There is no universal corrective action plan, but generalized contingency planning, such as documented organizational practices, may be a useful starting point for

1. fixing the mistake
2. keeping it from happening again, and
3. integrating lessons learned from the experience into the organization's existing engineering or other professional production, training, management and other systems.

One rarely reads a newspaper nowadays without noting where some device, already on the market and being used, was recalled for replacement of a defective part or for an adjustment. For example, a national business daily had the following item some time ago: Vehicles Recalled to Fix Door Latches, Seat Wiring reported that a US motor vehicle manufacturer was recalling more that 100000 vehicles of various models because of faulty secondary door latches, and an electrical harness support device which could develop a short circuit... possibly causing a fire...

Another item in the same newspaper, titled "Manufacturing Isn't the Same Old Smokestack," reported that the National Association of Manufacturers (NAM) had launched a high-tech PR campaign to improve industry's image among students. The NAM would provide interactive CD-ROM scenarios to test (students') reasoning in "...production, research and development, finance and sales." The goal, according to the NAM's Manufacturing Institute, was "...to get more teachers and counselors to recommend manufacturing careers." So mistakes are clearly as relevant to the education of tomorrow's managers, technicians, and production workers as to the work of today's.

As a manufacturing line-worker, a production and procedures specialist, and a management analyst tracking compliance with corrective actions required by government and private sector technical and management inspection/audit teams, I have been involved in management inspection and other oversight techniques. I have accumulated how tos based on follow-up reviews and seen many procedures changed for the better. Nevertheless, mistakes still do happen and always will. We have to keep up with the causes of mistakes and the means of fixing them, or resources will be wasted and lives will be placed at risk.

The text is intentionally general; no two manufacturers, institutions, service entities, down to their first line work sites are exactly alike in their tasks, equipment layout, skills, human factors and personalities, etc. and their interaction (within and outside the work unit) affects the hands-on elements of a fix (including who does what and when) and its implementation. Planning and integrating a fix must take into account this uniqueness.

Mistakes challenge a leader's sense of order. Timely and effective corrective action may be vital to product safety and consumer welfare, not to mention organizational stability.

Technical, production, and administrative errors cost the public and private sectors hundreds of millions of dollars each year, and they waste scarce resources. At times, managers, supervisors, and technicians are not sure what needs to be done to correct the problem and its causes. When the corrective action process itself is unorganized or in disarray, the adverse affects of the error will likely increase. The solution can be worse than the problem!

Example

Several thousand units of a newly designed device, manufactured in one plant, were found to have a defective part. The first-level assembly, into which the defective part was initially installed at a product-line work station, had then moved on to subsequent work stations on the product-line where they were incorporated into higher-level assemblies. Eventually, the units, still with the defective part installed, made their way through final assembly. Many were in post-final-assembly holding areas, on their way to or in the shipping department's temporary storage warehouse, or loaded on to shipping vans for delivery to wholesalers, distributors, or consumers. Others were in the transportation pipeline, at dealers and retailers, or already with consumers. Each unit and its outer shipping container had its own visible serial-number identification. Suppose you are a production manager: can you list the considerations and options that would help your management understand the significance of the mistake and its effects on the pipeline?

Here's what you might do:

• review relevant policies and procedures
• prepare a corrective action plan
• organize an implementation team, including representatives from all stages of design, production, manufacture and delivery
• notify your major customers and vendors of the plan, and secure if possible their cooperation
• integrate lessons learned from this process into all management systems to prevent the same mistake from happening again

