Apr 24, 2014

Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause
By Christine Park, Quality Architech, Christine Park & Associates

The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.  Effective failure investigation to true root cause is the heart of the CAPA (corrective action preventive action) system.
In an effort to simplify the analysis of data, failures are often grouped into generic categories (human error, inadequate training, procedure not followed, etc.)  Unfortunately investigations often stop at this point until the actual cause gets lost in this attempt at simplification.  Too often a “band aid” fix is put in place (re-train, change the procedure, etc.)

Apr 22, 2014

Principles of Lean Documents

Principles of Lean DocumentsBy José Ignacio Mora, Owner, Atzari Enterprises, L.L.C.

A medical device engineer walks into a restaurant …

He is handed a controlled document.  Most would call it a menu.  What is the purpose of this document?  How many elements of information does it contain?  Is it the correct revision?  Was line clearance performed?  Does it include step-by-step instructions?   Does it include a revision history?  What about the model number of the oven used to prepare the meal?  Does it show an approved list of ingredients and their suppliers?  Oh, that’s no controlled document, that’s a menu.  Or is it?

Many would chuckle at this story as a simplistic analogy.  Yet, there are many lessons from this example that could apply to a medical device facility.  No, it’s not a controlled document in the sense most understand it.  But the owner would not want it to be this morning’s breakfast menu during dinner, or to display last year’s prices.  Nor would she want it to show meal options that are not available.

Apr 17, 2014

Change Control and Its Role in Continuous Quality Improvement

Change Control and Its Role in Continuous Quality Improvement

By Lisa Weeks, Marketing Communications, MasterControl Inc.

The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and, more importantly, being able to control it, is critical to maintaining compliance and ensuring product safety and efficacy. Of course, it’s not just regulatory agencies that are demanding higher-quality products; today’s more sophisticated consumers expect the medicines, automobiles, and devices they purchase to be safe and effective, too. They also expect them to cost less and be developed more quickly and efficiently. Better, safer, faster, cheaper…it’s a tall order for any regulated company. Organizations that are able to respond quickly to increased regulation and consumer sophistication will become inherent market leaders. How does your company respond to change?

What is Change?

In the manufacturing environment, change refers to any modification in materials, facilities, utilities, product design, formulations, processes, packing/labeling, equipment, computer systems, as well as all associated documentation (SOPs, test methods, quality manual, etc.). A change control system may be called upon to handle a relatively minor adjustment, such as a part replacement or an updated document, or it may be expected to address an issue that is serious enough to shut down production.

Apr 15, 2014

Report from MD&M West Conference: Navigating through the PMA and 510(K) Submission Processes


By Peter Knauer, Senior QCC Consultant, MasterControl Inc.

I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conference. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.

Apr 10, 2014

Leverage TOQ for a Faster, Cost-Effective Software Validation

Leverage TOQ for a Faster, Cost-Effective Software ValidationBy Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc. 

More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy. 

Apr 8, 2014

On the Quality of Vendor/Supplier Audit Responses

On the Quality of Vendor/Supplier Audits Responses

By John Janeri, Independent CSV/Part 11 Auditor working with Polaris Compliance Consultants.

Edited by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.  I’ve done many of these solo audits, and I’ll admit that I've often wondered who at the Sponsor* company would communicate the findings to the Auditee and review their responses.  But no matter, I've completed the contracted assignment and I'm now off doing something else, right?  Not so much anymore.

In the past few years, I've noticed that many companies are now asking me to stick around a lot longer.  Some Sponsors are beginning to realize that there are benefits to maintaining continuity throughout the entire audit process by involving the auditor in the “follow-up” activities.  This seems natural since it appears to provide a level of consistency to their vendor qualification assessments that would otherwise be absent.
After the audit report is finalized, Sponsors frequently will ask me to gather up a summary of all the observations and send it to the Auditee in the form of a draft Action Plan.  I may also be asked to help the Sponsor review and comment on the Auditee's responses to the observations (i.e., the Auditee's completed Action Plan).  After all, since I’m the one who observed the deviation, I’m probably in the best position to assess the Auditee’s plan to remediate it.

Apr 3, 2014

Demystifying FDA/CDRH Appeals Process

Demystifying FDA/CDRH Appeals Process By David Lim, President and Principal of Regulatory Doctor
Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.

We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision.  It is worthwhile to note and get familiarized with the available options.  However, it is recommended the stakeholder try to avoid having such situations in the first place.
Avoiding a Dispute
The key to avoiding the FDA appeals process is to enhance your awareness and understanding of evolving regulatory issues. It is crucial to establish good knowledge of the perspectives and viewpoints of a given issue between the FDA and the stakeholder. More often than not, issues between the FDA and stakeholders arise from different interpretations and expectations of laws, regulations, rules, policies, scientific and technical requirements and how they should apply to the case on point. It is important to understand the reasoning of the FDA on a particular issue so that a sponsor can effectively address the issues with scientifically sound and justifiable reasons supported by data.   

