Chapter 4
Directive and Supportive Roles of Management
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G. Burnett, J . W. Smith, W. B. Nixon, and P. M . Hernan Agricultural Division, Quality Assurance Unit, Ciba-Geigy Greensboro, NC 27419
Corporation,
Management has both directive and supportive responsibilities for the operations of the quality assurance unit to fully achieve compliance with Good Laboratory Practice regulations (1,2). The tone for the entire testing facility is set by management since it is their ultimate responsibility to establish and endorse procedures and policies which ensure a commitment to quality. Responsibilities that management must meet for its quality assurance function can be broadly categorized as directive and supportive. These responsibilities must be executed by management by defining and implementing programs, including the establishment of a quality assurance program, to guarantee that a l l studies that management sponsors or conducts are in compliance with Good Laboratory Practice (GLP) regulations. It is management that establishes and endorses the concept of quality which is the cornerstone upon which GLP compliance is built. In accordance with GLP regulations, management must establish a quality assurance unit (QAU). Management must decide on the number of personnel required to provide effective and complete quality assurance. Further, management must ascertain the qualifications and training needed for personnel in the unit to perform effectively. Considerable thought, and foresight are required to structure a QAU which serves as an effective management tool. The QAU is responsible by being an independent observer, for monitoring nonclinical studies for GLP compliance and reporting to management the results of these monitoring activities. Management must rely upon its QAU to provide judgements whether research is being conducted according to applicable guidelines and regulations. Unbiased and accurate information is essential to allow management to make informed judgements on the quality of the studies conducted and the overall performance of their testing facility. Management must position the QAU within the hierarchy of the organization to vest it with sufficient authority to perform its management defined functions. Further, in order for the QAU to
0097-6156/88/0369-0024506.00/0 © 1988 American Chemical Society In Good Laboratory Practices; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
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4.
BURNETT ET AL.
Directive and Supportive Roles
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maximize i t s e f f e c t i v e n e s s , the u n i t must be p o s i t i o n e d s e p a r a t e from p e r s o n n e l c o n d u c t i n g or d i r e c t i n g s t u d i e s i n the o r g a n i z a t i o n a l s t r u c t u r e such t h a t the u n i t can be unbiased i n judgements o f the GLP compliancy o f the s t u d i e s a u d i t e d and f a c i l i t i e s inspected. A f t e r a QAU i s e s t a b l i s h e d and p r o v i d e d w i t h adequate numbers o f q u a l i f i e d p e r s o n n e l , management has the s u p p o r t i v e r o l e o f p r o v i d i n g t r a i n i n g to c o n t i n u a l l y upgrade the s k i l l s o f the QAU s t a f f . T h i s i s p a r t i c u l a r l y i m p o r t a n t as management r e d e f i n e s i t s expect a t i o n s o f the QAU. T h i s s h o u l d be a c c o m p l i s h e d by p r o v i d i n g c o u r s e s , a t t e n d a n c e at p r o f e s s i o n a l m e e t i n g s , promoting peer i n t e r actions, etc. Management i s r e s p o n s i b l e f o r the e v a l u a t i o n o f the QAU's a b i l i t y to p r o v i d e e f f e c t i v e q u a l i t y a s s u r a n c e . S i n c e management r e l i e s on the QAU f o r i n p u t on the GLP compliance s t a t u s o f the t e s t i n g f a c i l i t y o p e r a t i o n s and study c o n d u c t , and must make d e c i s i o n s based on t h i s i n f o r m a t i o n , management must be c o n f i d e n t o f the v a l i d i t y and a c c u r a c y o f the QAU's f i n d i n g s and recommendations. Thus, management must p e r i o d i c a l l y m o n i t o r the a c t i o n s o f the QAU and conduct r e v i e w s o f i n t e r n a l QAU SOPs. Management's assessment program s h o u l d i n c l u d e a r e v i e w o f QAU p e r s o n n e l r e c o r d s to d e t e r m i n e t h a t the s t a f f i s w e l l - q u a l i f i e d , a d e q u a t e l y t r a i n e d and i n s u f f i c i e n t number. Management must a l s o examine the QAU's adherence to r e g u l a t o r y r e q u i r e m e n t s , a b i l i t y t o a d e q u a t e l y defend company GLP and q u a l i t y a s s u r a n c e programs and adherence to QAU SOPs and m o n i t o r i n g s c h e d u l e s . In