manual sop silage 22 pp

SILAGE SOP MANUAL CRDP, Palestine

SILAGE SOP MANUAL, by Antonio D’Agnanno, Agronomist Expert, GVC of 22

CRDP – Community Resilience and Development Programme for Area C and East Jerusalem

Project “Promoting sustainable livelihood, economic recovery and self-reliance for most vulnerable Bedouin communities in

Jordan Valley Area C”

Village Councils of Az-Zubeidat, Marj Na'Ja and Marj Al-Ghazal

GUIDE FOR BEST PRACTICES AND MANUAL OF SOPs -

STANDARD OPERATING PROCEDURES- for

SILAGE MANUFACTURING

REVISION: V2

DATE: 30-11-2015

By Antonio D’Agnanno, Agronomist Expert for GVC Ramallah, November 2015



TABLE OF CONTENTS

GUIDE FOR BEST PRACTICES AND MANUAL OF SOPS -STANDARD OPERATING PROCEDURES- FOR ....................... 1

TABLE OF CONTENTS .............................................................................................................................................. 2

TABLE OF FIGURES ................................................................................................................................................. 4

ABBREVIATIONS .................................................................................................................................................... 5

I -TERMS AND DEFINITIONS ................................................................................................................................... 7

II -INTRODUCTION - PRINCIPLES........................................................................................................................... 10

A. PURPOSES .......................................................................................................................................................... 10

B. OVERVIEW ......................................................................................................................................................... 14

C. THE FOOD SAFETY LEGAL FRAMEWORK .................................................................................................................... 19

D. APPLICABILITY OF THIS SOP ................................................................................................................................... 20

E. CONTENTS ......................................................................................................................................................... 22

III – RESOURCES ................................................................................................. ERROR! BOOKMARK NOT DEFINED.

A. SOP FORMS ........................................................................................................... ERROR! BOOKMARK NOT DEFINED.

B. CHECKLISTS ............................................................................................................ ERROR! BOOKMARK NOT DEFINED.

C. OTHER ESSENTIAL SOPS ........................................................................................... ERROR! BOOKMARK NOT DEFINED.

- Activity Flow Layout Process Diagrams (see in Annexes NR. 5 and NR.6) ..... Error! Bookmark not defined.

- Silage Worksheet Monitoring (see in Annex nr. 7) ........................................ Error! Bookmark not defined.

D. OTHER RESOURCES .................................................................................................. ERROR! BOOKMARK NOT DEFINED.

IV - MANAGEMENT STRATEGY, RESPONSIBILITY, ADMINISTRATION AND GENERAL POLICIES . ERROR! BOOKMARK

NOT DEFINED.

V - JOB DESCRIPTIONS ....................................................................................... ERROR! BOOKMARK NOT DEFINED.

A. SILAGE FACILITY MANAGER /SUPERVISOR: ............................................................. ERROR! BOOKMARK NOT DEFINED. Job Summary ........................................................................................................................ Error! Bookmark not defined. Essential Duties .................................................................................................................... Error! Bookmark not defined. Additional Duties .................................................................................................................. Error! Bookmark not defined. Job Qualifications ................................................................................................................. Error! Bookmark not defined.

B. SF SECRETARY AND TREASURER : ........................................................................... ERROR! BOOKMARK NOT DEFINED. Job Summary ....................................................................................................................... Error! Bookmark not defined. Essential Duties................................................................................................................... Error! Bookmark not defined. Additional Duties ................................................................................................................ Error! Bookmark not defined. Job Qualifications ................................................................................................................ Error! Bookmark not defined.

C. SILAGE TECHNICAL OPERATOR: .................................................................................. ERROR! BOOKMARK NOT DEFINED. Job Summary ........................................................................................................................ Error! Bookmark not defined. Essential Duties .................................................................................................................... Error! Bookmark not defined. Additional Duties .................................................................................................................. Error! Bookmark not defined. Job Qualifications ................................................................................................................. Error! Bookmark not defined.

F. SILAGE MACHINES TRACTOR DRIVER: .......................................................................... ERROR! BOOKMARK NOT DEFINED. Job Summary ........................................................................................................................ Error! Bookmark not defined. Essential Duties .................................................................................................................... Error! Bookmark not defined.



Additional Duties .................................................................................................................. Error! Bookmark not defined. Job Qualifications ................................................................................................................. Error! Bookmark not defined.

G. INTERNAL MEMBERS OF FOOD SAFETY AND QUALITY SYSTEM MANAGEMENT TEAM. ............ ERROR! BOOKMARK NOT DEFINED. Key Tasks .............................................................................................................................. Error! Bookmark not defined. Qualification Requirements.................................................................................................. Error! Bookmark not defined.

