BioPharm

14 BioPharm International eBook March 2018 www.biopharminternational.com Outsourcing Resources Quality • V i s u a l i n s p e c t i o n . C e r t a i n activities related to the visual i n s p e c t i o n d e p a r t m e nt a r e also carried out. The qualit y oversight staff members check t h e v a l i d i t y o f t h e v i s u a l inspection test kits, monitor the inc ubation rooms for media- f i l l u n it s , a nd ve r i f y t he i r plausibility. • AQL check. For some time now, quality oversight staff members have a lso been ca r r y ing out the batch-specif ic acceptable quality limit (AQL) tests after 1 0 0 % v i s u a l i n s p e c t i o n . T h is add it iona l ac t iv it y was introduced as a concrete action fol low i ng consu ltat ion w it h F DA, a nd for t he f irst t ime, concrete work steps were taken o v e r f r o m t h e p r o d u c t i o n department. • Special tasks. Shift support and obser vat ion of process steps and workflows can be realized in a targeted and topic-focused manner. Here, root causes and deficiencies can be recognized retrospectively and afterwards, p r o c e s s o p t i m i z a t i o n s c a n b e p r o s p e c t i v e l y id e nt i f i e d a n d d e v e l o p e d . F o r t h i s pu r p ose, det a i le d c he c k l i st s are prepared, a representative number of affected processes observed, and the observations a n a l y z e d — i d e a l l y d u r i n g d i f f e r e n t s h i f t s a n d w i t h different operators. • P r o c e s s i n g o f i n t e r n a l n o n c o n f o r m i t y p r o c e s s e s . Additional further development o f t h e q u a l i t y o v e r s i g h t f unction is the processing of noncon for m it y processes by staff members. They coordinate the root- cause investigation, a ssess r i sk s, a nd c reate t he r e le v a nt r e p or t s . Mor e ove r, they initiate CAPA actions. The nonconformit y processes can be processed in a high-quality manner as the quality oversight staff members are experienced and know the processes well. A benefit of this procedure is t hat t he sta f f members who were on site when the relevant n o n c o n f o r m i t y o c c u r r e d a l s o wo r k d i r e c t l y o n t h e nonconformity process. CHALLENGES T he establishment of a qua lit y oversight team requires persua- s io n a nd p e r s e ve r a nc e . W h at seems to be a formal process on paper may, in practice, present one or more obstacles. Some of t he most i mpor ta nt challenges that need to be con- side re d whe n est abl ish i ng t he function are listed as follows: • Consistent personnel composition. R e q u i r e d p e r s o n n e l expenditures must be calculated depending on the number of produc t ion sites, produc t ion l i ne s, a nd sh i f t s, i nc lud i ng t he releva nt sh i f t model. A calculation of how many staff members ca n idea l ly ensu re complete site and shift coverage should be made. An important note: sickness and vacation days must be taken into account, which is often a challenge in the case of small teams. The possible consequence is that shifts are i nsu f f ic ient ly sta f fed or not covered at all during certain times. Sufficient staffing applies, in particular, to production sites that are operated around the clock. Because the personnel are an important cost factor, feasible solutions must be found for this cha l lenge. Person nel shou ld only be expected to deal with a certain degree of rescheduling, which must be accord ing to labor laws. • A c c e p t a n c e i n t h e p r o d u c t i o n depar tment and communication. Perhaps the biggest challenge is that the quality oversight staff members' function needs to be accepted in the operative areas. W hen qualit y oversight staff members observe, check, and correct established processes and work steps, it could potentially irritate operators, resulting in d i s c u ssion s c i rc l i ng a rou nd e x p e r t i s e a n d e x p e r i e n c e . More ove r, qu a l it y ove r sig ht c a n b e m i s u nde r sto o d a s a cont rol l i ng i nsta nce a nd b e rejected in general. But what does t h is mea n in prac t ice? O f c o u r s e , t h e m a n n e r i n which a company has already de a lt w it h noncon for m it ie s p l a y s a n i m p o r t a n t r o l e . Tact is necessary in this case, a n d d e f i c i e n c i e s m u s t b e d i p l o m a t i c a l l y a d d r e s s e d . Moreover, a ll sta f f members must know that observations a n d t h e i r d o c u m e n t a t i o n are not an end in themselves. T heir pr ima r y pu r pose is to improve quality understanding, compliance and, consequently, The timely documentation of observations, the assessment of irregularities, and the documentation of quality-relevant decisions are important aspects of quality oversight.

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