Quality management outsourcing

Quality management outsourcing is an OREX Pro service that provides the development, implementation, maintenance and improvement of a quality management system for a customer by a resident OREX expert. Outsourcing quality manager performs all the necessary functions for working with documentation, audits, QMS analytics. A third-party quality manager provides many benefits to the customer, namely:

An experienced OREX expert completes quality assurance tasks in less productive time.
In small organizations, quality management must function, however, the number of tasks performed does not equal the eight-hour workload of one staff member. The organization decides to either outsource quality assurance tasks to someone else, or take on an ineffective staffing position, or outsource quality management to OREX.
Quality management outsourcing means OREX will provide ongoing support when the customer needs it. If the designated third-party quality manager is on vacation or sick, OREX will provide another specialist to replace him or her.
OREX experts have high competence and extensive experience in quality management issues. Based on our knowledge and experience, we implement quality management systems that fulfill the goals of the customer's organization.

Quality management outsourcing covers the following steps:

• Determination of the QMS objectives

Every organization is different, and quality management objectives are also unique. Quality management outsourcing should address all of the organization's quality assurance needs. At this stage, OREX conducts introductory sessions with managers to collect information about the objectives of the organization, its features, priorities in the functions of the QMS.
• Diagnostic audit

A diagnostic audit is carried out with the aim of aquaintance with the current management system of the organization, with those responsible for the processes. At this stage, information from the performers is collected and analyzed, and a comparison is made with the QMS objectives.
• Functions of quality manager and terms of reference

Based on the results of the introductory session on the goals of the quality management system and the diagnostic audit of processes, a work program or quality management outsourcing function is formed. Such a Work plan includes work on the development or improvement of individual processes, training the customer's QMS personnel, documenting, preparation and presentation of the quality system at audits. After coordination of functions with the management of the customer's organization, an outsourcing quality manager / project manager is appointed, who becomes part of the customer's organization team.
• Outsourcing of quality management

Outsourcing of quality management is carried out in an agreed amount of working time to perform permanent tasks, such as training for the new personnel, updating quality management documentation, collecting and analyzing KPIs, interacting with customers on quality management issues, and internal audit. The outsourcing quality manager performs unscheduled work to support, for example, customer audits, audits of a certification body.

Our portfolio

Target:

Develop, implement and prepare for international certification a quality management system in accordance with ISO 9001

Result:

The system has been certified by the international body TÜV NORD CERT. Staff has been trained and motivated. Work continues to update the system to IATF 16949. All opinions and results in the interview: https://medium.com/wayray/how-to-prepare-for-iso-9001-in-4-months-and-nail-it-an-interview-with-aleksandr-bobryshev-6ff08257a09a

Term:

4 months
QMS remote training

Target:

Conduct remote training of the QMS for the new responsible for the quality management system

Result:

The remote QMS training has been conducted on the requirements of ISO 9001, internal audit of the quality management system. The training has been carried out on examples of the customer's organization - wallpaper manufacturer. Examples of documentation have been reviewed. Homework has been assessed in the course of the training.

Term:

3 months according to an agreed schedule
Quality management system implementation

Target:

Develop, implement and prepare for international certification a quality system in accordance with ISO 9001

Result:

The system has been certified by the international body TÜV NORD CERT. Staff has been trained and motivated. Work continues to update the system to IATF 16949. All opinions and results in the interview: https://medium.com/wayray/how-to-prepare-for-iso-9001-in-4-months-and-nail-it-an-interview-with-aleksandr-bobryshev-6ff08257a09a

Term:

4 months
Training for top management of the GAZ Group

Target:

Conduct training for top management on risk management

Result:

On-site training on risk management for managers has been conducted. A risk management algorithm based on ISO 31000:2018 has been reviewed. An exchange of opinions has been held. The main issues in the discussion: - how not "to get buried" among the huge number of risks and - how to involve key personnel in a real (not formal) risk management process.

Term:

2 days
Quality management. Outsourcing for Talan Medical

Target:

Quality management outsourcing services. Development, maintenance of QMS in accordance with ISO 9001, ISO 13485.

