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SECTION XIII QUALITY CONTROL
G M P 13.1 The q u a lity c o n tro l (Q C) p ro g ra m f o r each c a n n e d tun a m an u fac
tu rin g esta b lish m en t sh a ll b e d evelo p ed b y th e m a n u fa ctu rer a n d a p p ro ved b y th e c o m p eten t authority.
G M P 13.2 S ta f f resp o n sib le f o r Q C sh a ll b e specifica lly d esig n a ted a n d ap p ro p ria tely trained, w ith p e rio d ic u p g ra d in g to en su re th a t they rem ain a b rea st o f cu rren t know ledge. R e to rt su p erviso rs sh a ll b e tra in e d to m e e t th e sta n d a rd s req u ired b y th e co m p eten t authority.
Q C s ta f f sh a ll id en tify a n d app ro p ria tely m o n ito r in acco rd a n ce w ith esta b lish ed p ro c ed u re s, th e c ritica l co n tro l p o in ts in th e m a n u fa ctu rin g p ro cess.
G M P 13.3 Q C records m u st b e m a in ta in ed in an ap p ro p ria te m a n n er a n d b e a va ila b le f o r exam in ation b y m a n a g em en t a n d ap p ro p ria te g o v ern m en t reg u la to ry authorities.
R E A S O N
The quality and safety o f seafood products can be affected by a range o f different factors. The most important o f these include:
a) the characteristics expected o f the products themselves,
b) the characteristics o f the materials used to make them including ingredients, packaging and additives,
c) the conditions in which processing takes place, including the construction, equipping, maintenance, operation and sanitation of buildings, facilities and equipment,
d) the qualifications, reporting relationships and performance of personnel who perform work,
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e) the activities they perform, including work methods and equipment operating procedures, and
f) steps taken to preserve quality and ensure safety during post
p ro d u ctio n storage and d istrib u tio n , in clu d in g conditions of storage, inventory m anagem ent, shipping procedures and product recall.
A comprehensive quality m anagem ent program includes consideration o f all o f the following elements for each o f the factors listed above:
1. Specifying and defining the requirem ents set by the buyer, company, GMP and regulations,
2. Designation o f responsibilities for m eeting requirements, 3. Communication o f the requirements to people expected to meet
them,
4. D efinition o f system s for m easuring com pliance w ith the requirem ents,
5. Establishm ent o f guidelines and procedures for dealing with situ atio n s in w hich n o n -co m p lian ce is in d icated by the measurement system,
6. Im plem entation o f the system for m easuring compliance and o f the guidelines and procedures for dealing w ith non-compliance, and
7. V erification through docum entation, follow -up, audit and external evidence that specifications have been met and/or that appropriate procedures have been followed.
O f the above elements, the first five have customarily been referred to collectively as “quality assurance’, the sixth as “quality inspection and process control”, the seventh as “quality verification”; and the total as
“quality control”.
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Sensory evaluation of end product
Quality Control, or perhaps more appropriately “quality management”, in
volves planning, organizing and controlling operations to ensure that products consistently meet requirements set for them, whatever those requirements may be. In this context, quality management is not separate from but is an integral part of every management function. With respect to product quality and safety, it emphasizes prevention, rather than detection of problems and it should involve every person whose decisions and activities can affect the consistent meeting of requirements. It also involves the channelling o f raw materials into products for which they are most appropriate, considering the manufacturer's own needs to obtain optimum value from the raw material, process them efficiently, and satisfy the customers who will buy the products as well as any minimum requirements for product quality and safety set by regulatory authorities.
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Quality manuals
Quality record verification
