If I had to pick one area to focus on within all of the hundreds of management systems I’ve audited over the past 19 years, I would definitely choose the corrective action process. From my experience, and the war stories I hear from other auditors and quality professionals, most organizations just don’t get it. What makes this circumstance even worse is when management insists on “More audits! More Audits! MORE AUDITS!!!” while doing little to nothing about the previous audit findings, repeat customer complaints or piles of supplier issues. That would be similar to handing out tickets for traffic violations with no means of collecting money for fines. (Note: I’m not suggesting that auditors are Police officers.) Here are 10 questions you may want to consider to help improve your procedure for handling nonconformities (actual or potential) and corrective actions as first steps to improving your corrective action process.
1. Are the roles within your corrective action process defined? The following list of roles is a good place to start. Document these roles, ensure these roles are clear and understood, and document them in your written procedure.
- Sponsor or Process Owner (if different than Assignee)
- Problem solving group team members
- Review Board
- Evaluator or Effectiveness Checker
2. What are all of the sources of your nonconformities? List them out using the following categories as a guide (think “CIS” with a stutter):
- Customer complaints – External Customers (includes campaigns, field returns, warranty issues, service reports, etc.)
- Customer complaints – Internal Customers (sister plants, corporate office, etc.)
- Internal Product Nonconformities
- Internal Process Nonconformities (all management system processes apply, not just production)
- Suppliers – Internal Suppliers (sister plants, corporate office, etc.)
- Suppliers – External (goods & service)
3. How are these various nonconformities initially captured?
- Is there a single depository for collecting all types/sources of nonconformities (recommended)?
- Are there multiple tracking tools for capturing the various types/sources of nonconformities (not recommended)?
4. How are nonconformities reviewed and ranked in order to analyze severity, trends or systematic failures?
- How severe is the occurrence of a single nonconformity (1X)?
- How often does this nonconformity occur (1X, 15X, 23056X)?
- If nonconformity X “snuck into your facility”, how likely would you be to detect its presence vs. passing it along to the next process or customer (1X = easy to detect and 10X = impossible to detect)?
- Note: Some organizations use a formal ranking system for severity, occurrence and detection to provide an actual score for how risky or significant the nonconformity is or could be. Want to learn more about this approach? Read our FMEA blog.
5. When are nonconformities escalated in order to eliminate the cause to prevent recurrence of the issue via a formal corrective action request or a project (i.e. formal CAPA, major capital project, 6S project, Problem Solving Group, Value-Stream Mapping, etc.)? How does this escalation process work? Who studies the business impact of X and decides which course of action should be taken?
- Do you have a Nonconformity Review Board (NRB)?
- Is the escalation automatically based on a scoring system (see item #3 above)?
- How do you ensure there are not duplicated efforts or assignments? (18 CARs issued to the Purchasing Manager for the same issue is like telling your kid she’s grounded 18 times. One “grounding” should cover it.)
6. What type of progress tracking mechanism is used to ensure clear assignments, appropriate deadlines, progress tracking, etc.? At a minimum, this progress-tracking tool should include:
- Serial # (unique identifier)
- Source of the nonconformance
- Short description of the issue
- Expected due date
- Date done
- Progress indicator (i.e. % complete)
- Additional comments field
Ensure the tracking tool is visible and highlights those items that are on schedule, approaching a due date or past the expected due date. (Note: I like red/yellow/green indicators).
7. What types of problem solving tool(s) is/are used in order to clearly identify the root cause?
- Does your problem solving group facilitator know how to properly use the prescribed root cause analysis tool?
- Are there multiple root causes considered in the tool being used?
- Can data be captured to support the root cause(s) analysis conclusion such as % of contribution (i.e. P-value, Pareto, Histogram, etc.)?
8. How are necessary actions determined and assigned during the problem solving process?
- How is progress reported? (Note: Generally, I would recommend a macro view and top 3 micro view weekly in a top management meeting.)
- How are assignees of action items notified?
- Is there a process for acknowledging the action assignments in a timely manner?
9. How is corrective action(s) taken reviewed to ensure it has been effectively addressed?
- Verification by the assignee or the applicable Process Owner (must be done first)
- Verification by the Assignor, Originator or via the Internal Auditing Process (must be done second)
- How is long-term effectiveness evaluated? Consider giving each incident an “effectiveness grade” based on the overall method and evidence. The grade level should be directly proportional to your confidence level in the failure mode never showing its ugly face again.
10. How is the problem solving process documented and recorded for future reference?
Has the initial tracking tool described in item #2 been updated?
Are results of the “Lesson’s Learned” available and shared with other areas, sister plants, stakeholders of similar goods, services or processes within your organization?
- Has the action to prevent future occurrence been monetized?
- What is the cost of this instance of the failure mode X (CoPQ or cost of poor quality)?
- What is the estimated total historical cost of X since inception?
- What is the value of cost avoidance based on historical costs and future forecasts?
- Note: Validate these financial figures by getting input and approval from your CFO, Controller or other Financial Leader.
- Keep in mind the key to record retention is record retrieval. A good tracking tool with specific codes for each failure mode (i.e. X, Y and Z, etc.) makes future analysis of data much more likely.
Check out The Ultimate CAPA Report below to help you drive the right behavior. Stay posted to future blogs regarding corrective action tools and templates. These will be available on our products store. We also offer CAPA training.