• 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 – establishing a quality system for the purposes of ISO 9001 certification.

Quality management system development begins with the first step – understanding

which requirements

we need to consider when implementing a QMS in the organisation.  These requirements include:

• the requirements of ISO 9001 itself. In this part, on the one hand, it is simple, ISO 9001 is publicly available and can be read and studied. On the other hand, the standard without any explanations can be completely incomprehensible (that is why we invite all our customers to take online quality training with OREX Pro);
• the requirements of legislative, regulatory and statutory documents. The absence of legal violations is a prerequisite for certification, so at the start of a consultation project, we identify all the applicable requirements for the organisation’s activities, for issuing permits and licences to it. And while licences and permits are more or less clear, other applicable regulations can raise questions. What are these requirements? A very wide range of legal and regulatory documentation applies here: from the Labour Code, laws and industry standards, standards for products and/or testing.
• customer requirements. Here as well, everything seems logical: the development of quality systems is oriented to the main stakeholder of the organisation – our customers. Targeted deception of requirements and expectations of wishes is not acceptable. Where can the customer’s requirements be found? For example, in contracts, in quality agreements and in market research. This analysis also reveals the expectations of our customers;
• requirements of the parent company, management company, holding company, if the organisation does not operate as a separate entity.

After identification of each and every requirement, we are able to understand the scope of the audit criteria compliance with which we need to demonstrate at the certification audit, and we carry out the next step:

almost a certification audit, usually called a diagnostic audit of the quality system (in our description of services on the website it is named that way) for compliance with

all of the above identified requirements.

Development of quality systems must lead to ISO 9001 certificate, so regardless of complaints statistics; of recent “just the day before” inspections by fire inspectors, Rostechnadzor; of a positive client audit two months ago – we repeat a full, detailed, thorough diagnostic audit. The result of the audit may be the expected one, or it may be the exact opposite of what was expected. In the practice of OREX:

• spoilage of products, uncatalogued products in the warehouse with a positive inventory result from the previous month have been found;
• delivery of products from the warehouse to addresses other than those shown on the consignment note;
• delays in meeting contractual deadlines;
• frequent equipment breakdowns hidden under “unscheduled” maintenance and much more.

Development of quality systems will be completely dependent on the results of this first audit, which will lead to an Action Plan on the way to the goal. It may be unexpected, whatever it may be, but then the audit will be a success, as in our chat in the photo to the post.

To be continued…

Development of quality systems with OREX?

Of course, go ahead and order!

expert@orexpro.com

Сообщение Quality systems development появились сначала на OrexPro - business desigions.

We provide QMS training:

• for a group of employees. For top management, for middle management, for the working group. The purpose of group training is often to transfer knowledge and examples of how to implement the requirements of international standards in order to develop a consensus, then agree on a process model, principles for dealing with risks, non-conformities and so on.
• individually. Individual QMS training (the photo in the post shows a feedback on QMS training that we received exactly from individual training) is a rather new service in our company. It’s new not because we didn’t want to do such one-on-one coaching sessions with a trainee before, but because we haven’t received such requests before. The cost of training for a group and for individual training according to our principles of service calculation is almost the same, so customers considered it appropriate to increase the number of trainees when ordering QMS training. However, as our first five projects have shown, this individual approach is still highly reasonable when knowledge and skills are needed by one specialist rather than a group.

The benefits that individual QMS training demonstrates:

1. Individual previous experience is taken into account, as well as the pace of material learning.
2. Individual wishes regarding the schedule of the training are taken into account. All our QMS trainings with one participant so far have been conducted in short sessions of 2-3 hours over the course of several weeks.
3. There are no participants in the training who were invited “just to pile them on” and who did not particularly understand how they could apply this knowledge later in their everyday work.
4. The training method for one participant is a dialogue-explanation, definitely not a lecture.

Therefore, we will definitely continue to implement such QMS training, especially taking into account that all the feedback from our customers is very positive and motivates us to develop and improve this training format.

Read more about our ISO 9001 training on our website.

Your consultant

expert@orexpro.com

Сообщение QMS Training появились сначала на OrexPro - business desigions.

The photo to the article is a correction of the quality control record. The QMS record is crossed out and corrected to the new one. The signature of the person who made the correction is placed next to it. This correction is in line with the requirements of ISO 9001, as

• it is a “deliberate change”;
• the original, initial corrected version is visible;
• the person who made the change is indicated. So there is someone to ask in case of disputes with the data and its corrections.

If you consider that the employee who made the adjustment will leave the company, it is advisable to enter the regulations and next to the corrector’s name to put:

• an indication of the reason why the change has been made.

All of the above 4 points constitute the requirements for correcting handwritten records. The QMS record in electronic form shall be corrected in two ways:

• by overwriting the information. And then the history of changes can only be recovered by having a backup system in place for long periods of time
• by saving the modified information in a new version of the file. This option retains the ability to see the previous version without having to restore the files from the archive. Correcting a QMS record in a file under a different name is therefore a priority method for historically significant records in the quality management system.

These may include:

• approvals of terms of reference and contracts;
• quality control records;
• records of tests and new product development plans relating to changes in development inputs.

This would seem to be a minor issue in QMS, but can be very troublesome in the absence of clear rules for making changes to QMS records.

More examples and information on our QMS Training.

More free material in our article on QMS documentation.

expert@orexpro.rom

Сообщение QMS records появились сначала на OrexPro - business desigions.

The very definition of “QMS Documentation” sounds very strange, as we always talk about a management system. In other words, dividing the documents in the company’s application into

QMS documentation and

NON-QMS documentation

is not correct. We will consider all documents with reference to the requirements of the quality management system and define documentation management for each type of document.

Structure of QMS documentation

The structure of QMS documentation is usually represented by the following groups of regulatory documents and responsibilities:

• Top-level documents that regulate the procedures, processes and interactions of a wide range of company actors. The following document names are used here: Organisational Standard, Standard Operating Procedure, Regulations, Provision. Responsibility for QMS documentation management at this level rests with the quality manager.
• HR documents. This group includes job descriptions, regulations of subdivisions, temporary work regulations, staff schedules, organizational structure, orders, etc. HR documents are managed by the HR Department
• OH&S documentation, fire safety documentation. This group of documentation is of interest not only to the organisation’s QMS but also to external auditors. Documentation in this part is managed by a responsible employee or OH&S department.
• Process documentation, design and engineering documentation. Documentation is maintained by the relevant service.
• Quality control documentation. This includes sampling procedures, production control programmes, test methods, instructions for the preparation of test equipment. This block of QMS documentation is managed by the person responsible for quality control.

The departments also have in use:

• Records (documents reflecting evidence of activities carried out)
• External regulatory documents, statutory and legislative acts (EN standards, external Specifications, Construction Rules and Regulations, MD, ISO standards, Laws, Ministerial Orders, Government Decrees, Labor Code, etc.)

It is logical to assign the management of this group of documents to the department which:

• Creates, and therefore accumulates records
• Uses external documents, and therefore ensures that the organisation monitors the relevance and availability of regulations.

Using these structure guidelines, the management of the documentation can then be easily established. The rules will be divided into uniform requirements for documents and records, as well as defining special cases for the management of one type of document or another.

expert@orexpro.com

Сообщение QMS documentation. Structure of QMS documentation появились сначала на OrexPro - business desigions.

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 a consequence of the need for:

• inventory turnover due to shelf life and warranty periods
• management of balances of work in progress, semi-products.

The FIFO principle in relation to the purposes of application is presented in detail in our article:

For more information, see the section Warehouses, website www.be-expert.ru

Common methods to help apply the FIFO principle in life are

• barcoding system
• identification tags
• physical movement of batches of product.

The most common practice is the application of identification tags. The FIFO principle is then implemented by the performers by visual information. However, even in tags errors can occur.

Example 1. A tag with the general wording “To be used first” (as we have in the photo to this article). However, when it comes to inventory turnover and limited shelf life, you should know UNTIL which date the product can be used. If the “first call” for a component never comes, the tag will carry the wrong information.

Example 2. A tag stating “Date of manufacture: XXX”. This approach is applicable if there is not much variety in the expiry dates. For example, all products manufactured by the company have a shelf life of 24 months. However, there would be confusion amongst the staff if there are different expiry dates for different types of products.

An example of a procedure for inventory turnover management can be obtained during our online training on ISO 9001.

expert@orexpro.com

Сообщение FIFO, FEFO principle появились сначала на OrexPro - business desigions.

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:

1. by its calibration status (as in the photo)
2. by its marking, number

Variant 1

By means of the identification of a measuring instrument (MI) the user will always have a transparent overview on the serviceability of the used measuring instrument.

Variants 1 and 2

Information on identification is often required for traceability of measurements. The various reports should include information on which equipment the measurement was carried out (specify number) and what calibration status the MI had.

Identification of measuring instruments – in which processes?

There are usually a number of departments in the production plants which have measuring instruments in operation. It is reasonable to identify those that are used for:

• monitoring of the conduct of the technological process
• control of components (raw materials), control during the production process, control of finished products. Such measuring instruments will be available in production and quality control.
• monitoring of environmental parameters (temperature, humidity) in cases where these parameters are critical to maintain or achieve product conformity. Identification of measuring instruments is applied to hygrometers, thermometers, psychrometers in storage areas.

How to apply identification?

The answer is simple – in a way to fulfil the objective. In other words, the identification must be clear and visible to the staff in charge of the measurement. An additional aspect: as applying identification is also an “intervention” in the equipment, it should be applied without risk of changing the characteristics of the measuring instrument (e.g. not taping the buttons, not applying the identification tag to the weighbridge, etc.). And it is also recommended that such identification should last until the time of its replacement by a new one, until the next calibration period.

And one more interesting point in the identification of the measuring instrument.

What is more important: to specify the last date of verification or calibration or the date of subsequent calibration? To be objective, true information that a measuring instrument is valid is only contained in the date of the last calibration. Based on risk analysis and regulatory requirements, it is possible to assess which calibration interval is the most appropriate.

Learn more about process interactions and risk management in our training on the requirements of ISO 9001, IATF 16949.

expert@orexpro.com

Сообщение Identification of measuring instruments появились сначала на OrexPro - business desigions.

What is the reason for it?

In our opinion, a consumer audit is carried out for 3 main reasons:

What is the purpose of a customer audit?

1. Make a decision in favor of future cooperation or non-cooperation
2. Conduct a planned assessment of the current supplier
3. Analyse together the causes of defects, delivery delays, poor quality of service, etc.
4. Assess the supplier’s capabilities for a future project.

As you can see from the listed goals, consumer audit for a company is a serious business, possibly with consequences. Therefore, for those companies that care about the results of a consumer audit, it is very important to thoroughly prepare for the audit.

Preparation for a customer audit – what does it mean?

The good news is that every company has a management system that most likely works well. The customer does not go to the hopeless suppliers with an audit, and the customer audit is not the first stage, but rather the final stage in the supplier’s assessment.

The bad news is that almost all management system practices take time to “catch on”. It will not be possible to adequately introduce quality management methods in a couple of weeks, unless the audit of the customer is carried out by a completely inexperienced auditor.

In this regard, the concept of preparation for a customer audit depends on three factors:

• the scope of customer requirements that will be verified in the audit
• how much time the company has to prepare for a customer audit
• the initial state of the company’s management system

What should the preparation for a consumer audit be started with?

