Is Your Establishment’s Website Problematic?
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.
Tag Archives: regulatory compliance
Mistake Proofing
Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.
CAPA Corner: The Case of the Defunct TV
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
Step 4 – Test Possible Causes
We now test the possible causes against the facts in the IS / IS NOT Diagram to see which ones make sense. This is where the investments made in defining the problem and getting the facts pay off!
Step 3 – Developing a List of Possible Causes
The third step of the investigation is to develop a list of possible causes. All too often investigators stumble at this point as they rely solely on the fish-bone diagram.
Step 2 – Another Key Investment for Success with a Root Cause Investigation
In this third of a series of articles on conducting a root cause investigation, we explore a second key investment every investigator should make: assuring you have the facts! Unfortunately, investigators are often under tremendous pressure to complete the investigation and assume the information they have is entirely correct. As a result days, or weeks, are wasted going down the wrong path.
Step 1 – Key Investment for Success with a Root Cause Investigation
In this second of a series of articles on conducting a root cause investigation we explore a key investment every investigator should make: understanding the problem before defining a solution! Unfortunately, investigations often begin by brainstorming possible causes and prioritizing them for further analysis – leading to a trial and error approach resulting in a prolonged, expensive, and often failed investigation. With Step 1 we try to truly understand the performance problem.
MHLW MO 169 – Chapter 2/Section 6 – Corrective Action
A corrective action procedure requires a significant amount of intelligent thought to ensure all aspects required of an effective corrective action process are captured. Plan ahead and incorporate the preventive action requirements (Article 64) into the corrective action procedure; thus, creating a CAPA procedure.
Specification Requirements to Ensure Regulatory Compliance
There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.
There has been a sharp increase in regulatory oversight in the medical device industry. If your manufacturing requirements aren’t specific enough, your contract manufacturer might unknowingly make a problematic substitution. Which requirements are most important for your product? This week’s Ask the Engineer addresses material types, critical features and measurement methods.
MHLW Ministerial Ordinance 169
There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.
There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.
