"Up to 60% of products on hold are due to documentation and/or procedural errors."
Our clients are continually faced with resource, workload and time constraints,
and lack of a proven approach and methodology to attack the documentation, workflow,
and quality system problems resulting in non-conformances
The “band aid” approach is often taken as the corrective action with documentation,
procedural, and process non-conformances, and doesn’t effectively address or prevent
the incident from happening again.
The reality - corrective modifications become an accumulation of unnecessary
content, added steps, and documentation.
The result - Management and supervision continually spend more time and resources
on investigations then they do on the manufacturing and releasing of product. The
system eventually becomes overloaded with document revisions, repetitive retraining,
and unnecessary costs.
Malcom Associates business process improvement and redesign solutions assess and identify compliance gaps, unnecessary or redundant data requirements, and steps to improve the overall work flow and work process. Our redesign solution ensures quality issues are resolved and that the documentation, procedures, manual or automated work flow "fits" the process.
Our solutions deliver positive results such as reductions in:
- Documentation/procedural errors
- Missing entries
- Entries/data transactions
- Time spent on investigations
- Review cycle time
- Product release cycle time
- Time spent on training
- Document creation/revision time