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(8.5 Improvement)
8.5.3 Preventive Action
Determine action to eliminate causes of potential nonconformities to prevent their occurrence
Preventive action must be appropriate to the effects of the potential problems.
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:
ÞCorrective 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.
ÞSources 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; management review records; lessons learned from past experience; SPC charts and analyses.
ÞYou 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.
ÞWhile preventing potential quality related QMS nonconformities is our focus, 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, inadequate or inefficient production equipment, technology or information systems; loss of key or competent personnel; inadequate business financing; inadequate staffing, etc.
ÞThese issues may have far more serious consequences than QMS issues. Consider a process that involves developing a business plan 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.
ÞPreventive action also includes applying 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.
ÞPerformance indicators to measure the effectiveness of the preventive action process may include reduction in - cycle time for correction actions, problem re-occurrence, open corrective actions, costs; and improvement in QMS productivity.