1. Find out what the consumer representative will audit.
2. Insistently request that a customer audit date be agreed in advance.

Customer requirements can be contained in a Quality Agreement, very often in a checklist. An example of an excerpt from a customer audit checklist is given below:

Priorities in preparing for a customer audit

• If the audit of the customer is coming very soon, and you can’t shift it any way, then you should concentrate on the following topics:

1. order in production and storage areas
2. identification and isolation of nonconforming components, finished products
3. records of inspection / testing in the entire chain of product creation (incoming control, interoperational inspection, inspection of finished products)
4. technological and control instructions
5. well organized handling of complaints and claims from consumers
6. well organized handling of consumer orders: registration of orders, production planning, communication about order details
7. observation of the main rules of labor protection (PPE, order with fire extinguishers and emergency exits)

• The customer audit usually considers conformity with the second priority:

1. availability of documented processes of the quality management system (documentation management, internal audits, improvement process)
2. availability of a well-organized and traceable waste management process
3. an established process of service and maintenance of equipment
4. personnel competence management

• The last block is the development and operational implementation of those processes that do not exist in the company at the present time. Such frequent processes are management processes and analytical processes (they are emphasized in the latest revisions of the QMS standards: ISO 9001, IATF 16949, ISO 13485). In the practice of OREX, such processes are:

1. change management
2. management of outsourcing processes
3. continuous improvement process
4. risk management
5. knowledge management

It is in this order that OREX prepares its customers for a customer audit. As a result of such cooperation, we always achieve results.

If you have to undergo a consumer audit or, on the contrary, develop a system for monitoring suppliers using audits, then contact our company. We have a huge experience (please read the review!) and our own know-how.

LLC OREX

expert@orexpro.com

Сообщение Customer audit появились сначала на OrexPro - business desigions.

How QMS is usually implemented

In the usual “menu”:

• many attempts to start implementing the QMS by own means. It did not work, because there is no time, urgent tasks for the main functionality constantly appear.
• attempts to contract specialists from third-party organizations, who all turned out to be strange, provoked resistance from the staff. In fact, nothing happened.
• attempts to hire a specialist who carried out the implementation and maintenance of the QMS, the meaning of whose work no one understood. Periodically, the rate of a QMS specialist is reduced during periods of crises, isolation, and then a new one is hired again, everything is repeated in a circle.

The time is wasted, not a single employee in the company wants to hear about the implementation of the QMS.

Further we will consider working and economically viable approaches to the implementation and cost of a QMS for an organization.

What does it mean to rationally calculate the cost of QMS?

Rational calculation of the QMS cost means:

• take into account all expenses, that means, to know what it means to implement the QMS and maintain it. The implementation of the QMS is not only the cost of creating documentation, certification costs. For example, actions may be required to improve or change the infrastructure (organization of jobs, redistribution of flows, etc.).
• calculate the cost of the QMS and its payback.

Let us take an example of a typical small or medium-sized business that requires an ISO 9001-2015 certification. The announced cost of the QMS:

• 8,000.00 – 10,000.00 Euros for the QMS implementation project,
• an additional specialist in the staff with a salary of 1,000.00 Euros. The cost of wages for this specialist, excluding his training, maintenance of the workplace, will amount to more than 1 million rubles per year.

The question is, whether

the costs of implementing the QMS for 10,000.00 rubles and the QMS costs per year over 20,000.00 Euros pay off.

The answer to this question depends on several factors. In order to get the result from the implementation of the QMS and its payback, it is necessary

1. Analyze what a quality management system is, what resources the system will require. Not necessarily in detail, at least in general terms. Knowledge can be obtained:

• at a good training, for example, in our company OREX;
• as a result of a diagnostic audit from our experts.

The amount of resources for maintaining the quality management system will depend on the industry in which the organization operates (there are additional industry-specific tasks in the QMS, for example, drafting Quality Agreements, Quality Plans, notifying regulatory authorities, etc.), on the initial state of the management system, on the coefficient of “complexity” of the system being created, the requirements for it from all interested parties (for example, the development of processes can occur simultaneously with their automation, this is even advisable).

2. Answer the question: “What do we want from the management system, which result?” The expected result should be expressed in financial numbers.
3. Answer the question: “What are the deadlines until which we need the result from the management system?”
4. Determine the economically correct way, how to achieve the set goal, implementing the QMS, building a real and functioning system.

Below we provide working and economically viable options for quality management systems for small and medium-sized businesses. If your option is not presented among those described below, please write to us using the contacts following the link, we will provide you with an individual justification. All options are determined by a combination: the time to implement the QMS, the availability of resources (personnel), the availability of competence.

Let us begin:

If the system is needed PROMPTLY (obtaining a contract or order, or participation in a tender depends on the presentation of a functioning quality management system), but

• THERE IS NO competence, THERE ARE NO resources for the implementation of the QMS, then the effective cost of the QMS is a project with a consultant on QMS implementation, the use of an outsourced quality manager in the future.
• THERE IS NO competence, THERE IS personnel who can be entrusted with the work on the creation of a quality system, an effective model-project with a consultant for the implementation of the QMS, training of personnel in the course of a consulting project to maintain the quality management system.
• THERE IS competence, THERE ARE NO resources for the implementation of the QMS, then the effective cost of the QMS is a project with a consultant on the implementation of the QMS, further independent maintenance of the quality management system by own means (in the future, a large diversion of resources is not required).
• THERE IS competence, THERE ARE resources for the implementation of the QMS, then the right decision would be to develop and implement a quality management system independently.

