Change can be a significant source of risk. That is why compliance programs include a risk-based process for managing planned changes. This process is commonly referred to in highly-regulated, high-risk industries as, Management of Change or MOC.
This blog takes a look at MOC across a variety of regulations and standards that are used to help buy down risk.
What is Management of Change?
MOC is a critical process used to ensure that no unintended consequences occur as a result of planned changes. It is required by EMP-RMP, OSHA 1910.119, NEB, API RP 1173, CSA Z767-17, ICH, and now part of ISO 45001 Safety Standard.
An effective MOC process will help to plan, implement, and manage change to prevent or mitigate unintended consequences that affect the safety of workers, public, or the environment. Although MOC processes may look different based on the industry or compliance system involved, the purpose remains the same, which is, to avoid unnecessary risk.
MOC differs from change management which refers to the people side of change (Kotter, PROSCI, etc) and focuses on changing mindsets, attitudes, and behaviours needed to effect a change. This is often confused with management of change which refers to the technical side of change and focuses on risk management. However, depending on the type of change both these practices may be necessary.
An MOC process provides a structured approach to capture a change, identify and mitigate risks, assess impacts (organization, procedures, behaviours, documentation, training, etc.), define work plans to effect change safely, engage stakeholders, obtain necessary approvals, and update effected documentation. By following such a process risk can be adequately ameliorated which perhaps is the most important measure of MOC effectiveness.
While managing risk for individual changes is of value, companies with advanced MOC capabilities are able to measure the total level of risk proposed or currently being introduced across a facility, process, or product line. This information is used to ensure that overall risk is manageable within existing risk controls.
When to Use MOC
The applicability of an MOC process is determined by identifying proposed changes that have the possibility of high unintended consequences. These are called differently by each standard or regulation. Here is a list of examples:
covered pipeline segments
high consequence areas
safety critical roles or positions
safety critical procedures
safety critical equipment or assets
and so on
When changes are made to any of the above then an MOC is required. However, there is an increasing trend towards using a single MOC process to manage all changes even if not required by a given standard or regulation. This has become viable through the introduction of computer automation and adaptive workflows that can adjust the level of rigour commensurate with the level of risk.
When Managing Change Hinders Innovation
Innovation is necessary for growth and often requires that risks are taken. However, a common sentiment is that compliance is getting in the way of product or process innovation.
The pharmaceutical sector is one of the most regulated in industrialized countries. FDA has strict requirements for verification and validation of products and services. The risks to patients are many so it makes sense to scrutinize every aspect from design to delivery of new products. Changes made during the product life-cycle can lead to re-validation and conducting more clinical trials all of which introduce delays to the introduction of the new drug or medical device.
In 2005, the Quality Risk Management program ICH-Q9 was introduced to bring a risk based approach to this industry and parallels the risk-based approach introduced by the Center for Chemical Process Safety.
ICH-Q9 was extended to the medical device sector by the introduction of the ISO14971 Risk management standard. These were done to partially address the question of risk management and innovation and so was welcomed by the industry and FDA.
This risk based approach leverages the ICH-Q8 standard which introduced, among other things, the concept of design space. A design space establishes parameters that have been demonstrated to provide quality assurance. Once a design space is approved, changes within the design space boundaries are not considered a change from a regulatory point of view. This creates a space for innovation to occur.
Replacement in Kind
Now, let's consider the process sector where a similar concept to design spaces is used known as, "Replacement in Kind" or RIK.
Replacement in Kind uses the idea that when changes are made to the "design basis" a Management of Change (MOC) process must be followed to manage risk. Otherwise, the change is considered a "replacement" and not a change from a regulatory point of view.
In many ways, RIK has the same effect that design space has in the Pharma/Med Device sectors. They both define boundaries that allow certain changes to occur that will produce a certain design outcome.
Unfortunately, one notable difference between the two approaches is how design basis is currently managed in the process sector. Design information tends not to be as controlled or managed as well as it is in the Pharma/Med Device industry. In fact, it is common in older facilities to find that the design basis for a process or equipment is no longer known and engineers and maintenance crews resort to using the manufacturer's specifications for the equipment, parts, or material substitutions. This has the effect of reducing the options and innovations that might otherwise be available.
In a fashion, improving the management of design basis could allow for more innovation in the process sector. More changes could be considered as RIK without increasing risk. This would result in fewer MOCs and fewer resources being spent redoing hazard analysis, risk assessments and implementing unnecessary risk measures.
What the Standards and Regulations Say
For those who would like to explore the topic of MOC further, the following MOC requirements from selected standards and regulations are provided below. It is worth noting that the details of "how" to follow the guidelines are left to each organization to determine based on their business and level of risk.
Title 40 CFR Part 68 – EMP RMP Program
§68.75 Management of change.
