How CAPA should be verified?
Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it.
4 steps how to carry out RCA
Root cause analysis is basically a process with a systematic approach for identifying a problem
Cup of Joe 43# - Treat the cause, not the symptom
Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means?
Cup of Joe 42# - Dealing with CAPA
During the audit process, CAPA is always in the center of attention, and auditors are very strict when it comes to it. Also, failure to stick to proper corrective and preventive actions is considered a violation of regulations on good manufacturing practices.
Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS
When implementing and maintain ISO standard such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history.
CAPA Checklist - Step by Step Guide
The purpose of corrective and preventive action is to collect and inspect information, identify and examine product or potential quality problem, then take suitable and effective corrective/preventive action.
Correct way to follow procedures and processes
Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations.
Cup of Joe 40# - Documents and procedures amendment
It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records.
Cup of Joe 39# - Key factor during an audit–prepared employees
A successful audit relies on communication. So, preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps.
Cup of Joe 38# - There is such a thing like painless audit?
An audit is verification of activities – process or quality system in order to ensure compliance to some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade!
Cup of Joe 37# - Why we have to perform an audit?
At work, nothing raises the hairs on the back of your neck like the word “audit”. Audits mean fault, mistake, short-coming and blame, fault, culpability all wrapped in disappointment – you have failed! The bullies incorporate love them! But the wise manager embraced them and uses them to pre-empt the bullies, by self-auditing.
Cup of Joe 36# - Scary word “Audit”
An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature. Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs.
Cup of Joe 34# - How to organize your folders?
Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS.
Cup of Joe 33# - Revision History helps you with transferring to eQMS
One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, should we import every single version?
Cup of Joe 32# - Good Customer Service Reduces Problems
We offer innovative products and services. If you need assistance, let it be tips, tricks, QMS DIY techniques, Quality Issues or regulatory advice, your matter will be handled properly.
Weekly Cup of Joe 31# - Move Your Budget into the Right Direction
There are countless benefits to implement a quality management system. Think of the investment in modern QMS software as an investment in preventing quality issues.
Top 20 Medical Device Conferences and Trade Shows 2019
The power of trade shows is impressive. From showcasing your newest products, to expand your customer base, close sales, keep an eye on your competition, expand your distributor network, meet face to face with your remote customers, etc.
Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix
The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management.
Audit Day Fears are Gone! How Cardio-Phoenix carried out of an ISO Audit With Help from qmsWrapper
Read about how Medical device startup "Cardio-Phoenix" successfully carried out the audit with help of qmsWrapper.
Choosing a QMS system? Why you should seriously look at the new qmsWrapper!
It’s a cloud-based development and compliance management software, in layman’s terms, a QMS and Project management system specifically designed for medical device companies, including start-ups.
How to stay on top of your product development and easily organize your FDA and CE submission
The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management. Map and Trace the design control relationships for your medical device.
Weekly Cup of Joe 29# – Customer Feedback is a Wealth of Information
Improve Customer Retention and Ensure That You Keep the Finger on the Pulse. Joe will guide you through ISO compliance
Pitfalls and Best Practices in Establishing a Quality Manual
This article includes what is a QM, and what should include, Common mistakes & how to avoid them, Pro tips & best practices on how to do it right ...
Weekly Cup of Joe #28 – Is Employee Training Worth the Investment?
Smart companies invest in the development of their employees. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.