Chapter 15
Quality Assurance in Contract Laboratories Downloaded by UNIV OF MASSACHUSETTS AMHERST on May 30, 2018 | https://pubs.acs.org Publication Date: May 11, 1988 | doi: 10.1021/bk-1988-0369.ch015
Commitment to Excellence Charles R. Ganz and Kathleen H . Faltynski EN-CAS Analytical Laboratories, 2359 Farrington Point Drive, Winston-Salem, NC 27107 The present paper discusses one contract laboratory's approach to setting up and operating a successful quality assurance (QA) program. The discussion -focuses on the QA philosophy of the laboratory, the ingredients included in the QA program to help make it viable, and the responsibilities which both sponsor and contract laboratory must accept in order to optimize the contracting relationship and produce quality studies. The main product of the contract analytical laboratory is numbers. A number is an abstract entity. Unlike more tangible items, its quality cannot be estimated by conventional means such as taking it for a test drive or plugging it into an electrical outlet to see if it operates. In order to evaluate the quality of a numerical result, a sponsor must look beyond the number itself to the 1aboratory which generated i t ; to its people, its integrity ... in short, its commitment to excellence. What Constitutes Excellence What constitutes excellence? In rather simple terms, excellence in the contract laboratory can be defined as producing work which consistently meets high standards of quality. Emphasis is placed on consistency since without this factor the sponsor's confidence and trust in the laboratory will quickly evaporate. In more specific terms, a contract laboratory committed to quality work should perform its work in a way which builds and maintains mutual confidence between sponsor and laboratory. At a minimum, the laboratory should strive to ensure that the work being done satisfies the sponsor's study objectives and is produced promptly and accurately. In addition, frequent communication between the contract laboratory and the sponsor helps to assure the sponsor that adequate progress is being made and that problems are being 0097-6156/88/0369-0107$06.00/0 © 1988 American Chemical Society Garner and Barge; Good Laboratory Practices ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
Downloaded by UNIV OF MASSACHUSETTS AMHERST on May 30, 2018 | https://pubs.acs.org Publication Date: May 11, 1988 | doi: 10.1021/bk-1988-0369.ch015
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promptly addressed. L i k e w i s e , the p r e s e n c e of wel 1-documented r e s u l t s and w e l l - o r g a n i z e d s t u d y - f i l e s g i v e s the s p o n s o r a s t r o n g i n d i c a t i o n t h a t t h e i r s t u d y i s b e i n g p r o p e r l y c o n t r o l l e d and managed. F i n a l l y , t h e c o n t r a c t l a b s h o u l d make a c o n c e r t e d e f f o r t to a s s e s s the s c i e n t i f i c v a l i d i t y and r e a s o n a b l e n e s s of the a n a l y t i c a l d a t a b e f o r e r e p o r t i n g i t to the s p o n s o r . R e p o r t i n g of o b v i o u s o u t l i e r s can q u i c k l y erode a s p o n s o r ' s c o n f i d e n c e in the l a b o r a t o r y ' s d a t a r e v i e w p r o c e s s and t h u s in the s t u d y ' s r e s u l t s . T h e r e i s a g r o w i n g t e n d e n c y on t h e p a r t o f a n a l y t i c a l l a b o r a t o r i e s t o a c c e p t r e s u l t s g e n e r a t e d by s o p h i s t i c a t e d i n s t r u m e n t s a n d computers as i n h e r e n t l y c o r r e c t . A l l t o o o f t e n c o n c e p t u a l and manipulative e r r o r s (misplaced decimal p o i n t s , t r a n s p o s i t i o n e r r o r s , f o r g o t t e n d i l u t i o n s , e t c . ) a r e h i d d e n b e n e a t h t h e p r ima f a c i e v a l u e c a l c u l a t e d by the c o m p u t e r . The l a b o r a t o r y ' s s t u d y d i r e c t o r and d a t a