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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 Overview of Novo Nordisk Largest producer of industrial enzymes ... – PowerPoint PPT presentation

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Title: 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 SOPs
Departmental Specific Requirements and SOPs
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 SOPs)
  • 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 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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25
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)

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 AI 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
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