The With the strengthening of regulatory requirements or security and quality issues, many organizations in all sectors of activity are launching projects to obtain ISO 9001, 14001, 27001, etc. type certifications. These approaches are part of both the traditional compliance approach and new differentiation strategies aimed at reassuring customers, suppliers and partners about the operational excellence of the organization.
uality management systems and more specifically QMS software (quality management system) are therefore becoming increasingly important . But beyond the follow-up of the actions to be carried out and the dashboards, the implementation of a QMS covers many dimensions that go beyond the software alone, such as the management of the repositories and the risks that must be well understood if the ‘we want to sustainably improve quality… Our experience of digitizing processes and documents in the field of quality has given us some lessons that we share with you.
Reminder: what is QMS software? And what is quality management?
Before talking about QMS software, we must first go back to quality management, which consists of continuously and sustainably improving the functioning of the organization and, ultimately, its operational performance. For this, the approach generally aims to bring together all the stakeholders around an internal quality policy which defines the rules and therefore impacts the processes and the data.The team in charge of quality will therefore produce and then manage all the documents defining the applicable procedures and then follow all the related actions such as, for example, the recording of an inspection on a given date, the creation of the report, the registration of a non-conformity, planning of a control reminder, etc. So many documents and collaborative workflows to follow.
Quality management thus encompasses three main concepts and its performance is directly linked to their proper integration:The applicable repository , the tree structure of which makes it possible to identify the macro-processes and operations to be carried out and which must be able to be updated to take into account the evolutions and constant changes in the quality certification standards.Risk management, which makes it possible to identify all the assets of the organization and the associated risks in order to define the specific controls and the actions aimed at reducing these risks.
The continuous improvement of the system so that the teams can question themselves at regular intervals on the correct application of the procedures and review the evolution of the risks.
The QMS software supports this integrated management system
The role of the QMS software is therefore to manage the normative repository in accordance with a standard, it serves as a support for the quality team to facilitate the production of audits and to prove that quality management is both well managed and well applied. It thus supports many functions: planning audits, evaluation of partners and suppliers, monitoring of action plans, traceability of non-conformities and their resolution, document management , etc.
With a single tool that manages the different standards and benchmarks that the organization must take into account (ISO 9001, QHSE, cyber risks, etc.), it is easier to involve all stakeholders in the process of quality improvement. We facilitate the collaborative aspects, which speeds up the processing of any non-conformities and improves overall performance. However, not all tools have the same functional coverage and there are essential points to check before equipping yourself with QHSE software or a management system.
What has changed today and why should we drive more by risk?
Historically, quality system deployment projects have often focused on the repository to ensure comprehensive coverage of all normative aspects and activities in the QMS software. But the constant strengthening of security standards and the increase in certain risks such as cyberattacks for example are now pushing organizations to manage their quality management system by risk rather than by the standard itself .
The quality system thus focuses on its fundamental objectives: preventing risks, reducing non-conformities and incidents in order to limit the consequences and possible harm… Because the real question today is whether we have identified all the risks. and succeeded in reducing the probability and severity of the consequences, by considering two main types of risk:
Risks that are unlikely but have very serious consequences,
The case of the fire at the OVH Datacenter in Strasbourg on the night of March 9 to 10, 2021 had made an impression, causing significant disruption for many customers, many of whose websites and internet services had become inaccessible. But the consequences were far greater as many customers discovered that their backups were not on a second remote site and some of their data was lost. This raises key questions in the risk anticipation policy but also consequences because today, more than 50 companies have engaged in a class action against OVH. This unfortunately shows that what is at stake today is indeed to steer quality management through all the risks according to their seriousness and their probability in order to define the appropriate action plan as soon as possible.
Extra-ordinary organizations need a totally personalized quality management system
On the other hand, QMS software cannot always respond to atypical organizations whose quality and safety management needs are specific. At Anakeen, we have developed real expertise over the years to succeed in the digital transformation of organizations whose business processes are unique because standardized software packages cannot meet their expectations . They need tailor-made solutions as was the case for example for the Ministry of the Armed Forcesfor which we have developed the quality management system adapted to each context. The solution thus has a common backbone but all the specificities of the different army corps are taken into account within a single centralized system. The result: a quality management system better adapted to each entity and which promotes user acceptance.