r e v i e w e r s , b e f o r e g i v i n g f i n a l a p p r o v a l t o a s t u d y , s h o u l d l o o k at the r e a s o n a b l e n e s s of the r e s u l t s in terms of e x p e c t e d t r e n d s or r e s u l t s . F i n d i n g s such as s i g n i f i c a n t l y higher or lower than a n t i c i p a t e d r e s i d u e s , or i n v e r s e r e l a t i o n s h i p s between a p p l i c a t i o n r a t e s or t i m e - a f t e r - a p p l i c a t i o n and r e s i d u e s f o u n d , s h o u l d prompt the l a b o r a t o r y t o i n s p e c t the s a m p l e s , sample h i s t o r y , a n d t h e a n a l y t i c a l d a t a t o e n s u r e t h a t no p r o c e d u r a l e r r o r s are e v i d e n t . T h i s may i n v o l v e r e a n a l y z i n g s e l e c t e d s a m p l e s to o b t a i n c o n f i r m i n g r e s u l t s . I f no e r r o r s a r e f o u n d t h e n a d i s c u s s i o n o f t h e f i n d i n g s w i t h t h e s p o n s o r may l e a d t o a p o s s i b l e e x p l a n a t i o n f o r the i n c o n s i s t e n t d a t a . Some common o c c u r r e n c e s w h i c h we h a v e f o u n d r e s p o n s i b l e f o r i n c o n s i s t e n t r e s u l t s i n c l u d e l a b e l i n g e r r o r s , a c c i d e n t a l i n t e r c h a n g e of samples d u r i n g c o l l e c t i o n or p r o c e s s i n g , n o n - r e p r e s e n t a t i v e s a m p l e s , l a b or f i e l d c o n t a m i n a t i o n , u n u s u a l b i n d i n g of a n a l y t e t o s u b s t r a t e and i n c o r r e c t c o m m u n i c a t i o n of a c t i v e i n g r e d i e n t c o n t e n t by the sponsor. The a b o v e l i s t i n g s u g g e s t s t h a t t h e i n f o r m a t i o n a l a n d m e c h a n i c a l , as w e l l as the s c i e n t i f i c a s p e c t s of the work must a l l be o p t i m i z e d t o e n s u r e r e s u l t s o f c o n s i s t e n t q u a l i t y . What M a k e s E x c e l l e n c e
Happen
The a c h i e v e m e n t o f e x c e l l e n c e r e q u i r e s a c o n c e r t e d e f f o r t a n d commitment at a l l l e v e l s of the o r g a n i z a t i o n . Management must i n i t i a t e t h i s e f f o r t by m a k i n g i t c l e a r t o a l l p e r s o n n e l t h a t q u a l i t y i s the o v e r r i d i n g o b j e c t i v e of the o r g a n i z a t i o n . ( A l t h o u g h , i n a c a p i t a l i s t s y s t e m , p r o f i t i s s a i d t o be t h e p r i m a r y o b j e c t i v e of a commercial e n t e r p r i s e , in our e x p e r i e n c e , q u a l i t y a n d p r o f i t seem t o g o h a n d i n h a n d ) . Management's commitment must g i v e more t h a n j u s t l i p s e r v i c e t o t h e i d e a o f q u a l i t y . Its c o m m i t m e n t m u s t be b a c k e d up b y a c t i o n s t h a t d e m o n s t r a t e t o t h e s t a f f t h a t management i s w i l l i n g t o pay the p r i c e of r e j e c t i n g and r e w o r k i n g r e s u l t s t h a t do n o t m e a s u r e up t o t h e laboratory's quality standards. The c o m m i t m e n t e q u a t i o n i s c o m p l e t e o n l y when the l a b o r a t o r y ' s s t a f f f u l l y a c c e p t the i m p o r t a n c e of the q u a l i t y o b j e c t i v e t o the s u c c e s s of the o r g a n i z a t i o n . To e n s u r e the g r o w t h of the q u a l i t y o b j e c t i v e , management must r e s i s t both i n t e r n a l and e x t e r n a l p r e s s u r e s w h i c h might s u b v e r t its
Garner and Barge; Good Laboratory Practices ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
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goals. Such p r e s s u r e s m i g h t i n c l u d e s t a f f r e s i s t a n c e and unrealistic deadlines. Once t h e c l i m a t e -for a c h i e v i n g e x c e l l e n c e i s c r e a t e d by management, t h e n the i n t r o d u c t i o n of a w e l l t h o u g h t - o u t q u a l i t y a s s u r a n c e
