Case

FDA Inspection

GN Hearing A/S

Challenge

At 3 months’ notice, Corporate Quality at GN Hearing was advised that an inspection would be conducted by the FDA.
GN Hearing’s Executive Management would accept a maximum and 3-5 deviations (483’s), no warning letter (WL).

Vi valgte Genau & More til opgaven, da vi inden den forestående inspektion havde behov for management consulting og ikke blot projektledelse.

Vi havde behov for en tæt partner, der kunne bistå os i at tænke inspektionsparathed ind i vores kvalitetsstrategi og sikre en langsigtet implementering heraf, så vi i virkeligheden altid ville være inspektionsparate.

Pär Thuresson

SVP for R&D, GN Hearing

Solution - Proces

Establishment for X-Point plan and identification of high-risk sites and issues.
Establishment of heatmap (risk matrix / risk grid) guiding priorities.
Breakdown of actions into workstreams and action plans.
Training in Good Inspection Practice, ensuring proper attitude and behaviour.
Good housekeeping and clean-up communication to the company one week before audit.
Establishment of governance structure with C-level, line management and project organization, incl. direct access to board of directors.

Results

One 483.
Converting compliance issues to a common understanding for ‘Sense of Urgency’. This has provided a good indicator of the level and the majority of GN Hearing’s work with quality and compliance.
Useful input for any adjustments to the strategy, competencies and organisation to execute the adjusted strategy and as well as the management and governance of the strategy.
It has affected the entire organization’s attitude towards Inspection Readiness and the whole proactive approach to it.