Integrating ISO 9001 and ISO 14001

1. Integrating ISO 9001 and ISO 14001 Novo Nordisk BioChem North America Jennifer Pierce, QA Specialist

2. Overview of Novo Nordisk • Largest producer of industrial enzymes in the world. • Healthcare business produces diabetes care products (insulin) • Headquartered in Denmark. • Production facilities in Denmark, US, Brazil, China, Switzerland. • Sales offices throughout the world For more info: Visit our web site at http://www.novo.dk

3. Franklinton, NC Facility • Fermentation, Recovery, Granulation • Sales, Marketing, Regulatory Affairs • QC, Tech Service, Development/Research • Purchasing, Warehouse/Distribution • Waste Management, Engineering We employee approximately 350 employees on 3 shifts.

4. NNBNA- Franklinton, NC

5. Products produced with enzymes

6. Spreading Spent Biomass

7. Waste Water Irrigation

8. Laboratory Waste

9. Raw Material Unloading

10. ISO Background • ISO 9002 certified in 1996 • Re-certified to ISO 9001 in 1999 • Recommended for ISO 14001 certification in Mar 2000

11. Structure of Quality System Global Top Level Requirements Site Wide General and/or Cross-functional SOP’s Departmental Specific Requirementsand SOP’s

12. “Grass Roots” Implementation of ISO 14001 • Project called EQS “Environmental Quality System” • Decentralized implementation • Initial Management Roll-out • Steering Committee & Working Committee • Each employee trained in EQS program • Each employee participated in Aspect & Impact Analysis

13. EQS Organizational Structure • STEERING COMMITTEE: Responsible for direction and guidance implementation of ISO 14001. • WORKING COMMITTEE: Responsible for inter-departmental communication and implementation issues. Representatives from each functional area.

14. #1 Key Rule to Integrating • USE EXISTING DOCUMENTS WHENEVER POSSIBLE!!!!

15. Where did we use existing docs? • Corrective & Preventative Actions • Document Control • Records • Internal Audits • Training Programs • Operational control procedures in production and distribution • Change Control in production • Legal & Regulatory Requirements • Spill and Hazard Response (existing Safety SOP’s) • Equipment Maintenance

16. Corrective & Preventative Actions An Action Request must be initiated in the following cases: • A reoccurring problem that has negative effect on the quality of NNBNA products, services, development and optimization work. • A problem resulting in non-conforming product(s), including dispensations. • A reoccurring GMP issue that has negative effect on the safety of NNBNA products. • A reoccurring problem with an NNBNA product, process, or work related activity that adversely affects the environment An action request may also be initiated in the following cases: • As a preventative action to address a potential problem • Critical equipment problems • Process data analysis showing key process parameters to be outside the quality range specified in the Basis Directions • Unplanned process or development/optimization project deviations • Any departmental or facility problems that could result in a negative affect on NNBNA products, services, development and optimization work or the environment. • Any departmental or facility incident of non-compliance with environmental or safety regulations, or permit requirements.

17. Internal Audit Plan

18. EQS Awareness Training Quiz • What is EQS and what is it’s purpose? • Where is the environmental policy located at? • What is an impact to the environment? • Do you have any control over how your job affects the environment? • How does your job affect the environment? • If you see that an operation can or should be improved, can you do anything about it and if so what? • How do you clean up spills? • What would you do if you had an oil spill? • What are some significant impacts in this department? • Which of the top ten Targets and Objectives affect our department? • Where is the “Emergency Action Plan” located? • Who is responsible for EQS here at NNBNA?

25. Where did we write new docs? • Approximately 100 existing site-wide SOP’s • No more than 10 revised for EQS. • 12 new site-wide SOP’s written for EQS. • Hundreds of existing department SOP’s. • No more than 10 per dept revised. • Under 15 new department SOP’s • Examples: Hazardous Waste in Labs, Operation of Wet Scrubber • Approximately 25 Waste Management dept SOP’s written (were not part of ISO9001)

26. New Site Wide Docs • NNBNA Environmental Policy • EQS Guiding Document • Steering Committee Charter • Working Committee Charter • Environmental Aspect & Impact Identification • EQS Aspect Ranking & Significance Determination • Establishing Site Objectives and Targets • Identification of Legal & Other Requirements • EQS Management Reviews • EQS External Communications • Applicability of the ICC Charter to the NNBNA EQS • Environmental Compliance Auditing • Oil Spill Control & Countermeasures

27. EQS Commandments- Policy • Do it right! - Follow procedures to comply with regulations and NNBNA requirements. • Keep it clean! - Prevent pollution by following instructions, preventing releases, and containing any that do occur. • Make it better! - Do your part by suggesting ideas for improvement through the use of Preventive Action Requests.

28. Stumbling Blocks • The procedure that was the most time consuming to write and caused the most headaches was: Aspect & Impact Analysis • This process was re-done 3 times. It became easier to write the procedure after we had completed the process.

29. Aspect and Impact Analysis • The Steering Committee assisted each dept/area. • All activities at were evaluated. • A total of 864 aspects were identified and entered into a database.

30. Rating • Each activity and its associated aspect/impact was given an initial rating: • 1: Aspect needs attention or there is a high opportunity for improvement • 2: Possible opportunity for improvements • 3: Current controls are sufficient. Little or no opportunity for improvements • A total of 83 #1 ratings were identified.

31. Ranking • Aspects with #1 ratings were then ranked. • Ranking helps prioritize and determine significance • A total of 30 rankings were done, with some aspects combined, while others ranked separately.

32. Determine Significance • Anything above a score of 16 was considered significant. • Also did a “sanity check” to see if it made sense. • 1 additional aspect was considered significant even though its ranking was lower than 16. • A total of 11 aspects were considered significant.

33. Objectives & Targets • From the significance rating, a business practicability score was subtracted to give a final score. • Using the aspect with the lowest score from the ranking as the cutoff, anything with a higher score was used when considering objectives and targets. • A total of 14 aspects were used to set objectives and targets.

34. Summary of A&I Analysis • 864 aspects • 83 #1 ratings • 30 rankings • 11 significant aspects • 14 aspects used for setting objectives and targets.

35. Management Review • Decided to keep separate from quality management review initially to ensure proper focus by management. • Used same structure instead of re-creating. • Some elements are evaluated during both reviews (C/P actions, audits) • In the future will evaluate whether or not to combine.

36. Conclusion • Use existing documents as much as possible • Keep it simple • Involve as many employees as possible