Result:

Quality management system documents have been developed and updated. Staff training on basic QMS requirements, risk management and root cause analysis has been conducted. Risk register has been developed.

Term:

September 2020 - to date
Development of Control plan for the production of plastic products

Target:

Development of the Control plan

Result:

The incoming inspection process has been updated. Clear control points and quality control criteria in the production process have been defined. The scope of product testing in specifications, GOSTs and commitments in contracts with customers has been agreed. Reporting forms have been established. Staff training has been conducted. Approach to identification of initial and auxiliary materials has been updated. Control plans, incoming and inter-operational control instructions have been developed. Non-conforming product management procedure has been updated.

Term:

3 months
Management system development. Transportation

Target:

Management system development: organisation of the transportation process

Result:

Requirements for transport companies and transport equipment including requirements for quality, safety, cargo clearance and interaction with subcontractors have been formulated and agreed. A Quality Agreement has been drafted. Selection of transport companies has been carried out. Two transport companies have been audited. A system of KPIs and reporting on the results of monitoring of the transport process has been developed. Regulations "Organisation of the transport process" have been developed.

Term:

3 months
Quality systems training for Vladimir

Target:

Provide training on ISO 9001, IATF 16949, quality management methods

Result:

Several training sessions have been held in a personal training format. Evening schedule. Training on ISO 9001, IATF 16949 requirements, internal audit, quality management methods APQP, PPAP, FMEA, MSA, SPC has been conducted. Examples have been reviewed, the monitoring of the implementation of the knowledge gained into practice has been developed and is carried out.

Term:

3 months
Production risk analysis

Target:

Conduct a production risk assessment for subsequent certification according to ISO 13485.

Result:

A cross-functional risk assessment team has been organised. FMEA methodology training has been conducted. Risk register for the production of surgical kits has been established. Priority risks and necessary actions have been identified.

Term:

1 month
Tire component manufacturer

Target:

Develop and implement a quality management system in accordance with IATF 16949: 2016.

Result:

The quality management system is implemented, personnel are involved in its further development. Project details: 1. Warehouse facilities were expanded. The FIFO / FEFO system in the warehouse is implemented. 2. The TPM system is implemented. Spare parts management, PM planning and execution control are improved. 3. The PPAP, FMEA, SPC, MSA methods are introduced, which helped to successfully pass several consumer audits. 4. The documentation management process, process and product audits, 5S methodology, Poka Yoke management system, measuring instruments management system are implemented.

Term:

12 months
Training for Russhpala leadership

Target:

Training for process leaders: goal setting, goal management, process approach, planning and analysis of process results, data-driven decision making, communication and information exchange

Result:

Disclosure of new sides and personal qualities of leaders. Algorithms of communications and scripts of dialogues are received. Skills of working in a multitasking mode were acquired. A workshop on emotions management was held. Motivational and positive attitude.

Term:

2 days
ISO 9001 for SOLLERS Engineering

Target:

Development and implementation of a quality management system, preparation for certification in accordance with ISO 9001: 2015

Result:

The quality management system is certified by TÜV NORD CERT. Approaches to process management have been developed and specified. The personnel were trained in accordance with the requirements of ISO 9001, in the internal audit of the quality management system, in nonconformity management.

Term:

7 months
ISO 28000 for LLC “COMPOSITE”

Target:

Provide consulting services for the development and implementation of ISO 28000 requirements for subsequent certification.

Result:

The supply chain security management system has been developed, implemented, the certification audit was successfully passed. Technical and management solutions are implemented. Personnel training was carried out. The agreed approaches to the management of supply chain security processes are documented.

Term:

5 months
ISO 9001 development

Target:

Development of a quality management system in accordance with ISO 9001, preparation for a certification audit

Result:

Approaches have been developed and a management system has been implemented for an international company with locations in Switzerland and Russia. Training sessions were held in English and Russian on the requirements and practice of internal audit. The system harmoniously takes into account all the best management practices of the company, applied automated systems.

