Introduction
Quality audits give organizations confidence in the effectiveness of their quality management system and its ability to meet customer requirements. Similarly, organizations can access the obtaining of quality management certificates through a quality audit process carried out by a certifying entity.
Quality audits are those in which the effectiveness of the organization's quality management system is evaluated.
A quality audit allows evaluating the degree of compliance with the requirements defined in the quality manual, in the procedures manual and in the adopted standard, to detect those areas or activities that do not meet the established criteria and if these provisions are carried out. carried out effectively and are adequate to achieve the established objectives.
The audit is a tool that determines the effectiveness of the actions established to achieve the quality objectives, evaluating whether it is necessary to introduce improvements in the actions.
Quality audits play a major role motivated by the boost that certification has acquired in recent years. This has led to the development of standards on the methodology of quality audits, such as ISO 19011- Guidelines for the audit of quality and / or environmental management systems, from the International Organization for Standardization (ISO). in addition to the requirement to carry out internal audits of the quality management system, established in ISO 9001-Quality management systems.
Development
The ISO 9000 vocabulary standard defines quality auditing as "a systematic, independent and documented process to obtain audit evidence (records, statements of fact or any other information) and evaluate them objectively in order to determine the extent in which the audit criteria are fulfilled (set of policies, procedures or requirements used as reference) ». It is a methodical examination that is carried out to determine if the activities and results related to quality satisfy the previously established provisions and that they are actually carried out, in addition to verifying that they are adequate to achieve the proposed objectives. One of the most common classifications that is usually made of audits, is the one that differentiates between internal and external:
- Internal or first-party audit: it is carried out by members of the organization itself or by other people acting on its behalf, for internal purposes. They provide information for management and for corrective, preventive or improvement actions. External or second-party audit: it is carried out by the organization's clients or by other people acting on its behalf, when there is a contract. Provide confidence to the customer in the supplying organization External or third party audit: performed by competent certification organizations to obtain the certification of the quality management system. They provide confidence to the potential clients of the organization.
In an audit, “non-conformities” are detected, that is, discrepancies between what is required by the Reference Standard and defined in the Quality Manual and accompanying documents, or between these and the way of operating in reality. Like any tool, we have to make good use of the audit. We should not use it to find errors, blame people, departments… to investigate problems. If we make good use of them, we should not fear them as they really are the best means we have to verify that the company is carrying out the work as established.
An important aspect is that auditing is not synonymous with inspection, or supervision, which are carried out with the sole purpose of controlling a process or verifying the conformity of a product. Therefore, one of its specific objectives is to assess whether improvements need to be made, since the detection of deficiency allows us to correct and adapt the quality system, and move towards continuous improvement in our company.
This is the differential feature, because it is about detecting failures in the effectiveness of the company's actions when it comes to achieving quality objectives.
Thus, audits allow us to know to what degree the defined requirements are met, being able to detect areas that fail at some point in the process. It is a function of internal audit to assist members of the organization in the effective fulfillment of their responsibilities.
Any organization needs to carry out internal audits:
- To verify that the quality system is in place and continuously meet the specified requirements. To establish the effectiveness and efficiency of the system in achieving the established quality objectives. To give confidence to the clients of the organization that the It has a self-assessment tool that ensures that the quality characteristics of its processes, products / services are achieved. To facilitate registration in an organization's quality system registry with reference to an international standard. To comply to what is indicated by the requirements of international contractual norms in its relations with clients.
As regards internal audits, that is, those carried out in accordance with the company's procedures, either by duly qualified personnel, or by an external entity, the UNE EN-ISO 9001- standard.
Quality management systems, establishes that the organization must carry them out at planned intervals to determine if the quality management system, on the one hand, is in accordance with the planned provisions, with the requirements of the standard and with the requirements of the system established by the organization; and on the other hand, if it has been effectively implemented and maintained. In this way, the company that implements an ISO 9000 quality system is required to carry out internal quality audits.
