Exploring ISO 9000 -Part 14 Corrective and Preventive Action
ANSI/ISO/ASQC A8402 - 1994 Quality Management and Quality Assurance, Vocabulary provides the following definitions.
4.14.2 Corrective Action
Action taken to eliminate the cause of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.
- The corrective action may involve changes, such as in procedures and systems, to achieve quality improvement at any state of the quality loop.
- There is a distinction between "correction" and "corrective action."
"Correction" refers to repair, rework or adjustment and relates to disposition of an existing nonconformity.
"Correction action" relates to the elimination of the cause of a nonconformity.
4.14.3 Preventive Action
Action taken to eliminate the cause of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence.
Same as notes above using the word preventive instead of corrective. ANSI/ISO/ASQC Q9000-2 Quality Management and Quality Assurance Standards - Generic Application Guidelines offers the following guidance: Causes of detected (or potential) nonconformities should promptly be identified so that corrective action may be taken and recurrence (or occurrence) may be prevented.
These causes may include:
- the failures, malfunctions or nonconformities in incoming materials, processes, tools, equipment or facilities in which products are processed, stored or handled, including the equipment and systems therein;
- inadequate or nonexistent procedures and documentation;
- noncompliance with procedures;
- inadequate process control;
- poor scheduling;
- lack of training;
- inadequate working conditions;
- inadequate resources (human or material); and,
- inherent process variability.
The conditions resulting from these causes may be revealed by analysis of the following:
- inspection and test records;
- nonconformity records;
- observations during process monitoring;
- audit observations;
- field, service or purchaser complaints;
- regulatory authority or customer observations;
- observations and reports by personnel;
- subcontract problems;
- management review results; and,
- inherent process variability.
Clause 4.14 seems to confuse the reader rather than provide clear guidance, especially in the direction of preventive action. To simplify this confusion, read the following explanation: Corrective action is a process to address a problem that has already occurred resulting in a solution preventing the recurrence of the problem. There has to be an existing problem for one to take corrective action. Preventive action is forward looking using trend and analysis of data to discover possible failures and thenpreventing them from occurring. The confusion results because you do apply effort to prevent problems as part of the corrective action process, i.e., take corrective action. I find that many companies address corrective action (c/a) with procedures and defined forms. When asked about preventive action (p/a) they overlook and fail to adequately address this requirement.
Clause 4.14 includes:
4.14.2 Corrective Action
4.14.3 Preventive Action
General requires procedures for implementing corrective action and preventive action. This clause links other clauses as originators of corrective or preventive action. It further states "any corrective or preventive action taken to eliminate the causes of actual or potential nonconformances shall be to the degree appropriate to the magnitude of problems and commensurate with the risks encountered."
- Develop, document and implement corrective/preventive action
- How do you define "to a degree appropriate to the magnitude of a problem commensurate with risks encountered?"
The issue is one of time and resources to be allocated (or not) based on the seriousness of the problem. Use common business sense to define degree appropriate. For example, if during your internal audit process you find a critical measuring device way beyond acceptable calibration limits, would you classify it as a high or low degree?
Further fact finding shows that nonconforming product resulted from use of this measurement device. Some of this product was shipped to the customer. This is a high degree and undetermined magnitude requiring immediate corrective action. Your corrective action response would be to implement product containment for product in process and in inventory. Customer notifications would be necessary. Next, you would follow your corrective action procedure to identify the cause of the measurement device being out of calibration.
One company operating a production process for printing industry products discovered nonconformities during normal in-process testing. The product being produced is one that is manufactured once or twice a year based on customer demand. The appropriate corrective action was taken to correct the process thus producing conforming product. A corrective action was documented for future action. In this case, the company is not going to produce additional product without customer orders. This corrective action will not be acted on until the next customer order production run, one year away.
Another example might result from internal audits. During an internal audit you find a process data form in use but it carries an old revision number. The newer form has added additional process data; however, this data does not have an impact on product conformity. Therefore, even though the old form is in use it is a low degree or magnitude.
Your action item is to develop a method within your company to determine the degree appropriate to the magnitude of the problem. This method will consider the difficulty in identifying the (root) cause, the action required to eliminate the cause and any risk regarding delay of action especially affecting the customer. Document a problem-solving (see 4.14.2 b) process used for both corrective and preventive action. This process will provide management with information upon which to make decisions about degree and magnitude. Management will know what the problem (potential) is; the consequences of taking no immediate action; possible and preferred solutions with cost; and potential savings.
