Deviation Management Software or Deviation Management System is used to document and manage deviations in a business environment. A deviation is any event that interrupts the normal production process for a company. There are many ways to handle a minor or major deviation in a business: from manually opening up documentation and adding notes, to using an automated system, or even using an iPad app. Each method has its pros and cons, but typically when companies need to be more efficient with their production management needs, having one centralized place for managing deviations becomes extremely convenient and efficient.
In this guide, we review the aspects of Deviation Management Software, deviation process, temporary change control and planned deviation, and deviation procedure example.
Deviation Management Software
Let’s face it: the process of managing staff and rosters is complicated. Managing staff can be even more complicated if there are unexpected fluctuations in their productivity or attendance. That’s why some facilities use deviation management software to help keep track of how many people are working on any given day and where they’re located within the facility.
How does deviation management software work?
Deviation management software is a tool that helps you to identify and manage deviations, which are defined as “any difference between planned and actual performance.” It’s important to know what a deviation is as it will help you understand how deviation management software works.
A lot of the same technology that’s used to manage rosters and track workers can be used to manage deviations from plan.
A lot of the same technology that’s used to manage rosters and track workers can be used to manage deviations from plan. In fact, many companies already have a number of tools in place for managing deviations and other changes.
For example, if you use an online platform for managing rosters and time tracking, it should have some sort of change management system that allows you to:
- Track changes as they come up
- Notify people about those changes (if necessary)
For example, in most cases, facilities want to be able to communicate deviations from plan quickly, so that those responsible for staff will know what the situation is. As the changes occur, there has to be a system for notifying other people about those changes.
As an example, in most cases, facilities want to be able to communicate deviations from plan quickly, so that those responsible for staff will know what the situation is. As the changes occur, there has to be a system for notifying other people about those changes. In addition to this, facilities also want to tie together all of the data into one place in order to make it more efficient and easier for them (and their managers) conduct analysis on how well they are doing against their goals or targets.
That might mean using technology like text messaging or sending an email. But if a facility uses a more robust system like a staff and roster management app, it might be able to send out notifications automatically because it is already aware of any changes made on the system.
- That might mean using technology like text messaging or sending an email. But if a facility uses a more robust system like a staff and roster management app, it might be able to send out notifications automatically because it is already aware of any changes made on the system.
- For example: You have just added an employee in the app, but you forget to notify them or their manager that they’ve been added. The app can automatically send out a notification to both you and their manager after making the update.
- This kind of automation also allows facilities managers to know exactly who has been notified and when they were notified—which can help ensure that every employee is kept informed about important changes as soon as possible!
This can also help keep everyone on the same page because they’re all being notified at the same time when things change. It means that no one is left behind because they didn’t get an email or text message in time.
This can also help keep everyone on the same page because they’re all being notified at the same time when things change. It means that no one is left behind because they didn’t get an email or text message in time.
This is the most important benefit of using deviation management software, but it’s not the only one. Other benefits include:
- Easier communication between people who work together on projects and who need to stay in touch with each other more regularly than others might do so without this kind of system in place (for example, if there’s a delay on one end or another).
- Faster response times when someone needs to reach out because they have questions about something they’re working on right now.
And this information can be shared with managers and staff alike. If someone makes a change, then all of the relevant people will be notified at once. That way they know what’s going on and they can act accordingly, which might mean reporting back in or taking over certain tasks from an employee who has been called away from work unexpectedly.
And this information can be shared with managers and staff alike. If someone makes a change, then all of the relevant people will be notified at once. That way they know what’s going on and they can act accordingly, which might mean reporting back in or taking over certain tasks from an employee who has been called away from work unexpectedly.
The software is also set up so that if there are any problems with the changes that have been made, it warns other users so they can check their own systems for issues as well. If a fix needs to be made by someone else on your team, then they’ll know when to look out for that notification and get right on it!
deviation process
Whether you manufacture a medical device, pharmaceutical, automotive or software product that reaches a human end user, you know that quality is one of your top priorities. This is not only because a bad quality or defective product will impact your image, it is also because there are potentially serious consequences resulting from non-conformities of a product or system. Luckily, there is something that can help us: Deviation Management or CAPA.
