ISO 17025 Quality Manual Template
Tuesday, September 05, 2006
4.11 Corrective Action
4.11.3 Selection and implementation of corrective action
Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.
Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.
Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.
In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.
The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.
Once the cause(s) of the problem have been determined, potential corrective actions are identified. The most likely actions are selected and implemented to eliminate the problem and prevent recurrence.
Taking the initial corrective action will be the immediate fix, short-term fix, or the “band-aid”. You will put out the fire and make the customer satisfied. However, that’s not the end of what you need to do. Action also needs to be taken to prevent the problem from recurring. Therefore, something in the process must change to reduce the likelihood of recurrence.
If you use an example that involves a login problem at sample receiving what is the corrective action.
Do you retrain people? This isn’t always the most effective option. Clearly when employees understand what the process involves retraining is not the long term solution.
Do you need to change the procedure, process or environment? Do you change the location of login to reduce distractions? Do you change the process for maintaining updated customer product profiles? Do you change the process for identifying requests on submission forms by highlighting tests or denoting in some other fashion so they are more readily observable? Maybe. Do you do all of these things at once. Not likely.
Changing too many variables all at once makes it difficult to evaluate which actions were effective. Select the action that appears to be the one that will most likely fix the problem. Then monitor the process to see if the action taken resolves the problem. Record your investigations, findings, and actions taken so if the problem does happen again, you can see what was done in the past and select another action from your list. Once you are confident that the problem has been resolved, close out the corrective action as completed.
In the login example, an action definitely needed to be taken to prevent recurrence. But, what if after investigating it is determined that the problem was not with the process or training, but an isolated incident? For example, your investigation determines that a quality control sample did not perform properly because it was not injected into the instrument or inoculated into the well. Should you change the process because this happened once? In this case, you initiate the corrective action process by identifying the problem and investigating the circumstances surrounding it. This includes investigation to determine if this problem has occurred in the past, and if so, at what frequency. The corrective action may be to bring it to the attention of the analysts and monitor the process. If no instances occur in the defined monitoring period, close the action, but keep the record in the event the problem does recur in the future.
The corrective action system is the means for repairing problems in the laboratory. The key to effective corrective actions is to take the time to thoroughly investigate the problem. This allows the true root cause to be determined so that you fix the problem…not just the symptom.
