8 tips for cross functional quality success

8 TIPS FOR CROSS-FUNCTIONAL QUALITY SUCCESS

Driving Industrial Transformation. ©LNS Research 2016

Cross-Functional Quality: 8 Tips for Cross-Functional Quality Success


LNS Agenda

• About LNS Research• Survey Demographics Overview• Enterprise Quality Management Systems (EQMS) and Quality

Management Maturity • EQMS Drivers in Medical Devices• Technology and Quality Management Maturity• Cross-Functional Quality Practices and Benefits• Takeaways and Actionable Recommendations

©LNS Research 2016


About LNS Research

Our Mission isDriving Industrial Transformation

We are thought leaders and trusted advisors for Business, IT, and Automation executives

Our differentiators:Experienced analystsPrimary social researchDeep industry contactsInteractive data visualizations


Overall LNS Research Survey Demographics

LNS has benchmarked 700+ Quality executives, industry demographics include:


Digitalization andIndustrial Transformation Framework


Enterprise Quality Management System


Bringing Together Quality Data with EQMS

Quality management data is too valuable to be left in silos, even within the manufacturing environment


Disjointed vs. Harmonized Processes


Quality Maturity


Impact of Quality Maturity


EQMS Drivers in Medical Devices

Biggest Challenges Speeding Products from R&D to Patients



Issues in quality management are consistent



Processes automated using software


Evaluate Technology Maturity

• Technology should be deployed with the mindset that it will support (not replace) business process and human resources

• Tangible ROI

• Managing risk

• Cost of Quality across the value chain

• Supplier quality management

• Waste reduction

• NCRs

• Customer complaints

• Track & accelerate NPI


Cross Functional Quality Practices and Benefitsin Medical Devices

Benefits of Practice Deployment

Practice: Process Established to share compliance processes across functional areas

•7% Increase in Median Successful NPI

•Successful NPI = Meet time, volume and quality targets

•Quality Operational Excellence:Sharing processes (Process) establishesquality culture (People) distributed by enterprise software (Technology)



Practice: Ability to visualize risk factors across operations

•29% Increase in Median Successful NPI

•Successful NPI = Meet time, volume and quality targets

•Cross-functional Risk factors important for enterprise risk-based thinking; ISO 9001:2015




Practice: Closed-loop processes established to connect quality across design, manufacturing, and suppliers

•Shared process responsibility results in shared benefits

•Breaking quality out of siloed operations results in cross-functional improvement

•Including Suppliers extends Operational Excellence to supply chain




Practice: Suppliers are included in design for quality initiatives

•Engaging Suppliers early results in reduced Supplier Defect Rates

•Breaking quality out of siloed operations results in cross-functional improvement

•Including Suppliers extends Operational Excellence to supply chain



Takeaways and Actionable Recommendations

• Quality Maturity is driven by Operational Excellence, and higher Quality Maturity results in greater operational and financial performance

• Medical Device companies cite Quality Management and Supply Chain Issues as two of their top 3 challenges in Speeding Products from R&D to Market

• Medical Device companies should improve Quality Management Maturity by increasing focus on cross-functional Practices, specifically:

• Deploy Operational Excellence enhancements (People, Process, Technology) that connect Quality, Engineering, Manufacturing and Suppliers

• Focus on Design for Quality efforts that connect Quality, Engineering and Suppliers

• Clearly define and communicate Compliance, and use technology that allows sharing of these processes across multiple functions

• Leverage systems that enable cross-functional visibility to risk factors, driving increased collaboration and cross-functional continuous improvement

Driving Industrial Transformation. ©LNS Research 2016©LNS Research 2015

Thank you

8 TIPS FOR CROSS-FUNCTIONAL QUALITY SUCCESS

Sherry Dickson Solution Consultant at Arena Solutions

Quality Management System

AGENDA

About Arena

PLM - Product Lifecycle Management

8 Tips for Cross-Functional Quality Success

1. ‘Phase – In’ a Successful Product Launch through NPD / NPI

2. Supporting Supply Chain Optimization

3. Managing the Complexity of the Quality System Management

Summary

ARENA SOLUTIONS

CUSTOMERS• Pioneered Cloud PLM in 2000

• 900+ Customers Worldwide

• Scales from Start-ups to Fortune 500

• Accelerating Customer Innovation

Speed release of new products Enable supply chain collaboration Improve quality Meet compliance directives Improve profitability

PLM – PRODUCT LIFECYCLE MANAGEMENT

New Product Development and Introduction

Arena Solutions:

”Product Lifecycle Management —integrates people, data, processes and

business systems. It provides product

information for companies and their

extended supply chain enterprise.

Today, we will review NPD, Supply

Chain Optimization and the Quality

Management System, in a PLM

environment”

‘PHASE –IN A SUCCESSFUL PRODUCT LAUNCH THROUGH NPD / NPI

‘PHASE –IN A SUCCESSFUL PRODUCT LAUNCH THROUGH NPD / NPIADDRESSING PROJECT COST AND DELAYS

Current Issue

Reason Project Schedule Impact

PLM Solution

Project is not visible to the Cross Functional team

Most projects are managed in Excel or MS Project, and placed on a server.True status not always current and the functional team is not aware of NEW assignments or DELETED assignments.

Projects tasks not addressed in time, and results in a delay of the schedule.

Generate NPD / NPI projects in PLM where the team will always have the most current status and assignments are sent directly to the assignee via email.

Components Available for Re-use

Designer could spend additional time designing in a part that already exists

Generates excessive cost from a design, schedule and procurement standpoint.

