The Value of an EHS Management of Change
Process
Richard Hirsh, MPH CIH FAIHA
Director, EH&S
Nektar Therapeutics
December 6
th
, 2017, CIHC Professional Development Conference, San Francisco, CA
The Value of an EHS Management of
Change Process
DISCLAIMER
This presentation contains opinions and perspectives from various
EHS Professionals on the topic entitled: “The Value of an EHS
Management of Change Process”.
This presentation does not necessarily represent the opinion of the
presenter nor “Nektar Therapeutics,” nor are the practices and
approaches addressed herein warranted or guaranteed to sufficiently
address any or all EHS concerns. This presentation is informational
only; please consult an EHS professional to ensure your particular
circumstances are understood prior to implementing any EHS
program or change.
2
Agenda
MOC Process Rationale, Definitions, Principles
Real Life Scenarios
MOC Types and Workflow
Introducing Chemicals, Processes, Equipment, Personnel
EHS MOC Process Examples
Conducting an EHS Review: 10 Simple Steps
Levels of Change - Examples
Key MOC Processes, Tools, Learnings, Benefits
3
Why Manage Change?
Uncontrolled change is a frequent contributor to
incidents, and can result in injury to personnel,
damage to the environment, and loss of quality.
Managing change is essential to maintaining and
improving the EHS controls of existing operations,
and for the safe startup and operation of a new
process or facility.
4
Management of Change (MOC)
Management of Change (MOC) Process
A system to assess and address the EHS impacts of change
to a process, equipment, facilities, procedure, personnel or
organization, before the changes are made.
Key Principles
• Every change must be managed
• Changes must not be made without an appropriate review
• The type of review should be consistent with the
complexity of the change
• MOC system should be simple to use
5
Scenario - Polymerization Example
July 20, 1988: Tank-car of acid-washed MAA polymerized violently in
Houston rail yard. MAA put in car had low inhibitor. Car was stainless,
not normal lined car for this grade. H
2
SO
4
reacted with car walls.
Waste Water Tank Flashback
1988: Organic layer floating on water in tank. Tank draining to sewer
trench. Welding overhead. Tank emptied. Welding spark to trench.
Flashback into tank. Tank launched and turned upside down.
Other Real Life Scenarios
New -80C freezer requires 208V
Ammonia added to 4L DCM bottle
Ventilated enclosure installation
Switched HPLC solvent to DMF
Filtering “non-hazardous” product
Sub-contractor pouring wet cement
Runaway glacial acrylic acid polymerization
Heptane tanktruck explosion
Employee sprayed with hot 3,4-dichloropropionanilide
8
Why EHS inclusion is essential in both the
design and start-up stages?
9
Comply with EHS
Regulations
Mitigate
Environmental
Risks
Mitigate Safety
Risks
Protect Employees
EHS Inclusion in Design
and Start-up Stages
Integrate EHS aspects into
Design. Ensure start-up
addressed all issues.
Complex to retrofit
Live with design
flaws
MOC Types and Workflow
MOC Process needs to address Permanent, Temporary, Emergency Changes
Description, Justification, Impact on EHS
• What, Where, When, Who, and Why?
Initiating Changes:
• Reduce the risk of unintended consequences due to change
• Seek and maintain records of technical and financial input to a change
• Provide visibility to changes being planned or already underway
Approving Changes
• Review the change request to gain an understanding of the proposed change
and its impacts
• Indicate what changes to the initial request are necessary, if any, in order for the
change request to be approved
• Indicate support for proceeding with the proposed change
10
Introducing a New Chemical
Hazardous Material Business Plan updated?
Which work areas/employees will be handling this material?
What other employees might be affected (e.g. maintenance, waste
handlers)
Safety Data Sheet?
New Hazards Presented?
OSHA regulations? Fire Code? OELs? Monitoring method? Exposure
potential?
How will chemical be stored and used?
Training?
Medical surveillance?
Engineering controls? PPE? Respiratory Protection?
Waste Stream?
11
Example: Ordering Chemicals
How does the ordering process work?
New material or used before? Any adverse incidents or
institutional knowledge that needs to be integrated?
What documentation is needed and how do I find it?
How much do I need to order?
Is there sufficient storage space?
Do we have a waste stream designated?
What do I do if there is a spill of this material?
12
Example of how this process work?
