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

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

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.

NNBNA- Franklinton, NC

Products produced with enzymes

Spreading Spent Biomass

Waste Water Irrigation

Laboratory Waste

Raw Material Unloading

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

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

“ Grass Roots” Implementation of ISO 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

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

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

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

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.

Internal Audit Plan

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?

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)

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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