[ISO 45001 Series] Planning: Management of Change

Introduction

In the previous article, “[ISO 45001 Series] Planning: Overview of Controls and Planning Risk Controls,” I discussed how ISO 45001 requires organizations to plan controls for different situations and how those controls relate to one another.

For routinely occurring risks, I also combined relevant Taiwanese technical guidance with ISO 45001 to make the planning of risk controls more concrete.

Continuing from that discussion, this article addresses one situation in which a non-routine hazard may arise: the controls that must be activated when an organization undergoes a “change.”

ISO 45001 Requirements for Management of Change

ISO 45001 addresses the planning of change controls only briefly under the controls portion of its “Operation” clause. It does not consistently use the exact term “change controls”; instead, it describes particular situations in which change must be managed. In substance, the requirement is approximately as follows:

When temporary or permanent changes could affect occupational health and safety performance—such as new or modified products, services, and processes; changes to legal or other requirements; changes in knowledge or information concerning hazards and OH&S risks; or developments in knowledge and technology—the change may introduce new hazards and risks into the working environment. ISO 45001 therefore requires the organization to take the measures needed to manage the change, including reviewing and revising hazard communication, training, documented information, and other relevant arrangements so that adverse effects are controlled.

That is pretty short, right? It also shows that ISO 45001 does not prescribe a detailed method for controlling change, even though management of change takes quite a bit of work to turn into a concrete control process XD.

The Practical Method Proposed in This Article

Because ISO 45001 does not prescribe a specific method for controlling change, and because Taiwan’s Occupational Safety and Health Management System (TOSHMS) is broadly compatible with the ISO 45001 framework, the method proposed below uses the “Management of Change Technical Guideline,”_[1] which is based on the TOSHMS Guidelines issued by the Ministry of Labor in 2015, together with ISO 45001.

Why Does Change Occur?

An organization may modify its processes, activities, services, or other operations to increase productivity, improve product quality, or reduce production costs. Those modifications can move operating conditions or the working environment away from the safety state and controls on which the existing system was based, and may even intensify existing hazards and risks.

Of course, change does not always increase risk; it may reduce risk as well. The important point is that risk can change in either direction.

What Problems Can Change Create for an OH&S Management System?

An organization’s original risk assessment is based on its existing design or specifications. After the system changes, it operates under a different set of conditions, and the original controls may become partly or completely ineffective.

Yet change is normal for an organization, so the management system must include a corresponding way to respond.

Situations in Which Management of Change Applies

“Change” includes not only changes to operations within processes, activities, or services, but also the effects that organizational restructuring and personnel changes can have on OH&S performance. The Management of Change Technical Guideline was designed for the former rather than the latter, although it suggests that organizational restructuring and personnel changes may be addressed through occupational safety and health education and training.

The organization should therefore first determine which of these two groups a change belongs to. The process set out below is intended for changes to processes, activities, and services.

If an operation departs from its original design or specifications but the same departure has occurred before and records or written information are available, then—as discussed in “[ISO 45001 Series] Planning: Assessing Risks and Opportunities”—I consider it part of the organization’s current risk information that should already be covered in the risk assessment. The Management of Change Technical Guideline therefore excludes such a situation from its change-control process.

The following diagram summarizes the screening process used by the guideline to determine when it applies.

Where Management of Change Fits in the OH&S Management System

Management of change is part of the OH&S management system and is activated when changes to the organization’s processes or activities require its existing controls to be reconsidered. In sequence, the organization must first inventory its workers and working environments, complete broad and sufficiently detailed hazard identification and risk assessment under ordinary conditions, and establish its controls. Management of change becomes necessary after that foundation is in place.

I therefore place management of change after general hazard identification, risk assessment, and the establishment of controls. The process is activated when a change occurs.

Categories of Change

The guideline divides “change” into four categories and explains how each should be handled:

1. Permanent change: a permanent modification adopted after study or testing.

2. Temporary change: a time-limited change needed for a particular situation or for a performance or operating-efficiency test. Its duration must be clearly defined, and the previous conditions must be restored when the period ends.

3. Emergency change: a change for which following the ordinary change procedure may, because of time constraints, make it impossible to meet organizational needs or may create greater hazards or risks.

