The Importance of the Risk Assessment & Root Cause Analysis to the QMS

Filmed on April 14, 2023 - At times, risk cannot be eliminated; it can only be managed. Risk management helps organizations optimize workflows to quickly and effectively identify and mitigate potential areas of pitfalls. As a result, organizations that manage risk at all supply chain levels and actively embed risk management throughout their processes are better positioned to address these events as they arise. These companies have shown promising outputs, ranging from passing audits, gaining attestation/certifications quicker, reducing expenditures and increasing revenue.
The objective of this webinar is to discuss the importance of risk assessment as it relates to the QMS, ISO 9001:2015.
0:00 Introduction
4:13 Agenda
5:40 Part 1: Risk Management
11:03 Risk-Based Thinking
13:36 ISO 9001:2015 Clause 6: Planning
17:42 ISO 9001:2015 Clause 4
25:52 Putting it all Together
27:32 The Organization
28:34 Interested Parties
30:12 Processes
31:48 Qualitative Risk Assessment
32:54 Quantitative Risk Assessment
35:27 Analyzing & Assessing Risk
37:35 Part 2: Root Cause Analysis
42:22 Root Cause Analysis Process & Methods
46:29 The Fish Bone Diagram
46:51 The 5 Whys
47:52 FMEA
49:44 Root Cause Analysis Report
52:40 Evaluating Effectiveness
54:23 Q&A
Speakers
Sabrina Ippolito - Lead Auditor
Cindy Haight - Inside Sales Representative, Industrial & Medical Device, SGS North America, Inc.
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