Part numbers, AML info and meta data entered into Arena – available to all internal & global team members

Deliverables are poorly controlled

Placed in a server where the most effective revision of key documents are SUPPOSE to be stored, but are not, OR the location of the files are SUPPOSE to known & ACCESSIBLE by all impacted parties, but are NOT.

Purchasing orders down-rev parts; Manufacturing builds to outdated drawings and BOMS. This generates scrap cost and negatively impacts the schedule.

Arena PLM becomes the official archive of all product and process related files.

Deliverable of NPD files, are also required in other projects.

Duplicates of a file are placed in multiple projects, this can result in someone forgetting to replace the older files.

This can initiate scrap cost and create a schedule slip.

Place a file into Arena once, and ‘share’ with other projects or PLM objects such as a Quality process, document or part number.

RecordsParts

AssembliesFG’s

Quality Processes/

Change ControlDocuments External

Links

PLM

‘PHASE – IN’ A SUCCESSFUL PRODUCT LAUNCH THROUGH NPD / NPI

SUPPORTING SUPPLY CHAIN OPTIMIZATION

Wikipedia:

“Supply chain optimization is the

application of processes and tools to

ensure the optimal operation of a

manufacturing and distribution supply chain.…..”

Supply Chain Optimization

Supply Chain Optimization

SUPPORTING SUPPLY CHAIN OPTIMIZATION

SUPPLIER QUALITY MANAGEMENT SUPPLIER COLLABORATION SUPPLIER COST MANAGEMENT

SUPPORTING SUPPLY CHAIN OPTIMIZATIONSUPPLIER COLLABORATION (CONTINUED)

MANAGING THE COMPLEXITY OF THE QUALITY SYSTEM MANAGEMENTWHAT IS A ‘QUALITY MANAGEMENT SYSTEM’?

Quality Management System

Wikipedia:

“A quality management system (QMS) is a

collection of business processes focused on

consistently meeting customer requirements and

enhancing their satisfaction. It is expressed as the

organizational structure, policies, procedures,

processes and resources needed to implement

quality management…..”

FDA:

“Quality System [21 CFR 820.3(v)]: means the

organizational structure, responsibilities,

procedures, processes, and resources for

implementing quality management.. …..”

https://en.wikipedia.org/wiki/Business_process

https://en.wikipedia.org/wiki/Quality_management

MANAGING THE COMPLEXITY OF THE QUALITY SYSTEM MANAGEMENTPREPARING YOUR QUALITY MANAGEMENT SYSTEM

Country: Selling in US Europe China Canada

Regulatory System(s):

FDA 21 CFR Part 820

Quality System Regulation

ISO 13485Quality System Management


ISO 13485Quality System

Management


Example of additional

regulations and standards

that may apply

FDA 21 CFR Part 11

Electronic Records & Signatures

ISO 14971:2007Medical Devices

Application of risk management

to medical devices

93/42/EEC – Medical Devices Directive (MDD)

CFDA (China Food & Drug Admin) Med Device Regs

CMDR (Canadian Medical Device

Regulations)

FDA 21 CFR Part 801

General Device Labeling

ISO 15223-2:2010Medical Devices

Symbols to be used with labels,

and information

90/385/EEC - Active

Implantable Medical Devices Directive (AIMDD):

CFDA Guidance on IFU, Labels,

pkg…

FDA 21 CFR Part 806…Reports of

Corrections & Removals

IEC 62304:2006Medical Device

Software

Clinical trials in Europe must be

pre-approved by a European

Competent Authority.

CFDA Order No. 15

YOUR QUALITY MANAGEMENT SYSTEM

MANAGING THE COMPLEXITY OF A QUALITY MANAGEMENT SYSTEMTHE VIEW FROM PLM

Change Requests ECR DCR MCR

Product Record & files

FG Assembly Sub-Assy Mech Custom Firmware Electrical

~ 60 Product Records

Part Compliance

RoHS WEEE REACH CE UL LVF

DOCUMENT & files

Policy IFU’s Requirements SOPs Instructions

~ 13 Doc categories,

60 Doc sub-categories

RECORDS

DMR DHR Training Design Review Meeting Minutes

~ 32 types identified by ISO

Change ProcessECO DCO MCO

DeviationTHE PRODUCT

RECORD& CHANGE CONTROL

ANALYTICS & REPORTING

PROGRAMS

PROJECTS Part 803MDR

ISO 14971Risk Mgmt

Part 814PMA

Part 58Non-Clinical Lab Studies

Part 812 IDE

Part 807510K

Internal Audit Plan &

Schedule

Design Control /

DHF

PROJECTS

Supplier Qualification

NCMRCAPAAUDIT /483

Supplier Scorecard

ComplaintsSCARQUALITY PROCESSES

PROGRAMS

• NPD / NPI projects are more effective when visible by global team

• Task’ deliverables are more manageable when embedded

Supply Chain Optimization:

NPD / NPI:

• Invite your key CM into your Arena workspace to expedite time to market

• Collaborate with your CM, and their suppliers for increased efficiency and reduction in errors

Quality Management System:• Systematically update embedded, supported files, with the most effective revision• Place your QMS binder ‘On Line’ and you’re always ready for inspection

SUMMARY: ARENA PLM FOR CROSS-FUNCTIONAL QUALITY SUCCESS

These processes will manage your key processes, in the CLOUD! -increase efficiency -expedite time to market -and decrease operational costs

Arena PLM…

www.arenasolutions.com

866.937.1438

Thank you

8 tips for cross functional quality success

Software

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