4. Replacement not in kind: replacement equipment or parts that differ from the existing equipment or components in basic design, maintenance, or operation, or a proposed change in work methods or conditions for which no clear written specification or standard is available.

Defining the Scope of the Change

After confirming that the matter falls within management of change and identifying its category, the organization must define the scope of the change control.

I suggest using the hazard-identification and risk-assessment process described above to identify the areas connected with the change. Because even a small change can affect the entire OH&S management system, however, the guideline recommends phased control: begin with high-hazard, high-risk machinery and equipment and expand the scope gradually. An organization may also establish lists or standards for replacement in kind so that the control scope can be reduced without unnecessarily changing the structure of the OH&S management system.

Management-of-Change Procedures and System

Once the scope has been established, the Management of Change Technical Guideline calls for the organization to develop a management system, procedures, and a plan covering: 1. the purpose, scope, and definitions of the controls; 2. the responsibilities and authority of relevant personnel; 3. change application and review procedures; 4. OH&S hazard identification and risk assessment; 5. review and updating of documents and data; 6. consultation, communication, and training; 7. pre-start-up safety review; 8. temporary changes and restoration steps; 9. control of emergency changes or procedural deviations; and 10. closeout and records management.

The guideline also states that responsibilities and authority should be clearly defined in light of the organization’s size, characteristics, organizational design, and personnel.

Building on these recommendations, I suggest that an organization establish its operating model for management of change while designing the OH&S management system. This model should include the application and approval process and principles for assigning responsibilities, allowing the organization to respond more quickly when a change activates the process.

The following diagram presents the operating process I developed. It may be easier to digest together with the explanation below, and I recommend opening the full-size image while reading.

For the allocation of responsibilities, both the Management of Change Technical Guideline and the relevant ISO 45001 recommendations indicate that the person in charge must initiate the change, coordinate the relevant people, and complete the risk assessment. The role therefore requires sufficient management and command authority. I suggest assigning the manager of the organizational unit in which the change occurs. If a new step is added to a particular process in a factory, for example, the plant manager would be responsible for that change case.

In other words, the person responsible for managing the change corresponds to “managerial workers” under ISO 45001 and to the “persons in charge of workplaces and supervisors at all levels” under Taiwan’s Regulations Governing Occupational Safety and Health Management. This approach is consistent with the original technical guideline and with the managerial duty under the Regulations to direct and supervise subordinates in carrying out safety and health management matters and to coordinate and guide the relevant personnel.

Because management of change involves hazard identification and risk assessment, and because the guideline requires comments from other units when a change concerns them, I believe the organization’s OH&S unit must provide its opinion and every potentially affected organizational unit should countersign the case.

The effects, complexity, and cost of a change can be difficult for frontline workers or a unit manager to evaluate alone. Although the guideline allows different organizational units to review cases according to complexity or cost, ISO 45001 makes top management ultimately accountable for the OH&S management system. I therefore recommend that top management conduct the final review of change cases whenever practical.

For permanent changes, temporary changes, and replacements not in kind, the manager of the unit in which the change occurs should follow the organization’s application process and submit the proposed written management system, procedures, and plan. The OH&S unit and potentially affected units should countersign the proposal before top management reviews it.

An emergency change may use oral approval or authorization because completing the ordinary application process can take too long. I nevertheless recommend that the manager of the unit in which the change occurs discuss the proposal with potentially affected units and confirm that it is feasible before implementation. A supplemental application should then be completed through the ordinary process within a specified period, allowing top management to review whether the emergency change was appropriate and whether adjustments are needed.

For a specific organizational project, top management may delegate change-approval authority to the project manager so that design and construction can proceed without a separate change application for every individual decision.

The following sample form follows the application process described above. The details of the change should include the change plan, criteria for determining success or failure, operating conditions, and the instruments involved. A detailed project plan and explanation should be attached when necessary.

The next diagram shows the application process developed from the same approach.

After determining the category and scope of the change and after the responsible unit manager has prepared the change-control plan, the organization must carry out “hazard identification and risk assessment for the change” in accordance with that plan.

