Corrective and preventive actions in accordance with international standard The ISO series of quality assessments are carried out to eliminate actual and potential quality problems. By creating a functioning system of corrective / preventive actions, you can effectively manage the quality of products or services at any stage of production and at enterprises in any field of activity. This will have a positive impact on the development of not only the business enterprise, but also on economic development the entire region as a whole.
B presents a scheme for reducing quality costs, which indicates that the enterprise should strive to improve product quality by increasing the share of preventive costs, which, at the same time, will allow for a long-term reduction in overall costs. Correcting errors costs money. Moreover, not all mistakes can be corrected.
This means that management actions should be primarily aimed at preventing nonconformities, rather than eliminating them.
As research shows, measures to identify and eliminate the possibility of inconsistencies occurring at ever earlier stages life cycle products bring enormous economic benefits. This led to the emergence of the well-known rule of “a tenfold increase in the cost of eliminating a defect if it is identified not at this, but at a subsequent stage of the life cycle.” To implement this approach, a preventive action is used.
Specific actions that need to be taken or planned to eliminate the root causes that could lead to undesirable consequences should be identified. These actions should be sufficient to prevent the problem from occurring in the future.
The economic approach requires calculating the effectiveness of any action, be it corrective or preventive.
Several issues may arise in determining the effectiveness of preventive/corrective measures. The first problem appears at the stage of identifying preventive actions. The study of literature data and documents of QMS of enterprises showed that there is some confusion, or, if you like, misunderstanding of this term. Thus, many enterprises do not distinguish between preventive and corrective actions at all, carrying out their joint planning, which leads to the substitution of these concepts. The author, for example, classifies all actions for improvement or development as preventive.
Therefore, the first step in studying the problem should be the study and subsequent classification of incorrect approaches taken in identifying preventive actions. This classification was developed by the author based on studying the documentation of QMS of organizations and is shown in Fig. 1.
The diagram clearly shows that organizations mistakenly classify preventive actions for improvement, control, correction, measures to improve productivity, etc.
After classifying the errors that arise when identifying preventive actions, the next step should be a clear division of actions into preventive and corrective ones.
These terms are standardized, the ISO 900000 standard gives the following definitions:
“Preventive action is an action taken to eliminate the cause of a potential nonconformity (3.6.2) or other potentially undesirable situation
Note. There may be several reasons for a potential discrepancy.
Preventive action is taken to prevent the occurrence of an event, while corrective action (3.6.5) is taken to prevent the reoccurrence of the event.”
"Corrective action is an action taken to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situation
Note 1: There may be several reasons for non-conformity. 2. Corrective action is taken to prevent the recurrence of an event, while preventive action (3.6.4) is taken to prevent the occurrence of an event.”
This means that a corrective action is, in fact, some correction of what was created, received or occurred as a result of some action.
Thus, it is quite obvious that such measures as reconstruction of the ore crushing building to improve the quality of ore preparation, provision of a minimum supply of rolls to reduce the sorting of rolled products for flatness defects, installation of anti-corrugation equipment to eliminate the metal defect “longitudinal strips” are corrective actions, because unsatisfactory the quality of ore preparation, defects in “flatness” and “longitudinal stripes” have already taken place.
Any corrective action must have two results. The first is finding the cause of what happened. The second is an option for solving the problem itself.
Improvement actions are also often mistaken for prevention. For example, at the analyzed enterprise, the measure for modernizing the weight-dosing device for feeding raw materials on a rotary kiln was classified as a warning. The implementation of this measure will increase the productivity of the furnace and increase the durability of the converters. Obviously, we are still talking about an improvement/development event.
Once preventive and corrective actions have been accurately identified and implemented, their effectiveness must be assessed. At enterprises whose quality management system is certified for compliance with ISO 9000/2000, actions are considered effective if the causes of non-compliance are eliminated.
