RCA Investigation in the Medical Device Industry — The right tools, at the right time, with the right evidence
Identifying the true cause of a nonconformity is rarely a tool problem — it is a method problem. Symptom and cause get confused. The questioning stops too soon. A 5 Whys is chosen where an Ishikawa is needed, or an 8D where an Is/Is not analysis would suffice. This one-day course trains QA and operational quality teams to select, apply and document the RCA tools suited to each situation, within the precise framework of the requirements of ISO 13485 §8.5 and MDR 2017/745.
Audience Quality Assurance (QA) teams, operational quality managers and facilitators, and anyone involved in conducting investigations and writing root-cause analysis reports in a medical device company.
Learning objectives
- ▸ Select the appropriate RCA tool depending on the nature, severity and complexity of the nonconformity to be investigated.
- ▸ Correctly apply the 5 Whys, Ishikawa/6M, Is/Is not, 8D and fault tree analysis (FTA) methods on concrete cases drawn from the medical device industry.
- ▸ Distinguish an immediate cause, a contributing cause and a root cause — and document this hierarchy in a way that is defensible before an auditor.
- ▸ Structure an investigation report compliant with the expectations of ISO 13485 §8.5: factual data, reasoned analysis, demonstrated link between cause and corrective action.
- ▸ Identify the most frequent methodological errors that invalidate an investigation in the eyes of a notified body.
- ▸ Facilitate an RCA workshop in a cross-functional team by mobilizing the right method and producing a deliverable directly usable in the CAPA file.
Expected outcomes
- ✓ Mastery of a panel of at least 4 RCA tools (5 Whys, Ishikawa/6M, Is/Is not, 8D, FTA) applied to medical device cases.
- ✓ ISOFACADEMY RCA tool selection cheat sheet, usable as soon as you return to your post.
- ✓ Annotated Ishikawa, 8D and Is/Is not templates and examples of commented investigation reports (good and bad example).
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
No formal prerequisites. Suggested level: routine quality practice in an industrial environment or in the medical device industry. The course is even more effective when taken as a complement to the IA-SMQ-04 course (Management of NCs, deviations and CAPA), but it is accessible on a standalone basis.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Foundations of RCA investigation: why investigations fail (45 min)
- ·3 recurring errors that invalidate an investigation in the eyes of an ISO 13485 auditor: premature stop, symptom/cause confusion, confirmation bias
- ·Hierarchy of causes: immediate cause, contributing cause, root cause (systemic cause)
- ·Reference normative framework: ISO 13485 §8.5.2 and §8.5.3 — what the standard actually requires regarding the demonstration of root-cause analysis
- ·Notion of proportionality: adapting the depth of the investigation to the severity and systemic nature of the nonconformity
- ·Collective self-assessment on anonymized examples of failed investigations
- 02
The framing tool: Is/Is not — delimiting the problem (45 min)
- ·Principle and structure of the Is/Is not: what, where, when, who — what is observed vs what is not
- ·When to use it: at the start of any investigation to delimit the scope and guide the hypotheses
- ·Classic pitfalls: an Is/Is not that is too broad or too restrictive
- ·Framing exercise on a fictitious product NC case
- 03
The 5 Whys: power and limits (1h)
- ·Principle, construction, rules of a valid chain of questioning
- ·Real limits of the 5 Whys: multifactorial problems, looping causes, chains that are too short
- ·Conditions under which the 5 Whys are sufficient — and conditions under which they become dangerous
- ·Expected documentation: formalizing a 5 Whys chain in an auditable CAPA file
- ·Application exercise on a medical device industrial case with commented correction
- 04
Ishikawa / 6M: structured multifactorial analysis (1h)
- ·Building the diagram: the 6 branches (Material, Machine, Method, Manpower, Milieu/Environment, Management/Measurement)
- ·Adaptation to the medical device context: typical causes by branch in a medical device manufacturing environment
- ·Combining Ishikawa and 5 Whys: digging into each hypothesis down to the root cause
- ·Structuring the evidence validating or eliminating each hypothesis
- ·Workshop building an Ishikawa diagram as a team on a real or fictitious case brought by the participant
- 05
The 8D: collaborative resolution and full traceability (1h)
- ·Structure of the 8 disciplines: from team formation to congratulation and capitalization
- ·What the 8D brings that the 5 Whys and Ishikawa do not offer: immediate containment (D3), formalized effectiveness verification (D7), capitalization (D8)
- ·When to favor the 8D: customer complaints, recurring NCs, nonconformities with supplier impact
- ·The often-forgotten D8: capitalization, documentation updating, lessons learned in the QMS
- ·Example of a completed 8D file with educational comments
- 06
FTA (fault tree analysis): complex and safety-critical problems (45 min)
- ·Principle of the fault tree: top-down logic, AND/OR gates, basic events
- ·When to use FTA: NCs with high patient-safety impact, serious incidents under MDR Art. 87, failures with multiple combined causes
- ·Articulation between FTA and ISO 14971: link with the risk management file
- ·Commented reading of a simplified FTA on a medical device failure case
- 07
Writing an auditable investigation report (45 min)
- ·Components of an investigation report acceptable to a notified body: factual description, data collected, tool used, demonstrated causal chain, link to the corrective action
- ·What distinguishes a defensible report from an insufficient narrative report
- ·ISOFACADEMY field feedback: recurring observations from notified bodies on the quality of investigations
- ·Critical review of two investigation reports (good and bad example) provided by ISOFACADEMY
Assessment of learning
Assessment methods
Commented collective corrections after each practical workshop · oral verification questions interspersed between modules · final QCM of 15 questions (tool selection, methodological errors, ISO 13485 §8.5 documentation requirements — pass threshold: 60%) · Individual deliverable: a personalized RCA tool selection cheat sheet and the start of an analysis on a case drawn from the participant's professional context. Training certificate issued subject to full participation. This certificate does not constitute an RNCP/RS certification and is not equivalent to ISO 13485 certification.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.