Preventive Actions - Necessary to show either preventive action report or record?

Preventive Actions

Is it necessary to show any either preventive action report or record? What can be a evidence to show requirement compliance to 4.14.3?

Jim Biz

From my understanding of the issue "YES" you need to show evidence of "BOTH" corrective and Preventative actions.

Many discussion threads here in the forums explaining what the differences there are between the two items. The clearest one for me is 1) Corrective actions find you
2) You find Preventatives.

"In our System" we have placed responsibilities for "Preventative issues" at the top level of management - either as a result of formal Management Review AND/OR as a result of upper level management analysis of business records- system analysis etc.

Although nothing in the standards "says" it needs to be at that level.

The mechanics for both are accomplished in a similar fashion but is set up using two distinct forms used as evidence "records" ( the major difference) the prevent form lists assignment of "planned action" responsibilities & "planned completion dates". I'm sure there are other ways to handle it - but that's how it works here.

Our current concerns with the whole thing is that now that we have "Corrective and Preventative - will it be necessary to cite "preventatives" as evidence of "continious improvements" when we transition to the new standards set, or will we need to redefine "parts" of the Preventative system in place and initiate a distinctly separate Cont. Improvement format..


[This message has been edited by Jim Biz (edited 15 February 2001).]

Dan Larsen

The best resource I've found for preventive action is any action taken in response to trends. In effect, you're responding to an issue before it becomes a big problem.

There are any number of ways to tackle the documentation. Preventive action could be picked up in project type documentation, using action plans and activity reports (similar to continuous improvement). I've also used the same form as corrective action in dealing with smaller companies...just use the "long term action" section to reference the project plan or Gantt chart, and keep the action open provided monthly "progress reports" become part of the CA/PA record.

Al Dyer

One good tool to use for defining and recording preventive action is through the FMEA review process. While I would not use it as a sole tool it is very effective when alternating personnel are brought into the process. A new set of eyes reviewing the system can lead to unforeseen preventive actions.

Always keep operators and floor personnel involved, they are the ones that produce the product that pays our salaries!

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