According to ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), deviations are defined as “Departure from an approved instruction or established standard“. This means, that at any point your product or system is not performing or operating as you intended, or a certain instruction has not been followed – you would raise a deviation.
Within this process lies much reward: Deviations are a tool for the company to strive for improvement and eliminate non-conformities, resulting in a safer, higher quality product and potentially a reduction in waste.
How To: Deviation Management Stages
A procedure known as a Deviation or Non-Conformance Policy will be created by the company, which will outline what is considered a deviation and what to do if one occurs. Deviation Management generally involves the following steps:
Let’s break them down together:
(1) Identification
Our first step is understanding what happened (all details are important here!) and categorizing the deviation. We categorize according to the risk that this deviation poses to the product’s safety, efficacy or quality. Your company may use the following terms:
(2) Reporting
If it’s not recorded, it didn’t happen. Be sure to follow your company’s policy on how to report deviations and where to document the details you have found during the identification stage.
Anyone in the company can initiate a deviation report, but it is usually done by the responsible department. The deviation will be reported, up to 1 day after the discovery.
It is necessary to be as clear and accurate as possible in the details provided when reporting a non-conformance to aid the investigation. If the deviation happened in production, the manufacturing process will most likely be halted until the matter is investigated. In addition, any immediate corrective actions will be activated, if and when possible to “extinguish the fire”.
(3) Investigation
Part One: Finding the root cause
We have finished recording the events that transpired and understand the final result. Now the real work begins: determining the root cause of the non-conformance or deviation.
We start by brainstorming, often in a meeting composed of various departments, all the possible causes of the deviation. The idea is to form a creative forum where step by step, the causes of the deviation can be narrowed down to the most probable one.
There are a number of tools that can help us succeed in this sometimes-overwhelming process of deviation management. The relevant Department manager & The QA department, with the full cooperation of relevant department(s), initiate the investigation. This may be done using one or more of the following approaches:
FISHBONE
5W1H
5 WHYs
You and your team will determine what is the most appropriate approach for the situation – the central idea in all is to keep asking questions until you find the most probable root cause. When used in conjunction, these approaches are an effective and powerful way to get to the bottom of things!
Part Two: Determining Corrective and Preventative action (s) – CAPA
After analyzing the data gathered in the investigation the most probable root cause(s) are selected and Corrective and Preventive action(s) (CAPA) are determined. These shall be put in place to ensure that this non-conformance and similar non-conformities do not recur.
The CAPA is to be approved by the QA department, but it is the responsibility of the department manager to implement the CAPA and ensure its closure.
(4) Documentation
Following the completion of the investigation process, it is vital that the probable root cause and its corresponding CAPA (s) plan is documented and added to a system where it can be tracked. A due date is to be given for finalizing the activities and a clear plan shall be documented.
(5) Implementation
Time to get to work! We have CAPAs to close!
3 key take-aways
· Real-time reporting is vital when documenting – we all know that after a few days our memory becomes a little foggy.
· During investigations – use the knowledge and expertise of other departments, because everyone knows their field of work best and can share how to best prevent the next deviation
· Never start an investigation with a prejudice of what is the cause of the non-conformity.
Final Remarks
Deviations are not to be feared – they help the company understand where the problems are and give us the opportunity to fix them. Through corrective and preventative actions (CAPA), we make sure they do not happen again!
Always keep this in mind: Deviation and CAPA are tools for improvement and growth of the company. There are multiple approaches to help you!
What we can suggest
RS NESS is a highly experienced service provider in the Medical Device and Pharmaceutical industries. Our Services include Regulatory Affairs, Clinical Affairs, QA, Validation, and Engineering processes.
We can assist you with Deviation Management and CAPA in helping you to create appropriate policies and process, as well as to optimize deviation handling.
We differentiate ourselves by being quality-oriented. Our technical expertise comes with a hands-on experience and approach, ensuring that our clients receive the most effective and professional service.
Our clients range from small Start-Ups to international companies.
If you have any questions or need professional support, don’t hesitate to get in touch with us.
temporary change control and planned deviation
what is a planned change? the term “planned change” refers to any change in the system that has been recorded in the change log and approved by an authorized individual. this could include new hardware, software or systems integration; but also includes changes to processes and procedures, such as workflow changes or process improvement initiatives. if you think about it-all aspects of your organization will be impacted by some kind of planned change at some point.
temporary change control and planned deviation
Temporary change control and planned deviation is a process to manage the impact of changes to a system. It involves using temporary change control procedures when there is an identified need for immediate action, but no formal risk management plan has been developed yet.
