wonder if 'restricting' or controlling the templates-formats really have any meaning!
it is proved time&again that real value IS IN spirit+extent of implementation of QMS.
i.e., having SOP alone just does not yield the expected and required benefit.
viz., we might include the 5-why tools; or fish-bone diagram as formats in the SOPs, but real benefit will only be yielded WHEN&ONCE they are applied to fullest extent!
This perception is backed by examples of FDA 483s and warning letters to some of the established 'companies' in the market. ( infact, i am unable to say it as leaders ,
* as standards are not uniform......and
* they are quite a spectrum of requirements/practices for any given procedure!!! ( noted an simple 5d format
vs detailed 3-stage handling of incident procedures across organizations! )
* atleast there is little consensus on QMS requirements .., apart from the ISPE, PDA like organizations which focus on highly specific topics;
though this comment/observation is from outside, compare above ispe/pda initiatives to the standards of qualifications procedures followed by automotive industry from supplier qualification, MSA published by industry consortiums!)
* let alone the interpretation and implementation of standards by the regulatory agencies! ( barring the recent effort to share the audit observations, and joint audits being performed across agencies)
in one line,
what do we really gain by making the sops-templates-formats available in general ( atleast generic ones!_
is there a place-group which really makes the qms templates-formats available for free access!!!
Anyways, on note of forward looking.... its time to embrace a representation similar to that of SEI-CMM
this is nicely demonstrated in the SEI-CMM levels of software development!!!... which is in itself definition of process
Level 1 – Initial: Company has no standard process for software development. Nor does it have a project-tracking system that enables developers to predict costs or finish dates with any accuracy.
Level 2 – Managed: Company has installed basic software management processes and controls. But there is no consistency or coordination among different groups.
Level 3 – Defined: Company has pulled together a standard set of processes and controls for the entire organization so that developers can move between projects more easily and customers can begin to get consistency from different groups.
Level 4 – Quantitatively Managed: In addition to implementing standard processes, company has installed systems to measure the quality of those processes across all projects.
Level 5 – Optimizing: Company has accomplished all of the above and can now begin to see patterns in performance over time, so it can tweak its processes in order to improve productivity and reduce defects in software development across the entire organization.