Differences in opinion between the FDA and the stakeholder’s view can be addressed early on in the process through open communication. Here are some practical tips to minimize such differences in perspective early in the process.  

Apr 2, 2014

Making SMART Choices When Managing Quality Events: More Helpful CAPA Tips

By James Jardine, Marketing Communications, MasterControl Inc.

A previous blog post provided an overview of a portion of quality guru Ken Peterson’s “Taking Effective Action” webinar (the second of a three-part series) that outlines the keys to successful CAPA programs. This post summarizes the remainder of the second webinar in the series which can be viewed here.

Peterson provides a handy acronym to help us remember to make SMART actions when managing quality events and he provides helpful examples of each principle:

  • Specific: Is the action well stated and easy for the affected departments and stakeholders to understand?
  • Measurable: Can the action be validated and verified so that confirmation can be made easily in order to determine whether or not the action is indeed solving the problem?
  • Aligned: Does the action relate specifically to the root cause or is it possible that it is more closely related to a different cause?
  • Realistic: What makes you believe the action can actually be accomplished? Do you have the resources to take the action?
  • Time Bound: When does the action need to be accomplished? Are speed and efficiency factors?

Using the SMART criteria, Peterson gives some specific examples that illustrate how actions can and should be taken. He also reiterates the importance of documenting all actions. 

Apr 1, 2014

MasterControl 's Ken Peterson and Patricia Santos-Serrao Featured SQA Speakers

By Robyn Barnes, Marketing Communications, MasterControl Inc.

MasterControl will provide demonstrations of its document management and quality management solutions at the 30th Society for Quality Assurance (SQA) Annual Meeting to be held April 6-11, 2014 at the Cosmopolitan of Las Vegas in Las Vegas, Nevada.
Ken Peterson, MasterControl’s director of quality and compliance, will present “Overcoming Death by CAPA: Closing Your Quality Loops.” Peterson is a recognized CAPA expert who is a regular speaker at SQA.  He has more than 25 years' experience in consulting and organizational change, quality management and product development.  He frequently travels across the world consulting and educating companies and agencies on quality management and regulatory issues to help them improve efficiency and ensure compliance.

Mar 26, 2014

Changing Supplier Controls Requirements

Changing Supplier Controls Requirements

By John E. Lincoln,  J.E. Lincoln and Associates

Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products.  For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others. 

For much of the rest of the world, the European Union provides a major model, with its directives, emerging CGMPs,  and the ISO quality standards -- ISO 9001 for the majority of quality management systems, and ISO 13485 for medical device QMS. 

All these regulatory requirements mandate that a company establish a ‘total quality system,’ from customer requirements through development, procurement (supplier control), production, to customer use and feedback.   

Mar 25, 2014

Taking Effective Actions: CAPA Webinar Part 2

By James Jardine, Marketing Communications, MasterControl Inc.

Taking Effective Actions: CAPA Webinar Part 2In the second webinar of a three-part series from MasterControl, quality expert Ken Peterson demonstrates how companies can develop better corrective and preventive actions (CAPA) to ensure quality and compliance. In the second installment, Peterson focuses on key decision points and the types of actions that should be taken depending on the quality event. He points out the importance of containing issues at the department level, if possible, before moving them into a formal CAPA process. Peterson discusses four possible actions to be taken when dealing with quality events: no action (the “wait and see” approach), corrections (with a focus on the immediate situation or containment), corrective actions, and preventive actions (to preemptively deter issues from occurring in the future). 

Mar 20, 2014

An Introduction to Metrics Collection and Usage

By Christopher Ball, Senior Professional Services Consultant, MasterControl Inc.

An Introduction to Metrics Collection and Usage
Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.  Why collect data for “A” rather than data for “B”? Wouldn’t it be better to collect it all?
The problem is there is so much data available, much of it with an automatic collection option, that it’s easy to accumulate it.  The downside of blindly taking this approach is data saturation.  There’s so much to look at that nothing is done to analyze it.  Because the data isn’t analyzed, no action is taken based on the findings.  Effectively, the company drowns in data at best or worse still, makes random and or variable assumptions about the interpretation of the data. As a result, the company could make flawed and maybe fatal business decisions because “the data indicated …..”
The intention of this article it to put some simple steps into the armory of your business so that you won’t waste valuable resources collecting data you won’t use, need, or want.  Instead, collect data that fits with your business direction and strategy---data you can analyze appropriately and use to make balanced informed decisions.  You’ll see that having data and analysis that business management can trust has value.