Hi Fady,

when we say severe failure, are there critical components within the equipment that broke down or is the product itself being produced or being check incorrectly? I would say that we should treat this as a preventative maintenance to restore the equipment to a satisfactory operating condition and we could run a verification to ensure that it meets standards for production or for testing. Revalidating the equipment will not be necessary unless you move it.

Chris

Hi Fady,

I have to agree with chris vasquez, there is no need to revalidating something that is not being move. what is important here is understand what went wrong with me machine it seem that some components of the machine probably burn out that is causing maybe this failure, which it shouldn't happen since this machine will have maintenance schedule and calibration so if this would have happen than this issue would have been resolve when the maintenance is being done. as Chris said is it the components within the equipment or the product itself, this will actually clear a little more the question you asking fady.

If the machine severely failed in manufacturing, the first step is to investigate the root cause of the failure. Once the root cause has been found, a correction must be performed. If the failure can have a product risk then a CAPA might need to be initiated and this might include process changes therefor this might require revalidation.

I agree with the posts above. The investigation is definitely a key parts that should occur first to be able to find the answer. Even though sometimes it is a long process to find the issue, there are times that time and money can be saved due to the thorough analysis. I have seen in my previous experience that any movement of the equipment may require the re-validation and even re-calibration process due to sensitive sensors.

The above posts seem to discuss this well. It is very similar to this week’s simulation: assuming that a machine failed due to machine failure (or nearby machine malfunction), it would most likely not require a new IQ, OQ, PQ because the machine would most likely return to the functional condition when the parameters are changed back to the original state. Revalidation would be required if the machine moved, or possibly a recalibration, if there are errors or fragile parts/sensors.

Just how it is mentioned by many prior in this discussion thread, if the equipment in the manufacturing plant is damaged to the point of ineffectiveness, a root cause analysis would need to be conducted to identify the problem, perform a preventative maintenance and get the equipment fixed and properly calibrated according to the SOP's for this machine according to what the processing instructions has for their operators. In addition a to the process risk management, an investigation will look into how the failure accord since these processing equipment is maintenance and calibrated according to the maintenance schedule. I believe that the batch of products would need to be tested to spec to ensure that there isn't any variability.

I would like to add that it would be very costly to re-validate everything. Imagine there is mass production. This "critical machine" might have produced thousands of products if not more.
I agree with most of you about the decision to re-evaluate depends on the investigation of what went wrong. Some machines break down after a certain amount of usage or its own "expiration date". Since it's an important one, there must be a backup. In that case, I would say if nothing's majorly wrong (such as wrong specs, blueprint details...), re-validate a few products randomly (and according to protocol) before and after the machine replacement and go on with the production process.
If it's a mass production line, the company must have taken this type of event into account as well, in that case, maybe following the protocol is best.

I agree with the posts above, depending on the degree of failure and the complexity of the machine, it may need to undergo IQ OQ PQ again to ensure safety and efficacy. However, if it is just undergoing routine maintenance or is a minor discrepancy, there is no need to undergo these processes. It may just require a few start up runs before being placed in full production again.

When a component of equipment experience a failure,the nature and cause of failure should be investigated and analyzed.Root cause analysis is important to determine the cause of breakdown so that steps can be taken to manage the cause and avoid them in future.In repairs and maintenance of equipment the Revalidation could be avoided but be sure to assess whether quality is affected and how much .where no significant change is made during maintenance of equipment a quality review confirms that process is consistently producing material meeting its specification ,there is no need for Revalidation .

When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture. If so, then it can escalate to a CAPA through the development of a CRF. In terms of validation, it does not need to be revalidated unless it is moved from the production floor. If it is moved from its current location for fixing, the bare minimum to get it back onto the production floor for use would be an installation qualification, operational qualification and performance qualification. The maintenance procedure for that fixture might need to be updated based on the findings of why the fixture failed. The fixture will continue to require maintenance and calibration (if expired) to be able to check if the products being produced with the fixture match the specifications.

Ideally in manufacturing it is best practice to have spare equipment in the instance that a machine fails. Therefore, it is a simple task to bring it in and replace it. If the machine is the same make and model, no validation is required if a previous validation of the machine exist. In general, a "like for like" equipment doesn't require a validation if the equipment is being utilized and inserted into the same exact location as the previous equipment. As many have stated, if the equipment is being relocated then yes a new validation is necessary. Depending on the severity and criticality of the equipment an update to just the IQ should be sufficient, especially if a previous equipment exist and only the new equipment is being relocated.

In addition, Preventative Maintenance scheduling is important to ensure machines and equipment are routinely checked at certain time intervals to maintain the machine and equipment in top form.

In a situation like this, it is primarily important to determine the factor that caused the failure. Once the reason for failure is found, then measures can be taken to fix the issue and possibly prevent the failure from occurring again. After the machine is repaired or a new machine is installed, the maintenance and calibration schedule might need to be updated. This may call for more frequent checkups to prevent from failure again. In addition, if the machine has been updated and modified from the original, then it can cause for an entirely new maintenance and calibration schedule.

I agree with what most of said that determining the main cause of the equipment failure and to add to the discussion, I would say based on this week's Simulation, the importance of logging these incidences. In case there is a pattern and something else on the factory floor may be playing a role or other environmental causes. I think running a verification test would satisfy this particular case, but as @neb 2 mentions a CAPA might need to be initiated if the failure is considered a product risk and this might include process changes which could require revalidation.

As we learned from Simulation 2, ,the IQ, OQ, and PQ required for proper inspection. During the validation process all the data need to be analyzed and documented. You should analyze each input and fully verify the results. Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the validation is to make sure the user needs are met in a medical device. A successful validation process would clearly define inputs and user needs to ensure that a product is properly validated.
For your question, Do the manufacturer have to repeat IQ, OQ and PQ after the maintenance was performed?, you need to Quality Assurance test (like calibration) for the equipment, check(analyze) the results, then act according to the results. Also, its recommended to do PMs periodically for any equipment involved in the manufacturing process.