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Last updated on 2024年5月21日

How do you define SOP exception approval criteria in your organization?

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A standard operating procedure (SOP) is a set of instructions that guides your team to perform a specific task or process consistently and efficiently. However, sometimes you may encounter situations that require you to deviate from the SOP due to unforeseen circumstances, urgent needs, or improvement opportunities. In such cases, you need to have a clear and transparent SOP exception approval criteria that defines when, how, and by whom an exception can be granted. Here are some steps to help you create and implement your SOP exception approval criteria in your organization.

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1 Identify the scope and purpose of the exception

The first step is to identify the scope and purpose of the exception, which means clarifying what kind of situations can qualify for an exception, what are the expected outcomes and benefits of the exception, and what are the potential risks and costs of the exception. You should also specify the duration and frequency of the exception, and whether it is a temporary or permanent change to the SOP. This will help you evaluate the feasibility and necessity of the exception, as well as communicate it to the relevant stakeholders.

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Lokesh Singh
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Defining SOP exception approval criteria involves setting clear guidelines for handling deviations. I identify scenarios needing exceptions, develop criteria and conditions, and outline the approval process with specific roles. A tracking system documents all requests and approvals for transparency. At Cognizant, I categorized scenarios, set conditions, involved stakeholders, and maintained a detailed log to manage exceptions systematically and ensure alignment with standards.

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Maryam Daneshpour

Biotechnologist | Business Development Expert | MBA
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In fact, the first step is not only important but also crucial! When dealing with multiple SOPs, especially in sensitive industries like pharmaceuticals and healthcare, making changes or exceptions can be extremely difficult. It requires a thorough risk assessment, and decision-makers must be prepared to face harsh criticism if something is missed or if negative consequences occur. In my opinion, exceptions should not be made frequently within a system, even if they do not directly impact the quality parameters or features. This is necessary to prevent the potential devaluation of all SOPs within the organization.

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2 Define the roles and responsibilities of the approvers

The second step is to define the roles and responsibilities of the approvers, which means determining who has the authority and accountability to approve or reject an exception request, and what are their criteria and procedures for doing so. You should also establish a hierarchy or escalation path for the approvers, in case of conflicts, disputes, or complex cases. The approvers should have sufficient knowledge, experience, and credibility to make informed and objective decisions, and they should document and justify their reasons for each approval or rejection.

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3 Establish the process and format of the exception request

The third step is to establish the process and format of the exception request, which means outlining how, when, and where an exception request can be submitted, reviewed, and approved. You should also define the format and content of the exception request, such as the title, description, rationale, evidence, impact analysis, mitigation plan, and approval signature. The exception request should be clear, concise, and comprehensive, and it should follow a standard template or form that is easy to fill and track.

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4 Implement the exception monitoring and reporting system

The fourth step is to implement the exception monitoring and reporting system, which means setting up the mechanisms and tools to monitor and measure the performance and outcomes of the exception, and to report and communicate them to the appropriate parties. You should also define the indicators and metrics to evaluate the effectiveness and efficiency of the exception, and the frequency and format of the reporting. The exception monitoring and reporting system should provide feedback and insights to the approvers, the requesters, and the SOP owners, and it should support continuous improvement and learning.

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5 Review and update the SOP and the exception criteria

The fifth step is to review and update the SOP and the exception criteria, which means assessing the results and impacts of the exception, and determining whether it should be continued, modified, or terminated. You should also consider whether the SOP needs to be revised or updated based on the exception experience, and whether the exception criteria needs to be refined or adjusted based on the feedback and data. The review and update process should be done periodically and systematically, and it should involve the participation and consultation of all the relevant stakeholders.

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6 Train and educate your team on the SOP and the exception criteria

The final step is to train and educate your team on the SOP and the exception criteria, which means ensuring that your team members understand and follow the SOP and the exception criteria, and that they have the necessary skills and knowledge to perform their tasks and processes effectively and efficiently. You should also provide your team with the resources and support they need to comply with the SOP and the exception criteria, and to report any issues or challenges they face. The training and education process should be ongoing and interactive, and it should foster a culture of quality and excellence in your organization.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Christopher Sutton

Accomplished pharmaceutical quality executive with achievement in all aspects of technical operations, from initial concept to commercialized, regulated products.
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Finally; follow up! Check how the exception has affected the systems. Have there been other similar cases? Is this chronic, or merely and acute problem. Chronic issues should, of course, be folded into future SOPs. Often the Annual Report is used for this evaluation.

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How do you define SOP exception approval criteria in your organization?

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1 Identify the scope and purpose of the exception

2 Define the roles and responsibilities of the approvers

3 Establish the process and format of the exception request

4 Implement the exception monitoring and reporting system

5 Review and update the SOP and the exception criteria

6 Train and educate your team on the SOP and the exception criteria

7 Here’s what else to consider

Standard Operating Procedure (SOP)

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