VI – BASIC SAFETY RULES ................................................................................... ERROR! BOOKMARK NOT DEFINED.

VII - EQUIPMENT AND FACILITY ......................................................................... ERROR! BOOKMARK NOT DEFINED.

A. CLEANING, MAINTENANCE, HYGIENE AND SANITATION .................................... ERROR! BOOKMARK NOT DEFINED.

- Cleaning the Machines - proper procedures for care and feeding: ............... Error! Bookmark not defined.

- Unfinished Work and leaving your machines: ............................................... Error! Bookmark not defined.

- The recommendations: .................................................................................. Error! Bookmark not defined.

B. OTHER CONSIDERATIONS TO BE AWARE OF. ........................................................... ERROR! BOOKMARK NOT DEFINED.

C. CONTAINERS FOR WASTE AND INEDIBLE SUBSTANCES ...................................... ERROR! BOOKMARK NOT DEFINED.

D. PERSONNEL HYGIENE FACILITIES AND TOILETS .................................................. ERROR! BOOKMARK NOT DEFINED.

VIII - RECORDS CONTROL AND DATA MANAGEMENT. RCP. ............................... ERROR! BOOKMARK NOT DEFINED.

IX - QUALITY ...................................................................................................... ERROR! BOOKMARK NOT DEFINED.

A. QUALITY ASSURANCE.......................................................................................... ERROR! BOOKMARK NOT DEFINED.

B. QUALITY SYSTEMS .............................................................................................. ERROR! BOOKMARK NOT DEFINED.

X - PROCEDURES ................................................................................................ ERROR! BOOKMARK NOT DEFINED.

A. ENSILING FORAGES FROM DPBP ................................................................................ ERROR! BOOKMARK NOT DEFINED.

B. THE FERMENTATION PROCESS OF SILAGE ...................................................................... ERROR! BOOKMARK NOT DEFINED.

C. SUPPLIER EVALUATION ............................................................................................. ERROR! BOOKMARK NOT DEFINED.

D. PURCHASING, RECEIVING AND INSPECTION ................................................................... ERROR! BOOKMARK NOT DEFINED.

E. SILAGE MANUFACTURING ......................................................................................... ERROR! BOOKMARK NOT DEFINED.

F. STORAGE ............................................................................................................. ERROR! BOOKMARK NOT DEFINED.

G. CRITICAL LIMITS AT CRITICAL CONTROL POINTS ............................................................. ERROR! BOOKMARK NOT DEFINED.

H. CORRECTIVE ACTIONS ............................................................................................... ERROR! BOOKMARK NOT DEFINED.

I. SANITATION, PEST/RODENT CONTROL .......................................................................... ERROR! BOOKMARK NOT DEFINED.

J. IDENTIFICATION, LABELING AND TRACEABILITY .............................................................. ERROR! BOOKMARK NOT DEFINED.

K. FEED PRODUCT INVESTIGATIONS/RECALLS ..................................................................... ERROR! BOOKMARK NOT DEFINED.

XI - GENERATION OF NEW SOPS ........................................................................ ERROR! BOOKMARK NOT DEFINED.

C. AUTHORITY ............................................................................................................ ERROR! BOOKMARK NOT DEFINED.

D. GENERAL ............................................................................................................... ERROR! BOOKMARK NOT DEFINED.

E. SOP REVIEW .......................................................................................................... ERROR! BOOKMARK NOT DEFINED.

F. GENERATION OF NEW PROCEDURAL/ MAINTENANCE SOPS ............................................ ERROR! BOOKMARK NOT DEFINED.

G. SOP REVISION ..................................................................................................... ERROR! BOOKMARK NOT DEFINED.

H. VERIFICATION AND VALIDATION OF SOPS .......................................................... ERROR! BOOKMARK NOT DEFINED.

I. REVIEW OF COMPLETED SOP .............................................................................. ERROR! BOOKMARK NOT DEFINED.

J. DOCUMENT CONTROL AND TRACKING .......................................................................... ERROR! BOOKMARK NOT DEFINED.

K. RETIRED SOP RETENTION ......................................................................................... ERROR! BOOKMARK NOT DEFINED.

XII - EXAMPLES OF GUIDELINES .......................................................................... ERROR! BOOKMARK NOT DEFINED.



A. GUIDELINE 1: LIST OF MATERIALS WHOSE CIRCULATION OR USE FOR ANIMAL NUTRITION PURPOSES IS

(ORDINARILY) PROHIBITED .............................................................................................. ERROR! BOOKMARK NOT DEFINED.

