Need a turtle diagram for CAPA
- Thread starter tammydiz
- Start date
unfortunately, it's a corporate requirement for all divisions to have turtles for top level processes
Most people struggle with turtle diagrams because they don’t understand the purpose. First of all turtle diagrams are not mandatory. They are a way of having process descriptions per original ISO 9001:2001 section 4.1 and newer ISO 9001:2015 section 4.4.1 (a) which requires a process to define the inputs (head of the turtle) and outputs (tail of the turtle), (b) determine sequence and interactions (the process interaction map), (c) determine and apply criteria and methods (leg of the turtle), monitoring, measurements and related performance indicators (another leg of the turtle), (d) resources (split in to separate legs for equipment resources and people resources). What is new in the 2015 version is (e) assign responsibilities (process owner) and (f) address the risks. The process owner can be listed above and and risks below the turtle, like a saddlebag.
OK, now that is established. What are your processes? I would argue that the older ISO 9001:1994 standard elements like corrective and preventive actions are not necessarily processes and in fact, the ISO authors tried to make everyone understand this by separating preventive to be a proactive part of section 6 of the standard and corrective action to be a reactive part in section 10 of the standard, but a lot of folks still lump CAPA together. I would think your organization chart that lists the top executives and their direct reports align more closely with the organization and its key processes, but that is another rabbit hole to discuss later.
However if CAPA is to be a process, your inputs into the corrective and preventive action (do not leave this out) should list things like customer complaints, internal audit findings, external audit findings, internal issues not related to audits, subcontractor issues (if not covered under a material management or purchasing turtle). Preventive action (totally separate from corrective action) inputs could be from the suggestion system, Continuous improvement initiatives from six sigma, kaizen, lean or other projects. FMEA high risk items or high RPNs could be an input. Outputs to the turtle (tail) may overlap measurements (one of the legs), but that is OK. Outputs would be how you see the effectiveness impact, and the measurements would be the KPI or tool by which you get those measures, examples would be repeat issues, days to closure, # of customer complaints, # of audit findings, etc. Effectiveness would be the degree by which you see the improvement or betterment e.g. customer satisfaction surveys. Efficiency measures could play a secondary role in determining improvement, such as timeliness or meeting deadlines.
Overall summary, the purpose of the turtle is to understand how the process (the body of the turtle) can have its effectiveness compromised by any of the legs (e.g. people resources ; inadequate staffing, lack of qualifications, poor training), or equipment resources (need of a computer or printer, outdated software, electrical power outages), poor inputs - incomplete or error-filled customer complaint, customer complaint ignored or not documented. Criteria and methods - 8D, Ishikawa diagram, 5-why are all methods. Use of a CAPA procedure to follow is a method. Poor measurements or KPIs could compromise the process also. If you measure only compliance measures and not one that shows improvement over time, it is not really a measure of process effectiveness, but a measure of process compliance, but since most people (including some 3rd party auditors) don't understand the difference, this may suit your needs. Keep in mind that if an activity like Corrective Action is turned into a process, you may have difficulty determining effectiveness measures. This is because once the activity is proceduralized, (as is required for corrective action), you can only expect compliance to the procedure and your best effectiveness measures will just be ones of how correctly you followed the procedure.
Hope this helps,
Outoftown
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Good day @tammydiz ;
Consistent with what @Bev D stated....this is too bad indeed. Whenever an organization creates 'fluff', which provides no benefit to the organization ( to either satisfy an auditor or other entity...) the organization is setting itself up to cause the teams (and leadership) to become jaded ...
(i.e. "well, here's another 'ISO' thing we're doing which has no purpose"), ...
...and/or failure...i.e. creating documentation which may not be vibrantly utilized, that then is not maintained and then becomes 'wrong' over time. My advice is to ensure your leadership understands these risks and how continuing to acquiesce to outside pressure can cause the management system to turn in to a monster that becomes out of control.
If you must create a turtle, my only advice is to NOT include any dynamic information (for example, ...I once had a client who include their goals in the turtle, thereby, creating a bunch of turtles that someone then had to continuously 'feed'.)
Hope this helps.
Be well.
