Thursday, March 24, 2011
RAW MATERIAL QUALITY CONTROL and related terminology
Quality control sample — an uncontaminated sample matrix spiked with known amounts of analyses from a source independent of the calibration standards. Generally used to establish intra- laboratory or analyst-specific precision and bias or to assess the performance of all or a portion of the measurement system.
Quality management plan — a document that describes the quality system in terms of the organization’s structure, the functional responsibilities of management and staff, the lines of authority, and the interfaces for those planning, implementing, and assessing all activities conducted.
Quality system — a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out quality assurance procedures and quality control activities.
RAW MATERIAL QUALITY CONTROL:
High quality of raw material is the prerequisite of a good manufacturing practice. There is a possibility of major accidents due to contaminants in the raw materials. All raw materials, reactants, intermediates, products and by-products known and can be retained safely without a deterioration in plant integrity. Requirement of emergency procedures, systems and provisions in place, to deal with events, result from raw materials control failure.
Factors affecting raw material control/sampling:
1. Human factors: Human error during acceptance of delivery and sampling.
2. Poorly skilled work force: Incompetent quality control staff.
3. Unconscious and conscious incompetence: Failure of quality assurance procedures
4. Wrong material used in wrong place: Failure to understand the properties of substances handled.
5. Contaminated or out of specification material: Contaminant entering the plant for example, flammables in non-flameproof areas, oxidisers mixing with flammable solvents. Failure to identify all credible contaminants and resultant reaction pathways that could disrupt the integrity of the plant involved.
The staff should be sufficiently informed, instructed, trained and supervised to minimise a potential human failing during raw material delivery, test and storage.
Sufficient chemical inventory of all chemicals should be used on site.
The suitable quality assurance procedures should be observed in place of testing all incoming raw materials on site.
Validated quality control test methods and equipment should be employed to identify any potentially hazardous contaminants present within a raw material delivery. Prevent contamination during storage.