Understanding The ISO/TS 16949:2002 Standard 

8.5.2 Corrective Action  

You shall 

Take action to eliminate the cause of nonconformities in order to prevent their recurrence 

Take action appropriate to the effects of the nonconformities encountered

Define requirements in a documented procedure to: 

a)        review nonconformities (including customer complaints) 

b)        determine the causes of nonconformities 

c)        evaluate the need for action to ensure that nonconformities do not re-occur. 

d)        determine and implement corrective action needed 

e)        record the results of actions taken 

f)        review corrective action taken 

8.5.2.1 Problem Solving 

l        You shall have a defined process for problem solving leading to root cause identification & elimination. Use customer prescribed problem-solving format, where available 

8.5.2.2 Error-proofing 

You shall use error-proofing methods in your corrective action process 

8.5.2.3 Corrective Action Impact 

You shall apply the corrective action and controls you implemented to eliminate the cause of nonconformity, to other similar products & processes. 

8.5.2.4 Rejected Products test/analysis  

You shall: 

Analyze parts rejected by customers plant, engineering facilities and dealerships 

Initiate corrective action to prevent recurrence 

Minimize the cycle time of this process 

Keep records of these analyses and  make them available to customers on request 

Note:   Cycle time for product analysis should be consistent with determining root cause, corrective action and monitoring effectiveness of implementation  

Key Explanation Points and Tips: 

Þ      Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.  

Þ      You must have a documented procedure for your corrective action process which must address the following control requirements: 

Þ      Identify detected nonconformities that relate to your - products; QMS processes; resources; suppliers and outsourced work; product shipped to customers; customer complaints; cost of quality reports; and TGR (things gone wrong) reports. 

Þ      Define your process for identifying and using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity Use the customer prescribed problem-solving format (e.g. 8D form), where available. Review specific tools, methods and requirements at OEM customer or IATF websites. 

Þ      Problem-solving tools may include - analysis of failure mode; capability studies; correlation diagrams; data collection; fishbone diagram (Ishikawa diagram); FMEA review; histograms; Pareto analysis; probability charts; stratification of data; graphic representations; etc. Ensure that personnel applying these tools are competent and trained.  

Þ      Do a Pareto analysis of the root causes of all your corrective actions by type, process, product, etc to prioritize problem-solving resources and applying lessons learned. Also, consider doing a Pareto analysis of cost of poor quality data to prioritize corrective action. Top management understand dollars a whole lot more than numbers!    

Þ      Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc or any combination of these. Conduct tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence. You must keep appropriate records of these actions and follow-up activities 

Þ      You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity, you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of root cause may have been incorrect or incomplete. 

Þ       Apply successful corrective action solutions to other similar products , processes and sites where there may be the potential for the same nonconformity to occur. Use error-proofing methods across similar products, processes and sites, wherever cost effective and feasible, to prevent recurrence or avoid occurrence of nonconformity. 

Þ       Analyze and take corrective action on product rejected by your customer’s manufacturing plants, engineering facilities and dealerships. Minimize the cycle time for both – rejected product analysis and related corrective action.  

Þ      Keep appropriate records of all corrective action steps. Ensure timely completion of any open corrective action or be prepared to provide evidence to justify its continued open status. Make your corrective action records available on request to customers and provide a summary report for management review. 

Þ      All nonconformities may not necessarily result in corrective action. Evaluate the significance of nonconformities in terms of their impact on  - operating costs; cost of nonconformity and its correction; frequency of occurrence; product performance; process capability; process variation; dependability; safety; regulatory requirements; affect on customers product and processes; any other risks; and customer satisfaction. Consider using cross-functional teams in such decision-making, including the involvement of your organizations designated customer representative (see clause 5.5.2.1). 

Þ      Performance indicators to measure the effectiveness of the corrective action process may include - reduction in cycle time for correction actions, problem re-occurrence, open corrective actions, cost of poor quality; and improvement in QMS productivity.