Posts in Recall

CAPA Chapter II – Driving Source

September 21st, 2019 Posted by e-GMP, ISO 13485, Recall 0 thoughts on “CAPA Chapter II – Driving Source”

Often times, we suspect products and process as the main sources for CAPA. However, there are several other areas that we can consider as CAPA sources. They include;

  • Customer Complaints: It represents a majorly of all product-related sources for CAPA.  In the event that the customer complaints are repetitive, then there is a chance that the root cause can keep recurring. Also, complaints about the system are an indication that there is a problem with the training or instruction.
  • Yield Rates: Yields rates are most likely the main cause of CAPA rising in the manufacturing industry. Systemic issues become unavoidable when there are frequent expulsions in the process limit.
  • External and Internal Audits: Audits are the biggest identifiers that there should be a process PA or CA in the system.
  • Employee Feedback: The feedback from employees could help prevent process issues as well as enhance product development in the future.  Employee feedback is one of the direct sources a company can use to implement CAPA.
  • Vigilance: Another great resource for CAPA is to remain abreast of competitors in the same field. You can study your competitor’s product to try and implement steps to prevent certain likely problems that may arise in your product. For example, you learned that pumps develop a free flow problem by studying your competitor’s pumps. You can hereby take steps to eliminate the problem in your own pumps. We at Orcanos conduct daily research on every recall that is reported by the FDA site and conducts a technical analysis to allow the share of such events with our customers.

Managing Risks

Subconsciously most people find themselves managing risk by prioritizing their daily tasks and giving more effort to tasks they consider more important. Similarly, CAPA requires the same approach.  The actions to be taken should be prioritized based on risks. The reasons to apply such a strategy are;

  1.  To prevent the company from wasting resources on trivial problems.
  2.  To continue to create an opportunity to respond to public safety concerns.
  3.  The risk will help determine the approach of the investigation. For instance, you could take a scientific approach like the FMEA or FTA when dealing with patients safety. Meanwhile, a five-why approach can be used to address process issues.
  4. Always document your risk-based decisions.

The Process

In taking a closer look into the CAPA process, we will be expanding on the key requirements. They include;

  • Analysis
  • Investigation
  • Determining action
  • Implementing action
  • Determining the Effectiveness

First Thing to Consider: Understand

The step in the CAPA process is understanding. Without understanding the issue, it will be impossible to find the root causes or determine appropriate action. In the event that you do implement appropriate actions, there is a chance that actions and the changes would not be as comprehensive as they ought to be.

However, there are steps to take in order to understand the problem. The steps include;

  1. Defining the problem as well as writing it down. In so doing, you can better grasp the starting point of the issue.
  2. Try to identify the cause of the problem. A simple tool to use is the Fishbone Diagram.
  3. Using the Fishbone Diagram you have to determine if people, machinery, environment, process, material, and management are contributing to the problem. While you might not be solving the problem at this stage, you will be gaining a better understanding.
  4. The scope of the problem is the next step in the process.  For instance, perhaps you are using a piece of particular equipment to manufacture several parts. Unfortunately, there seems to be a fault with just one part.

Regardless of the fact that the other parts created using the same equipment have no faults, you should consider the possibility that the equipment could be contributing. Likewise, there could be a documentation problem. The ability to analyze scope ensures that you identify all the root causes.

In the event that a problem escapes detection, then it is important that there be an investigation as to why it wasn’t detected.  Perhaps there were no early-stage checks or the current checks are ineffective. 

The importance of early-stage checks is vital in the software industry where late-stage errors can prove to be costly. For example, an error that is not fixed in design stage can be 3 times or more expensive to fix at the verification stage of the process. Therefore, best to think of the early stages where the problems could be fixed and document them.

Containment

When you discover a non-conformity in a product, then it is time to exercise damage control. The damage control is not to divert the financial burden, but to ensure that the product does not cause harm to patients. If the product is already in the market then issuing a call-back and inform the customers to prevent more damage is the best course of action. 

