Deviation Management in the FDA-Regulated Industries: Basics and Best Practices

Deviation management is the systematic process of identifying, documenting, investigating, and addressing any unexpected or unplanned events that deviate from approved or standard operating procedures, guidelines, or specifications during the manufacturing, distribution, storage, or testing of a drug, device, or similar type of product.

Having seen and solved many deviation-related challenges with drug and device firms, it's clear that the general issue teams experience is effectively identifying, investigating, and resolving deviations in a timely and compliant manner. Without an efficient management system, deviations can quietly pile up, leading to a dangerous backlog that puts companies out of compliance with their own policies and even regulatory expectations.

Tackling a deviation backlog—or the precursors to one—can be a daunting task, especially for organizations that lack the necessary resources. As a result, many companies seek external support from regulatory consulting firms like The FDA Group to assist with deviation management and ensure compliance and return to a state of tight control.

If you need deviation assistance, contact us.

This guide explores the basics of effective deviation management and presents some best practices informed by our own experience solving these challenges. 

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Deviation Backlog Reduction, CAPA Management, and Long-Term Staff Augmentation

See how we successfully partnered with a multinational pharmaceutical company to address deviation and CAPA backlogs, implement corrective actions, provide staff training, and achieve the goal of eliminating all backlogs within the allocated time and budget.

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Deviation Management Basics

A deviation can be defined as any unexpected or unplanned events that deviate from approved or standard operating procedures, guidelines, or specifications during the manufacturing, distribution, storage, or testing of pharmaceutical and life sciences products.

Deviations are classified into two main types: planned deviations (or changes), which are anticipated and approved in advance, and unplanned deviations, which occur without prior notice or intention.

  • Planned deviations are anticipated and approved in advance, typically due to a temporary change in processes or procedures. They’re controlled and documented to ensure that product quality and safety are maintained.
  • Unplanned deviations occur unexpectedly and without prior notice or intention. They can arise from various sources, including equipment malfunctions, human errors, or unforeseen circumstances. These deviations must be promptly identified, documented, and investigated to determine their impact on product quality and safety and to implement appropriate corrective and preventive actions.

Here are a few common examples of deviations we've seen drug or device firm encounter:

  • An equipment failure or malfunction that leads to potential contamination or inaccurate test results.
  • Human errors, like miscalculations, mislabeling, or failure to follow the approved procedures.
  • Deviations in environmental conditions, such as temperature, humidity, or air quality that impact product stability or sterility.
  • Unanticipated delays in manufacturing or testing processes that result in product degradation or expiration.
  • Issues with raw materials or supply chain that can lead to product composition or quality variations.

Managing deviations is crucial in FDA-regulated industries for several reasons:

Compliance with regulations and guidelines. The FDA enforces strict regulations and guidelines to ensure the safety, quality, and efficacy of pharmaceutical products and medical devices. Failure to adequately manage deviations may lead to regulatory non-compliance, resulting in warning letters, fines, product recalls, or even suspension of manufacturing operations.

Maintaining product quality and safety. Deviations can potentially compromise product quality and safety by introducing inconsistencies or defects. Teams must identify and address these issues, ensuring that their products meet the required standards and are safe for use.

Identifying and addressing potential risks and process inefficiencies. A well-structured deviation management system enables organizations to identify recurring deviations, uncover underlying issues, and take corrective and preventive actions (CAPA) to improve processes, prevent future deviations, and reduce risks.

Enhancing organizational learning and continuous improvement — A strong deviation management program also fosters a culture of learning and continuous improvement within an organization. Companies can adapt and refine their processes by analyzing deviations and implementing CAPA, resulting in enhanced efficiency, reduced costs, and improved overall product quality.

A backlog of unresolved deviations can weaken the ability to identify trends, respond to issues, and maintain internal policy and regulatory compliance. Moreover, it can negatively impact product quality, safety, and the organization's reputation.

The Key Components of an Effective Deviation Management System

An effective deviation management system consists of several key components that work together to ensure deviations are identified, documented, investigated, and resolved promptly and systematically.

