2

PROCESS SAFETY,
ENVIRONMENT AL, AND
QUALITY CONSIDERA TIONS
2.1. Purpose
In this chapter we will examine severa! voluntary guidelines and regulatory
requirements dealingwith written operating and maintenance procedures.
Understanding the elements found in these guidelines and regulations
helps to produce effective procedures that will assist you in reaching your
process safety, environmental, and quality goals.
2.2. understandlng the Culdellnes and Regulatlons
There are man y reasons why you need to understand the requirements and
recommendations of the various voluntary initiatives and regulations covering
written operating and maintenance procedures. Written procedures
Help maintain your competitive edge
Make good business sense from a process safety, quality, and
environmental point of view
Reflect the best thinking on how to safely operate and manage your
facility
May be needed to comply with one or more govemmental regula-
tions requiring written procedures
May be required for a desired certification
9
10 2. PROCESS SAFETY, ENVIRONMENTAL. ANO QUALITY CONSIDERATIONS
Figure 21. Safety, environmental, and quality responsibilities are interrelated
As demonstrated by common elements of the guidelines and regula-
tions, quality, process safety, and environmental responsibility are interre-
lated. If a facility is free of accidents, quality is easier to achieve or maintain.
A safe, quality-conscious facility will likely be an environmentally respon-
sible facility. The elements of process safety, including effective, controlled
procedures, combine to achieve the overall goal of a safe, environmentally
responsible, quality operation.
In this chapter we will discuss guidelines, recommendations, and
regulations addressing procedures. Their common elements may affect the
way you manage your procedures. Many voluntary guidelines and recom-
mendations served as the basis for subsequent regulations. Appendix A,
Selected Initiatives, Consensus Codes, and Regulations Affecting Proce-
dures lists sorne of these guidelines, recommendations, and regulations.
2.3. Voluntary Ouldellnes
In response to highly publicized incidents such as Seveso (Italy), Flixbor-
ough (UK) Three Mile Island (US), and Bhopal (India), process safety has
become a global concem. Efforts to develop Process Safety Management in
an attempt to reduce accidents began in Great Britain, and have since
spread around the world. A result of this growing concem with Process
Safety Management is recognition of the importance written operating and
maintenance procedures can play in the prevention of accidents.
2.3. Voluntary Ouidelines
11
In response to process safety concems, several organizations developed
process safety guidelines. The guidelines address procedures and define the
elements that go into developing and controlling written procedures and
procedure management systems. These guidelines served as the basis for
regulations. For example, in 1988, Organization Resources Counselors
(ORC), Incorporated submitted Recammendatians far Pracess Hazards
Management af Substances wi.th Catastrophic Patential to the U.S. Occu-
pational Safety and Health Administration (OSHA). These recommenda-
tions, based on the input of a Process Hazard Management Task Force
established by ORC, served as a basis for OSHA's Process Safety Manage-
ment (PSM) Rule.
In 1989, the Organization for Economic Cooperation and Develop-
ment held the "Prevention of Accidents Involving Hazardous Substances"
workshop in Berlin, Germany. Acknowledging the importance of written
procedures for the prevention of accidents involving hazardous substances,
the workshop's written report (paragraph D.2) recommended that "each
location should develop written job and process operating procedures
sufficient to keep operating conditions within the design intent and main-
tain the integrity of the plant."
1
As another example, the Intemational Labor Office's "Prevention of
Major Industrial Hazards" explicitly states that "good operational instruc-
tions and sound practices should be provided and enforced by the works
management."
2
Organizations such as the World Bank also recommend written pro-
cedures relating to administrative, accounting, and financia! matters for
facilities involved in the use and production of hazardous materials. The
techniques described in this guideline can also be used to develop these
types of procedures.
2.3.1. Center for Chemical Process Safetv of the
American lnstitute of Chemica/ Engineers
The American Institute of Chemical Engineers (AIChE) has been a leader
in promoting process safety for many years. In recognition of the need for
Process Safety Management to help prevent catastrophic chemical acci-
dents, the AIChE established the Center for Chemical Process Safety
(CCPS) in 1985. In 1989, the CCPS published Guidelines far Technical
Management af Chemical Pracess Safety, one of the first titles in a series
addressing process safety. This guideline addresses the importance of
written procedures as part of an overall Process Safety Management system.
