This webinar will present a very simple four-step process that begins when the report is filed, determines whether the process owner can identify and deploy a solution without recourse to a formal CAPA process and, if it can, implements the solution and adds the project to a lessons learned data base (ISO 9001:2015 clause 7.1.6, organizational knowledge). The organization's formal CAPA process can however be invoked for more complicated applications that require, for example, cross functional teams.
Objectives of the Presentation
1. Recognize the advantages of providing workers and other relevant interested parties with a process for rapid initiation of CAPA, along with the virtues of a process that does not require a formal CAPA when the process owner or supervisor can implement a straightforward solution
- Know, however, that a formal cross-functional CAPA may be required when management of change (MOC) issues are involved. We don't want our process to become a "new" or "changed" factor for an internal or external customer
2. Know the applications of stakeholder-initiated CAPA
- Hiyari hatto or near-miss report: supports ISO 45001:2018's workforce participation clauses and also workforce participation requirements of OSHA's Voluntary Protection Program (VPP)
- Poka hatto or potential error report (quality in general), identical in concept to the Error Cause Removal (ECR) program
- Muda hatto or waste report, reveals waste that would have otherwise continued to persist—often in plain view—because nobody paid attention to it. Henry Ford credited his frontline workers with recognizing much if not most of the waste in his factories, and with very tangible financial benefits to all relevant interested parties
3. Learn a sample process for stakeholder-initiated CAPA
- Ensure consideration of management of change (MOC)
- Handoff to a formal CAPA process if the issue cannot be resolved by the process owner or supervisor
- Ensure that lessons learned become available as organizational knowledge
4. See examples of applications, including those drawn from real-world situations. These include:
- Occupational health and safety
- Medical mistakes
- Lean manufacturing (elimination of waste)
Attendees will receive a pdf copy of the slides and accompanying notes, including references and additional sources of information, and also a draft process they can adapt as a process of their organizations' quality management systems.
Why Should you Attend
"Hatto" is Japanese for "suddenly (realizing, understanding, becoming aware, etc.)" . A hiyari (incident) hatto is therefore a worker-initiated near miss report for a safety hazard, and it supports the workforce participation requirements of ISO 45001:2015. Poka hatto is similarly "recognition of potential error" that initiates corrective and preventive action (CAPA) for potential quality problems and potential worker error in particular. This is also known as the error cause removal (ECR) process as depicted in J.F. Halpin's Zero Defects (1966). Muda hatto is "recognition of waste," again by frontline workers or other relevant interested parties, and it has been used to achieve world-class results for 100 or more years.
All three reports can be acted on with a simple four-step process if a supervisor or process owner can implement a solution. If not, the "hatto report" can initiate the organization's formal CAPA process to address management of change (MOC) issues and use any necessary cross-functional resources.
Who will Benefit
- Quality manager
- quality engineer
- manufacturing engineer
- production manager
- lean manufacturing professional
- safety professional
- workplace safety committee
- All manufacturing industries