When you are a pharmaceutical or medical devices manufacturer, you will be conscious of the quality of your products. You do not want a defective product to reach the end-user. The consequences can vary from a negative impact on brand image to something far more serious – loss of lives.
Companies that have deviation management or a non-conformance policy in place will be able to detect and rectify such problems. The policy will detail deviations and what should be done when a deviation takes place.
Let us take the example of absorbable sutures that your company manufactures. During manufacturing, there is equipment breakdown, and a particular batch is found to be defective. Because of a proper deviation management process in place, your company will be able to identify and remove these defective products before they are sent to the market.
This article introduces you to what the deviation management process entails, how you can effectively capture and analyze data, and identify improvement actions related to deviations. Furthermore, the article showcases some of the advantages of using a digital solution for managing deviations.
Jump to sections:
- What Is Deviation Management?
- What Are the Different Types of Deviation?
- What Are the Different Deviation Classification Categories?
- What are Deviation Management Requirements?
- Deviation Management Process Flow
- Software for Managing Deviations
- Frequently Asked Questions About Deviation Management
What Is Deviation Management?
As per ICH Q7 Good manufacturing practice for active pharmaceutical ingredients, a deviation is defined as:’
“Departure from an approved instruction or established standard.”
Deviation management is the process of identifying, assessing, and correcting deviations from approved instructions or established standards.
Let us take an example in the context of the pharmaceutical industry. The high-efficiency particulate air filters in your cleanroom have failed, resulting in possible contamination of one or more batches. This is a critical deviation with potentially serious consequences.
At times, you may see that the term “deviation” and “non-conformity” or “non-conformance” are used interchangeably.
The former is typically used in the pharmaceutical industry, while the term “non-conformance” is classically used in the medical devices industry.
Nowadays, many life science organizations have streamlined the entire deviation management process by implementing an Electronic Quality Management System (eQMS) that allows to efficiently manage deviations.
One such software solution is the SimplerQMS. It provides a robust deviation management solution that allows for a variety of deviations to be tracked simultaneously, and managed from the identification of the problem, through the investigative process, root cause analysis, and finally implementation of CAPA and change controls.
What Are the Different Types of Deviation?
In general, your organization will face two types of deviation – planned and unplanned deviations.
Planned deviations are pre-approved temporary deviations from an existing protocol or process.
They cover a specific time period or a definite number of batches. These deviations are undertaken by your organization to avoid a problematic situation.
Planned deviations are organized in such a manner that they do not affect the safety and efficacy of your products.
Examples of planned deviations in the pharmaceutical industry:
- Change in batch size due to reduced availability of raw materials
- Change in batch size for a specified number of batches
- Change in supplier for excipients
Recommended Reading: Change Control in Pharma: Definition, Best Practices & Examples
Unplanned deviations are non-compliances from your designed protocols or systems at any stage of the lifecycle of a product manufacturing, testing, holding, packaging, or storage.
Unplanned deviations are also known as uncontrolled events, unplanned events, or incidents.
They may result due to human error, failure of a utility, equipment/instrumentation breakdowns, or malfunctions.
Examples of unplanned deviations in the pharmaceutical industry:
- Interruption of power supply resulting in equipment breakdown
- Accident at the site due to human error
- Disruption of utility services
What Are the Different Deviation Classification Categories?
There are four deviation classification categories – incident, minor, major, and critical deviations.
Incidents are deviations that do not directly affect the quality of your products.
However, they are against Current Good Manufacturing Practices (cGMP).
They include the following examples:
- Unauthorized personnel in the production area
- Material spillage in the cleanroom
- Staff not properly dressed in the production area
Minor deviations are deviations that have minimal or negligible impact on the overall quality of your products or cGMP.
Minor deviations include the following examples:
- Errors in the documentation that do not affect data integrity
- Spillage of a product during the dispensing process
- Free samples printed with a price tag
Major deviations are deviations that can have a moderate to substantial impact on the overall quality of your products or cGMP.
Major deviations include the following examples:
- Equipment breakdown during processing
- Raw materials received in damaged cartons
- Major variance from a standard output range
Critical deviations are deviations that have a significant impact on the overall quality of your products or cGMP.
These deviations can adversely impact the safety and efficacy of the product, patient’s health, personnel safety, or the environment.
Critical deviations include the following examples:
- Protocols not followed during manufacturing
- Use of contaminated raw materials
- Failure of the HEPA filters in the cleanroom
The following flowchart will help you understand the deviation classification process.
When an untoward event occurs, ask the following questions:
- Will the event have a significant impact on your organization’s manufacturing process parameters, SOPs, or cGMP?
If the answer to the question is NO, it is labeled as an incident.
You will then ask the following question:
- Does the event affect a product attribute?
If the answer is YES to the question, or, if there is a degree of doubt, then the event is a deviation – minor, major, or critical deviation.
You will then ask the following questions:
- Does the deviation affect operations or critical parameters?
- Does the deviation affect equipment or instrument?
If the answer to questions 3. and 4. is a NO, it is a minor deviation.
If the answer to these questions is a YES, or if there is a degree of doubt, you will label the deviation as major or critical deviation.
By using eQMS Software with good deviation management capabilities you will be able to do reporting on your deviation data and thereby show trending based on severity, frequency, issue types, etc.
What are Deviation Management Requirements?
When a deviation occurs in your organization, you are required to document it for complying with GMP regulations (FDA, ICH, and EU GMP).
GMP requires the following written procedures, at the minimum:
- Packaging and labeling controls
- Production and process controls
- Laboratory controls
The most important guidelines are the following.