However, if the product is still in the inventory, then the containment action will be to quarantine the inventory until the problem is solved. Containment actions should always match the risk as the damage control for issues that will affect customer’s health will differ from actions that have to deal will function or form.

Scope Analysis

Below is the summary of the thought that should go into scope analysis.

  1.  If a product is affected by equipment, then what other products are affected by the same equipment?
  2.  How thorough is your quality control system if a process is missing a particular document?
  3.  Are there audit gaps or any other gaps?
  4.  Are all of your software system validated? Is your validation process complete?
  5.  Do components affect the quality of your system and what role does your supplier play?

In conclusion, if you do not fully comprehend the extent of a problem in the CAPA system, then there is bound to be some missteps along the way.

Got Battery! – You Need a Battery Performance Alert (BPA) Test Protocol

January 24th, 2019 Posted by Recall, Risk Management 0 thoughts on “Got Battery! – You Need a Battery Performance Alert (BPA) Test Protocol”

Since the FDA issued an update a recall notice several times (St. Jude Medical, Philips,  ) with information about the Battery Performance Alert (BPA), a new battery performance test protocol tool is offered by Orcanos Medical new release.

Recent recall talk about poor battery performance that causes several injuries and potential for death that trigger us to write something out for you. A test protocol that Skelton the basic method to measure the performance of your battery and level of RISK you needs to address.

Orcanos monitor the recall market and perform engineering analysis on the events and try to come up with better ways to prevent such cases from happening again.

You can have access to this new Battery Performance Alert (BPA) Test Protocol (DOC-5009) directly by registering to our FREE application from our web site: www.orcanos.com.

 

 

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies

January 9th, 2019 Posted by ISO 14971, Recall, RISK Assessment, Risk Management, Safety 0 thoughts on “Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies”

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies. The software, when used with the medical device Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.

The Software glitch may affect the intended use of the device. This new risk, the following does not include reported problems that included a patient death potentially linked to the case.

It was a Class 1 recall alert for MRI-guided surgery device. Class 1 recalls, the highest severity level, involve product problems that can cause death or serious injury.

Hazard: The software displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm. During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain.

Failure Cause: The offset appears to have been caused by an interaction between the device probe and the MRI environment

Failure Effect/ Harm: The surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.

Risk Control (RISK-5005):

 

Preventing Potential Recall by Testing Right Your Product

June 23rd, 2018 Posted by Recall, Risk Management, Safety, Tip Of The Week, Validation and Verification, Workshops 0 thoughts on “Preventing Potential Recall by Testing Right Your Product”

On the QA Geek Week giving the following lecture based on a selected example of recalls researched by Orcanos to provide some preventive actions methods on the validation and verification methodology. These recalls give an example of how to pay attention to simple observational engineering faults that could harm the patient. All are true stories that just happened during 2017 – 2018 years which were already reported the increase in recalls during Q1 2018. The numbers shows that it is to be the largest recall quarter since 2005. Orcanos R&D effort is to continue to be a market leader by daily investigating these events and integrating into actions in Orcanos ALM/QMS system, helping to prevent the next recall to our customers.

Try for Free NOW!

 

Tip of The Week – How You Can Be The Best Recall Specialist

April 26th, 2017 Posted by 21 CFR Part 11, ISO 13485, Recall, Services, Tip Of The Week 0 thoughts on “Tip of The Week – How You Can Be The Best Recall Specialist”

Recall Specialist – Medical Devices

Author: Rami Azulay (ALM/Medical Specialist at ORCANOS)

Are you eager  to join an innovative organisation? Do you want to play an integral role   helping clinicians improve  healthcare outcomes for patients? Have you always wanted to join a driven, entrepreneurial organisation that promotes from within? Then your ideal role is that of a Recall Specialist!

