Even if only 2% of medical device companies have recalls, you can still worry about that first one.

FDA recalls have a small frequency that is dwarfed by their impact. So, they still may be your biggest worry. You're just being careful.

I have a white paper: "5 Ways to stop FDA recalls". Just ask me for it.

The process is complete when all risks have been accepted as part of Safety, and all requirements have passed Validation.

One solution is a method that drives down failure mode probabilities. Software could help a lot.

The method would implement Fault Tree Analysis (FTA), Failure Mode Effects and Analysis (FMEA), and Benefit-Risk Assessment (BRA) to iteratively and incrementally reduce the probability of failures or their effects to what is acceptable internationally, or to industry or global standards.
Software would help with managing the FTA and FMEA information mentioned. Switching back and forth is made easy by using the same data in the same database. Values and changes are shared within each project and securely documented.
The method and supporting software would help companies eliminate some or all recalls. Also, give companies without recalls the data and confidence their probability is reduced.
Download the PDF of 5 Ways to Stop FDA Recalls. Find it at the bottom of the page.

Lack of documentation means a lack of procedures, says the FDA. How often does that happen to you?

In the chart below, notice the number of times 'documentation' is cited in an observation. As an auditor the FDA wouldn't let me give credit for something if I didn't see documentation of the result.

A solution would eliminate errors of omission and commission. See how software can help.

Software should hold your QMS procedures with their steps. Assigned to team members they would systematically remind their owners of status and due dates and eliminate chances for errors of omission.
When subscribed by interested stakeholders they should send messages of status and due dates. Also, reminders to review work products. That would provide a painless mechanism for quality and eliminate chances for errors of commission.
Compliance has a lot to do with communication. They differ in time. Evidence is the documentation of what people did. Operational documents guide current activity.  Software should generate both of them and include conversation thread messaging like in the next section example.

Would generating compliance evidence from messaging and other communication solve a problem of yours?

Remote work in times of pandemics requires appropriate tools to auto-mate common tasks and facilitate high meeting performance.

In my time, we had telephone meetings where the agenda was a PDF or Word document shared with all attendees, remote or otherwise.
Later we had Webex to show PDF and Word documents online. Changes were saved  with red ink and notes to be made following the meeting. Minutes were still typed by hand.
Emails, text messages, and other communications use different systems and never form a secure and robust audit trail.

Software should allow changes to project data during a meeting and captured so they could be used to generate a minutes document.

Meeting agendas before a meeting are project data that meets topic criteria and includes changes made offline before a meeting.
Meeting minutes are essentially a generated copy of the agenda that includes the changes made during the meeting.
Email copies of the minutes to attendees to keep them in sync and in great detail.

A solution would create a secure and robust audit trail that records project data updates with dates and comments, online and offline.

The collection of logs for project data, like above and below, form a secure and robust audit trail.

Is remote work keeping team members out of sync?
Is it your #1 worry?

Multiple module solutions have many weak points, like interfaces and transfers, for hackers to attack.

Multiple module solutions can require file or database transfers. They may use third party products with inadequate protection.
Single module solutions integrated with other functions (e.g. requirements management) may not have the protection of 21 CFR Park 11. And, may integrate their vulnerable weak points.

A good one module solution should incorporate security, authenticity, and electronic signatures.

Powerful SHA-256 encryption or better should protect login, database access, and other security demands.
Software should integrate a messaging system to create a discussion thread for most work elements. These would document who did what and when and how and why. And, represent a secure and robust audit trail.
A document control system embedded in software would create secure storage linked to work elements and shared with interested, (subscribed and credentialed) team members and stakeholders.
In addition, documents should be indexed, searchable, and version controlled.

Would you define security as a problem like this?
Is it your #1 worry?

Project management discipline should not depend totally on elements of tradition and culture.

A typical practice of my time would have been to type an agenda manually. Maybe starting with a previous Microsoft Word document for the last meeting. Is this still a common practice?
It was not unusual for me and my peers to incorporate email content. And, populate much of the material and changes from memory and notes.
Relying on Microsoft Word or Excel documents to hold the status and history of work elements put valuable data at risk.
A 'fat finger' could delete a row or paragraph silently and without notice. How many versions could come to a meeting with competing values?
Was a comprehensive agenda expected along with the invitation to a meeting? Did it have all the information needed for discussion in the meeting?
Do team members and stakeholders get a complete cycle of documents? Like meeting agendas, minutes and tailored and detailed reports for operational status and compliance evidence?

A solution should support good project management practices and supplant bad ones.

Note the example agenda below. A good generated document should have information needed for a successful meeting. Team members and stakeholders should be mentioned that are invited or otherwise interested.

Would you define project management discipline as a problem like this? Is it worry #1 ?

Project management discipline needs to operate on your Quality Management System and translate its instructions into actions.

Procedure templates can digitally establish issues, risks, failure modes, and tasks, etc. for assigned team members to perform and be tracked and reported for interested stakeholders to follow.
Issues, risks, and tasks, etc. can be as large or small as needed. Just having a title. Or, owning many documents, and files. Also, making references to documents owned by other issues, risks or tasks, and projects or communities with controlling standards, regulations or variances.
Humans would read the procedure and follow the instructions. The solution would create user dialogs for input and update. Then create the documents, status and tracking by stakeholders.
Picture
At page bottom arrange for an interview and see a human and computer readable procedure example.

An idea solution would integrate QMS procedures digitally so that issues, risks and tasks are can be assigned, tracked, and reported.

Digital procedures can also form a hierarchy where sub-procedures can be used and re-used. They can also act on conditions, decisions and choices to incorporate repetition and iteration.
Just like humans write procedures in their own language for other humans to follow, a good solution would use a language readable by both humans and computers.
Projects incorporate procedures by making team member role assignments and entering parameters and choices. Then issues, risks and tasks, etc., show up in team lists of things to do for execution, tracking and documentation, etc.
Unlike SalesForce(R) and ServiceNow(R) workflows, all decisions, choices, reasoning and work is performed or controlled by humans.

Would you define QMS enforcement as a problem like this? Is it worry #1 ?

The Medical Device Interview

I would recommend starting with a new list. Focus on understanding of current problems. Define and evaluate candidate solutions. Not really doing anything at depth.
We could use Zoom or some other platform for a 30-60 minute meeting. Open the table below in Excel to capture early definitions, priorities and work-arounds.

- Name and define your top problems or worries.
- Who is affected and how?
- How is each problem dealt with?
- What is their work-around?
- Now rank them: 1, 2 and 3.
- For #1, if you had a magic wand, what would
     you change?
- Tell me what the future would look like.
...
- #2 ?  #3 ? if we have, or make, the time?

YOUR PROBLEMS HERE

Exploit your unfair advantages.

I am researching problems in the medical device industry. Common or chronic problems suggest software solutions that could be used industry-wide.

You may  find software that support process changes. We can start with your biggest problem that is pressing today.
At this time I am unable to travel to your location because of the Covid-19 pandemic.

I am, however, available for tele-work to help you to make the process changes required. I did that successfully for over 15 years. Zoom meetings and document exchanges make it possible and efficient.
INTERVIEW
TOKENS
5 Ways to Stop FDA Recalls
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Contact: rick@menloparksoftware.com
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