Working with a Quality Management System Consultant - Part 3

Working with a Quality Management Consultant – Part 3

I our discussions of making use of the services of a consultant to assist the company with the design, development and implementation of a quality management system (QMS), I would like to focus on the requirements of clause 5 of ISO 10019, Use of the quality management system consult’s services.

What services could the QMS consultant offer? Normally the company would consider one or more of the following services:

·         Definition of the objectives and requirements of the QMS (Ensure that the consultant takes the context of the organization into account)

·         Carry out an initial evaluation or gap analysis

·         Assist with design and implementation planning

·         Help with the design and development of the system

·         Give assistance regarding the implementation of the QMS

·         Evaluate the success of the implementation process (Internal audit of the implemented QMS, or parts of the QMS during implementation)

·         Assistance with ongoing training and maintenance of the system

·         Help with the identification of improvement opportunities to improve the effectiveness and efficiency of the system

It is always a good idea to put a contract in place between the company and the consultant (or consulting organization). It eliminates the possibility of later disputes about services that were supposed to have been delivered, etc. This contract must clearly define the scope of work (including the associated outputs). It should contain realistic milestones and the associated outputs for each milestone that are cost effective for the organization. The milestones and associated outputs should be based on an initial identification of the company’s needs, requirements and objectives presented by top management, as well as relevant customer requirements, conformity requirements of relevant standards, compliance with relevant statutory and regulatory requirements, present managerial and operational processes and the difference between the company’s current situation and the identified objectives that should be achieved.

Documentation requirements of the standards, as well as the company’s own documentation requirements should also be included.

The contract must be written in a clear and unambiguous manner and should include the following:

·         The scope of the work to be done by the consultant

·         Planning of the QMS consulting services

·         The consultant’s and the company’s commitment, roles and responsibilities, as well as the associated outputs

·         Commitment of the company’s internal resources (This is extremely important because the consultant cannot deliver his or her services without the total involvement of the company and its personnel. The company does not want to end up with a system that reflects the consultant’s thinking, but rather with its own, unique QMS)

·         A commitment form the company regarding the financial needs to support the consultant’s activities

·         The methods for monitoring progress and effectiveness

·         How changes to the contract will be managed

·         Confidentiality issues

·         Applicable standards

·         Milestones and delivery dates

·         Terms of payment

·         Time frames

The standard gives us an example of the realization process for a quality management system:

Activity	Responsibility
1. Information to top management of the main requirements of the relevant quality management system standard, and the roles of the organization and the consultant in quality management system design and development.	Consultant
2. Analysis of the needs and expectations of the organization's customers and other interested parties. NOTE The results of the initial evaluation are generally used: a) to establish the organization's strengths and weaknesses, opportunities and threats, b) to understand and help to define its quality policy and objectives, c) as a basis for planning the quality management system, d) to assess the availability of the resources needed to implement the quality management system, e) as a basis for initial auditing, and f) for the establishment of measurable objectives.	Organization's top management (consultant can provide assistance)
3. Appointment of a management representative and the establishment of definitions of policy, objectives and commitments for quality.  Reference of such objectives to appropriate levels and functions within the organization.	Organization's top management (consultant can provide assistance)
4. In-depth analysis of organizational structure, processes, channels of communication and existing interfaces.  Identification of the processes and responsibilities needed to achieve the quality objectives.  Definition of sequence and interactions among such processes.	Management representative and consultant, with the cooperation of the persons in charge of the various functions within the organization
5. Set up of a plan for defining the quality management system architecture and for identifying and developing the procedures needed for the quality management system. To assess the progress and quality of the implemented actions, appropriate milestones should be defined within the plan. The assessments may refer to:  a) consistency between what has been prepared and developed and the contractual objectives, b) work progress, and c) satisfaction of the organization (with regard to the services provided by the quality management system consultant).	Management representative and consultant
6. Review of the results of the analysis carried out and of the plan prepared in advance.	Organization's top management and consultant
7. Identification of internal resources needed to achieve the organization's quality objectives.	Organization (consultant can provide assistance)
8. Training of the persons responsible for developing activities for the quality management system realization, and of the organization's other personnel (“facilitators”) involved.	Management representative and consultant
9. Identification and definition of processes, interrelation of processes and preparation of the necessary procedures, including procedures for record maintenance.	Management representative (consultant can provide assistance).
10. Alignment of interrelated processes and relevant  procedures to avoid any inconsistencies, gaps and overlaps	Management representative and consultant.
11. Elaboration of the final version of the quality manual.	Management representative (consultant can provide assistance).
12. Training of all personnel involved with the quality management system.	Consultant and management representative, or management representative with the consultant's assistance. Training can also be delivered by other competent providers.
At this point the activities of the consultant stops, unless further assistance has been or is contracted at this point
Implementation of the quality management system.	Organization (consultant can provide assistance)

 The standard also gives an example of implementation support for the QMS:

Description of activity	Responsibility
1. Training of internal auditors, emphasizing auditing concepts, audit question development and audit report preparation and other required training.	Consultant (or other providers of training appointed by the organization)
2. Development of a program for internal audits.	Management representative and consultant
3. Participation in an initial series of internal audits, together with internal auditors, to provide them with additional training (including writing audit reports and reports of nonconformities) and assistance in the formalization of detected nonconformities and their causes.	Consultant
4. Assisting top management in conducting effective management review meetings.	Consultant
5. Assisting with any implementation difficulties, focusing on corrective action and preventive actions including nonconformities detected as a result of an audit.	Consultant
6. Continual improvement of the implementation process.	Organization's top management (consultant can provide assistance)
7. Information about certification issues, if required, including pre-assessment or readiness audit.	Consultant

 

Meetings should be conducted to evaluate the progress in implementing the system and the performance of the consultant. Include evaluation in terms of the plan and the budget for the QMS realization activities. Documented progress reports should be submitted to top management, if applicable.

It is important to ensure that the implemented QMS is not a generic system based on the opinions of the consultant. It must be based on the individual needs of the company, based on context, risks and opportunities. The consultant therefore cannot design and develop the system in isolation. It is a concerted effort between the consultant and the relevant personnel of the company.

Consider the following as far as the consultant’s services are concerned:

·         The resulting system should not generate unnecessary administration and documentation

·         The success of the QMS depends mainly on the involvement and commitment of leadership in the company, and not on the consultant alone

·         The company should assign a staff ember to coordinate and monitor the consultant’s activities (normally the person who will be responsible for maintaining the QMS)

·         Employees are involved at all levels in order to integrate the QMS within the company’s overall operations

·         The consultant should be empowered to interact with the company’s management and employees at all levels in order to appraise the company processes

·         Even in the case where QMS consulting was in response to contractual or market requirements, there is an opportunity to use the resulting QMS as an effective and efficient management tool

·         There is the potential for the QMS to provide a basis for continual improvement of the company’s performance

·         The consulting service should be compatible with the company’s culture, the competence of employees and existing processes and / or documentation.

Remember that the consultant is there to assist with the development of the QMS, not to do it for the company! The resulting system is that of the company, not the consultant.

The information contained in ISO 10019 are guidelines for the use of a quality management consultant. But these principles can be applied to any consultant and their services that the company needs to employ.

I hope that he information is helpful, and that the use of consultants in your business will be pleasant experiences!

Please feel free to drop me an e-mail at koosgouws10@gmail.com for more information or advice. You can also visit our website at www.sheqmanagementsystem.com, or alternatively, at www.sheq-management-systems.webnode.com.

Koos