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Using Instructions for Use and Labeling as Risk Controls in ISO 14971 – The Best of Blogs

Best of blogs Using Instructions for Use and Labeling as Risk Controls in ISO 14971   The Best of Blogs

Using Instructions for Use and Labeling as Risk Controls in ISO 14971” is the second in the “The Best Of” Medical Device Academy’s previously published blogs. We’re republishing these blogs due to tremendous popularity and response from our readership. In this blog, Rob Packard reviews the impact of the seventh deviation identified in the European national version of the ISO 14971 Standard.

Residual Risks Using Instructions for Use and Labeling as Risk Controls in ISO 14971   The Best of Blogs

Labeling, instructions and warnings are required for medical devices. Unfortunately, information provided by manufacturers is not effective at preventing hazardous situations and foreseeable misuse–especially if the user throws the paper leaflet in the garbage 10 seconds after the box is opened. Since information provided to the user and patients is not effective in preventing harm, the European Commission indicated that this information shall not be attributed to risk reduction. 

The European Commission is not suggesting that your company should stop providing directions or warning users of residual risks. The intent of this deviation is to identify incorrect risk estimation procedures. For example, if you are using Failure Mode And Effects Analysis (FMEA), (see Annex G.4 of the risk management standard) to estimate risk for a new product, you should not be listing labeling and IFUs as a primary risk control. Clause 6.2 of the ISO 14971 Standard correctly identifies “information for safety” provided by the manufacturer as risk controls, but the effectiveness of these risk controls is so poor that you should not estimate that risks are reduced by implementation of labeling and IFUs.

In Clause 2.15 of the ISO 14971 Standard, residual risk is defined as “risk remaining after risk control measures have been taken.” However, I prefer the following definition which incorporates the concept of clinical evidence, design validation and post-market surveillance:

“Residual risks are risks that remain: 1) after implementation of risk controls, 2) when products are used for new indications for use, 3) when products are used for wider user and patient populations, 4) when products are misused, and 5) when products are used for periods of time longer than the duration of pre-market clinical studies.”

The second essential requirement (ER2) states that users shall be informed of residual risks, but the conclusion that “information about residual risks cannot be a risk control” is incorrect. The most important wording in the deviation is ¨the information given to the users does not reduce the (residual) risk any further.¨ Failure to reduce risks any further is due to the lack of effectiveness of risk controls. Validation of risk control effectiveness should be performed during design validation, but validation will be limited to a small group of users and patients.

Risk Management Report & Post-Market Surveillance Plan

In your risk management report, risk control options analysis should be summarized. Instead of evaluating risk acceptability prior to implementing risk controls, risk controls should be implemented and any residual risks should be identified. A risk/benefit analysis must be performed for each residual risk and the overall residual risks. If the conclusion is that the benefits of the device outweigh the residual risks, then the device can be commercially released.

At the time of the final design review and commercial release, a Post-Market Surveillance (PMS) plan should be developed that includes an updated risk management plan. The updated risk management plan should specifically address how to estimate residual risks and verify the effectiveness of information provided to users and patients. Verification of risk control effectiveness should be part of the design verification and validation activities, but verification of effectiveness should also be part of ongoing PMS.

In order to facilitate future updates of your risk management report, you may want to organize risk controls into the following categories (in this order):

  1. Design elements (highly effective)
  2. Materials of construction (highly effective)
  3. Methods of manufacture (highly/moderately effective)
  4. Protective measures & alarms (moderately effective)
  5. Information provided to users & patients (least effective)

Each of the above risk controls will need to be addressed by your PMS plan.

If your company needs risk management training, please see our Implementing a Risk Management Process Compliant with ISO 14971 Webinar. 

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8 Steps to Writing an Effective CAPA Procedure – The Best of Blogs

Best of blogs 8 Steps to Writing an Effective CAPA Procedure   The Best of Blogs

8 Steps to Writing an Effective CAPA Procedure is the first in the “The Best Of” Medical Device Academy’s previously published blogs. We’re republishing these blogs due to tremendous popularity and response from our readership. In this blog, Rob Packard provides a list of 8 steps to writing a more effective CAPA procedure, proper implementation, creating a CAPA process flow chart, training, etc.