As a rule, at these enterprises the criterion for the effectiveness of corrective actions is the complete absence of inconsistencies to eliminate which the corrective actions were aimed. When a nonconformity is detected again, an analysis is carried out from the point of view of the correct determination of the cause of the nonconformity and the effectiveness of the developed corrective measures.
The economic approach to determining efficiency requires comparing costs with results. Therefore it is necessary to calculate economic efficiency actions taken. Any of the known indicators can be used as an indicator of efficiency, for example, the payback period for the costs of implementing activities.
Problems, as we know, arise suddenly, when they were not expected. The controls put in place, as well as an effective preventative action process in place, should function in such a way as to provide confidence that problems are prevented rather than detected after they occur.
Thus, to implement effective preventive/corrective actions it is necessary to:
Classification of errors that arise when determining preventive actions;
Clear distinction between preventive and corrective actions;
Determination and implementation of preventive/corrective actions;
Determining the effectiveness of preventive/corrective measures, taking into account the costs of their implementation.
Literature:
1. Zenkov A.N. Regional development: Quality management as a way to develop the regional economy. No. 1, 2006
2. Fet E.P. On quality cost management // Technology of production of metals and secondary materials” Republican scientific journal, №1, 2006
3. Alekseev V. Corrective and preventive actions // Methods of quality management, No. 08, 2005
4. ST RK ISO 9001:2009 Quality management systems. Requirements.
“The organization must determine actions to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions must be appropriate to the possible consequences of potential problems.
A documented procedure shall be developed to determine the requirements for:
a) identifying potential nonconformities and their causes;
b) assessing the need for action to prevent the occurrence of nonconformities;
c) determining and implementing necessary actions;
d) records of the results of actions taken (4.2.4);
e) analysis of the preventive actions taken" (GOST R ISO 9001-2008).
Corrective and preventive actions can be viewed as parts of the improvement cycle. The need for corrective actions arises when there are non-compliances of products (services) or the quality management system with established requirements. They are identified within the organization or from information coming from outside in the form of consumer complaints or requests for warranty repairs or maintenance, as well as when problems arise with suppliers. The scheme for developing and implementing corrective action is presented in Figure 15.1.
Corrective actions include determining the cause of a particular problem and taking the necessary measures to prevent reoccurrence. Useful information information about the essence of the problem and possible ways to resolve it can be obtained in accordance with clause 8.4 “Data analysis”.
Preventive actions begin with the collection and analysis, in accordance with clause 8.4, of all data on inconsistencies that have arisen - consumer complaints, applications for warranty repairs, information about problems encountered by suppliers, and from any other sources - in order to detect existing trends. If the analysis indicates that a problem is likely to exist, appropriate preventive measures are taken to eliminate possible reasons its occurrence.
Methods for performing both corrective and preventive actions should include the appointment of persons responsible for their implementation and with the appropriate authority.
A distinction should be made between actions to eliminate nonconformities (correction) and corrective actions. Elimination of non-conformity (correction) consists of resolving the problem by reworking, replacing or other actions with the defective product described in the explanations to clause 8.3 (Figure 15.1).
Revealing
Existing potential
inconsistencies inconsistencies
Definition
significance of non-conformity
Study
reasons for non-compliance
Development
Corrective warnings
actions actions
Performance assessment
Accounting for corrective
(warning)
actions
Figure 15.1 Scheme of development and implementation of corrective
(preventive) action
Corrective actions are related to searches causes of non-conformity and their elimination so that this problem does not arise again. Various factors may indicate the need for corrective action, including:
Consumer complaints;
Inconsistencies;
Alterations or repairs;
Reports on audit results (requirements for internal audit, see clause 8.2.2).
Analysis of the causes of the problem (clause 8.4) may lead to the proposal of some solutions, which may include retraining of personnel or changing production process control procedures.
