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  • Optimize Your Quality Management Review and Increase Management Engagement

ISO 9000 & AUDITS WORLD CONFERENCE ABSTRACT 

Optimize Your Quality Management Review and Increase Management Engagement

Presenter:

Pia Lise Sandau, Corporate QMS Expert, Novo Nordisk A/S, Bagsvaerd, Denmark

Co-Presenter: Yeliz Saföz, Project Manager, Novo Nordisk A/S, Bagsvaerd, Denmark

Keywords:

High Risk Audits, Improved Audit Tools, Process Auditing, Risk-Based Thinking

Industry:

Aviation/Space, Chemical, Energy

Level:

Advanced

Going from a QMR process perceived as detached and less value adding to a process where trends and improvements are in focus requires a change.

In Novo Nordisk, a global pharmaceutical company with many processes and external requirements, QMR was seen as a massive task. QMR’s were conducted at five levels across the company and often data were evaluated more than once. Management perception was that the review was double work and non-value adding as critical quality issues seldom reached Executive Management. Furthermore, in several areas, management already looked at the performance board once a month, so at the biannual QMRs there were no real surprises.

This called for a change. Although heavily reliant on the QMR for an overview of the performance of all regulated activities, Novo Nordisk acknowledged that the QMR had grown out of proportion. This made it hard for management to identify problems, issues and risks in order act.

Change was initiated using different methods to move the QMR to a more risk based approach that focused on critical quality issues. The foundation of this work was a previously conducted gap analysis that gave an overview of external requirements. This analysis was actively used in the project to narrow in on agenda points. In addition, stakeholders at different levels were interviewed to identify pain points, and several workshops were conducted focusing on the main issues identified during the interviews, such as format of the QMR, data collection and the risk assessment tool.

The change project revealed five actions to optimize the QMR and increase management engagement:

1) Perform a risk evaluation of the frequency and levels of needed QMRs

2) Focus on critical quality issues

3) Incorporate risk assessment in top management QMR

4) Look forward instead of only backward

5) Only look at data once.

The outcome of the change project is that Novo Nordisk now has fewer QMR meetings; a more lean and effective process; and a new focus on possible future issues and risks. QMR remains an important overview of performance of regulated activities but the risk based approach enables management to act faster and thus increases their engagement in the QMR and their perception of the QMR as being value-adding.

Call for Proposals

Proposal Submission Deadline:
October 11, 2019

Acceptance notification date:
November 11, 2019

Early Registration Deadline:
February 11, 2020

Please make sure to review and prepare the material needed before you start the on-line Proposal Submission Form. Click here to see Proposal Submission Guidelines.

Who May Submit: This online form may be used by a principal speaker, co-speaker, contact person, or a committee member submitting on behalf of a speaker.

Multiple Proposals: You may submit multiple proposals.

Conference Registration Fee:
The conference registration fee is waived for the principal speaker of accepted proposals. Speakers are responsible for their travel expenses and arrangements. Co-speakers will receive a 30% discount for the conference that they are presenting at.

Length of Presentations: Technical sessions are typically 35 minutes. There will be a limited number of "double" sessions, 70 minutes, at the end of each day.


You will need the following to submit a proposal

Proposal Title: Maximum 80 characters including spaces. 

Keywords:Please include three keywords with a maximum of 100 characters, including spaces. 

Industry Sector: Please select the most relevant Industry sector for the proposal from a list.

Abstract: The Abstract should be 1,500 to 5,000 characters (note that it is Characters, NOT words), including spaces.

Biography: The Biography must be 1,500 to 5,000 characters, including spaces.

Public Profile: LinkedIn or Public Profile for link for the Principal Speaker: 

Speaker's Photo (optional)

Sample Video (optional)


Government Organizations




Corporations

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(*) based on previous conference attendance


CONTACT US

Tel:  1 (408) 894-9910 or 1(800) 875-1960
Fax: 1 (866) 500-9081
Email: info@iso9000conference.com



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