6. Plan de Operaciones
6.5 Planeamiento de la Producción
17. Management responsibility
ISO 9001 and ISO 22000 are based on the assumption of commercially operating companies with a central management. The management in most smallholder producer groups is divided over a daily management (General Manager) under supervision of a democratically chosen board and general meeting.
This chapter contains an interpretation of the ISO top management requirements, to help the board, general management and quality team with an easy set up of the management process, procedures, and prepare for management review (see chapter 16).
17.1 Quality management system planning
Management must ensure that:The planning is carried out to meet quality objectives;
The integrity of the systems is maintained when changes to the system are planned and implemented.
Management must plan implement quality planning for the activities and resources needed to satisfy the quality policy, objectives and requirements.
17.2 Responsibility, authority and communication
Top management must ensure that responsibilities and authorities are defined and communicated within the organization.
In practice, management delegates most activities to the Quality Team. That sounds simple, but the experience of the Twin/FTO program is, that most Quality Teams get the task, but not the authority or the resources (budget, time) to set up a quality management system. Result is that this is not perceived as a high priority with staff involved, and that in some cases little progress is booked with setting up quality management systems.
17.3 Human resources
Although human resource management is often delegated to a department office, it remains a key duty of top management to see to it that staff be competent on the basis of:
Appropriate education Training;
Skills; Experience.
Competence, training and awareness
To ensure competency of staff, an organization must: Determine competencies for different positions;
Provide training or other actions to satisfy competence needs; Evaluate the effectiveness of actions taken;
Ensure awareness of the relevance and importance of activities and contribution to achievement of objectives;
Maintain appropriated records of education, training, skills and experience.
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Annex 1 Terms and definitions
Definitions and notes in this annex are copied from ISO 9000:2000 and ISO 22000.Where necessary the author of this guidance document has added additional editorial notes.
Acceptable level: The level of a safety hazard which is considered to present an acceptable, low risk to the consumer. The acceptable level of the final product, sometimes referred to as a target level, should be stated in the product description and would normally be set at, or below, any regulatory limits. An acceptable level for a hazard at an intermediate step in the commodity flow diagram can be set higher than that of the final product, provided that the acceptable level in the final product will be achieved.
Competence: demonstrated ability to apply knowledge and skills (see also the definition for qualification).
Control (verb): To take all necessary actions to ensure and maintain compliance with criteria established in the Quality Management Plan.
Control (noun): The state wherein correct procedures are being followed and criteria are being met.
Control measure: Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
EDITORIAL NOTE 1: Control measure is a collective noun referring to preventive action Correction and Corrective Action.
EDITORIAL NOTE 2: The term “Control Measure” is not used in this guidance document because the author thinks is clearer to use the distinct terms “Preventive action”, “Correction” and “Corrective action”.
Control Point: A step which has been identified as carrying a risk of non conformity with the - quality objectives of the process.
EDITORIAL NOTE 1: Although often used, the term “Control Point” is not defined in ISO 9000:2000 or HACCP or ISO 22000.
EDITORIAL NOTE 2: Control Points are identified with the help of the hazard selection grid see section 10.7 and 10.8of this document. All activities carrying potential hazards with an result of 4 and more (or in the old hazard selection grid section 10.8 combination above LL, LM and ML), are considered as risks. Steps carrying risks should be brought under control by the organisation through control measures.
EDITORIAL NOTE 3: ISO 22000 does not speak about CP’s, but uses the term Operational PreRequisite Program (Operational PRP), see definition.
EDITORIAL NOTE 3: As the above terms cannot specifically be connected to individual steps in the process, and as the programs concentrate on food safety only, the author of this manual thought it best to work with the term CP in conjunction with Quality Management Plan. See the respective definitions.
Correction: action to eliminate a detected nonconformity.
NOTE 1: A correction can be made in conjunction with a corrective action. NOTE 2: A correction can be, for example, rework or re-grade or re-dry.
Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of control.
NOTE 1: there can me more than one cause of a non conformity.
NOTE 2: Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence.
NOTE 3: there is a distinction between correction and corrective action.
EDITORIAL NOTE 1: Corrections are associated with Control Points ánd with Critical Control Points, whereas Corrective Actions are only associated with Critical Control Points.
EDITORIAL NOTE 2: “Correction” is usually a physical action (rework, regrade, redry) and “Corrective Action” is usually action on paper (revise procedures or working instruction prevent recurrence).
Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a quality hazard to the final product or reduce it to an acceptable level.