If there is NO EMERGENCY for the development and implementation of a quality management system and

• THERE IS NO competence, THERE ARE NO resources for the implementation of the QMS, then the effective cost of the QMS is a project with a consultant on QMS implementation, involving an outsourced quality manager in the future.
• THERE IS NO competence, THERE ARE resources for the implementation of the QMS, then the most appropriate approach for this option would be to train the organization’s specialists in accordance with the requirements of the quality management system, monitor the implementation of the project. In our company, this model is implemented through individual QMS training for 3-4 months. See the training program in the figure below.

• THERE IS competence, THERE ARE NO resources for the implementation of the QMS, then the effective cost of the QMS is to immediately contract an outsourced quality manager, who, in a planned mode, without haste, will work through all the company’s processes in cooperation with responsible persons. This option does not require budget planning for an operational project to develop a QMS.
• THERE IS competence, THERE ARE resources for the implementation of the QMS, then the cost of the QMS will add up, as in the first option with an urgent need, from the costs of the independent implementation of the QMS in the organization.

Do you have any questions yet?

Do not hesitate to write to us!

LLC OREX

expert@orexpro.com

Сообщение QMS implementation. QMS costs появились сначала на OrexPro - business desigions.

What should be the management system so that it is suitable for all interested parties (primarily for the organization itself, its customers, the certification body)?

1. Implementation of the management system should provide specific but flexible solutions. Let us consider an example in the photo that demonstrates the entry of personnel into another zone, where personnel must change clothes and shoes (for quality management systems with hygiene requirements).

Everyone knows ready-made solutions with expensive sanitary inspection rooms, but staff can be cleaned by changing clothes in the “before” and “after” zones. For small companies, this will be a good and economical solution, while still meeting the standard for staff hygiene.

2. Implementation of the management system should involve all mid- and top-level managers and other members of the organization. Joint decision-making on the management system will provide both possible (real) and agreed approaches that will be communicated as a joint management decision to all employees.
3. The project for the implementation of a management system must be completed sometime, therefore it is very important to have a plan for the development and implementation of the management system with specific dates for the completion of each stage of the project.

The implementation of a management system implies specific activities due to the requirements of a specific standard, as well as the initial data of the organization’s management system. All activities can be divided into 4 stages:

• Planning stage

The planning stage is the most voluminous one. It covers the development of a strategy, the formation of action plans for the nearest period of time, the development of algorithms for the implementation of processes and a system of indicators, the determination of resources, the distribution of responsibilities and authorities, as well as the planning and development of other practices of management systems, such as, for example,

— risk management;

— environmental impact management;

— information security management;

— change management;

— knowledge transfer;

— improvement management.

At this stage, training in the management system usually takes place for management, for heads of departments and for employees.

The duration of the Planning stage is usually 2-3 months.

• Implementation stage

At the stage of implementation of the management system, everything invented should be introduced in the daily life of the organization. And, of course, at this stage, different points appear: both positive and negative, indicating that the developed process is not convenient, not suitable for everyday practice. Such not quite correctly planned processes manifest themselves in nonconformities, erroneous actions or even sabotage of personnel. The implementation of the management system at this stage should allow for adjustments to planned decisions to ensure a convenient and cost-effective process flow.

The next example is in our photo:

What does the example say? The staff does not use the provided locker for storing everyday clothes, an additional hanger is installed in violation of the rules at the end.

The duration of the Implementation stage is 3-4 months.

• Stage of data collection, assessment, analysis

After some time, according to the indicators planned at the first stage, it is necessary to collect data that will indicate how successful the implementation of the management system was. Not all standards specify for what period of time it is necessary to collect data, at least this will be the period planned by the organization for the implementation of the management system, that is, 3-4 months.

Important components of the stage of collection and evaluation of the data are carrying out a full cycle of internal audits of the management system, conducting in-depth analysis of the data. The next example in the photo demonstrates the positive results of the functioning of the process. All received data are within the normalized value.

• Improvement stage

The implementation of the management system ends with the root cause analysis, the appointment of improvement actions for the identified nonconformities, deviations, negative trends. That is, the data that ended up outside the plan and expectations must be corrected in the next period. For example, the data can show a large accumulation of waste, a large number of reported workplace safety incidents, a lack of signed specifications with suppliers, and much more.

Having implemented all 4 stages, the management system continues to function, but not in a test, but in an operating mode. Yes, and this is the moment when the management system can be presented for certification by a certification body.

We suggest that you familiarize yourself with another article on the topic Implementation and Cost of the management system implementation at the link

LLC OREX

expert@orexpro.com

Сообщение Implementation of a management system появились сначала на OrexPro - business desigions.

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 of the enterprise, including the qualifications of personnel and the use of outsourcing processes. Thus, conducting a technical audit:

• concentrates on technical aspects, technology, quality control and ensurance. Issues of labor protection, strategy and development, social practices are not considered
• is implemented by experts with knowledge of production processes (often in the requirements for auditors – engineering education, work experience or auditing of certain industries). Sometimes technical experts with detailed expertise in technology, inspection and testing methods are involved in a technical audit.
• considers the performance, accuracy, reproducibility of equipment results.

This type of audit is accordingly often used for audits of manufacturers of complex equipment and systems. The term “technical audit” is also used to refer to quality system audits (not social audits).

A technical audit usually ends with a decision to start cooperation, for example, to place an order for the production of equipment.

A technical audit program for an equipment manufacturer, for example, might be as follows:

1. Opening meeting
2. Presentation of the enterprise, including presentation of production equipment and capabilities
3. Presentation of work on quality assurance to the organization
4. Assessment of requirements in the following areas:

• Quality system documentation
• Organizational structure
• The state of work on the design of equipment
• Technological documentation
• Personnel qualification
• Planning
• Incoming control of materials, components
• Production
• Technical condition of the main equipment and measuring instruments
• Storage facilities
• Interaction with third-party organizations.