a d d i t i o n , management needs t o r e v i e w the completeness and a c c u r a c y o f QAU r e c o r d s and r e p o r t s , and the a b i l i t y o f the u n i t t o e f f e c t i v e l y i n t e r a c t w i t h a l l l e v e l s o f the o r g a n i z a t i o n n e c e s s a r y to a c c o m p l i s h the q u a l i t y a s s u r a n c e function. The e v a l u a t i o n program s h o u l d determine whether the QAU i s p e r f o r m i n g as d e s i r e d . Management s h o u l d d e v e l o p , d u r i n g the QAU assessment, recommendations t o improve the o v e r a l l e f f e c t i v e ness o f the QAU o p e r a t i o n and s c h e d u l e programs to implement the recommendations. The most important s u p p o r t i v e r o l e o f management i s the c o r r e c t i o n o f d e v i a t i o n s from GLP r e g u l a t i o n s r e p o r t e d by the QAU. Management must d e s i g n , implement, e n f o r c e , and, i f n e c e s s a r y , a l t e r e x i s t i n g p o l i c i e s and p r o c e d u r e s to p r e v e n t r e c u r r e n c e o f reported deviations. Management must a c t promptly upon the f i n d i n g s r e p o r t e d by the QAU and ensure adequate r e s p o n s e s by study personnel. Only management has the a u t h o r i t y to ensure t h a t d e v i a t i o n s a r e c o r r e c t e d , o r , when n e c e s s a r y , t h a t o p e r a t i o n a l p r o c e d u r e s are changed. T h i s r o l e o f management s u p p o r t o f the QAU m i n i m i z e s the p o t e n t i a l f o r a d v e r s a r i a l r e l a t i o n s between study p a r t i c i p a n t s and QAU p e r s o n n e l . Another s u p p o r t i v e r o l e t h a t management must a c c e p t i s the p r o v i s i o n f o r a d d i t i o n a l r e s o u r c e s when QAU r e s p o n s i b i l i t i e s are i n c r e a s e d e i t h e r by management, by r e v i s e d or new r e g u l a t i o n s , or by i n c r e a s e d study w o r k l o a d s . Such r e s o u r c e s i n c l u d e p e r s o n n e l , o f f i c e space, equipment, c l e r i c a l s u p p o r t , e t c . Management must c o n t i n u a l l y r e v i e w and b a l a n c e the a l l o c a t i o n o f r e s o u r c e s t o the q u a l i t y a s s u r a n c e and s c i e n t i f i c study areas to e f f i c i e n t l y o p e r a t e w i t h the d e s i r e d l e v e l o f q u a l i t y .
In Good Laboratory Practices; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
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GOOD LABORATORY PRACTICES GLP r e g u l a t i o n s f u r t h e r charges management to e s t a b l i s h a r c h i v e s f o r the o r d e r l y s t o r a g e and e x p e d i e n t r e t r i e v a l o f study r e c o r d s , raw d a t a , and/or specimens. S i n c e most o r g a n i z a t i o n s choose to s t r u c t u r e the a r c h i v e f u n c t i o n under the a u s p i c e s o f the QAU, management not o n l y has the same d i r e c t i v e and s u p p o r t i v e r e s p o n s i b i l i t i e s f o r the a r c h i v e s as i t does f o r the QAU, but has a d d i t i o n a l r o l e s . Management must p r o v i d e the n e c e s s a r y f a c i l i t i e s f o r s t o r a g e o f a l l raw d a t a , study conduct d o c u m e n t a t i o n , or specimens under c o n d i t i o n s which m i n i m i z e s d e t e r i o r a t i o n d u r i n g retention. A r c h i v e f a c i l i t i e s must have adequate f i r e p r o t e c t i o n , the c o n t e n t s p r o p e r l y i n d e x e d , and e n t r y l i m i t e d to a u t h o r i z e d personnel only. Management must a l s o i d e n t i f y an i n d i v i d u a l to be r e s p o n s i b l e f o r the a r c h i v e s . In summary, management must p e r f o r m both d i r e c t i v e and s u p p o r t i v e r o l e s i n q u a l i t y a s s u r a n c e programs. Management d e c i s i o n s made r e g a r d i n g the QAU s t a f f i n g l e v e l , q u a l i f i c a t i o n s o f the QAU s t a f f members, and p o s i t i o n o f the QAU w i t h i n the o r g a n i z a t i o n p r o v i d e the b a s i c d i r e c t i v e s which lead to GLP c o m p l i a n c y . The s u p p o r t i v e r e s p o n s i b i l i t i e s o f u p g r a d i n g the s k i l l s o f QAU s t a f f members, e v a l u a t i o n o f t h e i r e f f e c t i v e n e s s , c o r r e c t i n g d e f i c i e n c i e s r e p o r t e d by the QAU, and c o m m i t t i n g the n e c e s s a r y l e v e l o f r e s o u r c e s to q u a l i t y a s s u r a n c e f u n c t i o n s p r o v i d e e s s e n t i a l elements f o r e f f e c t i v e QAU operation.
Literature Cited 1. 2.
Fed. Reg. 1978, 43, 59986-60025. Fed. Reg. 1983, 48, 53946-69.
R E C E I V E D January 29, 1988
In Good Laboratory Practices; Garner, W., et al.; ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