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EDITORIAL NOTE 1: This guidance document concentrates on quality compliance instead of food safety only. Therefore the term “quality hazard” replaces the term “food safety hazard” (ISO 22000).
EDITORIAL NOTE 2: to stress the difference between CP and CCP, the words “to the final product” have been added.
Critical limit: A criterion which separates acceptability from unacceptability, when monitoring a CP or CCP.
Customer: organisation or person that receives a product.
Example: customer, client, end-used, retailer, exporter, beneficiary, purchaser. NOTE: a customer can be internal or external to the organisation.
EDITORIAL NOTE: in cooperatives, the members are important customers of the organisation’s services. See for instance most mission statements of the cooperatives. Customer satisfaction: customer’s perception of the degree to which the customer’s requirements have been fulfilled.
NOTE 1: Customer complaints are a common indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction.
NOTE 2: Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.
Decision tree: A series of questions linked diagrammatically to be answered with Yes or No. The answers determine which path is followed and which decision this leads to.
Deviation: Failure to meet a critical limit.
Document: Information and its supporting medium.
EXAMPLE: record, specification, procedure document, drawing, report, standard.
NOTE 1: the medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.
NOTE 2: A set of documents, for example specifications and records, is frequently called “ documentation”.
NOTE 3: Some requirements (e.g. the requirement to be readable) relate to all type of documents, however there can be different requirements for specifications (e.g. the requirement to be revision controlled) and records (e.g. the requirement to be retrievable). Flow diagram: A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.
Food safety: Freedom from environmental and other contaminants and sources of toxicity (physical, chemical and/or biological) injurious to health.
NOTE 1: Definition (EU) “Food shall be deemed to be unsafe if it is considered to be (a) injurious to health; (b) unfit for human consumption.” Regulation (EC) 178/2002, Article 14 gives a further detailed definition of food safety requirements.
Scope (EU) “Food safety is a result of several factors including the respect of mandatory requirements, the implementation of food safety programmes established and operated by food business operators and the implementation of the HACCP system.”
Food safety hazard: biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.
See also Hazard.
HACCP: A system that identifies, evaluates, and controls hazards which are significant for food safety.
Hazard: the potential to jeopardise quality. See also Food safety hazard
Monitor: Conducting a planned sequence of measurements to assess whether control measures are operating as intended and meeting specified limits.
Mycotoxin: refer to toxic substances produced by certain moulds and fungus during their metabolic cycles. Mycotoxins can be both harmful (Ochratoxin) and useful (penicillin) when ingested.
Ochratoxin A (OTA): is a mycotoxin produced by several species of the mould genera Aspergillus and Penicillium. It is acknowledged to be responsible for certain kidney
pathologies in pigs and is suspected of causing some human kidney pathologies. It has been shown in rats that OTA has carcinogenic and immunotoxic properties.
Prerequisite Program (Operational PRP): food safety basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for the production, handling and provision of safe end products and safe food for human
consumption.
EDITORIAL NOTE: PRP is a term used in ISO 22000 to refer to the control measures to bring food safety hazards under control. With that, PRP is a hotchpotch of CP’s, Critical Limits, Preventive Actions and Corrections. The HACCP methodology works with the term, General Control Measures, or for specific sectors the terms GAP GMP. These terms are synonymous to Operational PRP of ISO 22000.
As the above terms cannot specifically be connected to individual steps in the process, and as the programs concentrate on food safety only, the author of this manual thought it best to work with the term CP in conjunction with Quality Management Plan. See the respective definitions.
Preventive action: action to eliminate the cause for a potential nonconformity or other undesirable potential situation.
NOTE 1: There can be more than one cause for a potential nonconformity.
NOTE 2: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
Procedure: specified way to carry out an activity or a process. NOTE 1: procedures can be documented or not.
NOTE 2: when a procedure is documented, the term “written procedure” or “documented procedure” is frequently used. The document that contains a procedure can be called a “procedure document”.
Process: Set of interrelated or interacting activities which transforms inputs to outputs. NOTE 1: Inputs to a process are generally outputs of other processes.
NOTE 2: Processes in an organisation are generally planned and carried out under controlled conditions to add value.
Product: result of a process.
NOTE 1: there are four generic product categories, as follows: - services (to internal and external customers); - software (computer program, dictionary);
- hardware (coffee, cocoa beans, tea, nuts, engine mechanical parts) - processed materials (grind coffee, chocolate bars)
Qualification: an official record showing that you have finished a training course or have the necessary skills (Cambridge English dictionary) (see also the definition of competence). Qualified: having finished a training course, or having particular skills (Cambridge English definition).