12 2. PROCESS SAFETY, ENVIRONMENTAL, ANO QUALITY CONSIDERATIONS
TABLE 2-1
lmportant Points to Be Addressed as summarized from CCPS
"Cuidelines for Technical Management of Chemlcal Process Safety"
Procedures should ldentlfy
Tasks to be performed by the operator
lnstrument readings and samples to be taken
Conditions to be maintained
Safety precautions
Safe operating limits for critica! parameters
Critica! operating parameters and instruments
Results of operating beyond safe limits
Corrective and emergency actions
Procedures should
Be accurate
Be understandable
Use familiar language
lnclude input from process and design engineers and operations and
maintenance personnel
Reflect how operations are actually performed
Be thoroughly documented
Be dated and/or have a revision number on everv page
Be reviewed and updated at regular intervals to capture procedural,
equipment. critica! operating parameter. software. and process changes
Be approved
users should
Be informed of all changes
Be familiar with critica! operating procedures
It also deals with factors relating to the development and use of written
procedures. Table 2-1 gives an overview of the major points discussed in
the CCPS guideline. These points should be addressed when developing
procedure management systems and written procedures.
2.3.2. Chemica/ Manufacturers Association
Another industry initiative, the Chemical Manufacturers Association
(CMA) Responsible Care Process Safety Code of Management Practices,
refers to operating procedures by noting the need for "current, complete
documentation of process design, operating parameters, and procedures"
3
(emphasis added).
2.4. Oovernmental Regulations
13
2.3.3. American Petroteum tnstitute
The American Petroleum Institute's (API) Recommended Practice (RP)
7 50 was issued in 1990 in response to the growing concem for process
safety and the prevention of catastrophic releases of toxic or explosive
materials. As shown in Appendix B, Common Points of the API RP 750,
OSHA's PSM Rule 29 CFR 1910.119, and EPA 40 CFR Proposed Rule Part
68, majar elements of APl's recommendations are reflected in both the
OSHA and Environmental Protection Agency (EPA) regulations.
2.4. covernmental Regulatlons
In an attempt to further reduce the number and effect of catastrophic
chemical incidents, govemment regulatory agencies have defined and
enforced many of the elements of process safety put forth by the voluntary
guidelines. Two influential regulations are from OSHA and EPA.
2.4.1. United States Occupationat Safety and Heatth Administration
OSHA's PSM Rule requires written procedures for facilities with specified
quantities of identified hazardous chemicals. Paragraph (f) of this regula-
tion directly addresses the need for operating procedures and specifies
requirements for those procedures, including the contents and the catego-
ries of operations they should address. Paragraph (j), Mechanical Integrity,
requires employers covered by the regulation to establish and implement
written procedures to maintain the ongoing integrity of process equipment.
This regulation is "a process safety standard in arder to protect employees
from hazards associated with accidental releases of highly hazardous
chemicals in the workplace."
4
2.4.2. United States Environmentat Protection Agency
The EPA's proposed rule 40 CFR Part 68, "Risk Management Programs
(RMP) for Chemical Accidental Release Prevention; Rule Subsection 28
Prevention Program-Standard Operating Procedures," also identifies the
need for operating procedures in language parallel to OSHA's PSM Rule
while reflecting EPA's concem with off-site consequences. The goal of the
proposed RMP rule is to "prevent accidental releases of regulated sub-
stances to the air and to minimize the consequences of releases by focusing
preventive measures on those chemicals that pose the greatest risk."
5
14 2. PROCESS SAFETY. ENVIRONMENTAL. ANO QUALITY CONSJDERATIONS
2.5. Quallty conslderatlons
The guidelines and regulations cited so far have focused on process safety.
However, certification and award programs such as the Intemational
Organization for Standardization (ISO) Standard 9002, "Quality Systems-
Model for Quality Assurance in Production and Installation," place heavy
emphasis on quality management. Written procedures and document
control are important factors for ensuring and maintaining quality, reli-
ability, and consistency.
The ISO Standard 9002 is a major global influence on procedures and
document control. It identifies the need for production and installation
instructions where the absence of such instructions would adversely affect
quality. Although this is a general statement, it is difficult to think of a
task worth doing that <loes not or cannot potentially affect quality as well
as safety. The ISO standard addresses procedures in general by requiring
that all documentation involved with quality be controlled. Table 2-2
outlines the major points of ISO 9002 dealing with documentation and
procedures.
TABLE 2-2
A Brief summary of ISO 9002 References to Procedures
4.4. Document control-Establish and maintain procedures to control all
documents and data that relate to requirements of standard. Documents
shall be reviewed and approved for adequacy by authorized personnel prior
to issue.
