Feature: Strengthening training for the environmental management system designed for internal auditors - Creating an environmental auditing system of industry-leading quality -

Chugai has reorganized its in-house training system with the goal of developing internal audit personnel for ISO14001 (an international standard for environmental management systems) with global-level skills.

As part of its efforts aimed at becoming the top pharmaceutical company in the field of environmental preservation, in 2014 the Chugai Group launched an initiative to reorganize and strengthen its system for training internal auditors.
This initiative is also partly in preparation for the first full revision of the ISO14001 standard in a decade (scheduled for fall of 2015). The revision will significantly enhance the ISO14001 standard in terms of making it more business-oriented and improving PDCA cycle management. While the Chugai Group’s Fujieda, Ukima and Utsunomiya plants have already obtained ISO14001 certification, we determined that to bring each plant’s environmental policies in line with the Group mission statement, we would need more highly-skilled internal audit personnel.

With an eye on taking our efforts to a global level, we decided to reorganize our system for training internal auditors with the support of the IRCA*, the world’s largest international register of certified auditors. The new system incorporates the IRCA’s belief that essential auditing requires not only knowledge but practical ability as well. As a result, to the existing two days of classroom work, we have added a third day focusing on practical training for the acquisition of skills such as observation and assessment tasks. (Diagram 1)

Diag. 1 Chugai Group internal auditor development training (comparison between relevant IRCA-certified training and existing training program)

The IRCA, which evaluated the content of this new internal training, determined that those completing the course would gain skills equivalent to those of a provisional internal auditor (Diag. 2). It then relevantly certified the course as Japan’s first - and presently only - ISO14001 Provisional Internal Auditor training course.

While supporting the acquisition of auditor qualifications, the IRCA is also strict in requiring that registered auditors maintain and improve their skills. In other words, those completing the training may register as provisional internal auditors, but that does not mean they hold a permanent qualification. To maintain their existing qualification or move up to a higher grade, registrants are expected by the IRCA to undertake a variety of continuing personal development programs.

Diagram 2 IRCA Grades (Revised summary of publicly available IRCA materials)

Grade Description
(Primary requirements)
Internal Auditor
Internal auditors who have completed an IRCA-certified or relevant certified internal auditor training course, but have little actual audit experience.
Internal auditors with the skill to conduct partial-system audits several times a year of either their own organization’s management system(s) or that of a supplier.
Third-party certified auditors who have completed an IRCA-certified auditor training course, but have little actual audit experience.
Auditor Auditors with the skill to conduct full internal system audits, second party full system audits, or third-party audits for certification purposes.
Highly competent third-party certification auditors with experience as team leader in conducting and managing third-party certification audits.
Management system consultants and independent auditors capable of providing consulting-based auditing of management systems.

To ensure the appropriate and effective administration of its internal auditors and this development system, the Chugai Group has not only reorganized its training system, but has entered into an Organizations Employing Auditors (OEA) system agreement with the IRCA. Under this agreement, Chugai gains priority access to the latest technical and specialized information from IRCA, as well as the technical support needed to improve the competency of our auditors. Given this, the OEA system is expected to contribute significantly to provisional internal auditor self-improvement and acquisition of higher auditor grades.

Note that the Chugai Group is not only the first pharmaceutical company in Japan to enter into an OEA system agreement with the IRCA, but also represents the first instance worldwide of a company employing an OEA system at the provisional internal auditor development stage.

With these steps, Chugai has put in place a system for developing internal auditors for its environmental management systems, one that offers global-level education from the development training stage. By ensuring the competence of its internal auditors, the Chugai Group will establish an environmental auditing system of industry-leading, global-level quality, as we work to become the top pharmaceutical company in the area of environmental preservation as well.

In November 2014, the nine individuals who completed this training became the first ISO14001 provisional internal auditors to be registered with the IRCA. We hope that in 2015 and beyond, these nine will go on to support the development of a new group of provisional internal auditors.

* Acronym for the International Register of Certificated Auditors. Headquartered in England, the IRCA is the world’s first and largest international auditor registry, with more than 10,000 management system appraisers and auditors in 150 countries.

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