We are using cookies in order to offer you the most relevant information. We have published
new Cookie Policy which you should read to find out more. more.
Please accept cookies for optimal performance.

Showing posts tagged with: audit

Remote audits – what are the limits?

Remote audits – what are the limits?

A remote audit, also known as virtual audit, is the method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence, just like during an on-site audit.  The overall aim is to evaluate this evidence objectively to determine the extent to which we have fulfilled the audit criteria. The...
Keep reading
Benefits of remote auditing

Benefits of remote auditing

Remote audits may have many benefits when it comes to efficiency, access to competence, increased reach and mitigating risks. But companies have to use it in the right context. The main benefit of remote auditing is cost flexibility. Auditors will incur fewer costs through every remote audit they conduct, such as travel expenses and billable hours....
Keep reading
Do remote audits becoming 'new normal'?

Do remote audits becoming 'new normal'?

Audits are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system performance, evaluating the adequacy and effectiveness of the quality management system; etc. A remote internal audit is usually done partially or completely off-site employing technology to support the auditor when a site...
Keep reading
How to do an Offsite Audits

How to do an Offsite Audits

An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology. The Initial Preparation  Prior to starting the offsite audit, most likely you, a medical device company, would need to provide copies of your quality manual, procedures, complaints, nonconformance, corrective and preventive action logs, etc. Also, you will have...
Keep reading
Extraordinary circumstances require extraordinary measures-Offsite auditing

Extraordinary circumstances require extraordinary measures-Offsite auditing

Certain audits of medical devices and processes are essential for MedDev companies if they want to place their product on the European market. However, audits are not used only for those reasons. There are used for a variety of reasons, including assessing compliance with standards and regulations, adherence to requirements and specifications, evaluating process and system...
Keep reading
Keep reading
How CAPA should be verified?

How CAPA should be verified?

“Efficiency without Effectiveness misses the Purpose Effectiveness without Efficiency misses all the Profit Effectiveness with Efficiency brings Performance.” ― Martin U.  Ugwu   Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it. Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...
Keep reading
CAPA Checklist - Step by Step Guide

CAPA Checklist - Step by Step Guide

CAPA – Corrective action Preventive action The purpose of corrective and preventive action is to collect and inspect information, identify and examine the product or potential quality problems, then take suitable and effective corrective/preventive action. It’s a process of improvement taken to eliminate causes of possible malfunction, problem or another unwanted situation.  It’s also a process which...
Keep reading
Correct way to follow procedures and processes

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. The procedure is correct, but are the follow-ups? But...
Keep reading
Cup of Joe 40# - Documents and procedures amendment

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. Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...
Keep reading
Cup of Joe 39# - Key factor during an audit–prepared employees

Cup of Joe 39# - Key factor during an audit–prepared employees

A successful audit relies on communication. So, the preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps. This means Meeting! If the staff members are able to work collaboratively with the auditors, the audit will be conducted more efficiently, and...
Keep reading
Cup of Joe 38# - There is such a thing like painless audit?

Cup of Joe 38# - There is such a thing like painless audit?

An audit is the verification of activities – process or quality system in order to ensure compliance with 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! Painless = prepared, the more prepared, the more...
Keep reading
Cup of Joe 37# - Why we have to perform an audit?

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”. What audit means to you? 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...
Keep reading
Cup of Joe 36# - Scary word “Audit”

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. A system audit also delivers objective evidence concerning the need for a reduction, elimination and most importantly, prevention of...
Keep reading
Keep reading