The scope of the problem and the associated business risks determine what action should be taken. If corrective action is taken, it should be reported and its results monitored over time to ensure its effectiveness. In this case, there may be a need to make changes to the Quality Manual, methods and other relevant documents. These changes must be made in accordance with the requirements of clause 4.2.3. "Document Management".
In the food supply company example discussed above, where meat products past their sell-by dates were used, an investigation into the cause may lead to the conclusion that
there is a problem with inventory circulation either at the supplier’s warehouse or at the company’s own warehouse. Another reason may be the operator misinterpreting the meaning of the marking with the date of sale. The actual corrective action taken will depend on the actual cause of the problem identified.
A company's own reports should be reviewed to identify trends that indicate potential problems may arise. Typical examples data that can be used for such analysis are:
Arises during production, the intensity of rework;
Defective products, waste levels;
Supplier complaints and surveys;
Applications for warranty repairs and maintenance;
Service reports;
Emerging needs for coordinating the supply of products with deviations from established requirements.
Other data sources may include market surveys, sales volumes, audit and quality reports. If a potential problem is detected, then certain actions should be outlined and taken to reduce or eliminate the risk of its occurrence. If preventive action is taken, this should be reported and the results monitored over time to ensure the effectiveness of the action taken. In this case, there may be a need to make changes to the Quality Manual, methods and other relevant documents. These changes must be made in accordance with the requirements of clause 4..2.3. "Document Management".
products
Figure 15.2 Procedure for resolving nonconformities
Examples of when preventive action should be taken include:
Identification of situations that can lead to destruction of the product, and implementation of techniques to prevent such situations;
Information received from personnel that indicates the possibility of using a more efficient process;
Re-evaluation of possible suppliers in order to prevent
problems associated with them.
In small enterprises, it is hardly justified to separate activities based on the results of management analysis and long-term corrective or preventive actions. When the workforce is small and the same people are involved in all these activities, this artificial separation can lead to duplication of effort. If such an approach is adopted, it should be reflected in the Quality Manual.
In the same example with a food supply company, as a result of a problem with expired meat products, an analysis of product delivery times, storage conditions and sales dates should be carried out in order to identify possible similar problems with other sandwich fillings and take the necessary measures to solve them. warnings.
Section 4 Comparison of the ISO 9004:2009 standard and GOST R ISO 9001-2008
ISO 9004:2009 Managing for the sustainable success of an organization. Quality management approach. Scope of application. Normative references. Terms and definitions. Managing for the sustainable success of the organization. Strategy and policy. Resource management. Process management. Monitoring, measurement, analysis and review. Improvement, innovation and learning. Self-assessment tools.
Before discussing the topic of this article, I would like to draw your attention to the terms used and their explanation, which are given in the ISO 9000 Fundamentals and Vocabulary standard.
- Inconsistency- failure to comply with the requirement.
- Correction - action taken to correct a detected nonconformity.
- Corrective Action- action taken to eliminate the cause of a detected nonconformity or other undesirable situation.
- Preventive Action- action taken to eliminate the cause of a potential nonconformity, or other potentially undesirable situation.
Preventive action is taken to prevent the event from occurring, whereas corrective action is taken to prevent the event from occurring again.
To better understand the topic under consideration, let's consider a situation that arises or may arise within any organization. So, a virus got into one of the organization’s computers and information was lost.
Having considered this situation, we have two discrepancies: first, the virus got into the computer, second, information was lost. What is usually done in such a situation is that we try to clean the computer from the virus and restore lost information. Cleaning a computer takes some time and possibly money, but the result can be achieved, but with information, the situation is more complicated, we can lose it irretrievably.
Many organizations, having cleaned the computer of the virus, i.e. Having made the correction (correction), they forget about the problem and continue to work as before, until the next time the virus hits. Based on lost information, actions are taken to restore it or other actions adequate to the scale of the lost data.
The problem is that most organizations limit themselves only to corrections and do not analyze the causes of problems that arise, and thus the problems are repeated over and over again.