Here’s a high-level overview of the recipe for such a system:

1. Clear policies and procedures

Establishing well-defined policies and standard operating procedures (SOPs) for deviation management is crucial to provide a consistent framework for handling deviations. These policies should outline the steps for reporting, investigating, and resolving deviations—and should be easily accessible to all relevant personnel.

The FDA Group recommends:

  • Ensure that your existing policies and SOPs related to deviation management are comprehensive, clear, and aligned with current FDA regulations and industry best practices.
  • Make these policies and procedures readily accessible to all relevant personnel. For instance, using an intranet or a dedicated shared folder could facilitate quick and easy access.
  • Define roles and responsibilities clearly within your policies and procedures to establish accountability in managing deviations.
  • Include practical examples in your policies and SOPs to aid personnel in understanding the real-world application of deviation management principles.
  • Use clear, understandable language in your policies and procedures, and provide comprehensive training for all personnel to ensure they understand and can effectively execute them.

Contact us for expert assistance and support in any or all of these areas.

2. Established roles and responsibilities

Clearly defined roles and responsibilities are vital in deviation management to ensure accountability, ownership, and effective communication among personnel involved in the process. Assigning specific responsibilities helps to streamline the deviation management process, minimize confusion, and promote the timely resolution of deviations.

There should be clear, documented roles and responsibilities established for all of the following duties within the deviation management process:

Identification of deviations — Special personnel should be assigned to monitor processes and identify deviations when they occur. These individuals should be trained to recognize potential deviations and understand the importance of timely reporting.

Deviation reporting — Individuals should be designated as responsible for reporting deviations promptly, using the appropriate channels or tools. This includes ensuring that deviations are documented according to the established SOPs and escalating issues when necessary.

Investigation — Personnel with the appropriate expertise and experience to investigate deviations should be designated to determine their root causes and assess their impact on product quality and safety. These individuals should be trained in root cause analysis techniques and familiar with relevant regulations and guidelines.

Resolution of deviations — These assignees should be responsible for implementing CAPA. This may involve cross-functional teams that collaborate to address deviations, monitor the effectiveness of CAPA, and make necessary adjustments.

System oversight — A person or team should be responsible for overseeing the overall deviation management system itself. This includes ensuring that the system is functioning effectively, monitoring performance metrics, and driving continuous improvement efforts.

Given the many moving parts of a modern deviation management system, it’s important to establish clear lines of communication and collaboration between different personnel and departments involved. This helps to ensure that information is shared effectively, facilitating the timely resolution of deviations and promoting a culture of transparency and accountability.

Here are a few ways we've seen companies open these lines of communication internally:

  • Established (and followed!) interdepartmental communication policies: These could include guidelines for how to escalate deviations, who to report to, and how to document these deviations. Such policies should be clearly communicated to all relevant staff members and regularly updated as necessary.
  • Modern collaboration tools: Utilize tools that allow for real-time collaboration and communication among team members, such as project management software, intranet, or dedicated communication platforms (e.g., Slack, Microsoft Teams). These tools can facilitate the immediate exchange of information and improve the speed and efficiency of deviation resolution.
  • Cross-functional teams: Establish cross-functional teams that work together to manage and resolve deviations. This fosters collaboration and allows for diverse perspectives in dealing with deviations.

Training and knowledge management is another important factor. Clear responsibilities should be established for providing training and assessing competency in deviation management to appropriate personnel or teams.

The FDA Group recommends: Despite having clearly defined roles and robust deviation management systems, we often see problems still arise due to human error or lack of coordination. We recommend implementing a proactive 'Preventive Action Culture' rather than relying solely on corrective measures. The companies we see doing this well invest in thorough training programs that not only teach the mechanics of their deviation management system but also promote a mindset of constant vigilance and proactive risk management.

3. Training and competency

Frequent training and competency assessments ensure employees are equipped to accurately identify, report, and manage deviations.

Training should cover not only the organization's policies and procedures but also regulatory obligations and industry best practices. For example, introducing scenario-based training sessions, such as a mock deviation event, can help staff understand how to apply these principles in a practical context.

