Quality Management Systems

Abstract

When performing project management multiple standards can be used and followed to enhance the projects chance of success and benefits. Standards that all suggest methods to follow and considerations that should be made by the project managers and the stakeholders before, doing and after the execution of a project. Projects managers should use knowledge from previous projects has input for their project increasing effectiveness and efficiently and the chance of a successful project. In order to do so some output from previous projects needs to be accessible for subsequent project managers and must include relevant experiences that can be included in the next project. This creates the obligations for the projects managers to use the output produced from previous projects as input for new projects. Furthermore, the project manager must note relevant experiences that can be noted in their final project report of lessons learned to be redistributed. But from all these standards and suggestion what should the project manager be aware of and note doing the project that constitute improvement of prospective projects? This article will explain how a QMS can help to address the problem of how to ensure consistent output from project that can be used as input for the next project and how project managers can use and benefit from this tool. It will furthermore be discussed if the benefits produced from a project increases when performed within the framework of a QMS. DS/EN ISO 9001 2015 outlays Plan Do Check Act (PDCA) as an essential part of the QMS and by this reason ways of incorporating the PDCA in a project will be suggested. General principles of risk-based thinking will be explained and why it is important to include in a company’s Quality Management System and project management, arguing that more organisations should implement a QMS in order to know their current level of performance of projects and knowing their progress from investments and initiatives. By combining methods from standards and literature upon project management and QMS’s suggestions of how a QMS can help a project manager and organisations to consistently do good projects and improve from each project to the next.

Quality Management Systems

A Quality Management System is a systematic tool that helps standardise and define processes in an organisation in order to improve the performance. QMS includes monitoring information from internal and external aspects of a company e.g. via collection of data such as internal performance indicators, training of employees, nonconformities and their root curse, well-argued management decisions based on such information and can insuring a gradually increase of the performance. It focuses on creating a closed loop in the organisation, known as the Plan Do Check Act (PDCA) cycle, which is the basis for gradually improvement of performance. It can be adopted in any organisation and must be customized to the specific organisation to enhance its effect. DS/EN ISO 9001 2015 encounters all aspects of the organisation that must be duly considered when designing the QMS for the specific organisation. Depending on the organisation, some processes of the organisations will be of higher priority than other. These prioritised processes must be identified via the risk-based approach. Performing projects also includes risk should therefore be included in the QMS where methods of performing these projects is described. Depending on the organisations dependency of well performing projects the consequence of badly performing projects will increase, arguing that actions to either decrease the consequence must be made or preventive actions to lower the probability of unsuccessful projects.

DS/EN ISO 9001 2015 describes the QMS in five main topics: Context of the organisation, Leadership, Planning, Support and Operation. In the following sections these key components of a QMS will be described briefly with its as consisting of five the content of five elements ded into - List all the aspects of a QMS with a short description and their main intensions.

Context of the organisation

An organisation implementing a QMS must consider what factors that needs to be monitored internally and externally. The factors monitored will vary for each organisation since organisations has different values, structure and risk. Therefore, when choosing what factors to measured, the organisation needs to look inwards and estimate which prosses is of particular importance to improving customer satisfaction. Processes for improvements of the organisations QMS must be in place.

Leadership

The management is obligated to follow the QMS and make decisions based on the collected information from it. These decisions must be made using a risk-based approach. Management have the responsibility that the QMS achieves it intended purpose, supports the organisations strategical direction and simultaneously remains focused on the costumer’s satisfaction operation within regulatory requirements. They are responsible for ensuring that the QMS is used throughout the organisation, has an established quality policy and that responsibilities are defined, delegated and understood.

Planning

When designing the QMS the organisations must encounter its own position in the market and how they influence stakeholders. The organisation must determine risk and opportunities which needs to be addressed. Mitigation actions to reduce identified risk shall be planned in order to lower the risk as much as possible. The organisation must define measurable quality objectives in line with the QMS-policy. These objectives must be known throughout the organisation and planned how to be achieved. The must furthermore describes how these measurable objectives is evaluated.

Support

Resources needed to create, maintain and improve the QMS shall be determined and provided by the organisation including human recourses and their competences, infrastructure and environment required for operation of processes. The competences of employees shall be documented to guarantee tasks is done is compliance with defined requirements. The organisation must measure relevant resources to insure sufficient supplies. Tracing the flow of the recourses is required in order to determine the status and make improvements where needed. The organisation must determine which processes and information from these that is needed to be documented in order to obtain and improve the effectiveness and efficiency of the QMS. Furthermore, the QMS must describe and document procedures for communication internally and externally. The documentation must be controlled and include necessary metadata to identify the author, date, format, changes that has been made and who approved these.

