IENG 461 System Safety I

Lecture 3 System Safety Standards and

Regulations

James R. Harris, Ph.D., P.E.

System Safety Standards and
Regulations
Overview of tonights topics
Consensus standards vs. regulations
Important system safety standards
Important system safety regulations

2
System Safety Standards and
Regulations

3
System Safety Standards and
Regulations
You need to start here!
Standards and regulations form the
foundation of system safetybut you
must build on top of themthey are
the floor and not the ceiling for
system safety

4
System Safety Standards and
Regulations
Why should you care?
In general terms, the plaintiff might
attempt to use such standards to establish
a standard of care that the employer
violated to such a degree that, under the
particular states law, it constitutes an act
not subject to workers compensation
exclusivity, perhaps gross negligence (in
states that have a gross negligence
classification) or intentional tort.*
*Source: Aguiluz RN. The use of voluntary consensus standards in SH&E
enforcement. Proceedings of ASSE 2005 Professional Development Conference;
2005 June 12-15; New Orleans, LA; session number 611 5
System Safety Standards and
Regulations
Specification vs. performance
standards
Specification standard specifies
dimensions or other design criteria (e.g.
protective eyewear lens must be >2mm thick)
Advantages?
Performance standard focuses on goal
of the design (e.g. lens must stop projectile
at 150 fps)
Advantages?

6
System Safety Standards and
Regulations
Consensus standards vs. regulations
Consensus standard represents
substantially agreed upon standard
practice
Developed through private-
sector/public-sector cooperation
Non-regulatory
Provides performance and design
guidance (on personal protective
equipment (PPE) and machine safety as
7
examples)
System Safety Standards and
Regulations
ANSI = American National Standards
Institute
The Institute oversees the creation,
promulgation and use of
standards
Ensures standards are developed and
approved according to set
procedures
(ANSI movie)
8
System Safety Standards and
Regulations
ANSI development process
Need a secretariat (an accredited
standards developer) to guide the
process and ensure ANSI guidelines
are met
Many associations have been
accredited
American Society of Safety Engineers
(ASSE)
American Society of Mechanical
Engineers (ASME) 9
System Safety Standards and
Regulations
Guiding principles (source: ANSI):
Openness The ANSI process is fair and open.
Any materially affected and interested party
shall have the ability to participate.
Balance Participants should represent
diverse interests and categories, and no single
group should have dominance in standards
development.
Due Process All objections shall have an
attempt made towards their resolution.
Interests who believe they have been treated
unfairly have a right to appeal.
Consensus Agreements are reached when
more than a majority, but not necessarily all, of
the participants concur on a proposed solution.
10
System Safety Standards and
Regulations
Balance
ANSI Z87 (eye and face protection) example
no more than one third of the total
membership from any one interest category*
Government (NIOSH, OSHA)
Manufacturer (Oakley, Younger Optics)
User (National Assn. of Optometrists and Opticians,
Z88 Comm. [respiratory protective equipment])
Technical/Professional (Am. Academy of Opth., ASSE)
General Interest (Prevent Blindness America, Z89
Comm. [protective headwear])

*Source: Procedures for the Z87 ANSI Accredited Standards Committee, 2/2006
11
System Safety Standards and
Regulations
Due process (using Z87 model)
Reaffirmation, revision, or withdrawal of
standard must be listed by ANSI in Standards
Action (see example) for comment (~30 days)
Public comment can occur concurrent with
committee letter ballot
Effort must be made to resolve all expressed
objections
Objector must be advised of objection
disposition and informed of appeals process
Any substantive changes are reported back to
committee

12
System Safety Standards and
Regulations
Consensus (using Z87 model)
New standard or reaffirmation requires:
At least a majority of the membership, AND
2/3 of those voting
~28 voting Z87 members
Can take 3-5 years (or more) - ANSI
requests that standards be addressed
within 5 yrs of previous approval