The FDA Group recommends: 

  • Use a Learning Management System (LMS) for training and tracking employee progress.
  • Conduct a skills-gap analysis to identify and address training needs proactively.
  • Regularly assess employee competency through tests and performance reviews.
  • Provide continuous learning opportunities and resources for upskilling.

4. Documentation and recordkeeping

Maintaining comprehensive and accurate records of deviations, investigations, and corrective actions is essential for regulatory compliance and audit readiness.

Using a standardized deviation report form, for example, ensures all necessary information is captured consistently.

The FDA Group recommends: 

  • Use a modern EDMS for efficient document control and storage.
  • Set guidelines for timely and accurate documentation of deviation management activities.
  • Implement periodic internal audits of deviation management records to ensure quality and compliance.
  • Ensure records are retained in line with regulatory requirements.

5. Documentation and recordkeeping

Structured reporting and tracking of deviations promote prompt identification and resolution. This may involve an incident management software that not only streamlines reporting but also facilitates real-time tracking and data analysis.

The FDA Group recommends: 

  • Develop a deviation escalation protocol detailing who, when, and how deviations should be reported.
  • Use automated tools for real-time tracking of deviations and trend analysis.
  • Ensure timely communication of incident information across all relevant departments.

6. CAPA/root cause analysis

Performing a thorough root cause analysis is a fundamental first step that paves the way for effective CAPA. Techniques such as Fishbone Diagrams or the 5 Whys can systematically unearth the underlying factors leading to a deviation. For example, a Fishbone Diagram might reveal whether a manufacturing process deviation originated from personnel, processes, or equipment.

Once root causes are established, suitable CAPA should be implemented. These actions aim to directly address the identified root causes and mitigate the risk of their recurrence. For instance, if frequent equipment malfunctions are discovered to be a root cause, a corrective action could involve increasing the frequency of machine calibration.

Over time, the effectiveness of this action should be evaluated to determine if it indeed reduces the number of equipment-related deviations.

The FDA Group recommends: 

  • Offer comprehensive training on various root cause analysis techniques.
  • Encourage the participation of cross-functional teams in both root cause analysis and the CAPA process to glean a breadth of insights.
  • Establish a formalized CAPA process that aligns with root cause analysis findings.
  • Prioritize the implementation of CAPA based on risk levels they address.
  • Regularly monitor and review the effectiveness of both root cause analysis and CAPA. This can involve tracking the recurrence of similar deviations to assess root cause analysis effectiveness, and conducting regular check-ins and audits to gauge CAPA effectiveness.

A Few Best Practices for Deviation Management from the Field

Consider these best practices as action items for review and improvement.

☑️  Assign clear responsibility for deviation reporting (and broader management). Typically, a department manager should report deviations to the QA department. However, if the manager is unavailable, the next highest-ranking employee is tasked with this responsibility. For example, if a deviation occurs in the production department and the manager is away, the assistant manager should take responsibility for reporting the deviation. This should be a documented, trained-on, and observed policy.

☑️  Use cross-functional teams. Siloing the work of reporting and managing deviations is a dangerous risk. The teams we see managing deviations effectively utilize a multidisciplinary team of quality assurance and other impacted departmental staff. Since deviations can occur in any part of the business and result in diverse types, a team with a wide range of experiences is vital. Such a team may include quality assurance specialists, engineers, and data analysts who bring different perspectives and expertise in fully diagnosing and resolving the problem.

☑️  Ensure timely reporting of deviations. Your system should explicitly specify the maximum delay allowed in reporting a deviation. Generally speaking, deviations should be reported as soon as they happen, but delays might reach 2 – 4 hours, not exceeding a working shift. Hold yourself to a tight but attainable reporting requirement. Document and live by it.

☑️  Write detailed deviation descriptions. When reporting a deviation, include detailed information like the observer's name, time of observation, initial reaction, potential causes, and details of the deviated procedure or standard. For example, a deviation report might include:

"Deviation observed by [Name] at 10 AM. Initial response was to halt the production line. Potential cause may be a calibration error in machine X. The deviation is from our standard production rate."