Quality: refers to all those features of a product (or service) which are required by the customer.
NOTE 1: Quality today embraces in addition to product quality also:
- the service, organisational, management and in particular process quality; - the compliance with third-party specifications;
- the perception of its excellence at a competitive price; NOTE 2: Quality is associated with all the activities related to
- Standardisation;
- quality management/assurance as a strategic discipline in company management;
- quality control, certification and accreditation; - quality marks and labels etc.
NOTE 3: Quality has changed its notion:
- from product quality that needed to be inspected; - through process quality that needed to be controlled;
- to quality assurance systems as a behaviour or mode of thinking being an essential element of the company strategy.
Quality is thus integrated in the management strategy of an organisation/company based on the overall commitment of the whole management staff and labour force to continuously improve value for their customers, for the organisation/company itself, and the society as a whole.
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Quality Assurance System (QA): QA Systems enable the application and verification of measures intended to assure the quality and safety of food. They are required at each step in the food production chain to ensure safe food and to show compliance with regulatory and customer requirements.
NOTE 1: Quality Assurance Systems are part of the Quality Management. They define the organisational structure, the processes and procedures necessary to providing confidence that quality requirements will be fulfilled.
NOTE 2: QA systems are generally not mandatory but increasingly adopted in the production and processing of food products. Selection and application of a QA system can vary
according to the stage within the food chain, the size and capacities of the company, type of product etc. QA systems may include:
- Good Agricultural Practices (GAP); - Good Manufacturing Practices (GMP); - Good Hygiene Practices (GHP); - Good Distribution Practices (GDP);
- Hazard Analysis and Critical Control Point (HACCP) systems.
Quality Management Plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.
Quality Management System (QMS): "Quality management" means what the organization does to ensure that its products or services satisfy the customer's quality requirements and comply with any regulations applicable to those products or services.
NOTE 1: Please note the difference with Quality Assurance Systems above.
NOTE2: Food quality can only be maintained if all activities/processes related to food production are subject to a systematic approach, i.e. integrated into a management system. Since the beginning of the 1990s, QM Systems have proved good as systematic approach for steering companies.
NOTE 3: Whereas the introduction of QM Systems is voluntary, product (food) safety constitutes a legal requirement. Thus, the EU General Food Law (GFL) formulates vast requirements regarding hygiene in the food industry. Furthermore, it stipulates the need to establish traceability systems. An internal QM System offers an ideal frame for the
implementation of hygiene and traceability requirements. A comprehensive and systematic HACCP-System can as well constitute the nucleus for a future QM System.
Quality objective: something sought, or aimed for, related to quality
NOTE 1: Quality objectives are generally based on the organisation’s quality policy. NOTE 2: Quality objectives are generally specified for relevant functions and levels in the organisation.
Quality policy: overall intentions and direction of an organisation related to quality as formally expressed by top management.
NOTE 1: generally the quality policy is consistent with the overall policy, of the organisation and provides a framework for the setting of quality objectives.
EDITORIAL NOTE: most smallholder organisations have a mission/vision statement in their legal papers and can be used to base the quality policy upon.
Record: document stating results achieved in providing evidence of activities performed. NOTE 1: records can be used, for example, to document traceability and to provide evidence of verification, preventive action and corrective action.
Requirement: Need or expectation that is stated, generally implied or obligatory. NOTE 1: “Generally implied” means that it is custom or common practice for the
organisations, its customers and other interested parties, that the need or expectation under consideration is implied.
NOTE 2: A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality requirement, customer requirement.
NOTE 3: Requirements can be generated by different interested parties.
Risk: is expressed as the probability that a hazard will occur and jeopardise quality.Formula: Risk = Probability x Impact
With that, risk refers to both the probability that a hazard will occur and to the seriousness of its impact on quality.
Safe moisture content: the moisture content at or below which toxigenic moulds cannot grow. Relates to a minimum water activity for mould growth and toxin production.
Specification: document stating requirements.
Note: a specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification).
Step: A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption.
System: set of interrelated or interacting elements.
Target level: The acceptable level of a hazard in the final product, such as the regulatory level of mycotoxins in a product description.
Validation: Obtaining evidence that the elements of the Quality Management Plan are effective.
Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the Quality Management Plan.