THE CASE FOR QUALITY: MOVING FROM COMPLIANCE TO PERFORMANCE IN THE REGULATORY WORLD NAME: Ron Lear TITLE: CMMI Institute Architect ORGANIZATION: CMMI Institute
Learning Objectives Discuss the drawbacks of a compliance-only focus in regulatory environments Get a notional timeframe for implementing a performance-based quality program with lasting cultural impact and improved patient safety at the ecosystem level Discover a hybrid approach including a quality and performance improvement program, coupled with a robust change management framework and model
Any regulation or quality standard, by definition, requires some focus on compliance The regulatory community leverages and depends on various standards for performance and quality Standards and regulations are critical, providing an objective framework and baseline for measurement, evaluation, control, and improvement However, standards & regulations are a means to an end, not an end in themselves MOST people and organizations lose track of this important concept and it usually ends up driving the wrong behavior
Focusing on compliance frequently assumes quality performance is an automatic result Compliance
The two focuses need to be in balance Fosters lasting organizational innovation, agility and improvement Appropriate levels of control and adherence to a standard Compliance data plugs back in to performance indicators Compliance Objective data related to business performance Qualitative as well as quantitative indicators Performance Focus of Approach
Compliance-centric focus typically assumes that quality/performance is a guaranteed outcome Tendency to become additional level of administrative overhead without clear value to bottom line or patient quality Tendency to inflexibility puts longterm change and improvement at risk Compliance Fosters lasting organizational innovation, agility and improvement Objective data related to business performance Qualitative as well as quantitative indicators Performance Focus of Approach
In fact, a primarily compliance-based focus can be disruptive to performance Tendency to become additional level of administrative overhead without clear value to bottom line Fosters lasting organizational innovation, agility and improvement Objective data related to business performance Tendency to inflexibility puts longterm change and improvement at risk Qualitative as well as quantitative indicators Compliance Performance Focus of Approach
In fact, a primarily compliance-based focus can be disruptive to performance Focus of Approach
The regulatory community is beginning to see the outcomes and risks of a compliance-only focus Recent trends in and changes to international models and standards add or emphasize performance Examples indicate that the quality community as a whole has not adequately addressed the vital importance of performance Compliance=adversarial approach, SCAMPI Appraisal=safe, collaborative approach Ad adversarial approach means people tend to clam up on issues vs. focus on improvement opportunities The compliance-only focus is NOT achieving the goals and objectives for better patient safety and care
These drawbacks are increased with complex business models and market conditions Additional complications arise when the business itself is complex: Multiple locations Multiple types of business, domains or product lines (within a single business) Long historical operations with entrenched bureaucracies Evolving marketplaces, requiring new capabilities Limited budget and resources create additional pressures, often driving compliance to become the only focus
Hybrid approach leverages top-down, horizontal-out, and bottoms-up implementation approaches Replace and/or augment the audit approach with an interactive, protected approach Over time, senior support and word-of-mouth combine, and the initiative gains momentum and credibility Critical mass is reached when the implementation is perceived as standard practice by all levels of staff, not just quality team or leadership Implementing continual improvement in a complex business environment requires coordinated implementation Senior managers (and clients) see and emulate success, spreading quality practices Quick wins that demonstrate value Production line staff have ownership for the improvement because their voice is listened to and acted upon Senior Management Buy-in Established, Continuously Improving Quality Program Staff Input & Buy-in Traditional top-down approach empowers and validates organization-wide change
Linking quality to performance (patient safety/quality vs. compliance) makes the improvement program a business priority Continuously emphasize performance (i.e. patient safety and results) as the foremost and lasting highest priority Operational approach links accountability with delivery Product/manufacturing teams own and drive quality Quality staff facilitate, assist, and enable, but the work unit (production line teams) OWN the process improvement