As a Recall Specialist, you will be required to provide Product Field Action, which means you will given direct access to all product design documents and verification, and validation protocols in order to perform effective  investigations. You will need access to both production and  manufacturing evidence documents on the device performance during production and  methods which support  the QC process. You will need access to the reporting entity so as to be able  to collect missing information needed to execute your CAPA process and of course, access to the support groups on Tier 1, 2, 3 and 4. These tiers support and manage a diverse range of medical devices. These tasks are only able to be carried out  through a collaborative working environment; not just in the human resource level, but also between the tools and repositories that hold that information.

The key duties of the recall specialist include: The regular reporting, follow-up and processing of regulatory actions, which require more time outside of your day to day tasks. While tools such as ORCANOS | MEDICAL system can provide you with proactive notifications based on Artificial Intelligence (AI) built into the system that compare your execution activity with the regulation and compliance to your organization standard operational procedure (SOP).  This will involve actioning on all aspects of Product Hold (PH) and Product Field Actions (PFA), and enacting the Universal Recall Procedure (Post Market Surveillance) to ensure the appropriate maintenance or removal of nonconforming products from the marketplace. Again ORCANOS | MEDICAL includes with the same system a Post Market Surveillance system call ORCANOS | SERVICE CENTER which act as gateway between the market to the manufacture or the distributor. It allows secured data communication between all parties, of course the AI system will cover regular reporting and follow up on actions, on that same system as well.

It is preferred that the Recall Specialist hold a tertiary science/engineering degree or equivalent. Such academic knowledge coupled with access to relevant and accurate information adds to the effectiveness of the Recall Specialist. ORCANOS Cloud based system, which is validated and 21 CRF Part 11 compliant, makes the world a much smaller place. Information that is needed is easily accessible  from anywhere – either from the event area (if you need to travel for investigation), or from your office where you communicate with other professionals, and information needs to be  secured as you work on  a quality event.

Having a single tool that can manage  all these activities R&D->Quality->Manufacturing->Support in one place, reduces lessens the learning curve for the recall specialist who has to be acquainted with multiple systems, reduces the cost of licensing which   enables access to  secured information needed to work efficiently. .

This role provides an exciting opportunity acting in the center of all things, using advanced tools and methods that can guide and protect the organization interest which will follow by constant recognition for creating a positive workplace environment. If you are looking to take your career within QA and post market to the next level this could a sure way to go.

Why there is a change in the approach regarding labeling as RISK mitigation

July 24th, 2013 Posted by 510(k), CE Marking, FDA, IEC60601, ISO 14971, Recall, RISK Assessment, Risk Management 0 thoughts on “Why there is a change in the approach regarding labeling as RISK mitigation”

A recent recall on Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: class 1 recall – mislabeled packaging – See more at: http://www.healthcarepackaging.com/trends-and-issues/regulatory/bryan-medical-tracoe-mini-30mm-tracheostomy-tube-class-1-recall/ has proven some of the justification regarding the change in approch when putting labeling as part of the RISK mitigation. In the above case in the RISK assessment we should expect to see that not just labeling should be used to differentiate between the different devices but also packaging and coloring could be a good way to use on the device. Such mistake in labeling could affect patient safety since an oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death. When we come to RISK assessment and decide to use labels as mitigation we may want to consider mistakes in packaging and address such cases as well or even perform change by design to avoid use of the device on the wrong application.

FDA puts highest-risk category on infusion pump recall

July 2nd, 2013 Posted by Recall 0 thoughts on “FDA puts highest-risk category on infusion pump recall”

Recently the FDA start building new guidance for infusion pumps medical devices. Such product shall require more concern on their RISK assessment. There are in the market different solution for infusion pumps some are fully mechanical and some has embedded hardware and software. 

Those more advanced products requires higher attention on the integration between the system and in that manner to be able to isolate each sub system by its verification and validation procedure as well to include the integration test that treat the product as complete.

Since in some product there are replaceable parts it may come that displacement of those replaceable parts may cause increased flow of the fluid into the patient and in that way put patient in higher risk.

What type of mitigation can be suggested to reduce that risk?

GOBlock® Rapid Recovery System

Orcanos

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