Aligning Incident Management with ISO 45001 Requirements
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2 [...]
17
08, 2023
8
08, 2023
EHS Incident Management and Root Cause Analysis
Workplace safety incidents are a key driver of risk in manufacturing organizatio [...]
26
07, 2023
Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
6
06, 2023
Linking Design Controls and Risk Management in the QMS
Design controls are a frequent citation in 483 observations and warning letters [...]
7
03, 2023
FDA Warning Letters Show Document Management System Issues in Food Industry
Documentation is a subject that comes up frequently in U.S. Food and Drug Admini [...]
12
01, 2023
6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and sub [...]
3
01, 2023
Root Cause Analysis Tools: Which Should You Use?
Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]
15
11, 2022
8 CAPA KPIs You Should Be Measuring Now
Corrective and preventive action (CAPA) is a core function in any quality manage [...]
2
11, 2022
Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
12
10, 2022
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