13
System Safety Standards and
Regulations
ISO process
Standards work is handled through
technical committees (TC),
subcommittees (SC), and workgroups
(WG)
Each TC and SC has a secretariat
assigned from the member
organizations

14
System Safety Standards and
Regulations
Example of ISO standard
organization:
TC199 (Safety of Machinery)
TC 199/WG 5 - General principles for the
design of machinery and risk assessment
TC 199/WG 6 - Safety distances and gaps

15
System Safety Standards and
Regulations
ISO process:
Stage 1: Proposal stage Is a new standard
needed? Needs majority TC/SC vote and 5
commitments to work on item.
Stage 2: Preparatory stage Convener
leads WG in completion of draft.
Stage 3: Committee stage Consensus
building at TC/SC level. Draft International
Standard (DIS) is produced(continued
next slide)
16
System Safety Standards and
Regulations
Stage 4: Enquiry stage Voting and commenting
on DIS by all ISO members for 5 months. Moves to
Final Draft International Standard (FDIS) if 2/3 of
TC/SC approve and 1/4 of all votes are negative.
Stage 5: Approval stage FDIS to all ISO
members for 2 months. Needs 2/3 of TC/SC and
1/4 of all votes negative to move on. Technical
comments go to next revision.
Stage 6: Publication stage Only editorial
changes. Published by Central Secretariat.

17
System Safety Standards and
Regulations
Group exercise

18
System Safety Standards and
Regulations
Regulations legal requirements found in
Code of Federal Regulations (CFR) - 50
titles total - first announced through the
Federal Register system (website)
Federal safety organizations (not exhaustive):
Consumer Product Safety Commission (CPSC)
Environmental Protection Agency (EPA)
National Institute for Occupational Safety and
Health (NIOSH)
Occupational Safety and Health Administration
(OSHA)

19
System Safety Standards and
Regulations
ANSI start date was 1918 compared to
~1971 for OSHA regulations
Many consensus standards were
incorporated by reference (IBR) and
became the OSHA requirement (see
1910.6)
For example, ~72 ANSI standards are listed,
such as ANSI Z87.1-89*, Practice for
Occupational and Educational Eye and Face
Protection, IBR approved for 1910.133(b)(1).
*Be carefulnewer version of this standard
exists. 20
System Safety Standards and
Regulations
Path to a regulation:
Advanced Notice of Proposed
Rulemaking published in the
Federal Register and officially begins
comment period
May have to consider cost, paperwork
burden
(show example from Federal Register)

21
System Safety Standards and
Regulations
Notice of Proposed Rulemaking the
proposed rule or official plan
published in Federal Register
Comment periods are typically 30-60
days
Regulations.gov is an important website
for tracking these events
Rule becomes part of CFR

22
System Safety Standards and
Regulations
Important standards related to system
safety (not exhaustive):
MIL-STD 882, Standard Practice for System
Safety
ANSI/ASSE Z590.3-2011, Prevention through
Design Guidelines for Addressing Occupational
Hazards and Risks in Design and Redesign
Processes (show this standard)
ANSI/AIHA Z10, Occupational Health and
Safety Management Systems (continued next
slide)
23
System Safety Standards and
Regulations
Important regulations related to
system safety (not exhaustive):
OSHA 1910.119, Process safety
management of highly hazardous
chemicals specifically 1910.119(e)
(2) (website)

24
System Safety Standards and
Regulations
Summary:
Standards and regulations are a
beginning
Standards and regulations are
developed through a processthat you
can influence
Know which standards and regulations
apply to your job and your company

25
System Safety Standards and
Regulations
Preview of next week
System life cycle
ReminderHomework 1 due next
week (9/13)
Questions?

26
Product Liability
Homework 1 (due Sept 8 by 5:30 pm
electronically to JHarris@mix.wvu.edu)
Research 6 product liability cases
Summarize each case in 1 page (6 pages
total, single spaced, 1 margins)
Basic facts
Decision for plaintiff or defendant
Monetary award amount if disclosed
Do not plagiarize or you will receive a
0/10!
27