<al Appropriate documents available at all locations where operations
essential to the effective functioning of a quality system are performed;
(bl Obsolete documents promptly removed from all points of issue or use.
4.4.2. Document changes/modlflcatlons
-Changes shall be reviewed and approved
-Nature of change identified in document/attachments
-Procedure in place to preclude use of non-applicable procedures
-Documents reissued <revisedl after practica! number of changes made
4.8.1. (a) Process control-Establish instructions defining manner of
production and installation where absence of instructions would adversely
affect quality
4.12. Control of nonconformlng product-Establish and maintain procedures
to ensure nonconforming product not used or installed
4.18. Statlstlcal technlques-where appropriate. establish procedures
identifying statistical techniques for verifying acceptability of process and
products
2.6. Sorne Elements of Effective Procedures and Procedure Management Systems 15
2.6. some Elements of Effective Procedures and Procedure
Management Systems
These consensus codes and regulations share common elements that can
guide you in developing and evaluating procedures. These elements are
shown in Table 2-3. In general, ali the guidelines and regulations require
current, complete documentation of process safety information including:
Process chemistry
Process design and equipment specifications
Process operating procedures
Operating limits
You will find that the common elements discussed in this section will
help make your procedure management system more effective.
2.6.1. Accessibility
Procedure users must be able to quickly and easily obtain current, approved
procedures to prepare for and perform their jobs. Needed procedures must
be readily accessible-available-at ali times. Procedures may be available
as printed (hard-copy) documents, they may be viewed on computer
screens, or they may be printed, as needed, from electronic files. The
current, approved procedures must be available to ensure that only up-to-
date procedures are used to perform operations and maintenance tasks.
2.6.2. Clarity
In addition to being readily available, procedures must be clear. They must
be written concisely in a straightforward manner and must consider both
the difficulty and importance of the task( s) being described. They must also
consider the skills, experience level, and needs of the user. If the user does
not understand a procedure, or does not have confidence in its accuracy,
the procedure will most likely not be used or it will be used incorrectly.
Procedure training will foster understanding and use of procedures.
2.6.3. Control
Many of the guidelines and regulations cited address the need to ensure
procedures are current and accurate. This means that a procedure manage-
ment system should be in place to implement and guide the development,
16 2. PROCESS SAFETY. ENVIRONMENTAL. ANO QUALITY CONSIDERATIONS
TABLE 2-3
List of Procedure Elements, common Regulations,
and Consensus Codes
CCPS API OSHA EPA
Procedure Elements (Safety> <Safety> <Safety> (Envlronment>
Procedures accessible
v v v
Procedures contain clear
v v v v
instructions
Procedures address steps
v v v v
for each operations phase
Procedures reviewed/ v v v v
approved before issue
Procedure approved by
v v v v
responsible party
Procedures reviewed for v v v
accuracy/adequacv
Procedure changes
v v v
documented
Method in place for
v v v
control/removal of
obsolete procedures
Periodic review of
v v v
operating procedures
Annual Certification
v v v
confirming that operating
procedures accurately
reflect current practices
Safe operating limits v v v v
Oeviations and v v v v
consequences
Safety & health
v v v v
considerations
Safety systems
v v v
Emergency actions
v v
Safe work practices v v
Training v v v
Procedures maintaining v v v
mechanical integritv
Employee input v v
ISO
<ouallty>
v
v
v
v
v
See Appendix A. Selected lnitiatives. Consensus Codes. and Regulations Affecting Procedures.
2.7. Additional Considerations 17
review, approval, distribution, accessibility, and updating of procedures.
(See Chapter 3, How to Designan Operating and Maintenance Procedure
Management System.)
As mentioned in Chapter 1, we should treat procedures with the same
respect as we do equipment and process materials. They are a majar
investment. Revisions or modifications to procedures should be analyzed,
tracked, and approved in the same manner as mechanical or technological
changes. To those familiar with the elements of process safety, this is part
of "Management of Change" or "Change Control." The CCPS Guidelines
far Technical Management of Chemical Process Safety also recommends
documenting all procedure changes. If your facility is considering ISO 9000
series accreditation, procedure control will be a key element.
2.6.4. Reviews and Audits
To ensure that procedures are accurate and reflect current practices, they
must be periodically reviewed. Revisions caused by changes or improve-
ments in equipment, process technology, standard practice, or facility
status must be incorporated as they occur. This is a function of your
procedure management system. The effect of changes in environmental
and safety regulations on procedures must not be overlooked. A Manage-
ment of Change system directly supports and controls these revisions.