B. GUIDELINE 2: RISK ASSESSMENT FOR SILAGE MANUFACTURERS. ...................... ERROR! BOOKMARK NOT DEFINED.

XIII – CONCLUSIONS AND RECOMMENDATIONS ................................................ ERROR! BOOKMARK NOT DEFINED.

XIV – MAIN BIBLIOGRAPHY ................................................................................ ERROR! BOOKMARK NOT DEFINED.

TABLE OF FIGURES

FIGURE 1 - SCHEMATIC FLOW DIAGRAM OF THE CRDP PROJECT AS AN INTEGRATED SYSTEM. OUR ELABORATION FROM MULLER, FAO

1980. ................................................................................................................................................................... 13

FIGURE 2- QUALITY PROCESS DOCUMENTATION PYRAMID. ...................................................................................................... 22

FIGURE 3 - COMPONENTS OF QUALITY SYSTEMS. ........................................................................ ERROR! BOOKMARK NOT DEFINED.

FIGURE 4 - SIMPLIFIED SCHEMATIC FLOW SHEET FOR SILAGE PROCESSING PLANT AS IN MARJ AL GHAZAL (PALESTINE). ERROR! BOOKMARK

NOT DEFINED.

FIGURE 5 - DIAGRAM SHOWING THE FERMENTATION PROCESS OF SILAGE. FROM JRA, 2005. ............. ERROR! BOOKMARK NOT DEFINED.

FIGURE 6 - FACTORS INFLUENCING SILAGE FERMENTATION. FROM MC CULLOUGH, FAO 1978. .......... ERROR! BOOKMARK NOT DEFINED.

FIGURE 7 - RESUME OF IMPORTANT POINTS FOR SILAGE MAKING. FROM JRA, 2005. ........................ ERROR! BOOKMARK NOT DEFINED.

TABLE OF TABLES

TABLE 1 - ISO 9002: 1987 QUALITY SYSTEM REQUIREMENTS. ..................................................... ERROR! BOOKMARK NOT DEFINED.



Abbreviations

AB Administrative Board

AFED Arab Forum for Environment and Development

ARIJ Applied Research Institute – Jerusalem

ASDPD Association for the Development of Palm & Dates

BDS Business development services

CB Capacity Building

CCP Critical control Points

DPBP Date Palm By-Products

DM Dry Matter

FAO Food and Agriculture Organization

FSQMT Food Safety and Quality Management Team

GMP Good Manufacturing Practice

GVC Gruppo di Volontariato Civile

HACCP Hazard Analysis and Critical Control Points System

HR Human Resource

IPM Integrated Pest Management

MoA Ministry of Agriculture

MoE Ministry of Higher Education and scientific research

MoF Ministry of Finance

MoFA Ministry of Foreign Affairs

MoL Ministry of Labour

MoLG Ministry of Local Government

MoNE/MNE Ministry of National Economy

MoT Ministry of Transport

NARC National Agricultural Research Center

NDP National Development Plan

NGO Non-Governmental Organization

OIE World Organization for Animal Health

OPt Occupied Palestinian territories

PA Palestinian Authority

PCBS Palestinian Central Bureau of Statistics

PMU Project Management Unit

PNA Palestinian National Authority

PPE Personnel Protective Equipment

PRPs Prerequisite program(s).

PSI Palestine Standards Institution

RA Restricted Area

RCPs Risk Control Plans

ROI Return on investment



SF Silage Facility

SMO Site Management Organization

SOP Standard Operating Procedures

SRLS Small Ruminants Livestock Subsector

TQM Total Quality Management

TWG Technical Working Group

UA Users Association

VAT Value Added Tax

WG Working Groups

WB West Bank



I -Terms and Definitions

Activity: An action, element or decision representing a prescribed step in the Procedure (see) process. Appropriate Level of Protection (ALOP): See Food Safety Objective (FSO). Cleanliness: cleaning and removing of residues, dirt, or other materials that carry contaminant agents in order to eliminate, reduce or prevent harmful microorganisms from causing harm to animal health and eventually to human health as well. Contaminant: any biological or chemical agent, foreign matter, or other substances not intentionally added to food which may compromise food safety or suitability. Contamination: the introduction or occurrence of a contaminant in food or food environment. 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. Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of control. Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Critical limit: A criterion which separates acceptability from unacceptability. Disinfection: the reduction, by means of chemical agents and/or physical methods, of the number of micro-organisms in the environment, to a level that does not compromise food safety or suitability. Establishment: any building or area in which food is handled and the surroundings under the control of the same management. Flow diagram: A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item. Foodborne Illness: means illness resulting from the consumption of foods/feeds or beverages contaminated with disease-causing microorganisms, chemicals, or other harmful substances. Foodborne Outbreak: means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food/feed. Food handler: any person who directly handles packaged or unpackaged food, food equipment and utensils, or food contact surfaces and is therefore expected to comply with food hygiene requirements. Food hygiene: all conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain. Food safety: assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use. Food Safety Objective (FSO): The maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the Appropriate Level of Protection (ALOP). Food suitability: assurance that food is acceptable for human consumption according to its intended use. Form: A pre-formatted document containing instructions and place-holders for data entry to monitor progress through a particular Procedure (see) and to ensure proper record-keeping. Hazard: a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety.



