Author: Monica
Product specification
helps in identifying an individual sample product by providing a detailed information and describing the characteristics of the product. The information provided in a product specification allows the stringent quality aspects to be met so that quality product can be produced. It helps to convey the ideal and expected products aspects so that technicians or workers in the manufacturing plant can follow. This ensures uniformity among manufactured products, allowing customer satisfaction. Therefore it helps attain its objective in ensuring that the product stays consistent every time, so as to earn the trust and continued customer’s loyalty.
A product Specification is a company’s Food Standard and a Trade Specification. It bears the statements of the attributes of the product and manufacturing process. By setting specifications, the manufacturer has control over the quality of raw materials and out-going quality of finished product. These specifications and standards will eventually become Standard Operating Procedures (SOP) for the operation departments as they provide information and parameters for the desirable qualities of finished products (Shahidi, 2004).
Sampling is the selection of a small segment of the product to represent the quality of the larger segment of the product. The objective of sampling is to decrease the size of the batch so as to make it more appropriate for laboratory testing and satisfy the sampling plan specifications (Bower,. 2009). There are many types of sampling plan such as Military Standard, Single and Double sampling plan and Second and Third class sampling plan.
In Two and Three Class Sampling Plans, some of the notations are being used to represent certain items:
• n – number of samples that is being tested.
• c – maximum allowable number of sample(s) that gives results that are of unsatisfactory.
• m – upper microbiological limit of the Good Manufacturing Practice (GMP)
• M – (applicable for 3rd class sampling only) limit beyond which the microbial count is considered hazardous or unacceptable.
Sampling methods
A single sampling plan decides to accept or reject the batch based on the examination of a single sample while a double sampling plan involves the inspection of a first sample and a second sample for rejection or acceptance after deciding to accept or reject the first sample (Schilling, 2009).
Random sampling is a method used to select a set of product from the batch to be examined in such a way so that every product in the batch had an equal opportunity to appear in the sample.
Cluster Random Sample is a technique that is used when the population is naturally divided into many clusters. The number of units within clusters is the same as the number of units between clusters. In such conditions, cluster random sample can give an estimation of the population mean that is much accurate as compared to performing a single random sample based on the same sample size (Beri, 2010).
Types of Sampling Plan
Systemic Random Sampling is a sampling that “spreads out” the random selection process so that no two random samples are too close together and it avoids grouping within the sample. The sampling of food can also be done this way, but if there are periodic differences, the data will be misleading (Hubbert, 2003).
A two class sampling plan is a simple plan used to select an acceptable or reject a whole batch of food while a third class sampling plan is used to select an acceptable, marginally acceptable or even unacceptable food of a batch of product.
A military standard creates a batch sampling plan for the examination of the product so as to decide whether to accept or to reject the batch of product (Bower, 2009).
The purpose of microbiological testing is to determine the degree of bacterial contamination on surfaces of equipment, tools, and premises as well as in products.Only proceed to test for the microbial results when leakage is present and nitrate ix insufficient. Microbial testing can be done qualitatively as microbiological screening, for example by contact such as using an impression plate or quantitatively by determining the exact number of microorganism per sample unit (in cm2 or grams) by using the swab or the destructive method.
ISO Packaging
ISO (International Standardization Organization) 11607 Part 2 describes the validation requirements for forming, sealing and assembly processes of sterile barrier systems. The sterile barrier system (SBS) keep the contents sterile up to the point of use (Charles 2001). This protective packaging system is needed the configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of assembly until the point of use.
Examples of outer protective packaging are dust covers, or trays. Specific names of inner protective packaging material includes Multi Wrap Vacuum Pack MW/VAC. Documentation needs to clearly show the minimum requirements to prevent of ingress of micro-organisms (Debby, 2001).
Quality Control (QC)
ISO 8402 defines Quality Control (QC) as “the operational techniques and activities that are used to fulfill requirements for quality” (Vasconcellos, 2004.) . In the industrial manufacturing profession, quality is being defined in a variety of ways, mainly on product based, user-based, manufacture-based and value-based.
• Product based is the product’s properties or traits that add to the quality of the product.
• User-based quality of the goods is established by the customers.
• Manufacture-based abide international rules.
• Value-based is the incorporation of price into the definition of quality. Value of a product is made up of the cost and grade of product. It also made up of the cost and grade of product.
Conclusion
The consumer’s expectation of quality products have lead to the evolution of stringent checks such as Military standards that are available in 3 different categories mainly “Normal, Reduced and Tightened”. The acceptable level of results is given in range as it is impossible for every batch to abide to a specific result number during testing.
The Sampling plans on the same batch of product is used in different objectives, such as “Normal” is used during outgoing checks, but “Tightened” is used to re-examine products when complaints are received.
Although there may be hidden cost from the maintenance of Quality Control (using Total Quality Management) and abide of ISO packaging requirements, in the long run, the manufacturing company still benefits compare to the additional cost that will incur due to product recall and product re-examination.
Thorough checks have to be checked right from the beginning. It allows safe in-coming materials and high quality out-going materials.
