The principle underlying contract production should be very simple and easy to understand. The work has to be well-defined, agreed upon and controlled to avoid misunderstandings. There has to be a written contract and documentation specifying the duties of all parties and the standards that must be met, to avoid such misunderstandings. The course of action after the rejection of materials or products should also be specified in the contract.
The contract giver (client/company) is accountable for examining the competence of the proposed contract accepter, that the work assigned can be carried out or not. This analysis must include an assessment as to whether the organization is able to operate as per the GMP principles. The contract accepter must also look that the necessary facilities to undertake the work and should have a manufacturing authorization to carry out the work.
7.4.8 Inspection, Supplier's Audit and Approval
Self-inspection Self-inspections should be conducted in order to monitor the implementation of GMPs. A team of experts may be constituted to conduct regular self-inspections. The frequency of inspections may depend upon the company’s requirements but should preferably be at least once a year. Self-inspection findings and the corrective actions should be recorded and management should follow up actions based on the reports and findings. The inspection/reviews should normally be conducted to verify the consistency of the product. The following evaluation may be carried out:
(a) Results from the in-process control and finished product test
(b) Processes, which failed to perform
(c) Products, which failed to meet specifications
(d) Any changes, carried out in the process
(e) Complaints and recalls
(f) Stability studies
Supplier's Audit and Approval In general, the person responsible for maintaining the quality should be involved along with other relevant departments for approving suppliers, who can supply materials of desired specifications. The suppliers of raw materials, used in the root and tuber produce, must submit documented proof of conformity. This should be a guideline in contractual arrangements with the suppliers:
• The processing plant should demand that the suppliers, without any delay, inform the processing plant, and bring up to date the food contract documentation, when there is a change of the raw material and/or additives.
• The details of the end produce, showing raw materials and additives used in the process, must be compiled as a check to allocate accountability to a supplier in the case of sub-standard raw material.
• The suppliers must be evaluated before their approval based on the supplier’s history and the nature of the materials is supplied.
• The practice of supplier audit is difficult to conduct, especially when the supplier is not interested in carrying out the business with the company. This difficulty may be more complex with companies dealing with small business volumes. In these cases, the suppliers can be approved based on their history and list of customers, dealing with the suppliers. Another approach may be to form a group of small companies, which can have an audit for the approval of suppliers.
7.4.9 Personnel and Training
Personnel The organization and maintenance of an adequate root and tuber production system and the correct manufacture and control of products is reliant upon personnel. The employee needs to have the qualifications, skills and knowledge with the right tools to enable them to develop a GMP in the organization (Karmacharya, 2012). The following points need to be considered:
• The responsibilities of the individuals should be defined and clearly recorded. It should be ensured that the responsibilities are understood to the employees.
• All personnel should be encouraged to support the enterprise and maintain high quality standards within the processing facility.
• The key personnel should further have good practical experience in the manufacture and quality assurance of the root and tuber product being processed.
• Unauthorized people should be prevented from entering the production, quality control and storage areas.
Training Requirements The root and tuber processor should provide training in accordance with a written procedure to the personnel involved in the production process. The following points may be considered:
• The employee should receive training appropriate to their assigned duties. The requirements of training should be clearly defined to ensure that staff ability and training are matched.
• The employee should be receptive to the principles of GMP that concern them and get continuous training to their requirements. Training must be documented to enable management to corroborate that staff are adept to conduct the responsibility requisite of them.
• The degree of training required for each practice should be defined to ensure that the ability of an employee and training are matched to procedural requirements.
Besides the above, the requirements needed to be charted, planned and put into practice are given in Table 7.7.
Table 7.7 Requirements to be put into practice
S. no. | Requirements
1 | Investigate the training requirements,
2 | Institute a training design with clear purpose.
3 | Perform the training.
4 | Measure the result.
5 | Appraise if the learners have obtained the required proficiencies.
6 | Quantify.
Training requirements must be regularly updated so as to give consistent results. Training should be established at all levels by identifying the gaps. The skill requirements in different areas within the root and tuber processing plamt can be observed, as per the given elements in Table 7.8.
Table 7.8 Skill requirements in various areas
S. no. | Required Skills | Areas
1 | Communication Skills | Oral, written and presentation • Negotiation art • Language
2 | Leadership skills | Training • Team work • Motivation • Facilitation • Feedback
3 | Process Skills | Quality planning • Preparation of proposals • Process management • Problem solving • Decision management • Risk analysis and management
4 | Manufacturing skills | Formulation and manufacturing procedures for R and T products • Statistical quality control • Equipment parameters • Processing parameters for R and T • Monitoring environment
5 | Food microbiology and food chemistry | Good laboratory practices • Automation of various instruments • Methods development • Validation of methods
6 | Auditor skills | Process/system approach
7 | Supplier/contractor/third parties | QA of suppliers • QA of third parties
8 | Quality systems | Product reviews • Complaints and failure investigations • Product release • Training • Material decisions • Review • Recall
9 | Customer awareness | Calibration and maintenance Handling customer complaints • Customer visits • Market surveys • Bench marking
7.4.10 Premises
Premises should be of appropriate size and located, designed, constructed, adapted and maintained to suit the different operations (Karmacharya, 2012). The features which should be focused upon in the premises for the root and tuber processing are given in Table 7.9.