An effective quality and performance program integrates seven key aspects 1. Identify a framework that will accommodate a majority of existing business practices AND make it non-adversarial to participants to continuously improve 2. Leverages, but improves the existing corporate culture 3. Use strategically focused communication message and venues 4. Apply parallel change management efforts, from the first through the last 5. Longer deployment enables organic deployment 6. Build quality performance expectations into each stage of the business lifecycle drive the change with data 7. Ensure ability to track and measure, both internally and externally
MEDICAL DEVICE QMM PROGRAM PROPOSED ELEMENTS Participant Status Status definitions: good standing, increased oversight, regulatory follow-up, Implications of status Conflict resolution Voluntary/involuntary exit Medical Device Industry Enrollment Appraisal Metrics Communicatio n Definition and selection of participants FDA recognition/ support for participants Expectations of participants ROI success stories Investment Training of LA s and ATMs Costs identification Specialized LA s SCAMPI C appraisal with MedDev guidance Check-in appraisal Continuous Improvement Program Model tailoring (guidance, profiles, etc) Training (program and industry) Appraisal results for FDA Appraisal results deidentified Performance metrics de-identified Data repository FDA communication plan (performance and status) Industry best practices Industry performance tracking
MEDICAL DEVICE CASE FOR QUALITY QUALITY MATURITY MODEL OBJECTIVES Objective: Develop a program which leverages CMMI as the standard by which a Develop a program which leverages CMMI as the standard by which a medical device organization may measure its capability to produce quality devices, and in return, receive incentives from FDA based on their engagement. Completed POC to prove out the mechanics & value of the modified CMMI model. Discovery style was determined to be enough to open the discussion of FDA incentives. Completed Pilots to demonstrate industry could use it and find value in it. Scalable to size and type of organizations (Innovize, CVRx & J&J). Determined need for 90d checkpoint in order for FDA to feel comfortable with any incentives. Held Panel between Industry and FDA to hear companies experienced in the CMMI model. Its about the right metrics and culture, not the score. Appraisals are experiences, not scored audits. Achieved common understanding of the model
MEDICAL DEVICE CASE FOR QUALITY QUALITY MATURITY MODEL OBJECTIVES A culture of quality and continuous improvement and learning across an organization, and an entire INDUSTRY An ECOSYSTEM of Quality Reduced defects / rework Reduced costs Decreased time to market Increased Customer Satisfaction/Experience
Aug 16 Sep - Nov 16 Oct 16 POSITIVE FEEDBACK 3 Pilots: Conducted three CMMI SCAMPI C appraisals tailored for the medical device industry. Pilots represented: contract manufacturer, large product developer and early-stage in clinical testing How valuable was the appraisal? Low (0%), Medium (66%, 17), High (34%, 9) Were there any appraisal assessment areas that conflicted with regulatory requirements? 100% No (26/26) Did the appraisal identify areas or processes that could improve how work is performed to improve product quality? 98% Yes (25/26) Did the appraisal accurately identify the culture of the leadership s value of quality and resourcing to monitor, assure and improve product quality? 100% Yes (26/26)
Monitoring and managing performance helps keep the focus on business needs Metrics need not be developed from scratch Business types have industry performance metrics and client ratings Established businesses have existing internal business measurement practices Use the metrics to focus attention on performance It IS important to regularly report performance metrics and trends to the regulatory agency Patient outcomes Process performance/continual improvement ratings Internally critical metrics Other leading indicators
Managing change is as important as managing quality for the organization and the individual Improving quality in an agile and flexible manner is a change for most, and needs to be managed accordingly
Keep metrics and analysis on a primarily customer (patient)-based focus Tying results to a common model (e.g. the CMMI) makes improvement possible at the INDUSTRY level creates the foundations of ecosystem improvement Traceability from the primary objective (patient safety and quality) all the way through the quality value chain/life cycle is CRITICAL but usually overlooked or underappreciated
Conclusion Quality programs that emphasize performance for program and business results will always be more successful than those that primarily focus on compliance Quality for the sake of compliance is an outdated concept only a focus on ensuring performance and customer/patient quality business delivery will let it become an established part of an organization s culture and value proposition A focus on compliance risks rigidity, when corporations often need agility, flexibility and innovation The CMMI (and SCAMPI method) are providing a full end-to-end view of quality in an continual improvement context (vs. compliance)
QUESTIONS/COMMENTS? Thank you! Ron Lear CMMI Institute rlear@cmmiinstitute.com This document is confidential and intended solely for the client to whom it is addressed.