The internal audits of the system must be carried out continuously, systematically, planned and scheduled; and they are carried out by duly trained internal auditors who must meet as a basic principle that of their independence. The reason auditors should not audit their own work is because people who are constantly performing a task know it so well that they can overlook things they have never thought of and that a third party can better detect and On the other hand, their involvement may prevent them from objectively weighing.
They are not surprise visits, each area or activity to be audited is duly notified, establishing the date and scope of the audit. The frequency depends on the activities and their importance.
The concepts to verify in an audit are (among others):
- That the procedures are in the place of application. That the procedures are appropriate to the function. That the personnel are properly trained in the corresponding procedures. That what has been done is according to what is documented.
Internal audits allow company managers (general manager, production manager, department managers,…) to discuss with their collaborators the situation of quality management at any given time, each in their area of competence, to verify the conformity of this situation with the foreseen provisions and adapting the entire management device to the real needs to achieve the established objectives. The audit report will be agreed with the person in charge of the audited area and its collaborators so that there is a collective recognition of the situation and an acceptance of the necessary corrective measures.The Directorate responsible for the area being audited must ensure that actions are taken without undue delay to eliminate the detected non-conformities (if applicable) and their causes. Follow-up activities should include verification of actions taken and reporting of verification results.
At the conclusion of the Internal Audit, the corrective actions must be documented, in addition to indicating that it is addressed to senior management for its evaluation, as well as the taking of corrective actions. They are indispensable for the reviews and evaluations that the company management must carry out periodically.
Internal audits and their follow-up activities constitute quality records, so it should be established who is responsible for their archiving and preservation.
In addition to routine audits, carried out in accordance with the program approved by management, others may be carried out due to changes in the organization, observed deficiencies, customer complaints, etc.
The start and frequency of quality audits are set by the auditor with the auditee based on:
- Initial evaluation of a supplier to establish contractual relationships Verification, during contractual relationship, that the supplier's quality system meets the specified requirements and is in place Internal verification that the quality system meets the specified requirements and is implementing changes in the quality system or that may be affected by the results of previous audits, monitoring or renewal of certification.
Types of audits:
Within internal audits, we can distinguish two basic types: System Audits that correspond to checks on the Quality System itself, affecting its establishment and implementation. Product audits that correspond to the verification that the products or services comply with the required requirements, stressing the effectiveness of the system to achieve it.
System audits:
The System Audits try not only to reveal the existence of a correct documented quality system, but also that this system is known by the entire organization and not only by the quality organization, and that it is also complied with. There are thus two fundamental aspects to audit:
- The documentary existence of the system (Quality Manual and Procedures Manual). The actual implementation of said documentary system at all levels from the highest (managers, directors), to the lowest (employees and operators).
Quality policy audit:
The quality policy must be documented in the Quality Manual. This quality policy must cover both the company's strategy policy and the functional quality policy or policy of each establishment. The objectives to be achieved must be established, as well as the system for measuring their degree of completion, as well as their periodic modification.
Organization audit:
The roles and responsibilities of all levels and people must be clearly defined in the Quality Manual as well as the authority in decision-making, especially in those that may be directly linked to quality, with a specific section dedicated to quality organization. Who can modify a decision made, and based on what they can do. As possible revocation documents are collected according to the established hierarchy. How many people can decide on the same issue. All of these issues have to be clearly defined and documented.
Documentary system audit:
This audit consists of verifying that the documents collected in the Quality Manual are duly completed and filed by the responsible persons or entities. Documentary proof is necessary to check the goodness of the system. In most cases, the quality system fails because the documents that appear to support it are not well designed, cumbersome, or hardly understandable for those who have to fill them out or the information they intend to collect is scarce or superfluous.
Process Audit:
Its purpose is to assess the effectiveness of the quality system by verifying that the processes and work development in the different sections or services comply with the specified procedures, and especially the knowledge and awareness, especially of the responsible managers., are the correct ones to achieve optimum quality.
