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ATL Blog

Developments and items of interest to the custom label and medical device markets.

Systems Validation Protocol Methods for Disposable Medical Devices

If your product must meet the requirements of FDA cGMP 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance.   They are the following:

  1. You must have a sound and strong Quality Management System (QMS).  This is an expression of WHAT you do (your quality policies and structure).
  2. You must have reliable Standard Operating Procedures (SOP’s).  These are expressions of HOW you do things.  SOP’s must be very detailed and employees must be trained for suitable proficiency for the task they perform.
  3. Missing in the above two items is an expression of HOW WELL you do what you do.  This is where you must establish your “Systems Validation Protocol” (SVP).  Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products.)

The SVP is a living and continuous document based on your quality records.  The ATL White Paper “What is Systems Validation Protocol?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use.  Click here to learn more.

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Control Plans for Disposable Medical Devices

The customers of many disposable medical device manufacturers require that their vendors adhere to a quality management system that is demonstrably planned and complete.

To do so, manufacturers often find they must:

  • Complete quality assurance functions and inspections for critical characteristics on their disposable medical devices
  • Detail, in chronological order, all phases of their production processes
  • Provide proof of cGMP compliance (Current Good Manufacturing Practices) for FDA products, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Our article entitled “What is a Control Plan or FDA Performance Qualification (PQ)” strives to help you understand the methods and control points the FDA and/or customer auditors will be looking for.  An actual Control Plan/ Performance Qualification is included for your review.  Please click here to read the article.

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Process FMEA for Disposable Medical Devices

Are you responsible for process and quality assurance functions (risk analysis) for critical characteristics on disposable medical devices?

Must you detail, in chronological order, all manufacturing risks associated with your production processes (so your customers can see your risk management is planned and complete)? 

Are you manufacturing an FDA product (or a product that requires the CE Mark) that requires proof of cGMP (current Good Manufacturing Practices) or ISO-14791 (risk analysis) compliance? 

The article “How to do a Process FMEA for Medical Devices after ISO-17791 Risk Analysis” (which includes an example of a Process FMEA form) attempts to help you understand the methods and control points in the contract review and risk analysis phases of your product development.  These are items that the FDA and/or customer auditors will be looking for.

To view an FMEA flowchart, please click here.

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Risk Analysis for Disposable Medical Devices

Are you or your company responsible for high level risk analysis, which includes critical characteristics on disposable medical devices?

For complex medical devices, risk analysis is sometimes required to be in compliance with ISO-14971:2012 and MDD/93/42EEC.  These are two medical device risk analysis knowledge bases.  ISO-14971 is an international standard and MDD/93/42/EEC is the law.  

Does your company have to detail all phases of your risk and hazard considerations prior to your production processes to be compliant?  The purpose of ISO-14791:2012 risk analysis is very similar to that of an FMEA (Failure Modes & Effects Analysis); only this time you must consider risk and hazards as they would potentially harm the end user. 

The ATL White Paper “What is ISO-14971 & MDD/93/42/EEC Risk Analysis for Medical Devices (CE Mark)” attempts to explain some of the risks and hazards you must consider so the people using the medical device are protected from potential hazards. 

Click here to view the white paper on Risk Analysis for disposable medical devices.  

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Process Capability for Disposable Medical Devices

Do you design, order, or have responsibility for quality assurance functions (inspections) for critical characteristics of disposable medical devices

Quality actually starts when the first concept of the product idea is postulated by the design engineering team.  The manufacturing of medical devices (made of medical foam or tape) is much different than manufacturing “rigid” items such as plastic components for a car.  This is because most medical materials have an elongation factor, so accurate and precise measurements usually demonstrate more variability. 

The article entitled “Process Capability/Medical Devices” strives to help you understand the common pitfalls in the main aspects of disposable medical device manufacturing (converting) from:

  1. The physical properties in the selection of materials
  2. Process inspection/controls
  3. The expression of critical characteristics into Cpk terms (capability)
  4. Accurately estimating your possible production failures and expressing this figure in defects per million.

 Click here to learn more about Process Capability for disposable medical devices.  

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When Quality Counts

Whether your application requires a pressure-sensitive label or an FDA-compliant disposable medical device, one thing in every project is true: a commitment to quality makes a difference in the end product.

It’s an easy sentence to type but a difficult concept to achieve. Here at ATL, we live that commitment every single day by consistently taking a Six Sigma approach in accordance with a number of standards and regulations, including ISO-13485, MDD 93/42/EEC and FDA cGMP.

These protocols, which involve a variety of elements, always begin with the same steps:

  1. Formulate product development by identifying customer needs from a variety of perspectives, including:
    • Stated customer requirements (the intended use of the product)
    • The Six-Sigma approach of DMAIC - Define, Measure, Analyze, Improve, Control
    • APQP (Advanced Product Quality Planning)
  2. Define and Implement process development from the customer's design goals by determining:
    • Necessary materials
    • Process flow
    • Timeline for completion
    • ATL roles and responsibilities
    • Feasibilities of the proposed product as ranked by manufacturability (cost effectiveness)
    • Feasibilities of the proposed product as ranked by potential product hazards to the end user (FMEA or ISO-14971 Risk Analysis)
  3. Measure, Analyze, Improve, and Controlthe manufacturing process by:
    • Understanding the critical to quality characteristics (CTQ’s) required by the client
    • Determining process stability
    • Determining process capability
    • Determining packaging standards
  4. Develop the client's product control plan or FDA cGMP Performance Qualification (PQ), which covers:
    • Product
    • Process
    • Operations
    • Machines
    • Characteristics class
    • Specification tolerances
    • Measurement technique
    • Cpk determination
    • Sample size
    • Sample frequency
    • Control method
    • Reaction plan

The process is time consuming and detail oriented but always attempts to achieve this final goal: the best product for the client made the best way with the best materials.

Click here to view a PowerPoint providing more details on our system validation protocolsand, when quality is paramount, make sure to contact ATL for assistance with your disposable medical device or pressure-sensitive label.

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