Outline process and form for stakeholder initiated CAPA process ("Hatto Report"), from Levinson Productivity Systems PC. It is intended to be modified by users to conform to their needs and quality management systems.
Scope
A stakeholder initiated corrective and preventive action (CAPA) request, or "hatto report" (hatto = sudden awareness or recognition) can be issued by any relevant interested party (ISO 9001:2015 clause 4.2) who perceives a risk or opportunity (ISO 9001:2015 clause 6.1) that relates to safety, quality, or waste (muda). Stakeholder initiated CAPA takes advantage of the fact that stakeholders, or relevant interested parties, are often in the best position to notice risks and opportunities related to safety, quality, and waste.
Hiyari hatto = "experience of almost accident situation" or "recognition of a safety risk." (hiyari = incident). "I could have put my hand into the machine because there are exposed moving parts!"
Poka hatto = recognition of the chance for error (poka), which might be remedied through error-proofing (poka yoke). "I almost assembled the parts backward." This category applies, however, to all quality-related risks, not just those that involve worker error.
Muda hatto = recognition of waste (muda). "Has anybody else noticed that we spend more time and effort picking up bricks from the ground than we do on putting them into the wall?" This was not, in fact, recognized for thousands of years, until Frank Gilbreth introduced his non-stooping scaffold in the early 20th century.
This process applies to situations upon which actions can be taken by the process owner (the person with the resources and authority necessary to implement a solution) without recourse to a formal CAPA process such as 8D (8 Disciplines) or the Automotive Industry Action Group's Effective Problem Solving guide (CQI-20), and when management of change (MOC) issues are not involved.
Scope
A stakeholder initiated corrective and preventive action (CAPA) request, or "hatto report" (hatto = sudden awareness or recognition) can be issued by any relevant interested party (ISO 9001:2015 clause 4.2) who perceives a risk or opportunity (ISO 9001:2015 clause 6.1) that relates to safety, quality, or waste (muda). Stakeholder initiated CAPA takes advantage of the fact that stakeholders, or relevant interested parties, are often in the best position to notice risks and opportunities related to safety, quality, and waste.
Hiyari hatto = "experience of almost accident situation" or "recognition of a safety risk." (hiyari = incident). "I could have put my hand into the machine because there are exposed moving parts!"
Poka hatto = recognition of the chance for error (poka), which might be remedied through error-proofing (poka yoke). "I almost assembled the parts backward." This category applies, however, to all quality-related risks, not just those that involve worker error.
Muda hatto = recognition of waste (muda). "Has anybody else noticed that we spend more time and effort picking up bricks from the ground than we do on putting them into the wall?" This was not, in fact, recognized for thousands of years, until Frank Gilbreth introduced his non-stooping scaffold in the early 20th century.
This process applies to situations upon which actions can be taken by the process owner (the person with the resources and authority necessary to implement a solution) without recourse to a formal CAPA process such as 8D (8 Disciplines) or the Automotive Industry Action Group's Effective Problem Solving guide (CQI-20), and when management of change (MOC) issues are not involved.