13
Requestor
submits PR and
supporting
documentation
EHS checks for
documentation
and EH&S risks
EH&S
approves
material
EH&S asks for
additional info or
provides specific
PPE/Safety
information
Dept.
Manager
approves
material
Purchasing
sources
material and
places order
Supplier
ships
material to
Company
Materials
Mgmt.
receives
material and
contacts
requestor
Requestor
picks up
material at
designated
area
MOC Example: Introducing an Active
Pharmaceutical Ingredient into R&D
Proactive Quarterly Dept Mgr Meetings to anticipate and
prepare for new API introductions
Chemical Review and Approval Process
Occupational Health Categorization (1-4); Default Cat - 3
SOP, Training, Exposure Assessment, Engineering Controls
Sample Shipment triggers SDS development
Phase 2B Clinical Trials triggers OEL/Monitoring and
Analytical Method Development
14
New Processes
Major new installations or process changes
involving hazardous chemicals. Examples: addition
of a new reactor; addition of a new process that
uses a hazardous chemical.
Requires HAZOP and formal EHS reviews in design,
construction and before startup.
15
Introducing a New Process
Batch or continuous process?
Operating pressures/temperatures?
Exothermic reaction steps?
Process flow?
Charging/removing materials from containment?
Open handling vs closed system?
Materials of construction?
Process hazard analysis?
16
Introducing New Equipment
17
Robotic?
Ergonomics?
What materials will be in contact with equipment?
Magnetic fields?
Ionizing or non-ionizing radiation?
Exposed moving parts?
Is noise generated?
Air emissions?
Waste generation?
Access by maintenance staff for repairs, PM?
Introducing New Equipment
18
For New Construction, Renovations and Remodels:
Storage, handling, release of potentially hazardous materials
(chemical, biological, physical hazards)?
Installation/removal of safety showers/eyewashes?
Permit required confined spaces or machine guarding issues?
Impacts on LEV or other control equipment?
Wastewater discharge?
Will project affect Life Safety issues?
• Installation/modification of fire alarm or suppression systems
• Installation of elevators or other lift devices
• Change of egress routes, exit signage
• Access/egress restrictions
Introducing New Personnel
Essential experience, skillsets and training to do the job?
Training curricula/assignments?
Evacuation roster?
Workstation ergonomics evaluation?
Medical surveillance program?
Respirator clearance and use?
Prescription safety glasses?
Clearly defined roles and responsibilities?
19
Example of an MOC Process –
Before Change Happens
• Identify the level of change and type of review needed
• Gather the information needed to identify hazards
• Gather the people needed for the review
• Include additional internal or external experts if
needed
• Conduct the EHS review
• Classify actions by priority
• Assign responsibilities and due dates for actions
• Follow-up on actions
• Document actions to closure
20
Levels of Change - Examples
21
Identical Change
• Same material, same quality, same concentration, same
everything
Like for Like (Replacement in Kind)
• Same material, same quality, same concentration, almost same
everything, exception, ex. different supplier
Basic Change
• Same or different material, same quality, different concentration
outside the scope of the
original review
Major Change
• New or unfamiliar material or equipment where no review has been
conducted
Example of How EHS Reviews Match the
Complexity of Change
22
Type of Review
Identical
Change
Like for Like
(Replacement
In Kind)
Basic
Change
Major Facility
or Process Change
Personal Review
EHS Review, EHS
Professional
optional
Always an EHS Review with
an EHS Professional
present;
May also require a Process
Hazard Analysis*
Level of Change
At this level add
the Specialists:
• Risk Analyst
• Specialists
• Environmental/
Regulatory Expert
•Facilities Engineer
Typical Parties Involved:
• Management of operation
• 2 Persons knowledgeable
of change
• Affected persons (e.g. lab
tech)
• EHS representative
Expertise of the person making the
change
Personal EHS Review - Example
The personal EHS review is used when you are
making an identical substitution. Verify that
nothing is being changed.
Documentation: none required
People involved: the person making the
substitution
23
Simple EHS Review - Example
Documentation: recommended but not required
People involved: the person who knows about the
effects of the change, and the owner of the
equipment. Always have two areas of responsibility
involved.
The simple EHS review is used when you are
making the same general type of substitution,
but not an identical substitution.
24
Formal EHS Review - Example
The formal EHS review is used when you are making a
basic change and when introducing new processes.