5. Closing meeting.

The technical audit ends with summing up, a discussion of the identified findings in the quality system of the enterprise. Since a technical audit is usually carried out for suppliers, the results of the audit can be presented for signature to the audit representative of the audited organization within the closing meeting.

The technical audit report consists of 2 parts: a description of the capabilities of the enterprise, its strengths and weaknesses, the experience of implemented projects; assessment according to the established audit criteria. A report is an often filled out audit checklist with comments and revealed nonconformities.

In response, the audited organization analyzes the root causes of nonconformities (again, a frequent requirement is to perform a root cause analysis using the 8D method), develops corrective actions and determines the deadlines and responsible persons for the implementation of corrective actions.

How to prepare for a technical audit?

• The objective is to implement and develop a quality management system, implement quality management methods. Pay special attention to priority topics such as:

• technical capabilities
• control program
• nonconformity management
• product development and change management.

• Work out traditional “weaknesses”, prepare answers and processes to the auditor’s questions on the following topics:

• qualification of personnel, personnel with unique qualifications and their replacement
• management and acceptance of the results of outsourcing processes.

 Do not hesitate to contact our company: we will conduct a technical audit, the necessary training of personnel, we will carry out the necessary preparatory measures that will make the technical audit a success. Our experience since 2005, work in international, transnational and big Russian companies allows us to guarantee successful preparation for any technical audit.

LLC OREX

expert@orexpro.com

Сообщение Technical audit появились сначала на OrexPro - business desigions.

How to choose the management systems training of the highest quality?

Opportunities, expectations for training in management systems have changed. As before, a management system training of high quality means

• the required learning outcome
• for a reasonable cost.

QMS training can be very diverse. To achieve the result of training in management systems, we carefully query the customer about this, we recommend the most optimal or correct options. For instance,

• It is illogical to study SPC, MSA quality management methods separately
• Training here is based on the initial knowledge of the requirements of international standards, according to which the internal audit is to be carried out.

The cost of training in management systems, of course, is customized. Here, as elsewhere in procurement, it is advisable to compare offers and get the result expressed in the ratio “training program – number of participants – cost”.

In addition to these two parameters, also important for management systems training are process parameters such as:

• a convenient training schedule. Now it is not always possible to participate in training during working hours, most often, especially for training managers, it is convenient to study, for example, during school hours or on weekends. OREX conducts training according to an individual agreed schedule. Our recommendation here is

 training in management systems in short sessions of 3-4 hours for several days / weeks

It is a proven fact that the effectiveness of training is highest in the first 1-2 hours, and after that, the ability to perceive information is greatly reduced. This is why we apply the second rule:

• training with examples, practical tasks, in relation to the processes and the organization of the customer

In the photo for the post and below is a photo from the corporate 5S training

After 1-2 hours of discussions, we get down to practice, “forcing” the participants to create draft decisions on the management system for their organization. The huge number of trainings and consulting projects that we have conducted help us to select examples that our customers can understand.

• individual training programs in management systems

The phrase “Individual training in management systems” may sound too annoying, but this is a process that we are especially proud of. We have eliminated the main disadvantage of training, when from the entire proposed program the participant needs only one part, or vice versa, he needs to deepen into certain topics. We determine the training program and the time for consideration of the topic together with our customers. It is very important for us that regardless of whether OREX conducts corporate training IATF 16949, individual training in FMEA quality management methods or any QMS training, each topic of the training program would be useful and could be applied in the customer management system.

If you share the principles of training described in this article, you can order training in management systems in our company.

Read our article about QMS Training, come and study with us!

expert@orexpro.com

Сообщение Management systems training появились сначала на OrexPro - business desigions.

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, will allow us to look back and remember the special moments of the quality management system implementation project.

Every project is a place of work, it is new lessons, conclusions, a new round of development. Every project is something to keep worrying about, no matter whether it was a short-term or long-term project, simple or complex. The details are of course forgotten over time, but the two main impressions remain forever, namely:

• the people you met and worked together on the project
• the best results and the failures.

An ISO 9001 consulting project is always a two-way training, for the consultant and the customer.

In this respect, comprehensive ISO 9001 QMS consultancy projects are particularly interesting because they:

• cover all company processes (and in this case, it does not matter that the financial block is not taken into account in the requirements of ISO 9001)
• make you work on improvement in a broad range of areas. There are no two identical “priority” areas in ISO 9001 consultancy
• last for a long time. It is also valuable for the consultant because it gives him time to get satisfaction from the results of his work, tips, innovations
• включают include various forms of work – from the development of documentation, workplace assessments, to clean-up days and training (Read more about ISO 9001 training)
• include consultations on strategy and new objectives for the company, i.e. it allows to visualize what the company plans to be after the ISO 9001 QMS project in the future.

The consultancy for SPECPRICEP was just that: interesting, but also out of the ordinary; for the first time there was online training on ISO 9001 requirements and internal audit, on handling and analysing non-conformities, on risk management; remote meetings, motivational briefings and much more, which allowed maintaining constant presence and supervision of the project by the consultant. The project was implemented as planned, thanks to the well-coordinated work of the entire SPECPRICEP team and the involvement of top management.

We thank SPECPRICEP for their feedback on our cooperation and wish them further prosperity and successful international orders!

Order a new management system with an OREX consultant: ISO 9001 quality management system

Сообщение Implementation of ISO 9001. Feedback from the Customer появились сначала на OrexPro - business desigions.

—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 external experts at all. The important thing here is to obtain correct, undistorted knowledge, without interpretation, which means to understand through training the meaning of the requirements of IATF 16949 as laid down by the developers of the standard. Hence there is a requirement to be trained by competent lecturers, e.g. accredited 16949 auditors or staff trained by IATF 16949 auditors. If employees with these competences are available internally, the training can also be carried out internally.