Product Audits:
Product audits are intended to verify that the products are in compliance with the technical documentation (drawings, specifications, standards, legal provisions, etc.), so that apart from the required technical documentation itself, the means of measurement and Necessary test to check the products.
Product Quality Evolution Audit:
With this audit, the Product Quality Note is collected for each section or phase of the production process, for example, Mechanization, Assembly, Painting, Packaging, etc. This Quality Note is established based on the defects detected in each inspected section or service, understanding that said inspection is carried out on the product, and with the technical documentation that said product affects in the phase it is in.
Product Quality Assessment Audit:
This audit consists of withdrawing, after final control or once they have entered the warehouse, a number of products from those arranged for shipment to the customer. The number of products to be removed from the same reference will depend on the number of equipment manufactured, and given that, in general, carrying out all the controls and tests is usually destructive, it must correspond to a very limited number of units.
Stages of the audits:
Every audit consists of the following stages:
Planning, understanding as such the choice of the type of audits to be carried out, the documenting of the procedures for carrying them out, understanding that in the case of conducting a product audit, it is necessary to schedule measurements and tests based on of the testing plans and standards, the election of the audit staff that may be unique, or different depending on the type of audit to be carried out, and the setting of its periodicity (monthly, annual,…). Sometimes it is convenient to assign a single person to plan and direct the conduct of all audits, that is, to appoint a leader who has the best characteristics in terms of training and character, to carry out this task.
Carrying out audits according to defined procedure and plan. It is convenient for the personnel to be audited to know this fact in advance, and the best from a practical point of view is that the audits are carried out systematically, and the director or person in charge of the area to be audited transmit the affected subordinates the specific dates in which these systematic audits are going to be carried out so that they give their greatest collaboration. Possibly if this system is followed, when those responsible receive this communication, they will try to instill in their subordinates the need for everything to be "in perfect condition" as was said in the past, which could initially alter the results, but if the audits they are periodic, this will stop happening,However, the fact that the person in charge communicates the dates of completion to his subordinates, as well as the recommendation that they provide their maximum collaboration, gives audits a prominent and important role within the system. The documents that collect the results of the audits, that is, responses, checks, results of measurements and tests, etc., must be agreed between the auditor and the auditee, in such a way that they reflect the conformity of both, avoiding useless discussions. It is about auditing the effectiveness of the system, both through the system itself and its degree of compliance, as well as through the quality of the product obtained, which is why it is necessary, in order to establish corrective actions, to determine the degree of compliance with the system, and its relation to the quality of the final product.If the purpose of establishing a quality system is to obtain a quality product, it is absolutely necessary to verify its effectiveness, but if this objective is achieved, it is necessary to change the system, and to discuss or prosecute the people who apply it.
Evaluation of the audit results. All audits must be carried out to obtain a final grade that serves, even if only comparatively, to measure the evolution, both of the implementation of the system and of the quality of the product. What is intended is to obtain a totally objective assessment, so the assessment system must be agreed, and also experienced for a certain time, in order to set the warning signs, weighting indices, etc.
Drafting of a report and proposal of corrective measures, if deemed necessary, expressing its degree of urgency. Once the audit has been assessed and before the final report is drafted and the corrective measures are proposed, it is advisable to meet with the director or the person most responsible for the audit to be the first person to be informed and may even collaborate in the proposal of corrective measures. as well as in the decision on the urgency of the same, since it is convenient that both the audit report and the proposal for corrective measures, assume it as their own, among other things because sometimes, it may exert more pressure on Management than the auditor himself, especially if any of the proposed measures correspond or require investments.
conclusion
In this work we were able to see that quality audits are a very powerful tool to evaluate the results of the quality systems implemented in our organization because they adhere to ISO standards and therefore provide clients with peace of mind and confidence about the Acquired products as they meet the quality requirements established by said standards, the different types of audits that exist and when they should be implemented were also shown, so we must make a thorough study to know which one adapts to each organization.