2.6.5. Employee Input
Your co-workers are important resources for developing, reviewing, and
updating procedures. CCPS recommends that input be included from
operating and maintenance personnel as well as process and design engi-
neers. OSHA requires employee participation in all phases of Process Safety
Management. Again, this makes good sense; after all, employees at all
levels are a critica! element in maintaining process safety.
2.7. Addltlonal conslderatlons
The following requirements of the OSHA and proposed EPA regulations
are tapies that deserve consideration even if your facility is not directly
affected by these regulations. Industry guidelines and initiatives also
promote these elements. Appendix C to OSHA 29 CFR 1910.119, Com-
1.8 2. PROCESS SAFETY, ENVIRONMENTAL, ANO QUALITY CONSIOERATIONS
pliance Guidelines and Recommendations far Process Safety Management
{Nonmandatory), contains additional helpful advice on procedures and
should be reviewed as a useful resource when you develop your procedure
management system.
2.7.1. Training
In addition to helping to ensure quality, procedures can be used as training
resources and on-the-job training aids or scripts. Effective procedures are
an important factor in maintaining consistency and ensuring that everyone
receives the same baseline level of training and information. Written
procedures may be used as the primary training device, serving as a guide
to train workers to perform their jobs. They may also serve the same
function as part of a more extensive training structure.
2.7.2. Safety and Health Considerations
Procedures should identify the hazards presented by the process. Proce-
dures should also state precautions necessary to prevent accidental chemi-
cal release, exposure, and injury. Process safety information is an important
resource in developing procedures. U sing this information ensures that the
known hazards are addressed properly.
2.7.3. Safe Work Practices
Practices that cancero process and personnel safety such as steps far
controlling hazardous energy, vessel entry, line opening, confined space
entry, and flame or spark-producing work (hot work) should be addressed
in procedures either as steps or as references.
2.7.4. Operating Limits
Including safe operating limits, the consequences of deviating from those
ranges, and how to correct/avoid those deviations in procedures helps to
prevent accidental chemical release, exposure, and injury. This informa-
tion enhances the users' understanding of the process, its limitations, and
how to run it safely.
Endnotes 19
2.8. concluslon
Although OSHA's PSM Rule, EPA's Proposed Rule, and APl's Recom-
mended Practice 7 50 identify categories of procedures to be written, they
do not clearly define those categories. Various regional and local authorities
may have additional procedure requirements. Based on the type(s) of
process(es) at your facility, such as batch or continuous, you will have to
decide which categories are appropriate and write your procedures accord-
ingly.
Table 2-3, List of Procedure Elements, lists the elements related to
procedures and procedure control and indicates which guideline(s) and/or
regulation(s) identify the element. It is intended to be used as a checklist
to help you determine which elements are applicable or required for your
facility. Methods for addressing the elements required to designan effective
procedure management system are discussed in Chapter 3.
The various guidelines, initiatives, and regulations reflectan emerging
consensus that ties written procedures to safety, environmental, and
quality considerations. Understanding these requirements and recommen-
dations will help ensure that your procedures contain the critical informa-
tion to run your process safely and effectively.
Endnotes
l. Organization for Economic Cooperation and Development (OECD). Discus-
sion Document Relating to the Development of OECD Guidance far the
Prevention of Accidents Involving Hazardous Substances from the Workshop
on Prevention of Accidents Involving Hazardous Substances Good Manage-
ment Practices. Berln, Germany, 1989.
2. Intemational Labor Office (ILO). ILO Code of Practice far the Prevention of
Majar Industrial Accidents. Geneva, Switzerland, 1991.
3. Chemical Manufacturers Association. Responsible Care: Process Safety
Code of Management Practices. Washington, DC, 1990.
4. United States Department of Labor, Occupational Safety and Health Admini-
stration. Federal Register Volume 57, Number 36, pp. 6356-6417: "29 CFR
Part 191 O .119: Process Safety Management of Highly Hazardous Chemicals";
"Explosives and Blasting Agents," Final Rule. Washington, DC, February
1992.
5. United States Environmental Protection Agency. Federal Register Volume 58,
Number 201, pp. 54190--54219, "40 CFR Part 68: Risk Management Programs
for Chemical Accidental Release Prevention." Washington, DC, October 1993.