recalls Not holding external suppliers and contract manufacturers to the same level of accountability as internal operations and not proactively managing quality in the supply chain has severe financial consequences. A Product Recall can cost a company between And can result in a significant drop in share price $10M $90M 6

The Big Challenge Quality issues can surface at any point in the supply chain and production process. It is imperative to catch quality issues as early as possible in the supply chain. The costs of unresolved supplier quality issues can be devastating if they are discovered after a product has been introduced to the market. Therefore, it is critical to identify quality issues early in the supply chain to manage quality related costs and risk. Corporate Planning & Design Supplier Network Manufacturing Facilities Distribution Centers Consumers Issue Resolution Cost The 1-10-100 Quality Rule 7

Visibility Into the Supply Chain Is A Problem Companies have 100s to 1000s of vendors in the supply chain network 30% Of companies have limited visibility to tier 1 partners Tier 1 Tier 2 & 3 0% Of companies have limited visibility to tier 2 and tier 3 partners 45% of executives agree the leading challenges to supply chain efficiency include supplier performance and quality management - KPMG Global Manufacturing, Outlook 2013 8

Communication With Suppliers about Quality Despite investments in enterprise quality management systems, many companies continue to communicate with suppliers using manual and disconnected methods of communication. These methods result in limited ability to trace, manage and report on supply chain related quality issues. Manufacturer Quality Management Process Manual Communication Suppliers 9

Prevent Quality Issues in the Supply Chain With a more diverse supply chain, comes greater risk. Reducing this risk means increasing the number, frequency and length of supplier evaluations and audits. The growth and pace of supplier diversification is outpacing current structure and resources leading companies to seek ways to scale beyond current supplier quality and audit programs. How can I more effectively manage suppliers, comanufacturers & copackagers How do I limit waste and rework due to supplier quality How do I manage stock inventory due to supplier issues How do I get better visibility to supplier cost of quality 10

Best Practices For Managing Quality In The Supply Chain 1. Broaden supplier assessments 2. Define clear measurement program 3. Invest in infrastructure that supports visibility into the supply chain 4. Close the quality loop with suppliers 11

Step 1: Broaden the Scope of Supplier Assessments Most companies restrict supplier performance measurement and monitoring to less that 1/39 of the total supply base. Organizations typically focus supplier measurement and monitoring on: Suppliers that comprise the largest portion of spend Suppliers that have a strategic relationship with regard to a key product Suppliers that have a strategic relationship with the client company Failing to measure the majority of the supplier base means companies lack visibility on the level of quality in the supply chain. As a result, companies are more exposed to potential quality incidents and cost increases that can negatively impact profit and brand reputation. Companies need to invest in infrastructure that enables broader visibility into the supplier base. 12

Step 2: Establish Clear Measurement Programs The majority of companies measure supply chain partner performance in specific areas: Quality On-time delivery Service Price Total cost Contract compliance Responsiveness Challenges for measurement Large number of suppliers Disparate data sources Inconsistent goals and metrics Limited systems and analytical tools According to a study conducted by Aberdeen, just over half of enterprise leverage automation tools to support measurement and monitoring suppliers. 13

Step 3: Invest in Infrastructure A key challenge of ensuring quality in the supply chain is communication. Many companies maintain decentralized supplier quality functions to be responsive to needs. While this approach can ensure responsiveness to issues, it often also is characterized by limited information sharing and limited best practice sharing that could provide better economies of scale. Furthermore, many companies still maintain processes that are supported with email and fax and maintain data in isolated and siloed repositories. In short, the tools and techniques for managing quality in the supply chain have not kept pace with the evolution of the supply chain itself. Leading companies are investing in infrastructure that more tightly connects their supplier ecosystem and automates what were manual or disconnected processes. Enabling process based communications such as escalations and approvals and automating quality workflows such as Supplier Corrective Actions delivers improved visibility and control. This in turn translates into a lower cost of quality from reduced detection costs and avoided recalls. This fact is further supported by research done in the Fall of 2013 by the Aberdeen Group. In this cost of quality study focused on the positive impact of streamlined communication with suppliers, the top 33% of respondents consistently outperformed their peers in supplier performance benchmarks. Companies that deployed a supplier quality management solution reported an average success rate of 94% for New Product Introductions (NPI) vs 70% success for those companies that have not deployed such a solution LNS Research, 2013 QM Survey 14

Leveraging the Cloud From a technology perspective, cloud computing and particularly the software-as-as-service (SaaS) model provides an ideal medium for collaboration on quality. In the SaaS model, suppliers essentially log in to a manufacturer s existing EQMS system and enter data via the same screens and in accordance with the same business rules as those that prevail internally (with strict access and privilege restrictions). Communications related to specific quality processes like NCMRs and CAPAs take place within the same environment so they can be appropriately routed and tracked. Enterprise Quality Management System Cloud computing can turn the concept of fully integrated quality management for supply chains into a reality. Cloud computing can turn the concept of fully integrated quality management for supply chains into a reality. 15

Step 4: Closing the Loop Managing supplier related non-conformances and corrective actions is a key challenge for manufacturers. Many companies attempt to manage these critical interactions with old communication methods (for example email) or systems (for example ERP, PLM) that are not built to manage quality issues. Leading companies are leveraging technology to connect and integrate suppliers into quality management processes. These companies are extending the features and benefits of internal quality management systems to suppliers with the aim of streamlining communication and facilitating faster resolutions. Integrating the supply chain participants into the quality management ecosystem delivers several benefits: Suppliers would input quality-related data directly into a common database. It would serve as a single point of truth for both suppliers and manufacturers, and a trusted source from which manufacturers could easily extract data for purposes of supplier evaluation and management, as well as regulatory compliance. Workflows and processes to support quality would be standardized for all the members of a supply chain, so that it would be easy for everyone concerned with an NMRS or CAPA to understand where things stood. Communications would be centralized. Those related to moving a process forward (e.g. reminders or approvals) would also be automated. Suppliers and manufacturers would abandon their adversarial stances in favor of a collaborative approach to quality. 16

Conclusion Benefits from extending quality management practices into the supply chain 1. Visibility Identify issues early before they become costly quality incidents 2. Traceability Understand the root cause and source of quality issues in your supply chain 3. Accountability Ensure supply chain partners understand issues and resolution requirements in a timely manner 4. Profitability Mitigate quality related financial risk and improve supply chain efficiency 17

Business Value The Quality Maturity Curve Companies who have adopted an integrated enterprise approach to quality management (Level 4) are able to gain competitive advantage. Point Solutions Multiple systems Disconnected processes Q Q Q Q Q Global Processes Disparate Quality systems Integrated Processes Single Solution Cross functional integrated quality management systems MES QMS ERP CRM PLM Global Integrated Enterprise Quality Solution Integrated into supply chain via cloud Delivered on multiple platforms Consolidated reporting and analytics Mobile Excellence in End to End Quality Maturity TrackWise QualityView MES TrackWise Level 1 Level 2 Level 3 Level 4 QMS ERP CRM PLM CMOs Suppliers Supplier Collaboration 18

Resources To learn more about how supplier quality management, please visit www.spartasystems.com or check out the following resources: Webcast: Improving Quality & Efficiency through Supplier Collaboration Article: Take Control over quality in your supply chain Whitepaper: Managing Quality and the Globalization of the Pharmaceutical Supply Chain 19

Back Page Founded in 1994, Sparta Systems is the world s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Companies in life sciences, consumer products, discrete manufacturing and more, rely on Sparta. 1.888.261.5948 1.609.807.5100 sales@spartasystems.com www.spartasystems.com 20