I APPROVED
General manager
PJSC "Company"
____________ P.P. Petrov
"___"___________ G.
ENTERPRISE STANDARD
Quality management system
Corrective and preventive actions
Copy No. ____________
PJSC "Company"
ENTERPRISE STANDARD
Quality management system
CORRECTIVE AND PREVENTIVE ACTIONS
Preface
1. DEVELOPED AND INTRODUCED
Technical control department
2.PUT INTO EFFECT
By order of PJSC "Company" dated "_" ________2018. No. ___
3. The requirements of STP SMK 8-003-2007 meet the requirements
ISO 9001:2008 standard
1. Scope and scope
2. Normative references
3. Definitions and abbreviations
4. General provisions
5. Corrective actions
6. Preventive actions
7. Responsibility and authority
8. Related documents
9. Procedure for making changes
Appendix A Algorithm for implementing corrective (preventive) actions
Appendix B Corrective/Preventive Action Plan Form
Change registration sheet
1 Scope and scope
1.1 This standard establishes the procedure for carrying out corrective and preventive actions in the processes and procedures of the quality management system to ensure continuous improvements.
1.2 This standard applies to the entire enterprise within the framework of the quality management system of PJSC “Company”.
2 Normative references
2.1 This enterprise standard takes into account the requirements of the following documents:
— ISO 9000:2005 “Quality management systems. Fundamentals and vocabulary."
— ISO 9001:2008 “Quality management systems. Requirements".
3 Definitions and abbreviations
3.1 Definitions:
— non-compliance: failure to comply with a requirement;
- requirement: a need or expectation that is stated, generally assumed, or required;
Note 1: “Generally assumed” means that it is generally accepted practice by the organization, its customers and other interested parties to assume the needs or expectations being considered.
Note 2. To designate a specific type of requirement, qualifying words can be used, for example, product requirement, quality system requirement, consumer requirement.
Note 3: A specified requirement is one that is defined, for example, in a document.
Note 4: Requirements may be made by different stakeholders.
— effectiveness: the degree to which planned activities are implemented and planned results are achieved;
— stakeholder: a person or group interested in the activities or success of the organization;
Examples. Consumers, owners, employees of an organization, suppliers, bankers, associations, partners or society.
Note. A group may consist of an organization, part of an organization, or several organizations.
— corrective action: action taken to eliminate the cause of a detected nonconformity or other undesirable situation;
Note 1: There may be several reasons for non-conformity.
Note 2: Corrective action is taken to prevent the recurrence of an event, while preventive action is taken to prevent the occurrence of an event.
Note 3: There is a difference between correction and corrective action.
— correction: action taken to eliminate a detected nonconformity;
Note 1: Correction can be carried out in combination with corrective action.
Note 2: Correction may include, for example, rework or reduction of gradation.
— rework: action taken on nonconforming product to make it conform to requirements;
Note. Unlike rework, repair may affect or change parts of the nonconforming product.
— preventive action: action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation;
Note 1: There may be several reasons for a potential nonconformity.
Note 2: Preventive action is taken to prevent the occurrence of an event, while corrective action is taken to prevent the occurrence of an event again.
— disposal of nonconforming products: action taken on a nonconforming product to prevent its original intended use;
Examples. Recycling, destruction.
Note. In a non-conforming service situation, application is prevented by termination of the service.
— permission to reject: permission to use or release products that do not meet established requirements;
Note. Permission to deviate generally applies to the supply of products that do not meet specifications for the agreed upon time or quantity limits for that product.
— permission to deviate: permission to deviate from the original established requirements for a product before its production;
Note. A derogation is usually granted for a limited quantity of product or period of time, or for a specific use.
— release: permission to move to the next stage of the process.
3.2 Abbreviations:
PJSC - public joint stock company;
QMS - quality management system;
MI - methodological instructions;
STP - enterprise standard;
ND - normative documentation;
VP - internal audit (internal audit of the quality management system);
OTK - technical control department.
