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Quality systems development: where to start? Such a project has two main objectives: obtain an ISO 9001 certificate or put the organisation’s processes in order. The purpose of quality system development affects the consultancy project, so we will cover quality system development projects in two different articles. We will start with the first objective – […]

QMS training is carried out at our company both as part of a consulting project and separately. Although IATF 16949, ISO 9001, ISO 13485 quality management system standards do not require mandatory training of specialists in external organisations, in practice such a need often arises. A trained specialist or group of specialists develop the quality […]

“QMS records” as a term has disappeared from ISO 9001 but has remained in ISO 9000. Many companies continue to use this term, especially as records’ management as a procedure and term has been left in other standards with management system requirements. The photo to the article is a correction of the quality control record. […]

The quality management system is accompanied by the QMS documentation. Even though ISO 9001 standard in 2015 refused a large amount of mandatory documentation, every organisation communicates and exists with documents. In this article, we will look at what is meant by “QMS documentation” and, accordingly, what document structure to identify. This will help to manage […]

The FIFO principle, the FEFO principle, are the basic requirements of a quality management system. The principles FIFO (First In, First Out) FEFO (First Expiry, First Out) are often applied in the management system to determine the order of release and operation of materials, shipment of finished products. The application of these principles is often […]

Identification of measuring instruments – for what purpose? There are several purposes here, and they depend on the content of the identification of the measuring instrument. A measuring instrument may be identified by: by its calibration status (as in the photo) by its marking, number Variant 1 By means of the identification of a measuring instrument […]

Despite the presence or absence of ISO 9001, ISO 45001, IATF 16949 and many others certificates in the company, despite the pandemic, customer audits not only continue to be carried out, but the number of customer audits is also growing. What is the reason for it? In our opinion, a consumer audit is carried out […]

QMS costs are important. The article “QMS implementation. QMS cost.” is not about how to buy a certificate, how to develop a quality management system quickly. The article is about our experience of working in enterprises, with consultants and already as consultants. I am sure that if you rationally approach the implementation of quality management […]

Implementation of a management system is our daily task. When we were developing a service for the implementation of a management system for our customers, we first of all asked ourselves the question: What should be the management system so that it is suitable for all interested parties (primarily for the organization itself, its customers, […]

Technical audit provision is one of the services provided by OREX experts. We conduct technical audits to prepare organizations for their audit or as auditors on behalf of manufacturing organizations. A technical audit is an audit that assesses the quality management system, production processes, the state of infrastructure, workplaces, as well as the technological capabilities […]

Our company has been successfully providing management systems training for a long time. We provide a wide variety of management trainings to meet the needs of our customers. In most cases, our customers, before ordering training with us, talk about previous negative experiences. It is not an ideal option, but a forced one, when we […]

The QMS ISO 9001 project during the pandemic time It is a pleasure to receive feedback from customers, especially when the ISO 9001 QMS implementation project was carried out in a pandemic environment for which no one was prepared. Informal and formal feedback, just after the completion of the project and especially some time later, […]

— Is IATF 16949 training required by IATF standard? —Yes, because competent specialists are required to carry out activities such as risk analysis, supplier audits. — Who should train staff when implementing a quality management system? — IATF 16949:2016 standard does not prescribe that training should be carried out by a third party or by […]

Business process audit What is a business process audit? What for? Business process audit is profitable. 1. Audit of processes gives a clear answer a. what is the actual result of the business process, b. how much better or worse this result is than other organizations in the industry c. how much better or worse […]

Talent acquisition is the main process in the management system .  Not only in the future. Not only for IT companies. But now for everyone. The talented staff develops the best products, talented sellers sell to the best target groups, and the talented production staff works without the human factor. Therefore, I always recommend to […]

An interesting point in management system. Do you know the most popular answer I get to the question: “How did you manage this deviation?” – “IT WAS NOT EXACTLY A DEVIATION!” What then does this regulation, this maintenance program, this technological parameter, this label … mean, if “everythink is also possible” In any case, when […]

VDA 6.3 is an excellent tool for process audits within the automotive industry acting as a guideline for performing audits. VDA 6.3 defines a process based audit standard for evaluating and improving controls in a manufacturing organization’s processes. The standard can be used by any organization, either for internal process audits, or for evaluating potential […]