Hazard Identification: The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods. Hazard Characterization: The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. HACCP: a system which identifies, evaluates, and controls hazards which are significant for food safety. HACCP 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. Manual: A system of approved policy (see) statements and corresponding procedural (see) guidelines and supporting forms (see) that direct an organization toward its operational goals. Monitoring: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control. Performance Criterion (PC): The effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures to provide or contribute to a PO or an FSO. Performance Objective (PO): The maximum frequency and/or concentration of a hazard in a food at a specified step in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable. Policy: A stated course of action or activity (see) with a defined purpose and scope to guide decision-making under a given set of circumstances within the framework of corporate objectives, goals and management philosophies. Primary production: those steps in the food chain up to and including, for example, harvesting. Procedure: A series of prescribed steps followed in a definite regular order which ensure adherence to the guidelines set forth in the Policy to which the Procedure applies. Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. Risk Analysis: A process consisting of three components:

- risk assessment, - risk management, and - risk communication.

Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) Risk characterization.

Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options. Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions. Risk Assessment Policy: Documented guidelines on the choice of options and associated judgments for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained. Risk Profile: The description of the food safety problem and its context.



Risk Characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment. Risk Estimate: The qualitative and/or quantitative estimation of risk resulting from risk characterization. Standard Operating Procedures (SOPs): are step-by-step directions for completing important procedures and are usually very specific. SOP may be used to address a specific hazard, for instance, an establishment may have specific preventive maintenance procedures for its processing equipment, which prevent the hazard of fragments. Sanitation SOP (SSOP) may be considered by establishments to reduce the likelihood of occurrence of some food safety hazards. For example, the SSOP may address washing and sanitizing of items and hands between foods to reduce potential contamination with pathogens. Step: A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption. Task: A detailed component of an Activity specifying required behavior to complete the activity. Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance. Waste: Any unwanted object or unusable material, substance, or by-product, which the holder discards or intends, or is required to discard. Feed materials resulting from the manufacture of food or drink and safe returns shall not be regarded as waste. Written documents: These may be substituted by electronic, photographic, or other data processing systems provided that the data will be appropriately stored during the anticipated period of storage (archive) and can be made readily available in a legible form.



II -Introduction - principles

a. Purposes North Jordan Valley Station (in this document called Facility) for silage production will be established to

reduce the production cost in livestock breeding through providing alternative fodder (silage) in lower

prices and better nutritional content and thus increase the profit rate in small ruminants and palm crops

local projects.

In the framework of the CRDP Project, the present Manual is related to the Output 2- Activity 1-

Development and implementation of a Strategic Plan for fodder production, and Output 2- Activity 2 -

Implementation of 15 small-scale silage plant; the Output/result 2 is about “Access to inputs for and

the management of fodder and animal production is increased through the introduction of innovative

practices”, in our case by producing silage fodder from the production of a Silage Facility (the

equipment unit of a machinery establishment located at every village and consisting of tractor, cart,

chopper, compactor, and containers-drums).

This document sets out a framework for Good Manufacturing Practices (GMP) of 3 Silage

Establishments, which defines essential elements for the development of best-practice for the

production of 3 Compound Silage Manufacturing Establishments acceptable to the leading retail groups

in the Region.

This document does not set out to provide prescriptive guidance on every method of silage production

in each of the 3 villages, and it is assumed that it’s following the prescriptions given in the “Strategic

Development Plan for Silage User Association” and the “Businness Plan” both prepared by Luay Al

Qasarwah.

Ensiling may be used as a general term to describe any procedure involving the storage of materials in

silos or pits. However, the term is commonly used to specifically describe the storage of green fodder

under anaerobic conditions that allow naturally occurring microbes to ferment plant carbohydrates to

organic acids, reducing the pH in the silo, inhibiting further fermentation and preserving the crop as

silage.

