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How to effectively resolve CAPA in the Accredited Lab

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QA/RA Director, Vesna Janic, and ViVitro GM, Gerry Wight, review pump head in manufacturing.

QA/RA Director, Vesna Janic, and ViVitro GM, Gerry Wight, review a VIA in manufacturing.

ViVitro Labs Inc (ViVitro) is accredited by A2LA and conforms to ISO 17025- General Requirements for the Competence of Testing and Calibration laboratories. For the current scope of ViVitro accreditation please visit A2LA website.

One of the key aspects of ISO 17025 Quality Management System (QMS) is the Corrective and Preventive Action process (CAPA). The standard requires that we have a policy (which is part of our Quality Manual) and standard operating procedure (SOP) for handling CAPAs. In addition, a clear designation of the authority for monitoring and implementing CAPAs has to be identified.

In general, any employee can create a CAPA. An important aspect of recording CAPAs is to clearly and concisely describe the issue that has occurred (corrective) or potential issue (preventive). For Management it is critical to nurture a company culture that is oriented to not only point out issues but also come up with constructive and timely solutions. Team work between Management, QA and lab personnel is integral to successful handling of CAPA. Determining root cause of the issue and outlining clear actions is definitely more successful with a team approach. However, usually QA personnel take leadership role in moving CAPA process forward.

The key for a successful CAPA system and the best way to resolve CAPA is having Management support and consistent follow up (and follow up, follow up…)  so that issues don’t slip trough the cracks. QA team plays main role providing guidance to both Management team and personnel working on CAPA.  Never give up!


Why use an ISO 17025 Accredited Laboratory?

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A common question from new clients is “Do I need to use ISO 17025 accredited laboratory, or can I rely on data from any laboratory?”   Both R&D and regulatory submissions of medical devices require accurate and reliable results. Using a technically competent laboratory minimizes the risk of developing or supplying a faulty medical device due to incorrect testing data or procedures.

Laboratory accreditation provides means of evaluating the technical competence of laboratories to provide specific test as listed on the scope of accreditation.   Accredited laboratory providers need to conform to the technical requirements of ISO 17025.  These include (but are not limited to):

  • Suitable testing facilities
  • Specific staff qualifications, training and experience
  • Equipment fit for the purpose of testing – properly calibrated and maintained
  • Traceability of measurements to national standards
  • Adequate quality assurance (QA) procedures
  • Ongoing internal auditing by independent QA personnel
  • Appropriate and validated test methods
  • Accurate recording and reporting procedures
  • Inspections by accredited bodies every 2 years
  • Participation in Proficiency Testing

ISO 17025 accreditation is internationally adopted via Mutual Recognition Agreements (MRA) between countries. This means is the data provided by an ISO 17025 accredited laboratory is more readily accepted in overseas markets then data from a non- accredited laboratory.

Testing of products and materials can be expensive and time consuming, even when done correctly.  If not done correctly, the cost and time involved in re-testing can be even higher if a product has failed to meet specifications. Not only do costs go up, but a manufacturer’s reputation can go down.

Choosing a technically competent and accredited laboratory minimizes the chance of retesting being required or faulty product being shipped.  ViVitro Labs ISO 17025 accreditation helps save time and reduce risk.  Our clients are generally developing heart valves and need to minimize time to the market; or they are testing heart valves already in production and can be held liable for any failure in the field that involves patient safety.


Can you conduct testing for feasibility, proof of concept, or for design or product development purposes?

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Yes. We will construct a test protocol to meet any of your needs. We enjoy the challenge of testing cardiovascular devices and find that a team partnership is the best way to advance your product development. We will conduct testing as simple as a daily rate for simplified studies up to full submissions acting as a R&D overflow facility.


What is required of valves that are shipped for testing?

