Integrating ISO 9001 and ISO 14001

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Integrating ISO 9001 and ISO 14001

• Novo Nordisk BioChem North America
• Jennifer Pierce, QA Specialist

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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
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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.
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NNBNA- Franklinton, NC
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Products produced with enzymes
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Spreading Spent Biomass
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Waste Water Irrigation
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Laboratory Waste
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Raw Material Unloading
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ISO Background

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

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

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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.

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1 Key Rule to Integrating

• USE EXISTING DOCUMENTS WHENEVER POSSIBLE!!!!

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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 SOPs)
• Equipment Maintenance

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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.

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Internal Audit Plan
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EQS Awareness Training Quiz

• What is EQS and what is its 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?

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Where did we write new docs?

• Approximately 100 existing site-wide SOPs
• No more than 10 revised for EQS.
• 12 new site-wide SOPs written for EQS.
• Hundreds of existing department SOPs.
• No more than 10 per dept revised.
• Under 15 new department SOPs
• Examples Hazardous Waste in Labs, Operation of
  Wet Scrubber
• Approximately 25 Waste Management dept SOPs
  written (were not part of ISO9001)

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Summary of AI Analysis

• 864 aspects
• 83 1 ratings
• 30 rankings
• 11 significant aspects
• 14 aspects used for setting objectives and
  targets.

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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.

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Conclusion

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