The main advantages of silage are:

1. It can be efficiently used for strategic off-season feeding

2. It is a means of increasing feed resource availability and form of insurance, especially for dairy farms

3. It can be fed to reduce pressure on pasture when required

4. It can be an efficient supplement to grazing sheep during the dry season

5. It is an inexpensive home-made feed resulting in the production of milk and meat at lower cost



6. It improves palatability, reduces significantly toxic substances present in some raw materials to safe

level concentrations and destroys harmful micro-organisms possibly present in poultry litter

7. It can provide a major diet source, as basal ration as well as a feed supplement for grazing animals.

This kind of integration of agricultural and livestock wastes represents a complementary system which

can be established on urban centers in arid areas for the direct benefit of urban communities. It would

enable them to have a supply of fresh animal products and vegetables without seasonal fluctuations

because the feed would be based on cheap waste resources. Only a relatively small portion of

traditional feed, such as grain, would be required. The system, making use of wastes, would thus release

land being utilized for forage so that it could be cultivated for vegetables, horticulture, and field crops

(in our case palm date crops).

In view of the fact that feed usually represents 60–90% of total animal production cost, its substitution

by processed waste inevitably leads to a significant reduction in the cost of all animal products. This is

the key to the economics of feeding waste.

During the long dry season (at least 6-7 months per year) animals are on poor quality feeds

characterized by low palatability, low intake and low nitrogen concentration.

Fruit, vegetables and grains crops are increasingly integrated in the farming system and play a key role

as staples in the human diet in most developing countries. Consequently, there is a wide range of

valuable by-products and residues resulting from food crops cropping systems and food processing

which are often inefficiently or totally under-utilized and wasted.

The ensiling of by-products is a simple and appropriate method of conservation. It is the most-effective

way to improve animal feed resources through the rational use of locally available agricultural and

industrial-by products likely to be available to small-scale farmers at village level.

DPBPs were viewed by locals as a relatively good and economic feeding source for small ruminants and

dromedaries, using local natural resources and solving part of the problem of treatment of crop wastes.

Among limitations, the two main observations concerned problems of bloating when distributed with

concentrates or bran, and seasonal unavailability.

The present Project aims at the conservation of DPBP as silage to enhance the use of readily available

by-products of date-palm, to expand the period of their use and to suggest complements or more

balanced diets.

Most ingredients of this kind of fodder have the advantage to be produced at the level of the 3 villages,

with the exception of poultry litter which could be incorporated at a limited level (5% of the DM). It has

a relatively low cost compared to commercialized hays/concentrates coming from Israel.

Such a silage system is suitable for smallholders in the Jordan Valley because it can:

· Have low investment costs.



· Be reliable and repeatable.

· Use uncomplicated technology.

· Use locally sourced equipment and consumables.

· Be safe.

· Give rapid and significant returns on investments.

Incorporating silage into feeding systems is often a matter of reallocating resources, rather than

introducing totally new resources, and it is consistently more difficult to show a profit from reallocating

resources than from introducing new ones.

It is therefore imperative that the Purpose of incorporating silage be clear. These purposes are defined

as: drought feeding; production increases; an aid to pasture or crop management; utilization of excess

growth; balancing nutrients in the diet (maize, vegetables); and the storage of wet feed products

(palm dates).

Silage is most likely to be profitable when used to increase productivity or balance nutrient content of

the diet. Special purpose local crops such as maize and vegetables are normally being used in these

roles, and their use in the feeding program will be integrated with other demands on modern

production systems, such as Quality Assurance and Sustainability.

A positive use for silage in the sub-tropics is as a means of increasing land productivity. There is a

continuing increase in the pressure to use natural resources more effectively, primarily land and water.

Associated with this pressure are demands for greater control over the production system, to meet

quality assurance targets, ensure animal welfare and facilitate sustainable land management practices.

The combination of cropping and conservation increased dry matter production per hectare compared

with pasture systems, and achieved a higher ratio of feed production to water input. This has resulted in

a relatively stable pattern of livestock production throughout the year.

The increasing level of control needed over the production system is also influencing the move towards

conserved crop systems. Livestock Farmers need to be confident they can produce a certain level and

quality on a specified date.

In the following Figure nr.1 we show the Rationale of the CRDP Project, seen as one sole local

integrated system. In this scheme we added one further component, the poultry farm, and ulterior

connections (f.i. the manure flow between the sheep farms and the crops) which at the moment are

absent but desirable and favorable in a near future with the implementation of the CRDP Project and

the improvement of activities and technical linkages in the area.



Figure 1 - Schematic Flow Diagram of the CRDP Project as an Integrated System. Our elaboration from Muller, FAO 1980.

The goal of our Policy and Procedure Manual should be to organize the contents to reflect your Silage

facility’s ways and means of communicating, getting the service performed, or the product

manufactured at the lowest cost in the least amount of time, with the added benefit of maintaining job

satisfaction and high worker morale. The importance of policies and procedures cannot be

underestimated for focusing your SF, simplifying training, and easing your ability to scale.

