D0. Recognize/Identify Problem – Identify the nonconformance and understand the difference between facts, and perceptions – how things appear to be. Use pareto charts, histograms, check lists, tally sheets, control charts, etc. to illustrate the problem.
D1. Establish Team – Team should include persons who own the process, who are responsible for the affected areas / equipment / processing / personnel, who are considered to be subject matter experts, and/or who can help with the Root Cause Analysis / Corrective Action. Cross-functional teams work best.
D2. Describe Problem - Define and quantify the problem to provide a starting point for solving it. An accurate problem description using terms understood by all helps in determining the correct root cause(s).
D3. Contain Symptoms – Take immediate action to contain the problem at each point in the process (All stock locations, WIP, in-transit, & affected prior shipments) to ensure that the customer is isolated from the problem. Document quantities and condition found.
D4. Root Cause(s) - Identify potential causes with team brainstorming sessions, fishbone diagrams, 5-why analysis, etc.
Evidence / Notes
D5. Select / Verify Corrective Actions - Identify potential solutions that address the root cause(s). Corrective actions to be evaluated for effectiveness using a decision-based analysis process such as a Process Failure Mode Effects Analysis (PFMEA). List corrective actions or dismissal reasoning for all root causes.
Verification - Utilize the Action Item page to document action plans.
D6. Implement / Validate Corrective Actions - Ensure that corrective action does "what it is supposed to do." Allows for the detection of any undesirable side effects. Utilize tools like error-proofing and process improvement, Poka-Yoke, natural mappings, visual factory, standard operating procedures (SOP), control charts (let the data illustrate process improvement), etc. If desired results were not achieved return to D4.
D7. Prevent Recurrence - Take the appropriate steps to ensure that the problem does not occur again by updating supporting engineering and quality documents (PFMEA, control plan, in-process masters, process flow charts, etc.), identify/implement changes to areas that allowed the problem to occur/escape (systems, practices, procedures, specifications, etc.), and identify/implement RCCA on any similar products that could exhibit a similar failure.