• What was the mistake?
  • Did a part break, crack, bend, misalign?
  • Was a circuit incomplete?
  • Were incorrect materials used or dimensions applied?
• What really happened as a result?
• Has physical evidence been examined?
• Has the location where the mistake was first noticed been examined?
• Have you pinpointed and brought to the attention of the management and production staff the specific work unit and work station where the error was first noticed?
• Were you able to isolate the mistake from the evidence?
• Did you track the mistake forward along the production system to ascertain the extent to which the fault was included in higher assemblies and end items?
• Did you stop the work step responsible? Did you need to stop production altogether? Do you know what the effects of a work stoppage will be on:
  • affected product lines and shop activities
  • contractual commitments
  Do you have alternate workloads that can be readily inserted into production line gaps until corrective action is implemented?
• Did you identify the people, skills, materials, tools, equipment, data in all related programs, work practices and procedures that caused the mistake?
  • Do you know which were directly responsible?
  • Do you know which were indirect contributors?
  • Do you know how they became part of the approved design, vendor support, and/or production process?
  • Have you identified where (functions, work units) and with whom (supervisors) the accountability lies?
• Is it possible correct the mistake on the completed/shipped units? Consider:
  • safe and economical use of the final product by the customer
  • established quality standards and governing technical specifications and contracts
  • the service life of the part and the resulting units
  • maintainability and accessibility of the part within the unit during normal usage
  • the effect on operating costs and time between inspections, parts replacements, and maintenance
• Have you reviewed the design specifications to ensure that the (consumer's) intended use of the device has not been compromised by the defective part?
• If the error will not cause significant deviations from approved drawings, technical and contractual specifications, should you review the situation with the customers before taking any further action?
• Are parts, assemblies or end items incorporating the error still being prepared for shipment?
  • Have you estimated the effects of the mistake on the market place?
  • Have you estimated the effects of a decision to recall the defective items from your customers, dealers, consumers?
  • Should further preparation for shipment (preservation and packaging) of the item be halted?
  • Are trucks or freight cars now being loaded?
  • Should the shipments be halted?
  • Should the shipments be off-loaded?
  • Do you know the effect of a stop shipment order on the customers/consumers who are scheduled to receive the items?
  • Do they have sufficient stocks on hand that do not contain the error to tide them over the re-work period?
  • Should you permit shipments to continue and then dispatch technicians to replace or repair the defective parts at the customer's site?
  • If the defective items have been shipped to distributors and then to customers, can you identify all shipments that incorporate the production error? Can you help the distributors and customers find them?
  • Have you issued instructions to cover the situation?
  • Have you confirmed that your instructions were followed?
• Should the recipients of items containing the defective part be notified?
  • If notification is to be made, have you issued instructions to do so and are your instructions clearly understood?
  • Have you and your legal advisors reviewed the notification for adequacy, including legal and contractual implications?
  • Do notification procedures include recording date/time/method of notification and names of individuals originating and receiving the communications?
  • Are you certain the notification was received and understood by the intended recipient?
  • If you have imposed a work stoppage on the affected items and stopped further shipments, do you know your shipping commitments for the near term?
  • Should the recipients for those shipping commitments be notified of the delays, lead time until the situation can be clarified, and when a new shipping date will be provided? Was this step followed up with the notification of a new shipping date?
• If the faulty items are to be recalled to the plant, can shipments in the transportation pipeline be diverted back?
  • Were instructions to that effect issued, and has your Receiving department prepared paperwork for the non-routine receipts and for their segregated storage until shop processing?
  • Should you arrange with your customers for rework of the defective items in their service support shops or contractually?
  • Would it be more practical for you to send your technicians to do the rework on site, considering your customers resources (time, special tools, equipment, replacement parts, materials, skills, calibration), the economics of the situation, and your company's reputation?
  • Have you identified and analyzed your options for each location where the fix will be made? Have you listed them and evaluated their interactions?
  • Have you evaluated the effects of your decision to fix or not fix?

Taking Action

If the mistake is to be fixed, do you know what needs to be done to develop the corrective action and put it into effect? Consider the demands that will be made on and the adequacy and availability of your

• plant facilities
• finances
• energy sources
• communications systems
• transportation
• public relations and marketing
• shop equipment and tools
• supplies and long-lead acquisition time materials
• data
• people (skills, training, safety, working hours, etc.)
• any other resources involved

• Do you need a special, one-time production task group for the defective sub-assemblies to do the tear down, repair, and re-assembly job?
• Can you return good parts to routine production, have you identified the points along the production system where each good assembly and/or component can be re-checked and reused?

• Do you know precisely how each will be affected?
• Do the supervisors and direct workers of those work units and at each work station understand the problem and what is expected of them?
• Have you ascertained which work units and work stations can be by-passed during the fix to minimize disruption to routine operations and production and thereby reduce cumulative adverse effects?

• Realign work space?
• Move shop equipment?
• Modify tools and equipment?
• Fabricate jigs and special holding devices?
• Redesign parts and assemblies?
• Revise quality assurance standards and procedures, and production practices?
• Retrain people?
• Reschedule and reprogram other work?
• Modify contracts with suppliers and customers?

Can the corrective action taken as a result of this error be applied to future designs, and management policies and practices, and for production system improvements elsewhere in your plant?

• Has this experience given you ideas to improve your operations?
• Have you documented what you learned, tested them, and injected the results into your plant practices?