"The supplier shall implement and record any changes to the documented procedures resulting from corrective and preventive action."
Develop a form for corrective and preventive action including an area to record actions taken. This section will address changes including document changes for procedures and/or work instructions. If you use a document request change form to change procedures or work instructions, this form becomes a quality record. Many companies include a reason for change box within each procedure. This notation could include the corrective action control number with a description of the document changes. I suggest including the original procedure with noted changes attached to the corrective action form as objective evidence recording action taken. When an auditor reviews your corrective/preventive action files, he/she will find complete records with supporting documentation.
"The procedure for corrective action shall include: (a) the effective handling of customer complaints and reports of product nonconformities."
First, determine who receives and records customer complaints. Are they typically communicated to sales, customer service, order entry or accounting? Differentiate between customer complaints and reported nonconforming product.
Develop a work instruction for nonconforming product returned by the customer. Consider using a nonconforming product report (NCR) form to document known details. This form also could contain the appropriate blocks for corrective action. Be sure to provide space for accounting details allowing credit to the customer or adjustments to billing. Nonconforming product reports could be generated internally or externally. If they are internal, follow Clause 4.13 Control of nonconforming product procedures.
Customer complaints may include late delivery, billing errors and missing product. Consider using a standard format (form or software) requiring documentation of all known details. Complaints need to be assigned to an individual for action and accountability.
In each case, communicate with the customer to indicate you have received the nonconforming product or complaint report. Develop a tracking mechanism or log to assure issues don't "fall through the cracks." Follow process to investigate the nature of the complaint. Develop a follow-up process to evaluate effectiveness during management review meetings.
(b) "Investigation of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation."
This requirement and that of 4.14.3 (b) are similar and I suggest development of a problem-solving process to address both areas. A seven-step quality problem-solving process includes:
- Collect Problems
If the customer complains or you have product nonconformity you do not need to collect problems to work on (for preventive action collect problems).
- Select Problem
Since you already have a problem, use this step to clearly define it (for preventive action select a problem or category).
- Collect Problem Data
Use of Know/Don't Know and asking if anyone has tried to solve this problem in the past. Document who, what, where, when, how and frequency.
- Cause and Effect Analysis I
Use the fish bone diagram to identify possible root causes.
- Cause and Effect Analysis II
Use of Pareto Analysis to prioritize root cause actions.
- Solution Selection
Use a Solution Selection Matrix to help choose the best solution for the degree and magnitude of the problem. Be sure to ask for input from those affected by the possible solutions. While you are asking, also ask if anyone has any additional ideas to improve your solution.
- Implementation and Tracking
Implementation schedule with required resources and expected results. Develop a method of tracking, i.e., measuring results for reporting effectiveness of implementation.
Consider developing a problem-solving form to document each step in the process and to meet the record-keeping requirements of 4.14.2(b) and 4.16 Control of Quality Records.
(c) "Determine the corrective action needed to eliminate the cause of nonconformities."
Refer to 4.14.2(b) and consider using the problem-solving process defined or develop your own procedure for doing so. It is important to identify who has the authority to approve selected solutions. Keep your procedures simple, useable by all employees and supported with good record-keeping practices. You will have to provide company wide problem-solving process training to effectively implement this practice.
(d) "Application of controls to ensure that corrective action is taken and that it is effective."
Include on your corrective action form, an area for implementation date. This allows anyone to determine when the corrective action was to have been completed. Good corrective action record keeping requires the responsible person to include objective evidence supporting implementation. Not only will the corrective action form describe the action to be taken, but will include attachments indicating actions completed.
Ensuring that corrective action taken is effective requires additional gathering of data and analysis. It's important to define effectiveness. It is also necessary to define the level of resources needed to address the corrective action (degree and magnitude). It could be as simple as the problem has not recurred in the last three months or as complicated as tracking the process data by shift. The point I am trying to make is that you will have to estimate a timeline per corrective action for evaluation and effectiveness. The results will be reviewed by management to ensure their agreement of effectiveness.