Reprocessing is a frequent case in the production for different branches. For quality management system, this process is a risky process, since it is not a standard process. We defined areas that you should think about in advance to manage risks of reprocessing: ➡️ The reprocessing method should be documented, including, if necessary, environmental requirements, labeling, […]

We live in a time when cameras are installed everywhere: on roads, in front of entrances, in production facilities (and here not only in workshops, but also in dining rooms, for example). Many managers told me about the positive effect after installing the cameras: staff productivity has increased due to control of “breaks”. Moreover, such […]

VDA 6.3 is an excellent tool for process audits within the automotive industry acting as a guideline for performing audits. VDA 6.3 defines a process based audit standard for evaluating and improving management in a manufacturing organization’s processes. The standard can be used by any organization, either for internal process audits, or for evaluating potential […]

When choosing any product, the first thing we see and evaluate is its appearance. Therefore, for manufacturers struggling for customer satisfaction it is very important to know how their product is visually evaluated by the customer and only then by its function and taste properties. Why visual control is considered to be the most difficult […]

Turned upside down. The worldwide best practices in management systems tells us to have change management procedure in order to implement actions in two areas (as per the rules of psychology, we start with positive factors!): increase the positive impact of changes. For example, we have a production of disposable sheets, which we can quickly […]

Once again time to “reboot”. Time to train the team on necessary changes in the organization’s goals and processes. Online training is an effective and cost-effective method of involving staff and take the right decisions, which has a number of advantages:   no travel costs and related expenses for the organization of the training optimal […]

My first online consultation experience is done. There are some positive aspects: Online consultations are very good for planning in schedules of many managers. It is much easier to agree on a timeline! Since distance interviews are very clearly planned regarding questions,  documents for analysis, necessary personnel, time is used efficiently, the time loss for […]

An interesting case happened 2 weeks ago. I evaluated the final readiness for the certification audit of the quality management system according to ISO 9001, analyzed the compliance with the requirements of the standard for corrective actions. The customer demonstrated a table with monitoring the implementation of corrective actions, the column “effectiveness” was not filled. […]

Very often I come across a substitution of the meaning of this requirement of ISO9001, IATF16949. The staff involved in the quality management issues focuses on the availability of a descriptive document (actual example in the photo). Given the fact that the input data block in international standards has expanded significantly, more and more voluminous […]

An audit is always an experience, an opportunity to find out the requirements of a client or supervisory authorities, to receive an external assessment from an experienced expert. Of course, the audit needs to show the organization and system in the best possible way, which means that it is necessary to prepare for the audit. […]

Visual Control How do you act with the rule the visual characteristics of a product or component must meet the criteria of a previous order? To cases when there are no layouts or visual standards? More details during our training for Visual Control Please apply for webinar: orexconsulting@gmail.com

AIAG & VDA FMEA Handbook ➡️FMEA stands for Failure Modes and Effects Analysis ➡️FMEA is the most commonly used risk analysis method in the automotive industry but not only ➡️Handbook provides direction to all automotive suppliers, including real-world best practices. New training for a new 7-Step approach for FMEA development, for understanding the new methodology.

An interesting point in management system. Do you know the most popular answer I get to the question: “How did you manage this deviation?” – “IT WAS NOT EXACTLY A DEVIATION!” What then does this regulation, this maintenance program, this technological parameter, this label … mean, if “everythink is also possible”.  In any case, when […]

Whenever possible, each leader ensures that the organization doesn’t have personnel with unique competence. The need for such conditions and actions is documented in the requirements block  knowledge management in ISO9001, IATF16949. At the beginning of this process, as in other areas, understanding is required, ✔️which staff ✔️ with what unique knowledge is available and […]

A new start, new trainings in the new year Trainings in full-time and distance format: ✔️ Quality management acc. ISO9001, IATF16949 ✔️ Quality management for top management and business owners ✔️ Quality management tools SPC , MSA , FMEA , PPAP , APQP ✔️ Problem solving 8D, A3 ✔️ Audit – Internal audit acc. ISO19011, Supplier audit, […]