Because this type of change has not yet occurred in the organization and there may be no records to consult, the existing hazard-identification checklist may be of limited use. To simplify the process and meet the technical guideline, I suggest that personnel and managers from the unit making the change work directly with the OH&S unit’s risk-assessment personnel to conduct a what-if analysis. They should identify hazards that could arise from the change and ways of treating those hazards, assess the resulting risks through the organization’s risk-assessment process, and plan controls to reduce them. Potentially affected workers must be consulted, and particular workers or contractors should participate in hazard identification and risk assessment when necessary.

Although the ordinary hazard-identification checklist may not apply, each part of the change can still be mapped to the existing inventory of workers and working environments organized by job title and work content. The what-if analysis may therefore use the sample “What-if Analysis Worksheet” introduced in “[ISO 45001 Series] Planning: Assessing Risks and Opportunities.”

ISO 45001 requires worker participation in the what-if analysis and risk-assessment process. I therefore recommend that all workers connected with the change participate in the discussion and planning of controls, while the personnel and managers of the unit making the change must provide all information about the change that the discussion requires.

After the discussion, the collected information, the hazard-identification and risk-assessment results, and the planned controls should be sent to the head of the OH&S unit and the managers of potentially affected units for countersignature, followed by review by top management. In addition to the reason for the change, cost, and effectiveness, reviewers should determine whether aggravated or newly introduced hazards and risks have adequate controls. A change without adequate controls should not be approved; it should be returned for replanning or rejected. If an approved change is modified during implementation, it should be approved again.

Even an emergency change must go through this step, including a review of whether its controls were inappropriate.

Before an approved change is put into operation, the relevant documents must be reviewed, updated, and distributed to the relevant units and personnel.

People associated with the change must be informed or receive the necessary training. At a minimum, communication should cover the purpose and content of the change, the hazards and risks after the change, the corresponding measures, and the handling of emergencies. Before start-up, the organization must ensure that the controls planned through hazard identification and risk assessment comply with occupational safety and health legislation and are effective. If an inspection identifies deficiencies, the change should not be formally started until they are corrected. I recommend preparing a safety checklist as part of the hazard-identification and risk-assessment process to make this inspection easier.

After start-up, the Management of Change Technical Guideline requires the hazard identification and risk assessment conducted for the change to be reviewed and updated within a specified period, then distributed to the relevant departments and personnel. The person responsible for the case must continue testing and checking how the change controls are being implemented.

A permanent change should then continue operating according to its approved content and plan and be included in subsequent OH&S performance reviews. When a temporary change reaches the end of its approved period, the manager of the unit that initiated it should determine whether it will become permanent, be extended, or return to the previous state.

If a change must be terminated or does not achieve the expected result, all relevant personnel should be notified, the change should end, and the previous conditions should be restored.

Retention of Documented Information for Management of Change

ISO 45001 requires documented information to be retained concerning the process and measures used to control change. Under the Management of Change Technical Guideline, the record for a change case should demonstrate that: 1. the change was properly applied for, reviewed, and approved; 2. its potential hazards and risks were identified before the change and the measures selected from the assessment were completed; 3. people associated with the change were consulted, informed, and trained; 4. relevant documents and data were reviewed and updated; 5. a safety inspection was completed before formal start-up; 6. testing and checks were conducted during implementation; and 7. the effects of the change and its closeout were addressed.

Conclusion

Establishing controls for routine risks does not mean that the organization will stop changing. Changes to processes and personnel are extremely common.

Any change may affect risks and, in turn, the organization’s previous assessments of risks and opportunities. The controls originally established within the OH&S management system may therefore need to change as well.

ISO 45001 says relatively little about how management-of-change controls should be planned and does not provide a detailed operating method. This article therefore uses the Management of Change Technical Guideline developed by Taiwan’s Occupational Safety and Health Administration to fill out this part of the ISO 45001 OH&S management system, adjusting the proposed process in light of ISO 45001 requirements.

The next article on non-routine risk controls will examine how the management system should respond when an organization engages in procurement. See you in the next article!

References

[1] Occupational Safety and Health Administration, Ministry of Labor, Taiwan. Management of Change Technical Guideline. 2015.