Paulo Sampaio @ ASQ European Summit 2015, Berlin, Germany

André Carvalho accepted in the MIT Portugal Program as PhD Student

André Carvalho, PhD Student of the Research Group on Quality and Organizational Excellence, has been accepted in the MIT Portugal Program with a full PhD scholarship.

André will begin his PhD project on January 2016, entitled “Operational Excellence Programs influence on organizational culture change”.

 

Congrats André!

DEVELOPING STANDARDS

The importance of standards

Standards are tools developed to help companies to ensure the quality and/or safety of their products, services and activities. Standards are voluntary, which means that businesses and other organizations are not legally obliged to apply them.

 

By providing organizations with a common basis for mutual understanding, standards enable companies to access markets and sell to customers in other countries. They are especially useful for communication, measurement, commerce and manufacturing. They enable compatibility between products and/or components and help companies/organizations to comply with relevant legislation.

 

To be useful and accepted by interested parties they need to be high quality standards, easily understandable and conveying accurate and relevant provisions. They should enable companies to achieve better levels of performance and reliability.  The process undertaken for the standard development should be underpinned by the principles of “credibility”, “transparency”, “alignment” and “consistency”.

 

Credibility can be achieved by following international reference documents providing credible practices. Transparency is achieved by making procedures available to the interested parties. Alignment can be achieved by adopting a structure that enables the integration with other standards. Consistency within the standard and with other standards can be achieved by being in accordance with the provisions from documents issued by european or international standardization organizations such as CEN or ISO Directives for standard development.

 

Consistency within the entire body of the document is also needed and can assured by clearly identifying the link between the standard objectives and the principles of the activity and the link between each requirement and the relevant objective.

Standard development procedures

The procedures undertaken for the standard development can be described according to figure 1.

 

 

Figure 1- Procedure for the standard setting activities.

Terms of reference
Terms of reference include the following elements:

(1) A justification study, to avoid standard duplication or overlap;
(2) The objectives that the standard aims to achieve;
(3) The scope;
(4) A risk analysis on the implementation, identifying the risks and how to mitigate for these.

In order to establish the objectives, the principles that govern the activity should be identified. These principles provide the foundation for the establishment of the provisions. They can also serve as an anchor for guidance on decisions that companies need to make in unexpected situations.

The objectives should be clearly established and justified, defining the outcomes that the standard seeks to achieve. Clear objectives, aligned with the principles of the activity are crucial since they are the pillars upon which the standard will be built.

The risk analysis should include (a) the identification of factors that could have a negative impact on the ability of the standard to achieve its goals, (b) unintended consequences that could arise from its implementation and (c) preventive actions that could be taken during the standard development to address these potential risks.

Establishing the type of standard, structure and rules for drafting

The type of standard is defined regarding the established structure (main clauses) and provisions. The technical provisions found during draft should be documented and their relevance to the attainment of the objectives evaluated.

The structure should be defined looking for alignment with other standards with overlapped scope enabling the integration of different disciplines.

Drafting should follow European or international provisions ensuring the uniformity of structure and style within the document and among ISO standards: identical structure and clause numbering, and the use of analogous and identical words to express analogous and identical provisions.

Establishing the provisions

The standards provisions are classified into “requirements”, “recommendations” and “statements” (ISO/IEC 2011). This facilitated the use of the correct terms within each provision, ensuring that all the requirements convey criteria and that the method to evaluate the fulfillment of the criteria is identified. This also make the standard easy to understand and facilitate the translation to other languages.

The requirements should be established in order to be clear, objective and verifiable. They should be expressed in terms of process management and performance criteria giving space for innovation and flexibility. When necessary explanations are added in order to facilitate transposition of pure performance requirements into practical solutions.

The use of terminology must be consistent with ISO or CEN terms and definitions.

In order to assure that (1) all requirements clearly contribute to the attainment of the standard goals, (2) only requirements that are relevant to meet these outcomes are included and (3) all the necessary requirements to address the defined goals are included, the link between the requirement, the leading objective and the related principle was identified.

To facilitate the link between the requirement and the appropriate objective, an intention declaration should be made for each requirement or set of requirements, defining the desired outcome.

Public consultation

Interested parties are invited to participate providing appropriate opportunities for valuable contributions in a transparent process whose different steps are identified in figure 2. Comments are registered according to the respective clause. They are analysed and discussed within the assigned commission for decision. Comments that are not accepted will be justified and recorded. These records are made available to participants.

 

  
Figure 2 - Procedure for the interested parties consultation/participation.

Final remarks

European and international standards are developed by teams of experts from different countries, nominated by the national standards organizations, who share their knowledge and expertise in a particular field.  Thus users can benefit from having access to the best available knowledge and state-of-the-art solutions.

These technical committees are expected to take account of the opinions and interests of all the relevant interested parties including business and industry, research institutes, consumer and environmental organizations. All of these interested parties are invited to express their views on draft standards by responding to public consultations or enquiries that are organized at national level in each country.

After publishing standards are reviewed on a regular basis to ensure that they take account of the latest scientific, technological, regulatory and market developments.

References

ISO/IEC (2011), ISO/IEC Directives, Part 2 - Rules for the structure and drafting of International Standards, International Organization for Standardization and International Electrotechnical Commission, Geneva, Switzerland.

Anabela Martins

PhD Student
Research Group on Quality and Organizational Excellence 
University of Minho

Paulo Sampaio @ MIT as a Visiting Scholar

 

 

 

During my sabbatical (March 1 - July 31), I will work with Eric Rebentisch (MIT) in a research project entitled “Business excellence models influence on organizational change”.

Paulo Sampaio @ Leuven, Belgium

Paulo Sampaio is in Leuven, Belgium, attending the EOQ General Assembly.

39º Colóquio da Qualidade

Paulo Sampaio, Cristina Fernandes, Mónica Melo and Síria Barros have attended the 39º Colóquio da Qualidade, that took place in Lisbon in November 13-14.

 

Anabela Martins, PhD Student from RGQE, @ ISO/TC 276

Anabela Martins, PhD Student of the Research Group on Quality and Excellence, was appointed by the Portuguese Institute for Quality (IPQ, www.ipq.pt) to the ISO technical committee 276 (ISO/TC 276 - Biotechnology). 

Anabela will participate in this TC to develop the future standard for management systems and quality of biobanks (biorepositories that store human derivative materials) and bioresources (e.g., bacteria, fungi, algae, etc.). The work will be developed in line with the OECD Best Practice Guidelines for Biological Resource Centres (BRCs).  

Anabela Martins has a professionally-strong profile on the ISO standards (9001, 17025, among others) as a consultant. In addition, she is undertaking her PhD thesis in Chemical and Biological Engineering PhD Program under the supervision of Prof. Nelson Lima from CEB, and Prof. Paulo Sampaio from the Systems and Production Department, on the topic “Development of a framework for quality management in BRCs”.