One additional issue under 4.14.1 General, the words used are degree appropriate to the magnitude of the problem. The printing product example of corrective action has been open for three years. The problem-solving process continues; however, the root cause has never been identified. There are so many variables that the customer agreed to accept a minimum level of nonconformance. It is a cost, risk and resource decision.
4.14.3 Preventive Action
"The procedures for preventive action shall include: (a) the use of appropriate sources of information such as process and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyze and eliminate potential causes of nonconformities."
Refer to the definition of preventive action with emphasis on eliminate cause of potential nonconformities. Put on your detective hat to uncover trends. 4.14.3(a) focus is on sources of information and data. It clearly defines sources for which you shall collect data. Without data you are not able to determine a trend either + or -. Most companies look at items like scrap levels, rework and repair records, warranty costs, customer complaints and concessions and corrective action/audit findings. Also consider process monitoring records showing where your processes were out of control. One source of information often overlooked is maintenance and records indicating how changes in maintenance schedules could prevent breakdowns and improve process run times.
Include preventive action as an agenda item when meeting with employees during departmental meetings. Keep meeting minutes documenting discussions about preventive action. Ask the simple question: "Does anyone have any ideas about how we can improve x?"
Preventive action includes changes to process flow, setup, simplifying production steps or application of robotics to eliminate repetitive motion injury. Your company suggestion box is a form of preventive action as are cost savings programs offering employee rewards. Start taking credit for each of these if they are in use in your company.
How do we determine which items warrant collection of data for analysis? Management is responsible for defining company goals.4.1.1 Quality Policy and 4.1.3 Management Review both reference organizational goals and objectives. Goals have to be communicated and translated to departmental goals. Each goal is a key measurement or trend analysis item. The clause identifies seven such items that become the base line for management. Don't collect data for the sake of data. Also, you will fine this data analysis frequently discussed during management and supervisory meetings weekly, monthly, quarterly and during management review meetings.
(b) "Determination of the steps needed to deal with any problems requiring preventive action."
Consider using the same corrective action form for preventive action use. Add a box to check off indicating its use for preventive action. Don't reinvent the wheel when developing a preventive action problem-solving process. Use the same process as defined for corrective action. Add trend forecasting to this process.
Preventive action is often cross-functional requiring knowledge and use of team activities.
If your company has not yet invested in team training basics, consider doing so.
(c) "Initiation of prevention action and application of controls to ensure that it is effective."
4.14.3 (a) and (b) identify the trend data and the steps to follow with problems requiring preventive action. 4.14.3 (c) addresses implementation of an improvement plan designed to address the problem requiring preventive action. Once you have completed the selection of a preventive action solution, the next step is implementation. This step requires you to notify everyone who will be affected by the planned changes. Hopefully, you have already included these individuals in the data gathering, analysis and solution selection process, so they are not caught unaware.
Upon determining the effect, follow your implementation plan. This plan will identify the controls measuring successful change. One control is to include both corrective and preventive action items in your audit schedule for follow-up audits. Your audit practice will verify that planned changes have been successfully implemented and or the situation (problem) has been corrected.
(d) "Confirmation that relevant information on actions taken is submitted for management review."
Use common sense in preparing reports for both corrective and preventive actions for management review. Support your reporting style with records indicating successful implementation. Preventive action is a mandatory agenda item for management review meetings. Meeting minutes document this review.
Use careful planning to clearly define procedures for corrective and preventive action. This activity is separate from Clause 4.13 Control of Nonconforming Product.
With a clear problem-solving process (suggested seven-step process) both corrective and preventive action work becomes easier. This methodology helps the individual or team navigate to successful implementation and follow-up for effectiveness.
Make sure that you qualify boundaries for issues requiring informal, formal, immediate or long-term actions. For example, your maintenance department repair of a press is part of corrective action. It is immediate and daily. However, it is never recorded as such. Only trend analysis of the press downtime causes would identify future preventive action.
Use forms and logs developed by others for this clause. Examples are available for the asking from many ISO companies in your area.
Clause 4.14 is a key to helping your company correct existing problems, detect and eliminate potential problems - resulting in improved quality and reduced costs. I find that most companies do a good job with corrective action and have not yet recognized the potential power of preventive action. Preventive action is a jewel in the rough waiting for your polish.
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