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We’ve collected tips and information on shipping valves based on our experience both shipping tissue valves and receiving them for the lab:

 

  • Valve container choice is important – Ideally something sturdy that will not leak or break. These containers can be further sealed and protected with bubble wrap, tape, foam, plastic baggies, etc. Any sort of extra cushioning and sealing is great. At this point, the wrapped and sealed containers can be packed in a box, with more foam to prevent jostling. Indicate which is the right way up on the box.
  • If valve container labels are not waterproof, they can be sealed over with clear packing tape. We have received shipments where the containers had leaked and paper labels were faded, damaged, and even falling off – Identifying the valves after that is very tricky!
  • Some valves come packed with shipping temperature indicators, if the samples are particularly temperature sensitive. They can also be packed in Styrofoam thermos’ with cold packs. That may be worth looking into for longer, over-seas shipments.
  • Generally, samples are express-shipped. We try to plan for shipments to go out on a Monday or Tuesday, to avoid having the package sitting around in a warehouse over a weekend.
  • Filling out the shipping forms, it is best to give as much contact information as possible (landline telephone number, cellular phone number, email, etc.). This way, if there is an issue with the shipment, the shipping company can make contact easily.
  • Also on the forms, you will need to include how many items/valves you are sending and the unit price for each. This is for tax and duty purposes. We use the same value given when valves were shipped to us. Different manufacturers use different unit value.
  • A “Description of Goods” is also required on the shipping forms. It is important to indicate that the items are not for sale (if that is the case). So something like the following would suffice: “Medical device: fixed porcine heart valves for testing and return. NOT FOR SALE.”
  • There should also be a “Special Handling Instructions” section – this is where any notes about chemicals contained, fragility, temperature sensitivity, etc. would go.
  • If there are any questions regarding the shipping process specifically, the shipping company should have some good information as well.

Choose an appropriate storage fluid for shipping (typically dilute glutaraldehyde or 0.9% saline solution). Most shipping companies like an attached MSDS for any chemicals in a package and the shipping form description should identify such chemicals. It is also good practice to put an extra MSDS just inside the shipping box, so it’s the first thing people see when receiving the package. Make sure to put in enough fluid to fully cover the valves and then some – we have received samples that leaked and were no longer covered by fluid when they arrived.

 

If you have any further questions regarding shipping valves, ViVitro Laboratory Technician, Marshall Kilduff, will be happy to try and answer them.


Are Reference (Control) valve(s) provided for testing?

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No. While we may be able to assist in the choice, the procurement is the responsibility of the client. You should consider that the guideline for reference valve choice is outlined in the standards documents and should be followed to ensure acceptability of the results.


What are the sample size requirements for standard tests?

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Sample size requirements are generally stated in regulatory standards. A guideline to consider is three test article and one reference (control) for hydrodynamic and durability assessment per size. Durability testing however is extended to 5 test article and one reference to fill a tester and is recommended to increase confidence. Other considerations and recommended for percutaneous valves are geometry, compliance, and deployment. We work closely with regulatory bodies to stay abreast of the latest concern so we can recommend the best matrix of test conditions.


Will you offer protocols for testing?

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Yes. In most cases, we have standard protocols that can be used “as is” or modified to meet your needs. Per ISO/IEC 17025 compliance we have standard test protocols for ISO and FDA testing as outlined above. We can create regulatory quality test protocols and reports to ease your burden of submission or simply provide a report brief for proof of concept or feasibility testing. Our experience in conducting regulatory studies for a variety of products provides you with the confidence that your results will withstand the highest degrees of scrutiny.


May I visit your facility to observe the testing?

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Yes. We are always pleased to have clients observe or work side by side. Your involvement in testing can be as simple as email or video conference to in-house observation and assistance.


How long will the testing take?

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The typical hydrodynamic test can be completed in 30-45 days. Provided below is a guide for durability testing at difference cycle rates:

AWT
to 200,000,000 cycles at 800cpm (~ 180 days) at 1000cpm (~ 140 days)

Quasi Real-time Durability
to 80,000,000 at 200bpm (~ 278 days)


After contacting you, when can you start testing?

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Once we have received confirmation of your testing intentions, we can provide a test protocol, which once approved we can begin testing in days. Instances requiring fixtures or mounts will require additional time to produce, however our in-house manufacturing capability allows for fast turnaround. ViVitro Labs has ample amounts of equipment and with the advantage of using our own products you can expect outstanding expertise. We can easily add capability with our own stock alleviating availability issues.