Documentation: minutes from the formal EHS meeting and
action points.
People involved:
• Originator of the change,
• Person(s) who will be affected by the change;
• Person who knows about the effects of the change;
• Management representative from the area that is affected;
• EHS representative;
• Person who will maintain the equipment.
25
Formal EHS Review - Example
Designed to identify, evaluate and eliminate potential hazards by
people who understand the hazards and necessary safeguards for
the change
Proposed change meets the criteria for Basic Change or Major
Process or Facility Change
Meeting with department management designee and personnel
responsible for proposed change, affected personnel, EHS
Professional
Documentation is required
• Classify actions by priority
• Assign responsibilities and due dates for actions
• Follow-up on actions
• Document actions to closure
26
PHA/HAZOP Review - Example
The PHA/HAZOP review is used when you are
adding a major new facility or new processes
Documentation: minutes from the PHA/HAZOP
meeting, action points and changes to P&ID’s.
People involved: a PHA/HAZOP expert is the leader,
and the team is made up of site personnel including
those affected by the changes being considered.
27
Major Accident Prevention Plan Study
A MAPP study is performed for process changes
and new processes involving bulk chemical
quantities above the minimum storage
amounts.
Documentation: minutes and action points from
the MAPP study.
People involved: a MAPP expert is the leader, and
the team is made up of site personnel.
28
Example of Conducting an EHS Review:
10 Simple Steps
1. Select a leader. This is usually the person who
initiated or knows the most about the change.
2. Appoint someone to take meeting minutes.
3. Agree on the purpose of the EHS Review.
4. Define scope and explain the proposed change.
5. If appropriate, review flow sheets, plans or other
drawings that shows the change being proposed.
6. If appropriate, visit the location of the change and
review each part of the change.
29
Example of Conducting an EHS Review:
10 Simple Steps
7. People ask questions to understand the change and discuss
the EHS aspects and potential impacts of the change. At
this point, it is useful to use an EHS review checklist.
8. During the review, the person taking notes records action
items.
9. After visiting the location of the change, the people return to
the meeting room. They review the action points and assign
completion dates, priorities and responsibilities for the
action points.
10. A system is used to track action points to closure. The EHS
review is finished when all action items have been closed.
30
EHS Review Summary
31
Type of EHS Review
Identical
Replacement
in Kind
Basic Change
New Process
Personal Review Simple EHS Review
Formal EHS Review
Formal EHS Review
and HAZOP /MAPP
No
documentation
needed
Gather People and
resources
Fill the simple EHS
review form
Gather People and
resources
Conduct the review
Document and update
systems and procedure
Key Management of Change Processes
Chemical Review and Approval Process
• In the Pharma World this would include APIs, Biologics and Chemicals
Capital Requests – EHS Review
• new project/ new equipment ≥$5000
Employee On-boarding/Off-boarding
• Training, ergonomics assessments, facility access/security, risk assessments, medical
surveillance
Workflows and Approvals for New Equipment Design and Start-up
Reviews
Technology Transfer between sites/partners
Emergency Changes – Non-Routine Tasks!
Process Hazard Analyses
32
Key MOC Tools and Learnings
EHS Management of Change SOP
Training on MOC Processes
Proactive Quarterly Dept. Meetings with EHS,
Facilities and Affected Department Managers
Defining Acceptable Process Parameters/Boundaries
beyond which the MOC Process is triggered
Leveraging Software Tools
33
Management of Change Benefits
Involves affected employees - Two heads are better than one
Identifies:
• Hazards before they become incidents
• Problems when they are least expensive to fix
• Safeguards and actions to reduce risk
• Training and procedures that are needed
Reduces risk of:
• Injuries and illnesses
• Environmental spills and releases
• Catastrophic events (e.g. fire / explosion)
Confirms built-as-designed, avoids rework, and verifies EHS
requirements for safe operations
34
Acknowledgments
Paul Snyder, CIH, CSP (retired) – former IH/Safety Director for
Rohm and Haas Company
Robert Bacci, CIH, CSP – VP EHS and Facilities, Nektar
Therapeutics
Ben English, CIH, CSP – Sr. Staff EHS Specialist, Nektar
Therapeutics
Sundar Ramachandran, CIH – Associate Director EHS, Nektar
Therapeutics
35
36
