Improvement Systems  8.5

Revision: 9/4/2008 added Action Response Form to note 5.

NOTES (in support of the flowchart on page 1):
1. Opportunities to improve our effectiveness come from the evidence generated by the system (audit results, measurements related to our objectives, and analysis of customer, process-related, product-related and supplier data [a.k.a trends or "Big"]) , significant events or the potential for significant events requiring immediate corrective or preventive action (a.k.a "Bad"), and/or action items from management review (see Management Review Matrix). These sources are also where we get system improvements geared towards making us "Better."
- In need of formal action?
See "B3 Big, Bad, or Better" to understand when formal action (corrective/preventive action, action items from management review, etc.) is needed. When formal action is not needed, we just deal with the incident and move on.
3. When deciding not to take any action, we should let those requesting the action know of our decision. This lets them know we gave it due diligence and could lead to them shedding new light (including a solution we had not thought of) on the subject.
4. The root cause is the real reason a potential problem can exist, a problem does exists, and/or an improvement opportunity should be pursued. It is the thing needing to be dealt with to prevent the problem from happening in the first place (preventive action), keep it from happening again (corrective action), and/or realize the improvement opportunity. The "5 Why's" (see "The 5 Why's Explained" above) and/or any other root cause methodology can be used when the root cause is not intuitively obvious.
5. Facilitated by either the Action Response Form, Process Improvement Form, Opportunities & Incidents Log, or management review action items (see Management Review Matrix) These forms also serve as the records of the results of actions taken and are maintained as defined in Master Control Plan (embedded in Document & Records Control).
- Did the action taken eliminate the potential/actual problem and/or promote continual
improvement after it was effectively implemented (put to use)?
7. Corrective or Preventive actions need to be summarized for management review (see Management Review Matrix). This summary may be a review of the completed corrective/preventive actions, an overview of significant issues (deemed as such by the management representative) compiled from corrective/preventive actions or a status of open corrective/preventive actions. The key is to recognize the goal of management review, that being to assess what has been done to determine if further action will improve the organization's effectiveness.
- Will trying something else help us or are we wasting time?

B3 Big, Bad, or Better 8.5
The decision to take action is based upon the size (magnitude) of the actual/potential problem or needed improvement (how big is it/how big can it get or how big of a difference can it make?), the impact (encountered risk) the problem had or could have (how bad is it/how bad can it get?), and/or increased effectiveness an improvement could have (how much better could we be for our customers [give the customer what they want and make money doing it]?). When the action we could take is not the result of either a big or bad problem (but instead a fluke) and will not make us more effective, we may choose to forgo the action. Coupled with the policy and objectives' ability to drive effectiveness, these actions are all considered to be continual improvement opportunities and are typically geared towards the quality management system (manual, procedures, etc.). The more effective we make the system, the more the system can and will drive our behavior toward good business sense. Continual improvement efforts can also be generated by finding ways to operate more effectively and by identifying cost reductions. In either case, we should all be looking for ways to make Pi-Co better.

The 5 Why's Explained
(Getting to the Heart of the Matter)
The 5 Why's is a problem solving technique used to gain a deeper understanding of a situation and to determine its underlying cause. Until the real cause is determined, an effective solution cannot be implemented. Here is how it works:
Ask "Why?" the condition/situation currently exists.
Each time the question "Why?" is answered, ask "Why?" again.
Continue to ask "Why?" until everyone involved is satisfied the real root cause (the actual reason) is determined (typically why is asked 5 times but may be more or less).

The Policy as an Improvement Tool 8.5.1
Our quality policy is intended to serve as a filter for making good decisions at Pi-Co. When the evidence or our actions show shortcomings not covered by the policy, we may choose to update the policy to ensure we are clearly setting expectations and are positioned to drive behavior. This is how we use the quality policy to continually improve our effectiveness.