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1 Measuring Performance, Driving Excellence Click to edit Master title style ISPE Nordic, Stockholm WTC November 26 th 2015 Dr. Nuala Calnan, Research Fellow, Dublin Institute of Technology 11/26/2015 1

2 Driving Patient Focused Excellence Patient Focused Excellence Nuala Calnan, PRST All rights reserved

3 Understanding the DNA Building Blocks The best potential to sustainably impact the outcomes that matter to the patient lie in the integration of three critical areas of influence for the pharmaceutical industry operational excellence, knowledge excellence and cultural excellence. Although there are many programmes and initiatives of varying levels of maturity across these areas of influence within the industry, the majority are not well integrated. The opportunities for benefit to flow to the patient (and the business) are therefore not fully realised. Nuala Calnan, PRST All rights reserved

4 The Excellence Framework : Knowing, Doing, Being The Excellence Framework combines the cultural excellence of a learning organisation with excellence in knowledge creation and utilisation, in order to deliver operational excellence based on a relentless restlessness for improvement The desired Culture of Excellence is one based on a reflective Learning Culture where people become proactive problem solvers and perpetual learners as members of Learning Teams 4 Nuala Calnan, PRST All rights reserved

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6 FDA Guidance Issued - What Did We See? Key items product v s site 10 data collection points 4 metrics Covered Establishments / Reporting Est. Optional metrics Data collection mechanism. 11/26/ Source: IPQ July / August 2015

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9 ISPE Quality Metrics Initiative The Journey Thus Far Click to edit Master title style Start Small, Learn and Evolve 11/26/2015 9

10 ISPE Wave 1 Pilot What Did We Learn? Feasible to collect standardized set of metrics Few companies aggregate metrics across supply chain to be able to report at product, differentiated by site Level of Burden not to be underestimated Understanding organizational context is crucial Start with a targeted set of relatively well established metrics The Wave 1 Pilot also provided some key insights in relation to the prevailing quality culture within an organization that merit further exploration. 44 Sites, 18 Companies, 14 Metrics Key benefits reported from Pilot Participants: Gaining a deeper understanding of the standardized metrics definitions and design Establishing a centralized submissions process trial Developing access to a benchmarking report that allowed them to examine progress against peers 11/26/

11 ISPE Wave 2 Pilot What are our Objectives? Evolve data set across segments, geographies and time to further the learnings from Wave 1 and evaluate trending patterns Test the proposed FDA metrics help develop robust definitions understand data collection challenges Evaluate logistics and effort of gathering data at a product application level Continue to develop measures, tools and dialogue related to Quality Culture and Process Capability to facilitate ongoing industry self-development and assessment Enable continued objective and data driven dialogue with FDA and other Health Authorities

12 ISPE Wave 2 Pilot Metrics Quantitative metrics Culture indicators Survey-based metrics Total complaints rate 1,4 Critical complaints rate 1 Recall events Lot acceptance rate 1,4 Invalidated OOS rate 1,4 Right first time rate Deviations rate 1 Recurring deviations rate CAPAs with preventive actions Planned maintenance Employee turnover Human error deviations Deviations with no assigned root cause CAPAs requiring retraining 4 APR approvals 4 1 To be tested in multiple variants (e.g. lots attempted vs. dispositioned, packs released vs. lots released, lots tested vs. total tests performed) 2 Only for sites which have not participated in wave 1 3 Will include additional questions to the ones tested in wave 1 4 Aligned with the Federal Register Notice guidance. Additionally OOS rate and Lots pending disposition for 30+ days can also be calculated from the data 5 questions to assess how standardized metrics can assist prediction of drug shortages Quality culture survey 2 Process capability 3 Drug Shortages 5 In addition to site data collection, participating companies will compile logistics and effort of gathering product data at application level (on 2-5 products) for complaints rates, lot acceptance rate and invalidated OOS

13 ISPE Quality Metrics Wave 2 What s Next? Data lock for Wave 2 pilot analyses Nov 30 Wave 2 Pilot enrollment Data collection and submission Industry analysis Individual reports Jun 2015 Launch Quality Metrics wave 2 Pilot We are here Oct 30 Data lock for analyses of selected date for the FRN response Feb-Mar 2016

14 Quality Metrics Vision A Journey Starter Set of Metrics Reported to FDA Benefit: Risk-based inspection frequency Additional measures to be discussed during inspections Potential Benefit: Simplification of regulatory process for sites in good standing Industry led work space to further develop metric program Reporting accessible to multiple agencies, based on firms granting view access Goal: facilitate regulatory convergence on requests for quality metrics Potential Benefit: Achieving transparency of quality performance across industry. Turning quality into a competitive advantage.

15 Cultural Excellence Promoting Behavior Based Quality Click to edit Master title style An Update From the ISPE Quality Culture Team 11/26/

16 Thought Leadership There is the virtuous cycle of execute, monitor, measure, and improve that is the quality system part of the modern concept of quality. You can do all these things and have wonderful systems and measurements, have wonderful procedures but if you do not have a quality culture in which people feel free to speak up there is problem. The people doing the work they have to own it. They have to feel their relationship to the patient and that what they are doing benefits the patient. They have to feel safe to speak up if something is going wrong. They have to feel empowered. That is really important. Dr. Janet Woodcock, CDER Director ISPE Quality Metrics Summit Baltimore, April 2015 Source: IPQ Monthly Update April/May 2015, Vol. 6, No. 3.

17 Thoughts from this side of the pond Impact of organisational culture: is your company behaving well? The impact of organisational culture and senior management behaviour on data governance must not be underestimated. Indicators with relevance to data governance provide a measure of the workforce s understanding and reporting behaviour, combined with the management s receptiveness to bad news. Is error or system failure reported as an opportunity for improvement, or is there a mind-set around not wanting to cause trouble? To remove the incentive to manipulate, re-create or amend data, the managerial response to bad news must be fair and consistent, and not based on a fear of consequences. Led from the top; empowered from below Organisational culture is not just addressed by senior management putting the right words in a mission statement. I have seen that communicating expectations clearly to staff at all levels in the company, and then living by these principles, is the key to success. Leadership, engagement and empowerment of staff at all levels in the organisation can then combine to identify and deliver systematic data integrity improvements where good practice becomes automatic. Source: We are what we repeatedly do. Excellence, then, is not an act but a habit.

18 Current Update ISPE Position from ISPE on Quality Quality Culture Culture Team Acknowledging the key influential role of Quality Culture with respect to the capture and reporting of quality metrics the ISPE Quality Metrics Core Team formed a Quality Culture Sub-Team in July 2014 The Quality Culture sub-team comprises of a cross section of Industry large and mid-sized pharma, incorporating both innovator and generics organisations, key industry suppliers and academia. The team has met bi-weekly since July 2014 with an initial focus on identifying and sharing the variety of practices currently used. A repository of approaches, practices and tools were captured for detailed review No single tool or practice provides a quantitative or qualitative silver bullet as a means to establish the current health of the Quality Culture within an organization. Six dimensions teams were formed July 2015, developing a program of tools, training and templates for companies to use to inform their cultural excellence programs. These tools will be published through ISPE during 2016 and 2017

19 Who we are

20 Six Dimensions of Cultural Excellence The ISPE Quality Culture Sub - Team proposes that the promotion of a relentless restlessness towards improvement in Quality Culture necessitates a 360 approach to Cultural Excellence A holistic Quality Culture Framework has been developed, entitled the Six Dimensions of Cultural Excellence

21 What has the team been up to?

22 Quality Culture In the News

23 What is Keeping Us Busy Now?

24 Dimension 1 Leadership & Vision Identify best-practices and leader-led behaviors most directly linked to positive culture transformation. Tools under development include: Leader interviews Intended to capture leader shared stories successes and learnings in their own words. Looking for commonality in actions (leaderled behaviors) or strategy (best practices). Leader Risk Assessment Assesses risks associated with turnover of key leaders and maturity / experience of current leaders.! Shaping Cultural Excellence Interview Interview questions for Key Site Leaders on Cultural Transformation Programs in Quality, Safety or Operational Excellence Design: Program Name: Purpose: Target Audience: Where implemented and when: Intended Results: Execution: Duration: What was the messaging strategy: Were different approaches necessary or used for different organizational group or levels?