4 General provisions
4.1 The purpose of corrective and preventive actions is to eliminate the causes of detected and potential nonconformities, ensuring continuous improvement of the effectiveness of processes and the quality management system.
4.2 Corrective and preventive actions are planned and taken for products, processes and procedures to achieve the satisfaction of customers and other interested parties. The algorithm for implementing corrective and preventive actions is given in Appendix A.
4.3 Planning of preventive and corrective actions should be preceded by an analysis of the problem to assess the significance and possible consequences of the problem.
4.4 The Plan being developed may include individual works: correction, corrective actions, preventive actions or contain a combination of these works. The form of the Plan is given in Appendix B. Corrective and preventive actions may also be included in the plans of the enterprise or divisions.
4.5 Corrective and preventive actions are monitored to ensure they achieve their intended objectives.
4.6 Changes to the QMS that arise when performing corrective and preventive actions must be included in the documentation in accordance with STP SMK 4-001, STP SMK 4-006, STP SMK 7-006, STP SMK7-015.
4.7 An assessment of the results of corrective and preventive actions is included in the data for management review.
5 Corrective actions
5.1 Corrective actions are taken in all QMS processes and procedures.
5.2 Corrective actions are planned based on:
— development of regulatory and technological documentation;
- inconsistencies in technological processes;
— process measurements;
— observations during work operations;
— test reports on the quality of materials, semi-finished products, products;
— claims and wishes of consumers;
— customer satisfaction;
— information analysis;
— proposals from enterprise employees;
— reports on internal and external audits;
— results of self-assessment.
5.3 Nonconformities are recorded in processes as specified in documented procedures. Records management is carried out in accordance with STP QMS 4-005.
5.4 Corrective actions are carried out in the following sequence:
— analysis of inconsistencies (including consumer complaints);
— establishing the causes of nonconformities;
— assessing the need for action to avoid recurrence of nonconformities;
— recording the results of actions taken.
5.5 Analysis of the causes of identified nonconformities is carried out as established in the procedures individual or commission.
5.6 Units where inconsistencies are found develop an Action Plan with wording sufficient to understand the purpose of their implementation, i.e. expected result.
6 Preventive actions
6.1 Preventive actions are planned based on:
— risk analysis;
— market analysis and review;
— process measurements;
— data on the compliance and effectiveness of the processes being carried out;
— analysis of consumer needs and expectations;
— information from stakeholders (external data);
— satisfaction measurements;
— results of self-assessment.
6.2 Preventive actions are performed in the following sequence:
— identification of potential nonconformities and their causes;
— determination and implementation of necessary actions;
— recording the results of actions taken;
— analysis of preventive actions taken.
6.3 Preventive actions related to the future of the enterprise, with the determination of development priorities and requiring significant costs and time, are planned on a systematic basis and included in the enterprise plan - Tekhpromfinplan, plan technical development (Technical plan PJSC "Company").
6.4 The formation of Plans is carried out annually by orders of the General Director.
7 Responsibilities and powers
7.1 Responsibility and corresponding authority for organizing work to carry out corrective and preventive actions in the QMS and assessing their effectiveness rests with the management representative in the field of enterprise quality.
7.2 Responsibility for organizing work on analyzing nonconformities, planning and implementing corrective and preventive actions in processes, procedures, monitoring and analyzing the results of corrective and preventive actions is assigned to the head of the relevant department or the owner of the process.
7.3 If corrective and preventive actions are carried out by several departments, responsibility for organizing the work rests with the head of the department (process) in which the nonconformity was identified
8 Related documents
8.1 All documents on corrective and preventive actions are stored in the Quality Control Department and with the head of the department (process);
8.2 The storage period for records under this procedure is at least 5 years.
9 Procedure for making changes
9.1 The procedure for making changes to this standard is regulated by MI SMK 4-001.
Head of Quality Control Department
Leading QMS Engineer
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