1. Quality Metrics - Gain or Pain
Quality Metrics - Gain or Pain ? Practical experiences from AstraZeneca Sweden Operations
Rickard Fjaestad Gustafsson, Dir Quality Systems
ISPE Nordic, Annual Meeting 2015
26th November 2015

2. AstraZeneca’s largest high-tech manufacturing and supply site
Södertälje
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
AstraZeneca | Sweden

3. AstraZeneca has extensive research and manufacturing in Sweden
Mölndal
2 400
Södertälje
3 800
6 200
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
AstraZeneca | Sweden

4. Improvement story
AstraZeneca | Improvement

5. Improvement story
AstraZeneca | Improvement

6. ? Metrics "what you measure is what you get "
"if you can’t measure it, you can’t manage it"
Kaplan, R. S. and D. P. Norton 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
AstraZeneca | Metrics

7. Improvement story 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)
AstraZeneca | Improvements

8. Balanced Scorecard What you do to get there The result you get
Image retrieved from
Adapted from R.S. Kaplan and D. P. Norton, “Using the Balanced Scorecard as a Strategic Management System,” HBR (Jan-Feb 1996): 76
AstraZeneca | Metrics

9. Pitfall Lack of focus on internal processes ? AstraZeneca | Metrics
Harvard Business School, R.S Kaplan, Conceptual Foundations of the Balanced Scorecard, Working paper
C. Chapman, A. Hopwood, and M. Shields (eds.), Handbook of Management Accounting Research: Volume 3 (Elsevier, 2009).
AstraZeneca | Metrics

10. Bias Behavioural impact User variability System design Administration
AstraZeneca | Research

11. Dev -20 % Bias Behavioural impact * Original data has been altered
AstraZeneca | Bias

12. Bias Behavioural impact Dev, repeats Differing results
depending on what is
measured ?
AstraZeneca | Bias

13. Bias Definitions M QC WD EM SM QA Alignment between areas and between
“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.
Definitions M QC WD EM SM QA
Alignment between
areas and between
sites ?
AstraZeneca | Bias

14. = ? Bias User variability User options to interpret definitions?
Image from R.Fjaestad Gustafsson, SPP Progam essay ”Performance, Evaluation and Controls”, Warwick University, 2014
AstraZeneca | Bias

15. System design, behaviour
Bias
System design, behaviour
What are you trying
to achieve?
Investigation days
AstraZeneca | Bias

16. 2 Bias System design …per lot (Lot size variability)
…repeats (”undetermined”, ”other”)
…per unit, ppm
…per sample (Sampling plan)
AstraZeneca | Bias

17. System design
AstraZeneca |Metrics

18. Administrative burden
’Path of least resistance’
Measurement fatigue
Perceived lack of priority
Effort to interpret strategy abandoned, fall back on obvious operational objectives
AstraZeneca |Metrics

19. Quality 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. “
AstraZeneca | Culture

20. The LEAN thinking model
- connection between values, principles, methods and results
Values
Principles
Methods
Results
How to think
How to do things
Ways to behave
AstraZeneca | Bias

21. Quality culture
AstraZeneca | Culture

22. Quality 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
AstraZeneca | Culture

23. Opportunities Business processes AstraZeneca | Opportuníties
K. M. Eisenhardt och J. A. Martin, ”Dynamic capabilities: What
are they?,” Strategic Management Journal , vol. 21, pp. 1105–1121, 2000.
AstraZeneca | Opportuníties

24. Opportunities efficiency improvement
Metrics:
Input RFT
RFT
Leadtime
Devs -75%
Resource
re-allocation
enabled
AstraZeneca | Opportunities

25. AstraZeneca Sweden Operations in numbers
What metrics
really drive
your results?
AstraZeneca | Sweden