FDA 21 CFR Part 211. 160
FDA 21 CFR Part 211. 160 (a) states that:
“The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.“
FDA 21 CFR Part 211. 192
Similar to FDA 21 CFR Part 211. 160, FDA 21 CFR Part 211. 192 states that any unexplained discrepancy in drug product production and control records, any batch or its components, must be thoroughly investigated. If required, the investigation should be extended to other batches of the same product.
EU GMP Guide Part 1
EU GMP Guide Part 1 in Chapter 1.8 about Good Manufacturing Practice for Medicinal Products state the following:
“(vii) Any significant deviations are fully recorded, investigated with the objective of determining the root cause and appropriate corrective and preventive action implemented.”
EU GMP Guide Part II (APIs)
Similar to EU GMP Guide Part I, EU GMP Guide Part II (APIs) in Section 2.16 states that all deviations from established procedures must be investigated and documented.
To summarize, your company will investigate deviations from established protocols and procedures thoroughly. These investigations must be documented. The purpose of such an investigation is to determine the root cause and to implement appropriate corrective and preventive actions (CAPAs).
Deviation Management Process Flow
The deviation management process flow has 5 main phases:
Your first step is to get a clear picture of the untoward event that took place.
Deviations can occur during the sampling and testing of raw materials and/or the finished product before packaging. You may get complaints from customers or notifications when your products have not met the necessary industry standards.
The persons in charge of Quality Risk Management in your organization will be responsible for issuing and handling all deviations.
Gather all details and categorize the deviation. As previously noted, the event can be categorized as an incident, minor, major, or critical deviation.
Your organization needs to record all deviations and have a policy in place for reporting deviations.
The department in which the deviation has occurred usually files the deviation report. The maximum time frame that is allowed is up to a day after identifying the problem.
During this phase, the concerned personnel will need to provide all details for aiding in the investigation.
With SimplerQMS, you have an option of using built-in best-practice forms and procedures that will guide you through the process of documenting all the relevant deviation data points. This helps lessen the margin of human error and make the right decision.
Once you have identified and reported the deviation, you need to determine the root cause of the deviation. The concerned department along with the QA department will do a root-cause analysis.
Root-cause analyses become necessary when the deviation is a major or critical one. This means that the deviation will have a significant impact on the overall quality of your product or cGMP. A root-cause analysis is not needed if the deviation is labeled as an incident or is a minor deviation.
Once the root-cause analysis is complete, the next step in this phase is to determine whether a CAPA is needed.
A CAPA is typically initiated when the root-cause analysis shows that the issue is recurring and systemic. CAPA is not initiated if the deviation does not impact the overall quality of your product or cGMP.
While the QA department approves the CAPA, it is the responsibility of the concerned department in charge to implement and close the CAPA.
Similarly, using a system like SimplerQMS you can decide whether the CAPA is needed or not when a deviation is created. Furthermore, our CAPA management solution allows you to easily link CAPAs to non-conformances, supplier findings, audit findings, etc. for increased traceability.
Once the investigation into the deviation is complete, you will need to document the root cause and the resultant CAPA plan for tracking.
It is also important that your company maintains an audit trail which is a regulatory requirement.
Audit trails are chronological records of all actions, events, and changes, including the activities concerning the deviation management process, root-cause analysis, and CAPA.
Using an eQMS that also allows you to efficiently handle deviations you can link deviations to related documents like Electronic Batch Records (EBRs), track the performance of all concerned personnel towards their due dates, and escalate overdue activities to supervisors. Plus, the system automatically creates and stores a time-stamped audit trail for every document change.
Recommended Reading: A Guide to Effective Pharmaceutical Document Management
Lastly, you will have a deadline to meet and a CAPA to close.
With this phase, you will ensure that this particular deviation will not occur again.
In CAPA, you will first describe the problem. Next, the scope should be addressed. Once the problem and scope are identified, you will bring about immediate checks to fix the issue while finding the root cause of the problem. After the root cause analysis is done, your company will plan and implement achievable actions (i.e. corrective and preventive actions).
One way of improving the efficiency of this process is to use an eQMS solution with CAPA management features that allows you to digitize and automate a bulk of routine CAPA activities. For example, document routing, notifications, task reminders, escalation, approvals, and more.
Software for Managing Deviations
Documentation of non-compliances, deviations, CAPAs, etc. is not an easy task when you have a manual paper-based system in place.
With efficient eQMS solutions such as SimplerQMS you are provided with a closed-loop workflow that helps manage deviation incidents, implements corrective and preventive actions, and avoids the recurrences of deviations. It helps your organization deal efficiently with deviations by automating data collection, routing, follow-ups, and escalation of overdue activities.
In the context of strictly regulated life science industries, this software provides your organization excellent support in documentation, analysis, generation of reports, preventing deviation recurrences, and for you to stay compliant with regulatory requirements.
Frequently Asked Questions About Deviation Management
The main difference between deviation and CAPA is that the deviation is a departure from an approved instruction or established standard, while CAPA is the complete investigation into the root cause for the deviation, solving the issue, and implementing the solutions.
An incident is a deviation that does not directly affect the overall quality of your product or processes. If either of these is compromised, it is labeled as deviation.
A deviation report is a real-time recording of a deviation. It will contain the investigations of the root-cause analysis and the implemented corrective and preventive actions. Deviation reports are mandated for compliance with cGMP.
Deviations can happen in any organization. They are particularly significant if you are in various life science industries since your products directly affect humans.
As soon as deviations occur, they need to be analyzed and solutions found using a deviation management process.
Manually doing this will be most cumbersome. With the help of efficient eQMS such as SimplerQMS software you can effortlessly identify, investigate, document deviations, and implement solutions for deviations.
If you are interested in learning more about how an eQMS solution can help you streamline deviation management processes in your organization we recommend you book a personalized demo and talk to our experts.