CAPA Procedure Image7 8 Steps to Writing an Effective CAPA Procedure   The Best of Blogs

The author provides a list of 8 steps to writing a more effective CAPA procedure, proper implementation, creating a CAPA process flow chart, training, etc.

During a recent internal audit I was performing for a new client, I noticed that they were not meeting one of the requirements of their CAPA procedure. Specifically, the procedure indicated that all CAPA plans must be written within seven calendar days of initiating the CAPA. Despite this requirement in their procedure, the client was indicating that CAPA plans were due within 30 calendar days on their CAPA form (http://bit.ly/CAPAForm).

This example is a minor nonconformity, but the reason why this client was not following their procedure is more interesting. The procedure was 100% compliant with FDA regulations (http://bit.ly/21CFR820100), but the procedure did not match how the company performed the process. The procedure and the process MUST match.

This client purchased their CAPA procedure from a consultant, changed the title, and had everyone in the company “read and understand” the procedure for training. If this sounds like your company, I’m not surprised, because this is not uncommon.

To avoid the mistakes this client made, follow the steps below for writing your own CAPA procedure:

8 Steps for Writing an Effective CAPA Procedure

  1. Create a CAPA process flow chart first
  2. Organize the layout of your CAPA form to match the process flow chart
  3. Write a procedure that follows the process flow chart
  4. Add references to the process flow chart for each section of the procedure
  5. Conduct group CAPA training using the draft version of your flow chart, form and procedure
  6. Make revisions to the procedure to clarify steps the trainees had difficulty with
  7. Ask the trainees to review the revised procedure and comment/edit
  8. Make final revisions and route the procedure for approval8 steps capa 8 Steps to Writing an Effective CAPA Procedure   The Best of Blogs

The specific order of steps is important to creating a CAPA procedure—or any procedure. Process flow charts help people understand the input, outputs and tasks within a process. Flow charts are also used by auditors to plan process audits (http://bit.ly/AdjacentLinkAuditing).

Most important of all, it’s very easy to create a form that is missing a step, but it is less likely to be missing a step if you create the flow chart first. [The flow chart example provided was created by Brigid Glass (http://bit.ly/BrigidGlass). Please connect with Brigid, or send her an email (brigid.glass@brigidglassassociates.net) and tell her thank you.]

Implementation

Procedures are often unclear, because the author is more familiar with the process than the intended audience for the procedure. An author may abbreviate a step, or skip it altogether. Authors should use outline formats that match the process flow and the form used exactly. There should be nothing extra in the procedure and nothing left out. 

Training

99% of companies hold off on their training until a procedure is officially released as a controlled document. In my experience, however, these procedures seem to have a lot of revisions made immediately after the initial release. New users ask simple questions that identify sections of procedures that are unclear, or were written out of sequence. Therefore, you should always conduct at least one training session with users prior to final review and approval of a procedure. This will ensure that the final procedure is correct the first time, and it will give those users some ownership in the new procedure.

After you train your initial group, and after you make the edits they recommended, ask those trainees to review and edit your changes to the procedure. Sometimes, we don’t completely understand what someone is describing, and sometimes may be only half listening. Going back to those people to verify that you accurately interpreted their feedback is the most important step for ensuring that users accept your new procedure.

After you approve the procedure, make sure everyone in your company is trained on the final version of the CAPA procedure. CAPA is a critical process in your quality system. Everyone should understand it. You should also provide extra CAPA training for department managers, such as root cause analysis training (http://bit.ly/RootCauseTraining), because they will be responsible for implementing CAPAs assigned to their department.

You can use this 8-step process for any procedure, but ensure you use it for the most important process of all—CAPA.

If you are interested in more information on conducting effective CAPAs, please see our How to Improve Your CAPA Process Toolkit.

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