— How often should staff be trained or retrained?

— IATF 16949 does not set requirements for the frequency of training. Accordingly, a sound logic is followed: if the requirements of IATF 16949 and related management methods change and are updated (e.g. a new version of FMEA was issued some time ago), retraining should be carried out.

— How should the certificate from the IATF 16949 training look like?

— On the basis of the provisions already studied above and taking into account the applicable requirements of IATF 16949, the certificates of the training provided should retain information on the topics of the training provided, the qualifications of the lecturer who conducted the 16949 training.

— Do employees need to be retrained if they have been trained by an organisation that does not have proper evidence of competence?

— The answer to this question is complex, as it depends on several factors. In our view, the most important one is whether or not the requirements of IATF 16949 are implemented correctly in practice. If the requirements are implemented, that is half the trouble. And the issue of correct training certificates can be dealt with as part of non-urgent, planned professional development activities. If, however, the requirements are not implemented or are implemented incorrectly, then even the highest quality certificates as a result of the training will not help, i.e. will not protect against a non-conformity from the certification body or the auditors from the customer.

— Can all the necessary training be completed by OREX?

— Yes, it can. Our training programmes include all the necessary courses – the requirements of the automotive standard IATF 16949, internal audits, second-party audits, separate courses on quality management methods APQP, PPAP, SPC, MSA, FMEA, on problem solving methods, on lean manufacturing and many others. And all OREX pro lecturers have all the necessary certificates confirming the correct competence. We have been trained by VDA QMC, Bureau Veritas, TÜV SÜD. And we provide training also in English.

— What remarks do the auditors make about the IATF 16949 training process?

— Remarks can be related to the lack of adequate qualifications of the lecturer, the short duration of the training, the lack of training for all employees who are involved in the process.

Still have questions about training 16949?  Go to our page with IATF 16949 Training Services!

More material on our projects can be found at Instagram .

Write to: expert@orexpro.com

Сообщение IATF 16949 training. Questions and answers появились сначала на OrexPro - business desigions.

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 this result is than in previous periods

2. The results of the business process audit provide information,
a. what are the risks of the business process, and
b. what opportunities the process as a whole has.
Thus, the audit allows you to give an objective assessment of the strengths and weaknesses of the business process.

3. Audit provides information about the personnel involved in the process, namely:
a. how many employees and what qualifications are involved in the process
b. are there any deficiencies in competencies, unique competencies
c. whether there are duplicate or unallocated functions

4. In the field of technology or algorithm for the implementation of the process, the audit allows you to identify existing losses, and therefore ways of optimization.

The result of the audit should be the setting of a goal for improving the process, accompanied by specific KPIs, activities and responsibilities.

The process audit approach is provided by VDA 6.3.

Contact us for more information and for our training VDA 6.3!

Сообщение Business process audit появились сначала на OrexPro - business desigions.

Orex Pro experts assist to create procedures and teach best practices.
Please contact us: expert@orexpro.com

Сообщение Talent Acquisition появились сначала на OrexPro - business desigions.

– “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 deviations are happened, actions are required: either we change the rules, or we define corrective actions. And we absolutely definitely change our attitude to deviations from established rules!

Сообщение Deviation Management появились сначала на OrexPro - business desigions.

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 or existing suppliers.

Compliance to VDA6.3 is mandated by some vehicle makers and encouraged by others.
Further Information: expert@orexpro.com

Сообщение Process Audit VDA 6.3 появились сначала на OrexPro - business desigions.

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, staff qualification.
 Production records should be kept (for which batch, when, by which method and others)
 The reprocessed lot is usually subject to enhanced #control. A specific  control plan should be defined for the reprocessing process.

The photo shows a fragment of our checklist for supplier audit regarding the reprocessing.

Quality management trainings, risk management, product audits, process audits, consulting services: expert@orexpro.com

Сообщение Quality Management System and reprocessing появились сначала на OrexPro - business desigions.

Moreover, such mass control is more a Russian phenomenon than the international best practice. The best practice is to monitor the operations, robots and equipment in the production, to do careful staff monitoring.

This means in practice that:

1. There is no need for universal and equal control over each group of staff.
2. Increasing staff productivity should be decided by other methods: the correct distribution of functions and processes, the definition of clear results and deadlines for the work, the creation of optimal work places etc.
3. The process should be monitored in places where risks exist. Such areas may be:

• assembly area. This will help to avoid litigation with consumers regarding under-investment, picking errors in orders.
• points of transfer of responsibility for material values, for example, transfer of products from production to a warehouse; loading finished products into vehicles for transfer to a carrier, etc.
• machines and operator’s workstations in cases where one operator serves several machines, and constant monitoring of the machine’s work, supply of material and packaging to the line is required.

The “image” of the control process itself should become positive. You can use results of the analysis of videos of different shifts to encourage teams with the best results, speed.

To order our service – the organization of work of the quality control team and the laboratory with the best ratio of “cost-result” – please use our email address:

orexconsulting@gmail.com

Сообщение Staff control or careful monitoring over staff’s operations появились сначала на OrexPro - business desigions.

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 or existing suppliers.

Compliance with VDA 6.3 is mandated by some vehicle makers and encouraged by others.
Further information:
 orexconsulting@gmail.com
 +7 910 798 1641

Сообщение Process Audit VDA 6.3 появились сначала на OrexPro - business desigions.

Why visual control is considered to be the most difficult tool?

The human eye is one of the most complex human organs and is a unique in terms of perception of the surrounding world. As a result, the visual perception is very individual.

When we speak about inspection of visual products, we mean that the person should check the quality and compliance of the product by looking at it and evaluating its visually.