The purpose of this SOP Manual is to ensure accurate conduct of all Silage Facility operations, including

all processes, policies, quality functions, as well as to insure compliance with all relevant accreditation

and regulatory standards including ISO, HACCP, GAP and Palestinian state laws and regulations.

This Manual was written also to provide a "roadmap" for evaluating silage processor establishments

based on the possible application of HACCP principles.



b. Overview TQM (Total Quality Management), HACCP (Hazard Analysis Critical Control Points), ISO9000

(International Standards Organization), are management programs designed to help companies

maintain process and quality control, and remain competitive in a global business environment. At the

heart of each of these programs, Standard Operating Procedures (SOPs) drive the results.

TQM is a broad management concept and log-term business philosophy that stresses meeting a "right

first time, zero defects". Both ISO 9000 quality standards and HACCP system embody a great part of the

TQM. The application of this preventive oriented approach would give the food producer better control

over operation, better manufacturing practices and greater efficiencies, including reduced wastes.

Standardization is defined as an activity that gives rise to solutions for repetitive application to problems in various disciplines including science and it is aimed at achieving the optimum degree of order in a given context. Generally, the activity consists of the process of establishing (determining, formulating, and issuing) and implementing standards. Therefore, standards are the ultimate result of a standardization activity and within the context of quality systems consist of quality documents or documents related to the quality systems.

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or

repetitive activity followed by an organization. The development and use of SOPs are an integral part of

a successful quality system as it provides individuals with the information to perform a job properly, and

facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not

always be appropriate and terms such as protocols, instructions, worksheets, and industry operating

procedures may also be used. For this document anyway “SOP” will be used.

SOPs describe both technical and fundamental programmatic operational elements of an organization

that would be managed under a work plan or a Quality Assurance (QA) Project Plan, and under an

organization’s Quality Management Plan. This document is designed to provide guidance in the

preparation and use of SOPs within a quality system.

The purpose of a SOP is to give detailed directions so that any individual can do a job correctly, on time,

every time. They document the way activities are to be performed to facilitate consistent conformance

to technical and quality system requirements and to support data quality. At the same time, any one

SOP may have a number of different uses. They may describe, for example, fundamental programmatic

actions and technical actions such as analytical processes, and processes for maintaining, calibrating,

and using equipment.

SOPs are intended to be specific to the Silage facilities whose activities are described and assist that UA

to maintain their quality control and quality assurance processes and ensure compliance with PA

governmental regulations.

Depending on the intended use at the time, the SOP may be written or presented differently to be more

effective. All original SOPs, with review signatures, validation studies, and training/review

documentation, must be kept on file with the FSQM staff.



If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are

not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management,

preferably the direct supervisor.

Current copies of the SOPs also need to be readily accessible for reference in the work areas of those

individuals actually performing the activity, otherwise SOPs serve little purpose.

A SOP that is part of a reference Manual may contain large amounts of explanatory detail and even

supporting background information so workers understand the biology and importance behind certain

SF SOP steps.

The acronym “HACCP” stands for “Hazard Analysis and Critical Control Point”. It is a preventive

approach implemented by industry to control food safety hazards. The voluntary strategies presented in

this Manual also foster food safety partnerships between your SF and your farmer’s operators, which

will facilitate your active role in improving their existing food safety management systems.

A Policies and Procedures Manual is the Silage best practices, process descriptions, and standards for

how work is expected to be performed.

Please note that this Manual is not a comprehensive resource for learning about HACCP principles;

therefore, you should have a basic understanding of the principles of HACCP before using this Manual.

HACCP should be considered as a system based on Good Hygiene Practices (GHP) and Good

Manufacturing Practices (GMP). GMP and GHP applications include building, environment

arrangements and personnel hygiene and behaviors. Sanitary and hygienic conditions of the plant can

be improved.

For serving high quality and safe silage products to the consumers/herders, inspecting the raw materials

purchasing, storing the raw materials at proper conditions, using well cleaned equipment in all steps of

the Silage process, according to receipts stated by Technician, and storaging, are determined as critical

points.

This Manual is based on experience gained from many of these approaches and is provided to you, the

regulatory food safety professional, to help you enhance the effectiveness of your SF management by

incorporating a risk-based approach.

The development and use of SOPs minimizes variation and promotes quality through consistent

implementation of a process or procedure within the SF, even if there are temporary or permanent

personnel changes. SOPs can indicate compliance with organizational and governmental requirements

and can be used as a part of a personnel training program, since they should provide detailed work

instructions. It minimizes opportunities for miscommunication and can address safety concerns. When

historical data are being evaluated for current use, SOPs can also be valuable for reconstructing project

activities when no other references are available. In addition, SOPs are frequently used as checklist by

inspectors when auditing procedures.



Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability,

credibility, and legal defensibility.

We use Procedures to plan out process expectations (Plan), collect data (Do), check the data against our expectations (Check), and then take corrective action (Act) on what we have learned. PDCA is the basis of a Process Learning. Why to use SOPs: - Facilitate easier understanding of a procedure by the person being instructed; - Ensure more consistent training of multiple trainees by multiple trainers; - Allow reviewers, auditors, and regulators to evaluate performance of a task in practice; - Document the procedures to provide evidence of the consistency and completeness of practice in SF; - To ensure compliance standards are met; - To maximize production requirements; - To ensure the procedure has no adverse impact on environment; - To ensure safety; - To ensure everything goes according to schedule; - To prevent failures in manufacturing; - To be used as training document. Having complete step-by-step instructions helps trainers ensure that nothing is missed and provides a reference resource for trainees. - SOPs will reduce system variation, which is the enemy of production efficiency and quality control. - People tend to be supportive of the things they help create. Involving employees in developing SOPs can help assure the final product is more complete, useful and accepted. - SOPs can help in conducting performance evaluations. They provide a common understanding for what needs to be done and shared expectations for how tasks are completed. - Employees can coach and support each other if there is documentation available on exactly how various tasks must be done and everyone knows what their co-workers are supposed to be doing. This can also help generate a more cooperative team approach to getting all the daily tasks done correctly, every day. - Having well defined SOPs, using them in training and insisting that they be followed can help keep employees safe at work and may provide some legal protection if an injury occurs. - Well thought out and implemented SOPs can greatly reduce biosecurity risks for your operations. - Developing and following SOPs for tasks where there is environmental risk, such as waste handling, help to protect the environment and may provide some legal protection if an environmental mishap occurs. - Having SOPs can encourage regular evaluation of work activity and continuous improvement in how things are done.

What is a Process? A process is a structured set of activities that transform inputs into outputs. We believe processes should be measurable with clear performance indicators. Processes are strategic assets of an organization that if managed well deliver a competitive advantage. And processes assist us in defining responsibilities, internal controls, and work standards for compliance, consistency, and performance. A “process map” visually describes the flow of activities of a process. A process flow can be defined as the sequence and interactions of related process steps, activities or tasks that make up an individual



process, from beginning to end. Process maps are used to develop a better understanding of a process, to generate ideas for process improvement or stimulate discussion, build stronger communication, and — of course — to document a process. Often times a process map will highlight problems and identify bottlenecks, duplication, delays, or gaps. Process maps can help to clarify process boundaries, process ownership, process responsibilities, and effectiveness measures or process metrics. Process maps can be very effective at increasing process understanding during training. For SF Activity Flow Layout Process Diagrams, see in Annexes NR. 5 and NR.6.



c. The Food Safety Legal framework

Silage Manufacturers apply their role and responsibilities under the following legislative framework

about Food Safety and QM:

Agricultural law: No. 2 for the year 2003, modified in Law No. 11 for the year 2005, in addition to the 14 bylaws (regulations);

Environmental Law: Law No. 7 for the year 1999;

Water Law No. 3 for the year 2002

Regulation on Animal Disease No. 39 for the year 1954;

Law on Natural Resources No. 1 of 1999;

Law on the Palestinian Specifications, Metrology and Standards No. 6 of 2000, and issued Standards;

Law of Cooperative Societies No. 17 of 1956 in force in the West Bank;

Law of Lands of 1857.

Public Health Law: No. 20 for the year 2004

Consumer Protection Law no. 21 for the year 2005.

The Palestine Industrial Law. In particular, Article 3, Article 5, Article 23.

Food safety in Palestine has distinguished characteristics from the rest of Arab and non-Arab countries

in the Region, this exception comes from the unique conditions of the Palestinian situation due to the

political and economic situation. Nevertheless, deterioration of the economic situation, and the lack of

control on food products, requires follow-up.

As there is no food safety law in Palestine, and because of the existence of alternative and multiple

legislations, which define the duties of some of the different entities concerned with food safety, one of

the most outstanding and problematic features were the different possibilities available to these entities

and in dealing with the topic of control, and being based on different laws, and the lack of

implementing regulations in most of these laws to ensure proper implementation.

The Palestinian specifications and standards, and the binding technical regulations are considered to be

the basis to verify the safety of most of the food items.

There is also still a need to develop many of the specifications and technical instructions, and to enact

legislation governing the safety of the outdoor sale. This should also include improving its packaging,

and applying principles of good manufacturing, and ways to bind producers and manufacturers with

such principles.