Operation

Planned action must be follow in order to perform processes in compliance with established criteria and how to obtain. Hereby controlling the processes and ensuring the QMS improve the organisations performance. IF changes are made to processes a revision of these changes must be made to ensure compliance with defined criteria. If a nonconformity accrues as an output of any processes a defined CAPA-process is to handle this. Products and services must comply with internal requirements as well as external. These products and services must go through regular provision of defined requirements in order to identify necessary actions to make improvements. This includes check of input and output requirements.

In order to control internal processes, requirements and provision of external provided resources must be established. When choosing an external provided following steps must be follow: - Define requirements for supplier and the service - Selection of the best fitting supplier - Monitoring of the chosen supplier to evaluate their performance - Re-evaluation of supplier

Performance evaluation

The organisation must determine which data and information to measure, analyse and evaluate upon. This should be processes with is of the highest importance for the organisation. Management must perform reviews of this information which they must use to decided actions to improve the QMS and its processes. As part of the evaluation internal audits shall be performed regularly with the focus of checking compliance with internal procedures, DS/EN ISO 9001 2015 and the efficiency of the QMS.

Improvements

The organisation shall decide upon ways of improving the internally and externally to improve costumer satisfaction. Handling of non-conformities shall be done through CAPA (Part 820 Quality Systems Regulations)

Plan Do Check Act

- Explain the PDCA – 

As indicated on the PDCA it incorporates all of the chapters of the DS/EN ISO 9001 2015 and illustrate it as a circular process. Project Management Project management is the way of controlling and guiding a project and its stakeholders towards the project goal by use of methods, tools and expertise within the projects constraints. ref(ISO21500 and PRINCE2 2017 edition). A project is a contemporary constellation with a defined timeframe which create or add value in reference to the baseline. - A project is a temporary constellation with a start and end date, which must fit into a QMS with the lifespan of the organisation. - Multiple factor from outside the organisations boundaries can effect the project and must therefor be encountered by the PM in order to reduce risks. These factors can be minimised by an efficient QMS where SOP's describe and standardise genereal methods and cosiderations which must be encountered when a project is carried out. - Pre project and post projects is controlled and documented vie the QMS. The standardisation of the project eases post projects since the documentation and method use in the last project is well described. Revison and evaluation of the projects will gradually evaluate and improve the quality of the projet (and value. Likevise will a QMS also help to standardise and improve the programs and portefolie. - Important to mention that managenet standards can be used within the QMS, but the QMS help to custemise the way of performing project in the particular organisation. The QMS could also directly refer to a standard which must be used for execution projects. - The QMS will provide the PM with information of the personals competences e.g from a competence matrix. Easing the processes of creating teams with the necessary knowledge and experience. - The lifecycle of the project can be managed in the QMS and beyond. (Nok ikke nødvendigt and nævne) - The QMS could include SOP describing general templates of what should as minimum be included in a project plan and project management plan. Template describing what to be included in a baseline. - Defined change control system that formalises the acceptances from both the client and contractor before actions upon this is made.

General principles - Stakholders - Critical path - Preventive action

Project Management within a QMS - What is difference of performing a project without a QMS from without - What to encounter as PM - SOP's - DS ISO 21500 2012 speaks of inputs into new project plan, such as the business case, lessons learned from the last project, approved changes etc. In relation to the QMS the input of lessons learn from the previous project is of particular importance in order to make improvements upon the last project.The PDCA method also describes this continues processes of improvement. I order to ensure the inputs is at an acceptable level of quality some standardisation of what these inputs should include must be defined. An example of this could be a template for a project evaluation with specific topics that must be evaluated both internally in the project group but also an evaluation from the clients. Value creating - How a QMS captures value from the project and enables and ensures that the lessons learn will be accessible and reused. - Use of best practice - Suggestions in the DS ISO 21500 2012 mention that lessons learned during the project should be noted and accumulated in a report when the project is finalised. General inputs for this report is suggested but only with general terms. These should be specified in order to obtain consistent performance indicaters, best practices and what to avoid in subsequent projects and included as a SOP for PM in the QMS. Discussion - Pros and Cons

Conclusion

[https://webshop.ds.dk/da-dk/standard/03-120-10-kvalitetsstyring/ds-en-iso-90012015 DS/EN ISO 9001