But is it possible to evaluate with the same eyes what is very individual? All complex tools require very careful adjustment, and absolutely the same applies to the eyes.

How to develop the correct visual inspection process?

• First of all, you need to make sure that the inspectors have no physical limitations (color blindness, shortsightedness, farsightedness, etc.), since such restrictions are unacceptable for a certain type of control.
• Next, check the availability of visual master samples, defect catalog, and border samples and make sure that they are used correctly and the inspection method is available.
• Special attention should be paid to the process of sample management, which is itself a very complicated process. It is necessary to identify and apply correctly such aspects as: the number of samples, storage location, storage method, storage time, identification, and staff training rules.
• The best is when the training process is organized in the way that it takes 20% as theory and 80% as practice. Training should be as close as possible to the production conditions. Special characteristics management and archiving should be included in the visual inspection training course. After the training is completed, check the effectiveness.

Finally check the correctness of visual control configuration. This can be done by using MSA method (analysis of measurement systems). MSA is the methodology to assess the performance of the inspectors, environment, inspection methods and measurement tools.

Today the importance of the visual inspection is underestimated. Many companies are” stewing in their own juice” forming the rules of visual inspection independently, without looking back at the world experience and available best practices. And what is the result? Businesses are suffering losses for years either from “excessive quality” or insufficient quality, receiving customer complaints related to visual characteristics.

Order visual inspection course by orexconsulting@gmail.com

Сообщение Visual Control появились сначала на OrexPro - business desigions.

• increase the positive impact of changes. For example, we have a production of disposable sheets, which we can quickly reorient to the production of disposable masks and provide the population with masks in conditions of increased demand, having a positive effect from the absence of production downtime and from the company’s participation in a project of national importance (as far as this situation can be called positive, of course)
• reduce the negative effects of changes. For example, we received a letter of resignation from the commercial Director. Here we can have the risks of sales drop, leaving customers, and the subsequent dismissal of other employees from commercial department, to which the organization should react in the organized way but not chaotically

In my opinion, the change management procedure is necessary and always relevant. Not because everyone is now facing unforeseen changes but as all processes are moving faster in the 21st century. Business community is constantly facing many changed in their processes, and so that it does not look like a constant “fire fighting” or “force majeure”, it is proposed to have a clear structural approach.

Excluding a lot of theory, here are the main statements and practical steps for implementation:

1. You can manage the changes that you initiated by yourself. For example, a company decides to switch to electronic document management system, and accordingly, specific actions are planned with responsible persons and deadlines in order to avoid mistakes during the transformation period.
2. It is impossible to manage changes that have already occurred in the external environment or that the company has already faced. You can and actually need to adapt to changes and “catch a fair wind” but not to “swim against the current”. All activities here will be aimed to reduce the negative consequences. An example of such external changes can be the changes in legislation.
3. The development of actions must be based on team work approach. The team should include finance specialists, sellers, buyers, technologists, and HR specialists. Consider all participants as equal and necessary. Very often, the change affects many aspects of the company. For example, the above-mentioned electronic document flow may not meet the requirements of legislation in terms of personnel records management or immediately take up all available server space, which will require additional capacity for storing and processing the information by IT.
4. It is not necessary to consider the implementation of changes only as introduction of changes to the documentation. Other areas of change may be: infrastructure (remember our new server for electronic document management?), communication with staff and their training, the changes of processes, and so on.
5. And finally, change management is always associated with risks. Ideally, the risk management procedure, describing the way of permanent external and internal environment information receiving, should be implemented in such a way that we are ready for all upcoming changes. And if the risk of change was underestimated or not detected at all, the algorithm for assigning actions should help to develop the correct response to changes.

Finally not so difficult, isn’t it?

Сообщение Change Management появились сначала на OrexPro - business desigions.

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 planning, much less time is required for training organization
• ability for parallel connection of a large number of participants without losing the results
• ability to share and see live examples online as participants can easily go live
• easy processing of test / exam results
• comfort, you can organize webinars in your “favorite” place at home, in the country, in a cafe, etc.

What needs to be done to make distance learning as effective as possible?

First, we must eliminate distractions. Sometimes it is difficult to fully immerse participants in the training topic, as they are forced to respond to questions and tasks from their colleagues/managers and family members while at work or at home.

Second, you should not include a really large number of participants. With a large audience, it is impossible to devote sufficient time to everyone, it is impossible to build individual conversations and control presence, respectively, there is a risk of episodic disappearance of some listeners.

During the webinars the practical exercises used are different and for those who have their first experience of online learning, this may seem unusual.

The main risk is the failure of the Internet or/and communication platforms. To avoid these risks and be able to react quickly to system failures it is mandatory to test the system before training start. Surely, we provide technical support for prompt feedback.

Now is again the time for business to “reboot”. Time to adjust the targets, to mobilize and train the team on necessary changes in the organization’s management and processes.

Online training is an effective and economically reasonable method of involving the 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 planning, much less time is required for training organization
• ability for parallel connection of a large number of participants without losing the results. Participants can work in parallel.
• Online web training allows to exchange the opinions using brainstorming. In face-to-face training everyone is often prevented from expressing their opinion by” activists ” who set the tone and main focus of the discussion in the first seconds after the question is raised. Good and important aspects can be lost, as such leaders try to convince everybody. As part of distance training, participants type their thoughts in the webinar chat, they do not have the opportunity to immediately get lost in other people’s ideas, since it is not possible to print and read the chat at the same time.
• ability to see and share live examples online as participants can easily go live
• easy processing of test / exam results
• comfort, you can organize webinars in your “favorite” place at home, in the country in a cafe, etc.
• comfort, you can organize webinars in your “favorite” place at home, in the country, in a cafe, etc.

What needs to be done to make distance learning as effective as possible?