Temporary change control and planned deviation are used to manage the impact of changes to a system.
introduction
Change control is a process that ensures an organization can manage planned changes and make sure they are implemented in a controlled manner. Change control helps ensure the integrity of data, systems, and resources by managing changes to them.
Change control helps ensure that:
- Changes are made only for approved reasons;
- All relevant parties are consulted or informed about the change;
- The impact of the change on other systems and processes is understood;
- The consequences of not implementing the change are considered;
- Changes have been reviewed by all stakeholders so no unintended consequences occur (e.g., errors).
all aspects of the system must be identified to determine whether any aspect of the new change will impact a system not yet monitored, such as electronic records.
To determine whether a new change will impact systems not yet monitored, you must know all aspects of the system.
- The system is the entire process.
- A change may affect the system in a way that was not previously considered (e.g., by creating additional work for staff).
- A change may affect the system in a way that was previously considered but no longer relevant (e.g., an order of magnitude increase in processing time due to automation and re-engineering).
there are variety of methods for reviewing a proposed change with the potential to impact the record and its integrity. these include approving a treated deviation, approving a temporary change, or approving a permanent change
There are variety of methods for reviewing a proposed change with the potential to impact the record and its integrity. These include approving a treated deviation, approving a temporary change, or approving a permanent change.
Temporary changes are those that will not be permanent, but will be in place for a limited period of time. This can include:
- Approving workarounds (e.g., bypassing systems)
- Approving temporary access to critical systems
this is an opportunity to identify key aspects of the proposed change which may be worthy of inclusion in subsequent revisions to standard operating procedures or protocol updates.
determining and documenting the impact of planned changes on system functionality is essential for ensuring data quality and regulatory compliance as well as providing options for data re/engineering if necessary.
Determining and documenting the impact of planned changes on system functionality is essential for ensuring data quality and regulatory compliance as well as providing options for data re/engineering if necessary.
The impacts of change should be identified and documented for each system impacted by the change.
deviation procedure example
Before we get into how and when to use an SOP Deviation, let’s revisit what we mean by SOP Deviation. Standard Operating Procedures (SOP) are, of course, a set of defined steps in a procedure. The purpose of the SOP is to outline how a process is completed and who is completing it. Since an SOP qualifies as an audited process, it is extremely important to follow the SOP exactly as described. Going outside the defined SOP, can lead to an audit finding and potentially create a material issue for an organization. BUT, if going outside an SOP is defined by a different SOP, then you are still within your compliance framework. When you define how to have an exception to your SOPs, then this becomes your SOP Deviation process.
SOP on SOP Deviation
The most common and universal SOP exception process is to have a dedicated SOP Deviation process. Similar to your SOP on SOPs, an SOP Deviation SOP is a supporting SOP that is not related to the operations of the organization, but the Governance and Compliance. The SOP Deviation SOP needs to be designed in such a way that it can be applied to virtually any other SOP in the organization at the time of an exception. Your SOP Deviation needs to be able to have several universal components in it:
1. An initial trigger.
Since an SOP Deviation can be used for any other SOP, the initial trigger for the Deviation needs to be defined in your SOP Deviation SOP. Otherwise, you would need to build the Deviation trigger into every SOP! Typical trigger points range from light options like a notification to Quality Assurance or Compliance to heavier options such as a dedicated Deviation Form.
2. Deviation Form
Since SOP Deviations are a structured process, how a deviation is recorded should be standardized. The is typically competed through an SOP Deviation form. Some of the sections that should be included in your SOP Deviation Form, include:
3. Authorized Approvers
When a deviation occurs, it is critical that key personnel are aware of the exception and the appropriate measures have been taken in response. Since it is impossible to predict every deviation situation, it is important that subject matter experts (SMEs) are involved in the process. Your SMEs need to include the process owner to effectively document the exception and the impact of it, plus Quality Assurance, Compliance or similar function. Depending on the severity of the exception, additional leadership may need to be formally included.
