[ Pobierz całość w formacie PDF ]
.Guidance8.5.1 Continual ImprovementEach organization should continually seek to improve, rather than wait for a problem to reveal opportunities for improvement.Potential improvements can range from short projects to long-term activities.Examples are:lSitting down with the most important suppliers in order to increase the effectiveness of the communication and to reduce nonconformances;llMaking an action plan to reduce the reject from a certain type of machine;llFinding opportunities to reduce the delivery time.lContinual improvement should be based on all relevant information available.Audit results and other data should be analyzed and compared with the policy and objectives so that corrective and preventive actions can be taken to ensure continual improvement.Management reviews should be used as tools for enhancing this improvement process.Often, it is not practical or advisable to take all needed actions at once, so it becomes necessary to prioritize improvement actions on the basis of their status and importance to determine when action should be taken.The output of the continual improvement planning process should be a list of improvement initiatives and anticipated results.The effectiveness of these actions should be reviewed as a normal part of the corrective/preventive action processes (see clause 8.5.2 and clause 8.5.3) or during management reviews (see clause 5.6)8.5.2 Corrective ActionComplyN/AYNThe organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.Corrective actions shall be appropriate to the effects of the nonconformities encountered.A documented procedure shall be established to define requirements forlreviewing nonconformities (including customer complaints);lldetermining the causes of nonconformities;llevaluating the need for action to ensure that nonconformities do not recur;lldetermining and implementing action needed;llrecords of the results of action taken (see 4.2.4); andllreviewing corrective action takenlGuidance8.5.2 Corrective ActionEvery indication of a failure (i.e.complaint, rejection, audit finding, return, etc.) requires an immediate correction.In addition, the organization needs to evaluate whether a corrective action is needed to prevent (or minimize the likelihood of) the failure from recurring.This requirement is related to ensuring that corrective actions are identified, taken and verified for timely and effective implementation.This involves finding the cause of the problem, recording the results of the action taken and verifying that the action was effective.The intent of this requirement is to have a disciplined approach to problem solving (i.e.identifying the root cause of the problem, the actual costs with the failure, and the potential costs/risks associated with taking no action to prevent its recurrence.Corrective actions are ineffective when they do not achieve desired results (usually meaning, the problem/failure recurs).8.5.3 Preventive ActionComplyN/AYNThe organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.Preventive actions shall be appropriate to the effects of the potential problems.A documented procedure shall be established to define requirements forldetermining potential nonconformities and their causes;llevaluating the need for action to prevent occurrence of nonconformities;lldetermining and implementing action needed;llrecords of results of action taken (see 4.2.4); andllreviewing preventive action taken.lGuidance8.5.3 Preventive ActionIt is better to prevent a problem from occurring than to correct a new or recurring problem.Based on the information available to them, organizations must identify ways of preventing problems from occurring in the first place.Examples of preventive actions are:lpurchasing additional tools or machinery, because of an expected increase in activities or production;llchecking computer systems to see if they are capable of handling information from a new customer;llintroducing a new identification system for nonconforming product, so that any potential misunderstandings can be avoided;llproviding training on new processes, equipment, customer requirements, etc.lPreventive actions are usually handled in the same way as corrective actions, just with a different `focus'.This involves finding the cause of the potential problem or failure, recording the anticipated results of the action taken and verifying that the action was effective.The intent of this requirement is to have a disciplined approach to risk analysis (i.e.identifying the root cause of the potential problem and the potential costs/risks associated with taking no action to prevent its occurrence.Preventive actions are ineffective when they do not achieve desired results (usually meaning, the problem/failure occurs).Page 2 of 1
[ Pobierz całość w formacie PDF ]
