FMEA

ISO 9001:2015 Changes: What It Means for You

ISO 9001, ISO 9001:2015, new standards, international standard changes, change management, planning for change, leadership, tips for preparing for change, QMS changes, quality management, quality systems By now, you’ve surely noticed the buzz around the upcoming changes to ISO 9001. ISO 9001:2015 is projected to be approved and released in Q4 of 2015. If you haven’t heard the buzz, then perhaps you need to subscribe to a blog or two, pick up Quality Digest or raise your head a bit from the rock you’ve been hiding under! All rocks aside, this revision looks to have several significant changes to the standard including the overall structure, basic terminology as well as what is NOT going to make the cut for the new release.

What you can do to start preparing now.

The reality is quite simple. Change happens whether we like it or not. Markets change. Businesses change. Customers change. Nearly everything changes. Most of the time we hate change. Our brains are just programmed that way. We don’t like what we don’t know, but we know what we like. As quality practitioners in particular, our job as change agents tend to be easier when WE are driving the change versus times when we are being asked to change ourselves.

This round of ISO 9001 revisions will undoubtedly be the most significant change to international QMS standard in the past 15+ years. We have seen a draft that gives a little understanding of what to expect with the changes ahead (ref. http://www.acommoncenter.com/iso9001_2015). But what are you doing with the proposed changes, if anything? Are you preparing your organization’s risk management efforts through the use of tools such as the FMEA? What is the appropriate amount of control needed for any process that effects the customer or “other interested parties” (do you know what that means)? Have you appropriated defined expected process outputs by ensuring proper management of customer-specific requirements?

I encourage you to set aside 30 minutes to review this Google+ Hangout video titled ISO 9001 revision - Conversation with Nigel Croft. Mr. Croft is the Chair of the Subcommittee revising the ISO 9001 standard (aka “the horse’s mouth"). Watch the YouTube video here.

Our philosophy is that it is better to be proactive than reactive. While we don’t currently know all of the requirements that will make the final cut, we do have several opportunities to begin to be proaction with the changes ahead. It is at least time to start discussing potential changes to the requirements in order to think strategically about potential impacts and resource needs over the next 3-5 years.

What are some of your thoughts on these big ISO changes that are being proposed in the current draft? How are you preparing for these proposed changes? Let us know in the comments and share with the community. And if you are interested... keep up to date with our upcoming forum and online discussions in September.

Improving Your Corrective Action Process

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.

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  • Originator
  • Assignee
  • Sponsor or Process Owner (if different than Assignee)
  • Problem solving group team members
  • Review Board
  • Approver
  • Evaluator or Effectiveness Checker

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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):

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  • 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)

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3. How are these various nonconformities initially captured?

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  • 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)?

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4. How are nonconformities reviewed and ranked in order to analyze severity, trends or systematic failures?

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  • 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.

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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?

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  • 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.)

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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:

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  • Serial # (unique identifier)
  • Source of the nonconformance
  • Assignee
  • Short description of the issue
  • Expected due date
  • Date done
  • Progress indicator (i.e. % complete)
  • Additional comments field

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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?

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  • 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.)?

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8. How are necessary actions determined and assigned during the problem solving process?

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  • 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?

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9. How is corrective action(s) taken reviewed to ensure it has been effectively addressed?

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  • 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.

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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?

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  • 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.

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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.

Ultimate CAPA Report

 

What the heck is an FMEA?

A systematic group of activities intended to: recognize and evaluate the potential failure of a product or process and the effects of that failure recognize and prioritize ALL potential causes of each failure. assess risk throughout the entire process (not just manufacturing) identify actions that could eliminate or reduce the chance of the potential failure occurring be a living document that should always be updated to reflect current conditions, including changes FMEA Process objectives:

The FMEA drives product and process improvements Addresses all high risk failure modes Used to develop control plans Integrated with process flow diagram and the process control plan Considers all major “lessons learned” (i.e. nonconforming product, warranty data, customer complaints, corrective actions, etc.)