Resources: CAPA — root cause to effectiveness check
Each link below was checked this session and loads.
21 CFR 606.100 — Cornell Legal Information Institute — the SOP and investigation regulation. Paragraph (c)’s “conclusions and followup” sentence is this module’s regulatory floor under root cause analysis. Local verbatim copy:
sources/cfr/606.100.md.21 CFR 606.171 — Cornell Legal Information Institute — the biological product deviation reporting rule. Paragraph (f)’s “should be investigated” language, quoted in this lesson, is a rare example of guidance-tier wording inside an otherwise “must”-heavy regulation. Local copy:
sources/cfr/606.171.md.GovInfo: Code of Federal Regulations collection — the U.S. Government Publishing Office’s official CFR collection. Use it as a fallback primary source if eCFR or Cornell is ever unreachable, or to pull an official PDF of a full CFR part for the record.
A note on this module’s fourth possible link: ASQ (American Society for Quality) publishes public pages on root cause analysis and the 5 Whys technique, and would otherwise be a good industry- practice reference for this lesson. Its site returned an HTTP 403 to this session’s automated requests (a bot-blocking response, not a broken page — a human browser likely reaches it fine), so it isn’t listed here. If you want a plain-language walkthrough of 5 Whys or fishbone diagrams beyond what this lesson covers, search “ASQ five whys” or “ASQ root cause analysis” directly in your own browser.