While working in any organization whether manufacturing or services one will encounter the specifications and standards in any case. But QA people has more concerns about these as these are the people how are responsible not only for implementation but also for the development of some specification. Before going in detail of this subject it is essential to have the exact idea that what are specification and standard.
Specification is a typically company document with set parameters for an item, activity, product, step while standard is typically specification/parameters applicable to many things or type of things. Standard will have some sort of QA associated with it like accreditation and certification program. Standard can also be described as a set of technical definition and guidelines that functions as instruction for manufacturer of anything. So a standard is generally applicable to various type of organization like ISO 9001 is a standard which is applicable to all types of organization. When any standard is adopted by any governmental institution and enforced by law or incorporated in the business contract agreement, then it becomes the code of practice. So in summery while working QA person must have some
1. Specification (standard specific to some specific product in an organization)
2. Standards (voluntarily applicable) and
3. Code of practices (Standard enforced by law)
HOW WE CAN DEVELOP SPECIFICATIONS:
It’s a very important job for quality assurance or processing person to develop various type of specification for the manufacturing of product or procuring of specific type of material.
The possible approaches in this regards are as under
1. Literature review
2. Competitor’s product analysis
3. Previous data analysis
4. Legal requirements
5. Supplier’s provided information.
6. Mix approach
1. Literature review:
Literature review is somewhat difficult option, because this requires a lot of efforts for collection and then its review to have some desired information. This approach requires lot of time and suits in the situation for development of new system.
2. Competitor’s product analysis:
After collecting samples of specific type of products or materials these are then analyzed, and then specifications are finalized on the basis of these analyses. This is very easy approach and requires very less time.
3. Previous data analysis:
Whether any organization has developed some specification or not still they perform some test at various stages of product production or at the time of material procurement. So most of the organization having this type of data. To establish the specification one could analyze that data and on the basis of the results obtained one can develop his own specification. This approach requires some time to collect the data and then analyze it using the desired quality toll to have some specific type of information. But the specifications developed on this basis are more realistic and more applicable.
4. Legal standards:
Sometimes all the organizations produced or procure some material as per some legal obligation. Which may be either?
• Or international
So one can also develop some of its specification by studying all applicable regulation. Whatever the approach is adopted to develop specification finaly you have to match these with applicable regulation especially the local and national.
5. Supplier provided specification/information:
This is one of the easiest approaches to develop your own specification. This approach is mostly used for specification development for storage. Sometime this approach can also be used to develop the specification for raw or packaging material by collecting the information from various specification provided by the various type of supplier for specific type of marital.
6. Mix approach:
Sometimes one should see, all applicable standard, review of literature and previous available data, supplier’s provided information and competitor’s product analysis to develop their own specification. The specification developed in this way having more trust in it.
NEEDS OF SPECIFICATIONS DEVELOPMENT:
We need to develop specifications of following
1. Raw or packaging materials
2. Storage conditions
3. Semi finished products
4. Finished product.
5. Manufacturing practices like GMPs.
6. Analytical procedure
Specification development actually eases daily routine work,
1. These helps to negotiate with the supplier of materials.
2. These also help to resolve the issue between various departments.
3. Approved specifications provide you the sound ground to discuss various issues with the management. These also help to give the training to existing staff and also help to train the new staff.
4. These also provide the sound ground of procuring staff for price negotiations.
5. These also help to reduce the quality issue at every stage of product development.
6. These also help to reduce the losses.
7. Appropriate time usage at all stage.
While developing specifications one should consider following
• General Safety standard
• Food Safety
• Process capability
• Quality and
1. General Safety standards: Pallet heights, non reactive container, are some of the thing need to be specified as per the general safety standards.
2. Food Safety: the level of safety required in raw material or processing step. E.g. safe limits of raw material as per food safety management system (HACCP or ISO 22000). Safety required as per the final consumer. E.g. if product is consumed by infants more safety precautions needs to be indulged in specification at every step of processing or procuring of some specific type of material.
3. Availability: while developing the specification especially for raw or packaging material one must consider the standard on which it is most commonly available in market. E.g. mango pulp Is mostly available in market with Brix ranging from 14-16, so if we develop mango pulp specification with 17-18 Brix it means we have to develop some specific supplier for this and hence we are limiting the availability of pulp. Rather it is best approach that we specified that the Brix required is 14-16.
4. Legality: some times while developing the specification we have to see the legality issue. For example the pasteurization stand for milk for microbiology may vary from country to country or region to region. So in specification we have to specify any parameter as per the legality.
5. Process capability: this is also a very important consideration during the development of specification either for raw material or processing step. E.g. separator could not remove all fat from milk during separation, it means at the end skim milk must have some fat percentage. So we could not specify that skim milk has zero percent fat. In the same way while specifying homogenization standard for milk we could not specify the homopressure which homogenizer could not produce.
6. Quality, Cost & Usability: quality and cost are interlinked; good quality more cost and vice versa. So before specifying anything one should have to see the cost implication and usability. E.g. crystal white sugar though having more cost are good in quality as compared with the dull colored sugar. So before specifying the color of sugar we must need to consider the usability of sugar, like either it would be used in beverages, as we can use dull colored sugar in beverages very easily.
7. Handling: as per the easy handling we need to specify the packaging requirement for any kind of raw materials taking in consideration the cost implication. E.g. guava pulp is available in small can and also in drums. Some companies have system to open the small cans so these companies can handle these can very easily while other don’t have that system so in that case we need to specify the pulp in drum.
Shahid Hafeez Khan,
Quality Assurance & Product Development Manager,
A’Safwah Dairy & Beverage Company, subsidiary of DCF Co.(SAOG)
Salalah, Sultanate of Oman.