Process capability and standardization
Today's organization makes a shift on its focus from process standardization to process capability. There is a realization that standardization of the process alone does not make organizations efficient and their deliverable effective.
More than just standardization of the process, organization should be involved in assessing the capability of its processes and evaluate against its standards. Process capability continue to let organizations sustain in the competitive landscape and at the same time strive to be leader in its final output (to market, to customer, to supplier and to regulators). Continuous review of its capability also triggers innovation / experiment within the standard process to achieve more and reach higher quality goals.
There are multiple ways we can assess and enhance process capability. In my personal experience, here is simpler model. Of course, there is no one best way to achieve this.
1. Assess process steps and identify value-addition, value-enabler and non-value addition steps in nature (by mapping process steps). Value addition is something which is integral to the deliverable while value enabler is essential for connecting value added steps for output. For example; training new hire to understand organizational process or performance evaluation of associates to let them perform better and motivate etc.
2. Brainstorm / discuss ideas to modify the process so that it contains lesser and lesser non-value addition steps. Sometimes, non-value added steps may be necessary to retain in the process. Of course, process should consider regulatory compliance and customer expectation into account. This is where imagination and creativity becomes handy.This depends on the severity of the impact it may cause if something fails. For example; a QC process to review a Study Report may be necessary as the consequences of anything that is either incorrect or inappropriate will be serious.
3. Continue to evaluate the need to automate steps to support step 2. Continuous review of the technological advancement in the industry may also be required. Organize should contemplate the need of science and processing this with caution. Too much automation in the process may not be the best prescription.
4. This exercise should be encouraged by organizations down stream to all its line functions.
There is a caution attached to the above. Process capability assessment should only be performed after first demonstrating process stability* with the current standard process.
*In layman terms, process stability means delivering consistently (and or delivering consistent results) by following standard process.
Disclaimer - Above post is a representation of an individual opinion and not an organization / group. This is as per the individual's learnings and experience which is being shared on the public forum.
Thanks Rohit Prasad this what ISO standardization requirements.