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 2·1. Safety, environmental, and quality responsibilities are interrelated

As demonstrated by common elements of the guidelines and regula­tions, quality, process safety, and environmental responsibility are interre­lated. If a facility is free of accidents, quality is easier to achieve or maintain. A safe, quality-conscious facility will likely be an environmentally respon­sible 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 recom­mendations served as the basis for subsequent regulations. Appendix A, Selected Initiatives, Consensus Codes, and Regulations Affecting Proce­dures lists sorne of these guidelines, recommendations, and regulations.

2.3. Voluntary Ouldellnes

In response to highly publicized incidents such as Seveso (Italy), Flixbor­ough (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. Occu­pational Safety and Health Administration (OSHA). These recommenda­tions, based on the input of a Process Hazard Management Task Force established by ORC, served as a basis for OSHA's Process Safety Manage­ment (PSM) Rule.

In 1989, the Organization for Economic Cooperation and Develop­ment 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 main­tain the integrity of the plant." 1

As another example, the Intemational Labor Office's "Prevention of Major Industrial Hazards" explicitly states that "good operational instruc­tions and sound practices should be provided and enforced by the works management." 2

Organizations such as the World Bank also recommend written pro­cedures 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 acci­dents, 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 regula­tion directly addresses the need for operating procedures and specifies requirements for those procedures, including the contents and the catego­ries 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 sub­stances 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 Systems­Model 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, reli­ability, 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-to­date 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 manage­ment 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 Codesª

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

ªSee 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 improve­ments 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 Manage­ment 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 engi­neers. 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. Proce­dures should also state precautions necessary to prevent accidental chemi­cal 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 informa­tion 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 Recom­mended 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 accord­ingly.

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 recommen­dations will help ensure that your procedures contain the critical informa­tion to run your process safely and effectively.

Endnotes

l. Organization for Economic Cooperation and Development (OECD). Discus­sion 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 Manage­ment Practices. Berlín, 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 Admini­stration. 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.