Term:

8 months
VDA 6.3 audit, an internship for auditors

Target:

Conduct a process audit according to VDA 6.3

Result:

A process assessment was carried out in accordance with the VDA 6.3 methodology for a raw material manufacturer in the automotive industry. An internship was carried out for the auditors of the processes of the customer's company.

Term:

2 days
VDA 6.3, VDA 6.5 audit

Target:

Conduct an assessment of compliance with VDA 6.3, VDA 6.5 prior to the certification audit

Result:

The process and product were assessed in accordance with the VDA 6.3 and VDA 6.5 methodology for a automotive component manufacturer.

Term:

3 days
IATF 16949 audit

Target:

Preparation for an audit of the certification body according to IATF 16949: 2016

Result:

2 major, 10 minor nonconformities and 8 potentials for improvement are identified. Consultations are held to eliminate the nonconformities promptly before the certification audit, and an action plan for further improvement is presented.

Term:

2 days
Preparing for an audit

Target:

Preparation for a rating audit of a client (a large retail chain) in order to improve the previous assessment, the possibility of subsequent deliveries

Result:

In a short time, the basic processes of the quality management system, 5S principles have been introduced. A quality control system has been organized. The FIFO system has been introduced in warehouses. Much attention is paid to the training and motivation of employees. For this purpose, a motivation system has been specially developed, based on an assessment of the effectiveness of the implemented improvements. Preparation of the audit was completed successfully and received a high rating.

Term:

6 months
Description of warehouse business processes

Target:

Describe the warehouse business processes for their subsequent automation. Optimization of business processes.

Result:

Internal regulations have been created for the processes of acceptance, placement, selection and shipment of products from the warehouse. Performance and effectiveness indicators have been introduced. Improvement of the speed of acceptance and selection of products for shipment after 4.5 months. Determination of the required competencies and interchangeability of personnel. Determination of the causes of errors in the selection of goods. Development of technical specifications for automation of acceptance, placement and shipment of products, for automatic accounting of process indicators.

Term:

4,5 months
QMS for Speсpricep

Target:

Implementation of a quality management system for certification in accordance with the requirements of ISO 9001.

Result:

Staff training in the requirements of ISO 9001, problem solving techniques, risk management system, process approach, internal audits and supplier audits. Development of all basic processes, procedures such as: Internal and external audits, Management review, Management of non-conforming products, etc. Development of a KPI system, developing the company's strategy, policy and goals. Development of production technology, work instructions, implementation of lean manufacturing methods.

Term:

4 months
Implementation of equipment maintenance system

Target:

Reduced unplanned downtime by 20%. Reduced Maintenance time by 15%. Increase OEE from 54% to 75%

Result:

Employees were trained. A predictive maintenance system has been developed and implemented. The maintenance planning system has been changed to take into account equipment loading. An automated system for managing equipment repairs and maintenance has been introduced. The most important maintenance activities were standardized. The system of spare parts planning and accounting was modified. 5S system has been implemented. The OEE level has reached level 70-75%

Term:

4 months
IATF 16949 training for Pavlovsky Bus Plant

Target:

Training of an inter-functional group of employees of PAZ LLC (28 employees; logistics, production, quality, financial services, technology) in the requirements and methods of IATF 16949 for the subsequent development and implementation of a management system. Online training with audio and video communications.

Result:

OrexPro has applied new, unique methods for presenting information, working with feedback and conducting practical exercises as part of online training. Studied such topics as FMEA, MSA, SPC, APQP, PPAP; IATF 16949 requirements; practice of conducting internal and supplier audits. Participants acquired basic theoretical and practical knowledge of the implementation of IATF 16949 requirements.

Term:

88 hours / 3 months
JSC ” Russian leather»

Target:

Obtaining the IATF 16949 international certificate for sales of products in the automotive industry, in order to fulfill customer contractual obligations.

Result:

All IATF 16949 methods have been implemented. Successfully passed IATF 16949 certification. The personnel was trained on the following topics: FMEA, internal audit, problem analysis techniques (8D, 5W, FTA, Ishikawa).