25 Dimension 2 Attitudes and Mindsets This group is focusing in on the relationship between the prevailing employee attitudes and mindsets and the actual behaviors practiced in the day-to-day execution of tasks. Tools under development include means of assessing the success of Engagement Strategies, Peer Involvement and Employee Ownership Maria Meier, Senior Advisor/Director, Senate Democratic Diversity Initiative The work of this group examines the effectiveness of the Leadership and Vision activities Examining Provide how connection much the employees for every own employee it about Establishing how their how efforts each employee matter feels to the about patient their relationship and the to the patient company quality mission. Understanding the level of empowerment

26 Dimension 3 Gemba Walks: Manage for daily improvement Gemba walks offer a key opportunity for coaching and mentoring, knowledge sharing and early issue intervention. Practicing Gemba helsp to understand the influences which inform the decisionmaking on the shop floor which directly impacts quality and the continuous improvement mindset The objective of this team is to define critical success factors and best practices for effective GEMBA walks as well as training, tools and templates that support the effective implementation of Gemba walks Talking the Talk! Gemba is principally about the Dialogue Opportunity for management engagement, learning, and recognition

27 Dimension 4 Leading Quality Indicators (LQI) & Triggers Indicators and triggers represent the information and actions taken at specific thresholds that guide incident recognition, response, and recovery The Leading Quality Indicator Model: Changing Behaviours, Measuring Results A set of quantitative measures of the behavioural changes which enable the delivery of enhanced quality regulated products called the Leading Quality Indicators (LQI) Index. These measures target behavioural change across the key operational areas of Patient, People, Places, Prevention and Performance Reinforcement.not Enforcement Measuring what Matters Monitoring for Risk Triggers 27 Source: Crisis Standards of Care: A Toolkit for Indicators and Triggers, Dan Hanfling, John L. Hick, and Clare Stroud, Institute Of Medicine Of The National Academies

28 Monitoring the Risks Designing Measures for IMPACT

29 Dimension 5 Oversight & Review Focus on the necessary management monitoring system (including reviews by Leaders of the right combination of key data and observations) needed to aid Leaders in forming a holistic assessment of an organization s Quality Culture at an Enterprise level. This team will develop relevant and practical management monitoring system tools (e.g. best practices, templates, governance). Providing the Link! Enabling the link between management oversight and risk management/risk prioritization through the use of these tools. Visibility, Ownership Action.

30 Example Oversight & Review Tool Highlights best practices and areas of focus. Leadership & Vision Mindsets & Attitudes Assessment & GEMBA LQIs & Triggers Structural Enablers Component 1 Component 2 Component 3 Component 1 Component 2 Component 3 Component 1 Site A R R R R Y R R Y R R G Y R Y G Site B Y Y R G G G G G R Y R G Y Y G Site C G G G Y G G G G Y G G G G G G Site D Y Y R Y G Y G G R Y Y Y Y Y G Site E G G R G G G G G G Y G G G G G Site F R R R Y G Y Y Y G Y Y R Y Y G Site G R R R Y G Y Y Y Y Y R R R R Y Site H G G G G G G G G G G G G G G G Site I G G Y G G G G G G Y G G G G G Site J Y Y R Y G Y Y Y Y Y Y Y Y Y G Site K G G R Y G G G G G Y G G G G Y Site L G G R Y G Y Y G G Y G G Y Y G Site M R R R Y G R R R R Y R R R R G Component 2 Component 3 Component 1 Component 2 Component 3 Component 1 Component 2 Component 3 Horizontal view indicative of site performance Vertical view indicative of cultural component performance from a global/enterprise perspective.

31 Dimension 6 Cultural Enablers Focus on Cultural Enablement: 1. Organizational Enablers: Learning Organization Development- Enabling Recognizing Change and Aligning Behaviors Recognition System - Recognizing the right behaviors 2. Continuous Cultural Improvement Proactive Problem Solving Getting to True Root Cause Enable a Learning Organization! One that continuously improves by aligning key performance indicators for each system with behavioral indicators (throughout organizational levels) enabling cultural change, recognizing and rewarding appropriate behaviors

32 Spreading constructive beliefs and behavior from the few to the many Sincere gratitude to all the volunteers on the Quality Culture dimension teams Click to edit Master title style Interested in joining the effort? Sutton & Rao, Scaling Up Excellence (2014) Contact: 11/26/