Quality Metrics - Gain or Pain ? Practical experiences from AstraZeneca Sweden Operations Rickard Fjaestad Gustafsson, Dir Quality Systems ISPE Nordic, Annual Meeting 2015 26 th November 2015
Jan 21, 2016
Quality Metrics - Gain or Pain ?Practical experiences from AstraZeneca Sweden Operations
Rickard Fjaestad Gustafsson, Dir Quality SystemsISPE Nordic, Annual Meeting 2015 26th November 2015
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Södertälje
AstraZeneca | Sweden
AstraZeneca’s largest high-tech manufacturing and supply site
Sweden Operations activities include manufacturing of active pharmaceutical ingredients, formulation, tabletting, filling and packing of finished products
Launch site for new medicines in form of tablets and capsules entering the global market
Accounts for more than 35% of AZ’s total sales value
Runs one of the largest tablet manufacturing plants in the world, producing approximately 10 billion tablets every year
Produce 30 different medicines for more than 100 markets
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AstraZeneca has extensive research and manufacturing in Sweden
AstraZeneca | Sweden
• Mölndal is one of three strategic Research & Development centers within AstraZeneca
• Södertälje is AstraZeneca’s largest high-tech production and supply site
• In Sweden the AZ Nordic Marketing Company is responsible for the marketing & sales of our medicines and they have their offices in Södertälje
Södertälje3 800
Mölndal2 400 6 200
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Improvement story2007 -2008
AstraZeneca | Improvement
0
2
4
6
8
10
12
2005 2006 2007
%
Rejection
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Improvement story2007-2008
AstraZeneca | Improvement
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Metrics
AstraZeneca | Metrics
"what you measure is what you get "
Kaplan, R. S. and D. P. Norton. 1992. The balanced scorecard - Measures that drive performance. Harvard Business Review(January-February): pp71-79.W. Edwards Deming, The New Economics for Industry, Government, Education, 2nd Ed
"if you can’t measure it, you can’t manage it"
?
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Improvement story
AstraZeneca | Improvements
Success attributed to
• ”Copy with pride” (early adoption of standardization)
• ”Common language” (early adoption of business process concept)
• Cross-functional work (early adoption of supply system; quality leadership,
responsibilities, empowerment)
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Balanced Scorecard
AstraZeneca | Metrics
Image retrieved from http://balancedscorecard.org/Resources/About-the-Balanced-ScorecardAdapted from R.S. Kaplan and D. P. Norton, “Using the Balanced Scorecard as a Strategic Management System,” HBR (Jan-Feb 1996): 76
What you do to get there
The resultyou get
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Pitfall
AstraZeneca | Metrics
Harvard Business School, R.S Kaplan, Conceptual Foundations of the Balanced Scorecard, Working paper 10-074C. Chapman, A. Hopwood, and M. Shields (eds.), Handbook of Management Accounting Research: Volume 3 (Elsevier, 2009).
Lack of focus oninternal processes ?
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Bias
AstraZeneca | Research
• Behavioural impact
• User variability
• System design
• Administration
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Bias
AstraZeneca | Bias
Dev-20 %
Behavioural impact
* Original data has beenaltered
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Bias
AstraZeneca | Bias
Behavioural impactDev,
repeats
Differing results depending on what ismeasured ?
Bias
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Definitions
M
M M
MM
M
QC
WD
EM SM
QA
“FDA intends to carefully review data submitted in response to its requests, to help inform decisions about additional quality metrics data requests the Agency may make in the future.
Alignment betweenareas and between sites ?
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Bias
AstraZeneca | Bias
User variability
?
Image from R.Fjaestad Gustafsson, SPP Progam essay ”Performance, Evaluation and Controls”, Warwick University, 2014
User options to interpretdefinitions?
=
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Bias
AstraZeneca | Bias
System design, behaviour
Investigation days
What are you trying to achieve?
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Bias
AstraZeneca | Bias
System design
…per lot (Lot size variability)
…repeats (”undetermined”, ”other”)
…per unit, ppm
…per sample (Sampling plan)
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System design
AstraZeneca |Metrics
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Administrative burden
AstraZeneca |Metrics
• ’Path of least resistance’• Measurement fatigue• Perceived lack of priority• Effort to interpret strategy abandoned, fall back on
obvious operational objectives
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Quality culture
AstraZeneca | Culture
FDA recognizes that any individual data point or quality metric is not solely indicative of the state of quality of the establishment or products; rather, FDA intends to use this information in context.
FDA acknowledges the importance of quality culture to the overall state of quality of the product, process, and commitment to quality. We also recognize that many companies measure quality culture and encourage this practice. “
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm455957.pdf
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The LEAN thinking model
AstraZeneca | Bias
- connection between values, principles, methods and results
Values
Principles
Methods
Results
How to think
How to do things
Ways to behave
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Quality culture
AstraZeneca | Culture
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Quality culture
AstraZeneca | Culture
Quality Culture drivers:
• AZ Supply system• ”LEAN Leadership”, ”Right From Me”, ”Right First time”• Senior leadership Townhall meetings• Senior leadership webcasts• AZ Values (”we do the right thing”)• ”Development week”• ”Culture Tree”• Pulse surveys, FOCUS, Springlife• ”Dialogue day”• Gemba walks
Opportunities
23 AstraZeneca | Opportuníties
K. M. Eisenhardt och J. A. Martin, ”Dynamic capabilities: What are they?,” Strategic Management Journal , vol. 21, pp. 1105–1121, 2000.
Business processes
Opportunitiesefficiency improvement
24 AstraZeneca | Opportunities
2013 2014 20153000
3200
3400
3600
3800
4000
4200
4400
4600
4800
5000
0
5
10
15
20
25
30
35
0
16.7 %
30.6 %
Masterdata, productivity
# changes % change/fte vs 2013
Metrics:• Input RFT• RFT• Leadtime
Devs -75%
Resource re-allocationenabled
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AstraZeneca Sweden Operations in numbers
AstraZeneca | Sweden
What metricsreally driveyour results?
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