Slide 95 of 262
8.5.2 Corrective Action
NOTE: There are no new requirements in Corrective Action from the 1994 version.
The company 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 for
a) Reviewing nonconformities (including customer complaints),
Reviewing nonconformances is inclusive of many aspects as is illustrated by the “…including customer complaints…” verbiage. Nonconformities may be discovered internally and externally.
b) Determining the causes of nonconformities,
While there is no specific mention of Root Cause, more and more auditors are looking for root cause. It is not clear how this will ultimately be interpreted (if in the extreme) so stay tuned!
c) Evaluating the need for action to ensure that nonconformities do not recur,
A problem in most companies initially is how to decide what nonconformances need to be acted upon. In many companies there are lots of things which do go wrong. Some are extremely minor. One cannot do a full blown corrective action on every nonconformance. There has to be a ‘gate’ – someone who evaluates nonconformances and decides of the ‘amount’ of a reaction to follow through on. An important feature is to ensure the ‘gate’ person considered past history. Has this happened before? When? How often and in what timeframe?
d) Determining and implementing action needed,
While the 8-D methodology is not addressed here in, nor is Root Cause specifically stated, it is expected that you will have a system which does, indeed, look for the source of the problem.
The 8-D methodology is briefly described in Implementation.ppt. There is a very complete description of structured corrective action at: https://elsmar.com/8D/.
e) Records of the results of action taken (see 4.2.4), and
f) Reviewing corrective action taken.
There are a number of threads on corrective action in the forums of which https://elsmar.com/Forums/showthread.php?s=&threadid=297 is one. https://elsmar.com/Forums/showthread.php?s=&threadid=687 is another good read.
You might also want to take a read through the main 8-D course file at https://elsmar.com/8D/
8.5.2 - Corrective Action correlates with element 4.14, corrective and preventive action, of the 1994 standard. It states that your company must take corrective action to eliminate the cause of nonconformities to prevent them from happening again. The standard states that the corrective action you take must be appropriate to the impact of the problem encountered.
The standard states that you must have a documented procedure for corrective actions and that the procedure must define requirements for:
a) Identifying nonconformities (including customer complaints);
b) Determining the causes of nonconformity;
c) Evaluating the need for actions to ensure that nonconformities do not recur;
d) Determining and implementing the corrective action needed;
e) Recording results of action taken;
f) Review of corrective action taken.
Basically, corrective action is aimed at preventing recurrence of a nonconformity. The purpose for this requirement is to develop a process for implementing an effective and appropriate corrective action when needed. This is a six step process, taking you through a complete cycle with your corrective actions.
First off, you need to define your process for identifying nonconformities, including customer complaints. You will want to identify those persons who are qualified to a) identify and record problems and opportunities for improvement; and b) initiate, recommend or provide solutions through designated channels. Then you will refer to your requirements for element 8.3 - Control of Nonconformity, 8.2.2 Internal Audit, and 8.4 Analysis of data to define your processes for identifying nonconformities.
The next step in your corrective action process is to define your process for determining the cause of nonconformity. Typically, the personnel that identifies the need for corrective actions are usually aware of the cause of the problem. Try to encourage personnel who are requesting corrective action to also be suggesting solutions, they may be the most qualified to determine a solution, try to encourage constructive criticism. Your process for determining the causes of nonconformity should be timely so that any investigation takes place while the information is current and available. The results of this determination should be recorded, including the personnel who performed the determination, when the determination was conducted and the basis for the determination.
Once the cause is determined you must then determine what action is needed, if any. The required action should not be hastily determined, in some cases the cause of the problem is not fixable because it is out of your control, beyond your means of action, or the benefit of fixing the problem does not equal the cost. Ensure that the personnel that make the determination have time to make a sound judgment. It is always recommended to identify a number of suitable actions and then pick the best one. Obviously, the action should solve the problem without creating more severe problems and without an unacceptable cost - benefit ratio.
The desired course of action should be recorded. Your company may also wish to record the alternative actions which were not selected. When the required actions have been chosen, someone must approve it to ensure it is appropriate to the problem encountered and that person's signature/initial should appear on your records.
Now you must define your process for implementing, verifying and recording the corrective action needed. For the purpose of this, your company must develop a process to plan the implementation of that corrective action, including verification to ensure the action is effective. Your company should document this plan, identifying the:
a) Affected quality system processes,
b) Nature of any required document changes,
c) Subject and audience of any required training,
d) Means of verification and criteria for acceptance,
e) Personnel responsible,
f) Due dates.
After you have completed all of the above, you must review the corrective actions taken. In clause 8.5.1 - Planning for Improvement, you would have developed a process for ongoing reviews of your improvement processes, which includes the corrective action process. The frequency, personnel responsible and records of review would be defined according to that requirement. Open and verified corrective actions should be reviewed according to that process. In addition, ISO 9001:2000 requires that the results of corrective action be reviewed by top management.
Potential Audit Questions
1. How does your company decide which nonconformances become (require) corrective actions? Is the person who initiates the nonconformance involved with the corrective action?
2. Explain your review process for corrective actions. Does top management review them, do those who initiate the nonconformance get introduced to the review cycle?