The system
once established and also gets endorsed by certification, the organization is
relaxed. Slowly inertia in the system creeps in and organization goes back.
Let us see the indicators:
1. Management Review is cooked.
2. Internal Reviews are just formality and very few NC/ no NC.
3. System manual/ Procedures do not get
revised for years.
4. There are no CAPA.
5. Customer satisfaction is also a
formality the data is collected a few days before audit .
6. Vendor assessment shows all vendors
are passing.
7. All objectives are achieved.
8. The work instructions are not on the
pertinent points.
9. HIRA/ Aspect impact is never revised.
10. No incidents recorded.
11. Only the completed improvements
projects are recorded.
12. Only the completed design projects
are tabulated in design system clause wise.
The reasons
are:
1. It is believed that certification is
aim.
2. The implementation is only to achieve
& maintain certification.
3. The certification is only maintaining
of certain papers.
4. It is responsibility of MR since he
has got the credit.
5. Rest all have to work and MR has no
other work.
6. System is burden and s just set of
rules.
The revival
plan should be:
1. Revisit the system documentation with fresh look.
2. Identify the gaps in current practice
and documents.
3. Involve team.
4. Show the improvements possible thru
PDCA, process approach.
5. Link business goal with objectives.
6. Reorganize, Energize team for audits, trainings, Improvement
projects
7. Link improvements to system.
