Using Compliance Initiatives For A Competitive Advantage

 White Paper Series
Using Compliance Initiatives
for a competitive advantaGe
Turn your compliance initiatives into a competitive advantage. Admittedly, at first this seems counter-intuitive. Compliance initiatives have a reputation as overhead - not productivity. Several factors have converged in recent years that are changing the face of compliance initiatives.
1. Standards have shifted from a checklist approach to a process-based approach2. C ost pressures continue in the manufacturing marketplace, making any initiative that can truly save White Paper Series money or reduce time to market one that is gaining traction.
The biggest shift has been the orientation - some would say the maturation of compliance initiatives to a process orientation. The advent of recent financial scandals exposed "compliance standards" as shells that often did not provide guarantees of execution as expected. ISO and other bodies have shifted their emphasis from an overview of checklists and manuals for certification, to an audit of the underlying processes as the basis for certifying an organization. It is not longer acceptable to simply "have the answers" - inspectors want to know "how" you got the answers.
Consequently, today's compliance initiatives involved time and effort often to develop compliant processes as well as develop a way to demonstrate effective processes.
Given the level of effort to achieve current compliance standards, the jump to using these initiatives as a competitive advantage, no longer seems like such a large leap. Once an organization has developed the processes to be certified, taking the additional effort to optimize the processes to get a leg up on my competitor can turn an investment in compliance from a sunk cost, to an investment that shows immediate return. The advantages for a lifecycle-wide quality operations process far outweigh the effort to develop it:
. R educed redundancy . Reduction in error prone data - improved decision making .  Reduction in duplicate labor and redundant software packages Upwards of 40% of .  Reduced scrap and rework respondents in arecent . Shortened time to deliver products, PPAP, and other critical deadlines Aberdeen survey reported they are using Compliance is not one-dimensional - particularly in manufacturing. It is not unusual for an organization to have 3-4 ongoing compliance initiatives, each with their own manual and checklists and set of steps compliance initiatives to pass each individual test. The good news about a process orientation, is that once compliance is as a competitive "built-in" to a process, the effort to demonstrate compliance requires minimal added labor, and audits advantage. go much smoother. Compliance initiatives What is involved in order to make a process compliant? typically have been 1. Document the functionviewed as overhead 2. Link the inputs and outputsprojects. In this white 3. Train on the functionpaper, learn how 4. Provide visibility/metrics of the process you can turn your Regardless of the function - if its approached with a systematic, process approach then the ability to compliance initiatives comply with a whole host of industry, regulatory and customer requirements such as ISO9000, AS9100, into a competitive 21CFR11, TS16949, GMPs, ISO13485, etc. can be easily met. advantage.
IQS n March 2007 n www.iqs.com
Using Compliance Initiatives
for a competitive advantaGe
As business and IT recognize the overlapping requirements of individual compliance mandates, leaders are taking steps to build out a sustainable architecture that minimizes time and cost while maximizing future reuse
- Source AMR Research
Centralization and Reuse is KeyA common framework for compliance initiatives is the backbone of process approach to built-in compliance. It allows for common information to be distributed, and kept up to date. It provides distributed teams with the ability to work together off of one source of information. In complex manufacturing this not only helps with compliance, but provides companies that employ this strategy with a competitive advantage to reduce cycle time, and reduce costs.
When AMR looked at how to develop this active compliance framework, they asked survey participants who had achieved best in class status how they had implemented the framework. The results are ... [download for more]