4. Supporting Documentation
An SOP Deviation cannot be used to simply skip paperwork or a standard process. Depending on the reason for the Deviation, all original documentation and controls may still need to be completed after the fact. In addition to the Deviation Form, all communication around the deviation, retro-actively prepared documentation and other related documents from the Deviation should be attached to the Deviation Form to create the overall Deviation Process. In the event of an audit, each Deviation Package needs to be able to stand on it’s on and prove that the final outcome was sufficient for the situation.
Planned vs Unplanned Deviations
During an Audit, it is very likely that a list of Deviations will be provided. The number of Deviations can determine the amount of scrutiny applied to an organization during the Audit. Therefore, trying to keep the number of Deviations to a minimum is highly recommended. In addition to the number of Deviations, the type of Deviation can determine how much time Auditors spend in this area. Since having SOPs is all about having a control environment, completing a planned deviation is much less of an issue than unplanned deviations.
Planned Deviations
A planned deviation is something that is identified and even approved BEFORE it happens. One of the most common reasons for a planned deviation is time. Controlled processes can take additional time, because it always takes longer to do things right. There are a number of instances where some objective needs to be met, but completing the defined SOP will lead to failure due to time constraints. In a planned deviation, it is important to include a proper risk assessment and impact to the overall result by completing the deviation. As long as the overall result is not compromised, an SOP Deviation can be a very powerful tool if time is an issue.
Unplanned Deviations
Unplanned deviations should be avoided at all costs. An abundance of unplanned Deviations can call into question your entire compliance framework. If an unplanned deviation has occurred, then something broke and much more research is needed. Depending on the severity of the unplanned deviation, a Corrective Action and Preventative Action (CAPA) may need to be completed. CAPA is a separate process that is designed to understand what caused the deviation, what needs to be done to fix it in the short-term and how to prevent it going forward. Some unplanned deviations may not be severe in nature (eg. Two signatures happened in reverse order) and can still fall under your SOP Deviation SOP. During the review and approval process, subject matter experts will decide if an unplanned Deviation needs to go through the CAPA process.
Built-in SOP Deviations
Some processes are high volume in nature and a level of deviation is not only acceptable, but expected in the process. In these instances, the exception is the same every time and individual occurrence does not have a material impact on the overall compliance framework. In these types of situations, following the SOP Deviation SOP may become suffocating to the overall process, but there is still a need to note the individual deviations. An example is to include a dedicated Exception Form in your process.
For example; before an entry is put into a system, a second manual signature needs to be obtained. Due to the high volume of entry, there are 2 – 3 deviations a week that fail to get the signature because of time constraints. In this case a quick Entry Deviation form is filled out and attached to the original signature sheet as an exception.
As long as this exception situation and process is included in the source SOP, it does not fall under the global SOP Deviation SOP. You have not actually deviated from the SOP since the deviation is detailed in the SOP. It is important to be cautious with built-in deviations. A built-in deviation should always be immaterial, expected and addressed in the core SOP.
When the exception becomes the rule
Monitoring the number of Deviations that occur is important as it provides insight into the overall compliance framework. A number of planned deviations in the same SOP usually indicates a need to optimize that SOP. A number of unplanned deviations can indicate a general lack of control in the compliance framework or perhaps training issues. Lastly, an excessive number of built-in deviations may indicate that the deviation process is too easy and encourages exceptions. This can be addressed by expanding the exception process to be more difficult than following the standard process.
Regardless of the type of Deviation (Planned, Unplanned, Built-in), monitoring the frequency of Deviations is critical to assess the health of the overall compliance framework.
SOP Deviation Training
As with all SOPs, documenting the SOP is not enough. Having an effective notification and training program in place is key to compliance by employees. It is natural to focus training on how to complete a process. In life and death situations, there is significant training on what to do when something goes wrong. This mentality needs to be universal though. In the case of the built-in deviation, the deviation process is typically included in the base SOP training. Global SOP Deviations can be trickier for employees to grasp and should be included in multiple training sessions. Beyond the obvious training on the SOP Deviation SOP, all other SOP training should reference the SOP Deviation SOP and ideally provide examples related to the process. It is important for employees to understand that exceptions and mistakes can only become an unrecoverable situation if they go unnoticed. It is important for everyone to know where to find the escape hatch if they need it.