In all cases, the harmonized rules and regulations must deal with methodologies for applying risk and

critical points analysis.



d. Applicability of this SOP All Standard Operating Procedures / Policies of the Silage Facility which are generated or revised, on or

after the effective date of service of this SOP Manual on Standard Operating Policies / Procedures must

be prepared in compliance with the provisions contained herein.

SOPs generated and fully approved and placed into service prior to the effective date of this SOP Manual

may remain in current form until they are next revised.

In pre-effective-date SOPs, significant deviation from the provisions of this SOP may be grounds for

requiring revision, at the discretion of the Silage Facility Managing Director.

Compliance and enforcement are essential elements of a regulatory program and involve all voluntary

and involuntary corrections made by the operators. Voluntary corrections by the operator are referred

to in this Manual as “intervention strategies.”

Intervention strategies can be divided into two groups:

1. Those designed to achieve immediate on-site correction

2. Those designed to achieve long-term compliance.

Successful intervention strategies for out-of-control risk factors can be tailored to each operation’s

resources and needs. This will require you to work with the operators to identify weaknesses in their

existing food safety management system and consulting with them to strengthen any weak areas noted.

Intervention strategies can also be adopted as part of a progressive compliance and enforcement

program. If the operator is willing to work with you to gain ownership of food safety, a long-term

behavior change will more likely result. This may help reduce the amount of enforcement proceedings

that occur as a result of involuntary compliance.

Involuntary compliance results from the following enforcement activities:

• Warning letters

• Re-inspections

• Citations

• Administrative fines and hearings (by the Administrative Board)

• Permit suspensions.

Although these enforcement activities are a necessary function in your regulatory work, obtaining

voluntary corrections by the operator has proven to be more effective in achieving long-term

compliance.

- 1. On site correction:



It is essential to consumer protection and to regulatory credibility for on-site correction to be

obtained for any out-of-control risk factors. Obtaining on-site correction conveys the seriousness of the

violation to management. Failure to require on-site correction when an out-of-control risk factor has

been identified implies that the risk factor has little importance to food safety. If the operation is briefly

stopped to address the out-of-control risk factor, the operator may be more responsive to addressing

the practices resulting in the out-of-control risk factor in the future. A more favorable impact on future

behavior may result that might not have been achieved through discussion alone.

When recommending on-site correction, effective communication regarding out of control risk factors is

essential and can often be accomplished by

• Discussing food safety concerns in words that can be easily understood by the person in charge and

the feed service workers

• Conveying the seriousness of the out-of-control risk factors in terms of increased risk of illness or

injury.

Although the person in charge is ultimately responsible for the conditions in the Silage facility and

should therefore be informed of all out-of control risk factors, timely training of the food service

workers can in many cases have a great impact on future behavior.

Discussion of lesser code violations should be deferred until out-of-control risk factors are discussed

and on-site correction is obtained. It is important to point out to the operator that while most basic

sanitation problems do not pose a significant threat to the public, foodborne illness caused by out-of-

control risk factors often results in significant losses to consumers and the operator. Negligence for not

having a strong food safety management system in place to control risk factors can result in economic

ruin for even the largest of the SF operations.

- 2. Long term compliance:

A misconception is that training alone will result in risk factors being controlled. While training may

help, there is no guarantee that knowledge acquired will equate to knowledge applied in the workplace.

Another assumption is that enforcement actions such as citations or administrative hearings (by AB) or

on-site corrections (by technicians) will automatically result in future management control.

Unfortunately, there is no assurance that any of these actions will result in the long-term control of risk

factors.

Long-term compliance may best be achieved through voluntary actions by the operator.

If an operator supports the concept that a food safety management system is needed, there is a better

chance that long-term compliance will be achieved.



e. Contents Our Criteria for Standard Operating Procedures (valid also for HACCP): - Title - Purpose (objective or goal) - Scope (who/what is affected) - Keywords - Definitions of important terms; - Responsibilities - Materials, Equipment - Procedures - Frequency, Critical limits, operating limits - Regulatory criteria - Precautions and monitoring - Corrective actions, troubleshooting - Record keeping - References. For this SF Manual, we preferred the “simple steps format”. As for work of SFs, this is for routine procedures that are short, have few possible outcomes, require few decisions and are fairly to the point. Apart from the necessary documentation and safety guidelines, it's really just a bullet list of simple sentences telling the reader what to do. Each individual area within the Silage facility (i.e., Admin Board office, Compressor machines area, etc.) must have access to the SOPs.

Figure 2- Quality Process Documentation Pyramid.

MANUAL

SOPs

Work Instructions

Records (after operations)

DOCUMENTATION (during operations)

manual sop silage 22 pp

Documents