Root Cause Analysis: nice article !
Hey, Ms. Auditee: Did Mickey Mouse Do Your Root Cause Analysis?:
http://www.qualitydigest.com/inside/quality-insider-article/hello-mr-auditee-did-mickey-mouse-do-your-root-cause-analysis.html
Similar Posts
Is it mandatory for the Internal quality auditors to be certified by QMS certifying agency or in house training is good enough?
BySylvieIt is NOT mandatory. However, Section 6.2.2 requires the organization to a) Determine the necessary competence for personnel performing work affecting conformity to product requirements, b) Where applicable, provide training or take other actions to achieve the necessary competence, c) Evaluate the effectiveness of the actions taken, d) Ensure that its personnel are aware of…
ISO 13485:2015 to be published early 2016
BySylvieReference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…
What are some best practices for Root Cause Analysis and Preventive Action?
BySylvieOur recommendation in terms of effective corrective and preventive action plans is to be very systematic in every step…. 1) First of a all VERY good definition of the defect…. If not defined correctly the action plan will not be effective. 2) Define corrections and containment actions. Make sure everybody understands the difference between those…
Curso de Auditores en ISO/TS 16949
BySylvieEl curso de “Interpretación de la norma y Auditores Internos ISO/TS 16949” se llevará a cabo la semana del 16 de Noviembre en la Ciudad de México, D.F. Si deseas inscribirte puede hacerlo a través de este link http://goo.gl/forms/QAgQQzDOKf
New Guidance for PMCF – MDR
BySylvie4 new guidances related to Clinical investigation and evaluation were recently published on the commission website including a template for the PMCF, the guidance on sufficient clinical evidence for legacy devices and a guidance for equivalent devices ! https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
COVID-19
BySylvieWhile the world is fighting against the virus, company fighting about economical crisis, certificates are still expiring and notified bodies and auditing organizations have to look for new ways to work. Our partner GMED NA, has put in place exceptional provisions for certification audits impacted by this health crisis. Depending on the type of audit,…