Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are carefully thought out to minimize any critical errors that could compromise the product. Therefore, there must be an investigation when a product step is missed or a deviation occurs. The investigation needs to assess what happened, why it happened, and how to prevent this error from happening again. Here we give you an overview of the proper process after a deviation has occurred.
There could be several factors that can cause a deviation to occur. For example, there might be a new hire who is not familiar with the process, or the manufacturing crew may be rushed in completing a batch. Other potential factors include: distractions in the room, the wrong material was added, or the equipment being used may have an expired calibration. Suppose a member of the manufacturing team used a piece of equipment on which the calibration was overdue. During an in-process check by a member of QA, they spotted the calibration on the equipment had expired. This is when the deviation process begins.
There are several steps when talking about the deviation process. The purpose of the deviation is to identify, investigate and close. Also, remember that the amount of time to complete a deviation from beginning to close is very important and should be specified in your deviation Standard Operating Protocol (SOP). Here are the three principles for the deviation process:
- Identify the error – Notify the appropriate management/personnel and fill out the required form that describes what exactly happened to cause the deviation.
- Investigate what happened – Talk to the personnel involved, review any videos in the room, review any paperwork inside the room, and look at how this piece of equipment’s calibration was missed. This part of the process is basically to understand why this deviation occurred.
- Closing of a deviation – Occurs is when the investigation is complete. We now know exactly what happened. Closing of the deviation consists of correcting the error. In this example case, get the equipment checked out to make sure that it is within specification. The other part is putting in place a check to ensure that this doesn’t continue to occur. Once these items are in place, the deviation can be closed.
The entire company needs to be on the lookout for anything that may cause a deviation. You must have checks and double-checks because we are all capable of missing something. What it all comes down to is deviations will happen, but how you handle them and learn from them is what matters to make your company the best it can be.
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Share, Engage, Stay Current
Quality is the driving factor that keeps our food system safe. In the United States, there is an unspoken trust put into our food system to keep it safe. How does this safety happen? There are systems and procedures that maintain the integrity of the products consumed...
When thinking about the heart of the company, the equipment that produces your product must come to mind. Without good working equipment, your products may become compromised and hurt the company’s reputation for producing good quality products. Let’s say that during...
Since the publication of ICH Q9 “Quality Risk Management,” applying the principles of Quality Risk Management (QRM) as part of Pharmaceutical Quality Systems is an expectation of global regulatory agencies. The effective application of QRM requires a significant...