Quality Dialog Workshop
Building and maintaing a quality culture is difficult. Our experience shows that rarely any part of the organization wilfully does not want to participate in a postive quality culture or not deliver quality work. Thus, the issue must be that different parts of the organization of have different percpetions as to what constitutes "Quality". In this situation it is insufficient to remind people that quality is a regulatory requirement and compliance mandate.
To align the perceptions, senior management must engage all parties in an open and meaningful dialog about quality and shape this discussion to improve Quality Decision Making.
In collaboration with the client, QORM Consultants have developed a format for such development, the Qulaity Dialog Workshop. The purposes of these workshops were:
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To improve Quality Decision Making
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To give participants a forum to openly discuss quality issues
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To improve comprehension about quality and compliance related issues
The workshops were held monthly at 6 different times within 3 days to allow all staff to attend at least one meeting. In the beginning, the workshops were mandatory for all manufacturing staff. Within two month, QA, Technical Services, Regulatory and Facilities has made attendence to at least one session mandatory as well.
The sessions were well frequented by senior management as well, so as to underline the support and importance of these sessions. Ideally, staff from different groups would attend the same session so as to allow a discussion reflection many different points of view. A typical session was visited by approximatley 30 participants.
The content of the Quality Dialog Workshops was initially developed and presented by QORM Consultants, who also facilitated the workshops. Over time, the client took over, first the content development and presentation, and later the facilitation of the workshops. There was no preset format, but the desire was to have about 30 minutes of some sort of presentation of an issue and about 30 to 40 minutes of discussion amongst the participants. The format followed the content. Here are four examples:
One workshop discussed the importance of the deviation process and built frameworks to its better understanding. For instance, the intake of deviations follows a journalistic framework where the analyst shall collect quickly information about who, where, when, what, and how the deviation came to pass, who was involved, and so on. QORM Consultants engaged in some role playing supported by memers of the the newly formed PODs. After the role play, participants of the workshop were invited to comment on the performance and suggest improvements or voice concerns and perceptions.
Another workshop involved the Regulatory Group presenting the history of one of the flaggship compounds of the client and discussed some of the pitfalls during its development. Moreover, it involved patients who depended on the lifesaving drug of the client who spoke directly the participants. Participants were encouraged to ask quesitons and enabled to experience first hand the importance their quality work made on a daily basis for these patients.
Another workshop was a "griping session". Participants were encouraged to voice their frustrations with management and their peers. QORM Consultants collected the comments and grouped them along themes. Then the participants were invited to find a theme of their interest and discuss with their peers on how the situation could be improved. Some of the ideas were picked up by the Operational Excellence Group.
In a fourth workshop groups of participants, under the guidance of the OpEx Group presented the results of some of their work performed in the last year, and its effect it had on operations and quality in the company. The session, in form of a poster session invited participants to discuss their improvements, hear critique and discuss possible further improvements.
This is probably the most important program we are doing for our site at this point.
Comment by the VP, Site Head Quality about the Quality Dialog Workshops.
QORM was not able to ascertain metrics that would indicate the postive impact of this approach. However, anecdotal evidence suggests that both, the staff and senior management valued these sessions. Attendence was regularly high and the discusions were lively.
Moreover, one could notice that concepts discussed in the workshops were discussed outside the workshop, too. In discussions with staff the overwhelming response to the workshops was positive.
Further, at the time when QORM Consultants stopped being involved in the workshops discussions had started to bring these workshops to other sites, too. We are confident, therefore, that these workshops were an integral part in improving the quality culture at the client.