First, we must eliminate distractions. Sometimes it is difficult to fully immerse participants in the training topic, as they are forced to respond to questions and tasks from their colleagues/managers and family members while at work or at home.

How to fix it? Turn off your mobiles, lock yourself in your office, keep your kids busy, and so on. We strongly do not recommend staying in the open space office to participate in online training.

Second, you should not include more participants (we mentioned this factor as an advantage above), despite the temptation. With a large audience, it is not possible to devote sufficient time to everyone, build individual conversations and conduct presence control. This approach is very similar to face-to-face training. If you gather a lot of people in a conference room and turn off the lights to demonstrate the projector presentations, you can always hear lively working discussions and snoring of individual participants in the pauses.

What to do? There are several possibilities:

• if you need to train a large number of staff, plan online training for no more than 2 hours per day
• if you need to practice with participants the application of the reviewed management practices (8D, A3 methods; quality management methods FMEA, SPC, MSA, APQP, PPAP; lean manufacturing; writing the working instructions; KPI system; risk management, and much more), then you should not plan more than 30 participants for such webinars.

During the webinar, other practical tasks are used, and for those who have their first experience of online learning, this may seem unusual, and the participants may feel themselves uninvolved.

How to prevent this?

• In advance develop and inform all participants of online training about the system of interaction with the coach. Communicate in the chat about the rules, about the reaction symbols used. For example, in the first webinar that I conducted as a lecturer, I heard nothing but silence in response to my question. It was not clear: either the participant was distracted from training, or did not know the answer. Therefore, I have introduced a rule to put a minus sign if it is not clear.
• Mandatory feedback control should be introduced every 10 to 15 minutes of training. In receiving such feedback, always use an individual approach: call for answers in the cities of presence (“What does the branch in Kaliningrad think?”), by division (“What is the main risk of the purchasing process?”) or even to call the participants by name.

The main risk is the failures of the Internet and communication platforms. To avoid these risks and be able to react quickly to system failures it is mandatory to test the system before training start as well as the presence of a technical support officer for prompt feedback.

Let’s share our experience to make online training as effective as possible. We all understand that this is a form of obtaining knowledge in the future?

Online trainings with Orexpro: orexconsulting@gmail.com

Сообщение Online training появились сначала на OrexPro - business desigions.

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 searching an employee or a document is excluded as much as possible.
• The discussion is more polite, online discussions don’t allow speaking at the same time, interrupt the interlocutor.
• Sometimes the staff forgets to turn off the microphone and you can hear real opinions, doubts, objections, which are not always expressed directly.

Of the minuses:

• It is more difficult to analyze documents.
• It is harder to convince, motivate, as there is no direct personal contact with participants.
• Sitting in front of a computer is difficult, you need to move, to do some kind of exercises.

This is a very interesting and useful experience, the first step to the forms of consultation of the future.

Thanks to all the customers!

Please contact us at orexconsulting@gmail.com for online consulting!

Сообщение Online Consulting появились сначала на OrexPro - business desigions.

To my question about the reasons, I got the question from quality responsible person back: “And how can I evaluate the effectiveness from developing a job description?”

It was not immediately clear what was the reason for misunderstanding. When we figured out, several errors “surfaced”:

• an action has been assigned to eliminate the non-compliance, not a corrective action. Nonconformity was “no responsibility for function XXX” , then the action came “to define responsibility in the job description”.
• the need to develop a corrective action was not evaluated. That is, the approach and reporting form , in principle, does not make possible not to define the corrective action. It means, for each nonconformity must be one or more corrective action.

  Of course, in this case it is not possible to choose a method for conducting an adequate and understandable review of the effectiveness. True, this trial did not solve the problem for all interested sites. The customer has its own customers who, in their audits, require the appointment of corrective actions for each non-compliance. For them, they decided to put in the column “action effectively.”

Сообщение Review of the effectiveness of corrective actions появились сначала на OrexPro - business desigions.

Сообщение Management review появились сначала на OrexPro - business desigions.

Recommendations for the behavior of the staff during the audit:
1⃣ Experienced staff should answer the questions of the auditor. Eliminate all newcomers from the audit participants!
2⃣ Personnel with responsibility for the processes should answer the questions of the auditor. Do not make the head of the sales department the sole accompanying person of the auditor! The participation of process owners and heads of departments demonstrates to the auditor  involvement of staff in the quality management system.
3⃣ Provide detailed answers, all the rules for the implementation of processes, documents, points of quality control and decision-making.
4⃣ Don’t give the auditor the folder with documents, show only one example, one document!
5⃣ Repeat the terminology of ISO9001 , IATF16949 In my practice, failures in audits were often associated with a misunderstanding of the terms “validation”, “visual control”, “context”, “preventive action”, “product audit”, “speсification”, “quality agreement” etc.

To be continued…

orexconsulting@gmail.com

Сообщение You are getting audited появились сначала на OrexPro - business desigions.

More details during our training for Visual Control
Please apply for webinar: orexconsulting@gmail.com

Сообщение Visual Control появились сначала на OrexPro - business desigions.

Сообщение FMEA появились сначала на OrexPro - business desigions.

– “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 deviations are happened, actions are required: either we change the rules, or we define corrective actions. And we absolutely definitely change our attitude to deviations from established rules!

Сообщение Deviation Management появились сначала на OrexPro - business desigions.

At the beginning of this process, as in other areas, understanding is required,
which staff
with what unique knowledge is available and
to whom it is possible (expediently, necessary) to transfer this knowledge.

A classic example is the competence of equipment engineers. Equipment maintenance skills should not be generated by only one installer.

Сообщение Staff interchangeability появились сначала на OrexPro - business desigions.

Сообщение New trainings and webinars появились сначала на OrexPro - business desigions.