☑️  Be mindful of deviation entry and sequencing. Keep a complete, numbered list of recorded deviations for easy review and audit purposes. This list should contain essential data recovered during deviation handling such as the source, date, time, brief description, and corrective/preventive actions taken.

☑️  Adopt a risk-based approach. Categorize deviations according to their effect on the product quality into four categories - Incident, Minor, Major, and Critical. This helps prioritize responses if such prioritization is needed. Here's a simple starting point from which to build out your categorization framework:

Incident: Deviations that don't affect product quality, e.g., a minor equipment malfunction that doesn't disrupt production.

Minor: Deviations affecting equipment or utility function but not product quality, e.g., a malfunction in a non-essential machine.

Major: Deviations affecting quality attributes, specifications, or critical process parameters, e.g., a key machine producing defective parts.

Critical: Deviations having a direct impact on patient’s health, personnel safety, or environmental effect, e.g., a toxic substance leak.

☑️  Take lessons from past deviations. Drive improvement by learning from past deviations and preventing recurrence. Regularly analyze past deviations and root causes and create a centralized repository for documenting and storing information on past deviations.

Signals You Need Third-Party Consultant Support

There are several scenarios where engaging third-party consultant support can be highly beneficial for addressing deviation management or backlogs.

The following are key situations when seeking external assistance is advantageous:

Limited internal resources or expertise. Companies may lack the necessary internal resources or expertise to effectively manage deviations or address backlogs. Third-party consultants with specialized knowledge and experience in the pharma and life sciences industries can provide valuable guidance and support to help organizations navigate the complexities of deviation management and ensure compliance with regulatory requirements.

High deviation volume or significant backlogs. When a company faces a high volume of deviations or has accumulated a significant backlog, third-party consultants can provide additional capacity and expertise to help manage the workload and expedite the resolution of deviations. They can work alongside the company's internal teams to prioritize, investigate, and address deviations more efficiently.

Preparing for inspections or audits. In preparation for inspections or audits, companies may benefit from third-party consultant support to assess their deviation management systems, identify gaps, and implement corrective actions. Consultants can provide an unbiased perspective and help organizations ensure that their systems are robust, compliant, and capable of withstanding regulatory scrutiny.

Implementing new technology or systems. When implementing new technology or systems for deviation management, third-party consultants can provide valuable expertise in selecting the right tools, customizing them to meet the organization's specific needs, and integrating them into existing processes. They can also assist with training and change management to ensure a smooth transition to the new systems.

Get Expert Deviation Management and Backlog Assistance

Deviation management is a critical aspect of ensuring regulatory compliance and maintaining product quality and safety. At The FDA Group, we understand the challenges that organizations face in managing deviations, including identifying and addressing root causes, implementing effective corrective and preventive actions, and managing backlog.

Our deviation management services help organizations streamline their processes and reduce the risk of compliance issues by providing guidance on best practices, developing policies and procedures, and training employees on proper deviation management techniques. We work closely with our clients to understand their unique needs and challenges and provide customized solutions that align with their goals and objectives.

We routinely assist organizations in conducting root cause analysis, developing and implementing CAPA plans, and tracking and trending deviations. We also provide support in addressing backlogs and compliance issues related to deviations. We help organizations improve their deviation management processes, reduce costs and risk, and maintain compliance with FDA regulations. We also assist organizations in preparing for regulatory inspections or audits by conducting mock audits, identifying potential gaps in their deviation management systems, and providing recommendations for improvement.

Contact us today and download our free case study below to learn more about our deviation management services and how we can help your organization maintain compliance and improve its operations.



Deviation Backlog Reduction, CAPA Management, and Long-Term Staff Augmentation

See how we successfully partnered with a multinational pharmaceutical company to address deviation and CAPA backlogs, implement corrective actions, provide staff training, and achieve the goal of eliminating all backlogs within the allocated time and budget.

Read the case study »



Topics: Quality Systems