(a) The owner or operator shall establish and implement written procedures to manage changes (except for “replacements in kind”) to process chemicals, technology, equipment, and procedures; and, changes to stationary sources that affect a covered process.
(b) The procedures shall assure that the following considerations are addressed prior to any change: The technical basis for the proposed change; Impact of change on safety and health; Modifications to operating procedures; Necessary time period for the change; and, Authorization requirements for the proposed change.
(c) Employees involved in operating a process and maintenance and contract employees whose job tasks will be affected by a change in the process shall be informed of, and trained in, the change prior to start-up of the process or affected part of the process.
(d) If a change covered by this paragraph results in a change in the process safety information required by §68.65 of this part, such information shall be updated accordingly.
(e) If a change covered by this paragraph results in a change in the operating procedures or practices required by §68.69, such procedures or practices shall be updated accordingly.
OSHA 1910.119(l) – Process Safety Management
1910.119(l) Management of change.
1910.119(l)(1) The employer shall establish and implement written procedures to manage changes (except for "replacements in kind") to process chemicals, technology, equipment, and procedures; and, changes to facilities that affect a covered process.
1910.119(l)(2) The procedures shall assure that the following considerations are addressed prior to any change:
1910.119(l)(2)(i) The technical basis for the proposed change;
1910.119(l)(2)(ii) Impact of change on safety and health;
1910.119(l)(2)(iii) Modifications to operating procedures;
1910.119(l)(2)(iv) Necessary time period for the change; and,
1910.119(l)(2)(v) Authorization requirements for the proposed change.
1910.119(l)(3) Employees involved in operating a process and maintenance and contract employees whose job tasks will be affected by a change in the process shall be informed of, and trained in, the change prior to start-up of the process or affected part of the process.
1910.119(l)(4) If a change covered by this paragraph results in a change in the process safety information required by paragraph (d) of this section, such information shall be updated accordingly.
1910.119(l)(5) If a change covered by this paragraph results in a change in the operating procedures or practices required by paragraph (f) of this section, such procedures or practices shall be updated accordingly.
API Recommended Practice 1173 – Pipeline Safety Management
8.4 Management of Change (MOC)
The pipeline operator shall maintain a procedure for management of change (MOC). For the MOC, the pipeline operator shall identify the potential risks associated with the change and any required approvals prior to the introduction of such changes.
8.4.2 Types of Changes:
The type of changes that MOC address shall include: Technical, Physical, Procedural, and Organizational. Changes to the system shall include permanent or temporary. The process shall incorporate planning for each of these situations and consider the unique circumstances of each.
8.4.3 Elements of MOC Process:
A MOC process shall include the following: Reason for change, Authority of approving changes, Analysis of implications Acquisitions of required work permits, Documentation (of change process and the outcome of the changes), Communication of changes to affected parties, Time limitations, Qualification and training of staff.
7.2 Management of change
7.2.1 The PSM system shall include a MOC system. The primary focus of MOC shall be to manage risks related to design changes and modifications to equipment, procedures, and organization. The MOC system shall:
a) define what constitutes a change (such as temporary, emergency) and what constitutes replacement in kind which is not subject to MOC;
b) include changes in and deviations from operating procedures or safe operating limits;
c) include changes in organizational structure and staffing levels;
d) define the review processes and thresholds for approval of changes, based on scope or magnitude of the change;
e) require an assessment of hazards and risks associated with the change consistent with Clause 6.3;
f) ensure that the change is communicated to affected stakeholders prior to the change, and that any required training is provided before the change is implemented;
g) provide procedures for emergency changes including a means to contact appropriate personnel if a change is needed on short notice; and
h) define the documentation requirements (such as a description of the proposed change, the authorization for the change, the training requirements, the updated drawings, and the verification that the change was completed as designed).
ICH Pharmaceutical Quality System Q10
The change management system ensures continual improvement is undertaken in a timely and effective manner. It should provide a high degree of assurance there are no unintended consequences of the change.
The change management system should include the following, as appropriate for the stage of the lifecycle:
(a) Quality risk management should be utilised to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk;
(b) Proposed changes should be evaluated relative to the marketing authorisation, including design space, where established, and/or current product and process understanding. There should be an assessment to determine whether a change to the regulatory filing is required under regional requirements. As stated in ICH Q8, working within the design space is not considered a change (from a regulatory filing perspective). However, from a pharmaceutical quality system standpoint, all changes should be evaluated by a company’s change management system;
(c) Proposed changes should be evaluated by expert teams contributing the appropriate expertise and knowledge from relevant areas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulatory Affairs and Medical), to ensure the change is technically justified. Prospective evaluation criteria for a proposed change should be set;
(d) After implementation, an evaluation of the change should be undertaken to confirm the change objectives were achieved and that there was no deleterious impact on product quality.