Term:

9 months.
Chain of fitness clubs with SPA services

Target:

Development of internal processes, system approach.

Result:

Successfully passed certification audit for ISO 9001 compliance. The staff was trained on the following topics: ISO 9001 requirements, process approach, internal audit, including practical audits and certification of internal auditors, risk management, problem solving techniques, and continuous improvement management.

Term:

7 months.
LLC NPO “Composite»

Target:

Meet customer requirements, for example, BRP, Arctic Cat, Polaris.

Result:

The quality management system fully meets the requirements of IATF 16949. The TPM, 5S system has been implemented. A number of projects for continuous improvements have been launched. The personnel was trained on the following topics: IATF 16949, APQP, PPAP, SPC, MSA, FMEA, problem solving techniques, internal audit, risk management. As part of the training and exchange of experience, visits to similar industry enterprises with world-class QMS were organized. New projects have been initiated.

Term:

10 months.
Vehicle assembly plant (OEM)

Target:

Train internal auditors how to conduct process audits. To develop the auditor's practical skills and ability to ask questions, conduct interview in the "right“ way, assess the situation and formulate the nonconformities. Together with the company's management, identify ways to motivate auditors and adapt the methodology to the company's needs.

Result:

Internal auditors have acquired the necessary knowledge to conduct process audits independently. Possible improvements and changes to internal audits are identified in order to optimize the process. Possible options for motivate the auditors and approach to self-motivation are identified.

Term:

2 months
Furniture manufacturer, mass production

Target:

Investigation and analysis of the root cause of defects in the batch of new products, analysis of sufficiency and necessity of changes in the control program, equipment maintenance processes.

Result:

Production batch reworked and delivered to the client, identified key areas for development, identified ways to optimize the processes in order to prevent defect recurrence. Specific recommendations are given for improving the work of the warehouse, technical service, and production.

Term:

1 week
Holding with companies from different industries

Target:

Develop a process KPI system deployed to the level of employees.

Result:

Set KPIs for processes and employees. Monitoring periods, data collection and reporting methods are defined. Developed a Technical Describtion to implement KPI software. A bonus Fund planning system has been created. Communication regulations have been clarified and supplemented. Reduction of the bonus Fund by 2.350,000. 00 rubles while increasing staff satisfaction with the KPI system.

Term:

6 months
Manufacturer of plastic products

Target:

Identification of major nonconformities, selection of a team of performers to present the system to the customer's client and subsequent project management, prompt implementation of improvements.

Result:

The customer's audit was passed without any findings, an order was received for the amount of 450,000 Euro. Product prototype is agreed. Additional channels for product sales have been identified.

Term:

2 months

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Quality management outsourcing

Quality management outsourcing covers the following steps:

• Determination of the QMS objectives

• Diagnostic audit

• Functions of quality manager and terms of reference

• Outsourcing of quality management

Our portfolio

Target:

Result:

Term:

QMS remote training

Target:

Result:

Term:

Quality management system implementation

Target:

Result:

Term:

Training for top management of the GAZ Group

Target:

Result:

Term:

Quality management. Outsourcing for Talan Medical

Target:

Result:

Term:

Development of Control plan for the production of plastic products

Target:

Result:

Term:

Management system development. Transportation

Target:

Result:

Term:

Quality systems training for Vladimir

Target:

Result:

Term:

Production risk analysis

Target:

Result:

Term:

Tire component manufacturer

Target:

Result:

Term:

Training for Russhpala leadership

Target:

Result:

Term:

ISO 9001 for SOLLERS Engineering

Target:

Result:

Term:

ISO 28000 for LLC “COMPOSITE”

Target:

Result:

Term:

ISO 9001 development

Target:

Result:

Term:

VDA 6.3 audit, an internship for auditors

Target:

Result:

Term:

VDA 6.3, VDA 6.5 audit

Target:

Result:

Term:

IATF 16949 audit

Target:

Result:

Term:

Preparing for an audit

Target:

Result:

Term:

Description of warehouse business processes

Target: