Understanding The ISO/TS 16949:2002 Standard 

8.5.3 Preventive Action  

You shall: 

l        Determine action to eliminate causes of potential nonconformities to prevent their occurrence 

l        Preventive action must be appropriate to the effects of the potential problems  

l        Define requirements in a documented procedure to:  

a)        determine potential nonconformities and their causes 

b)        evaluate the need for action to prevent occurrence of nonconformities 

c)        determine and implement the needed action 

d)        record the results of action taken 

e)        review the preventive action taken   

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      Sources of information for finding potential QMS nonconformities include – analyses of data (see clause 8.4); audit results; cost of quality reports; quality records; service reports; supplier performance; customer satisfaction feedback; FMEA’s; management review records; lessons learned from past experience; SPC charts and analyses. 

Þ      You must have a documented procedure for your preventive action process which must address basically all of the explanation points and tips covered under the corrective action process. 

Þ      While preventing potential QMS nonconformities is our focus for ISO 9000 and TS 16949, it might be very useful to think of preventive action in a wider context, i.e. the entire business. Think in terms of actions needed to prevent – loss of market share; loss of product profitability; loss due to lack of product diversity; loss of business opportunities due to lack of capacity, inadequate or older facilities, production equipment, technology or information systems; loss of key or competent personnel; inadequate business financing; inadequate staffing, etc.  

Þ      These issues may have far more serious consequences than QMS issues. Consider a process that involves developing a business plan covering these issues, based on - gathering relevant research data on these issues; use of appropriate risk evaluation and management methods; developing proactive strategies and action; monitoring and reviewing performance against the business plan. This would constitute the ultimate preventive action process.  

Þ      Consider using a Pareto analysis to organize and rank the dollar value impact of the data on the issues listed above in order to: 

Þ      Determine the magnitude of risks and effects on the organization and 

Þ      Prioritize preventive on these issues as they are all important and may need significant amounts of resources to address them.  

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