Important aspects to be kept in mind while
preparing Food Safety & Quality Manual:
Policy: Organizations policies to be framed
Organizations overall and departmental Quality Objectives in measurable terms to be
framed
Identifying the positions and competencies (education ,relevant experience) needed
for performing the work to be documented
Recruiting the personnel meeting the requirements as documented above
Organization chart and roles & responsibilities to be documented
Total layout of the plant in building to be kept including men and material movement
Identifying each machine in plant and preparing inputs to the machine and output
from the machine to be documented
Process flow chart for manufacturing process from raw material inputs to the finished
products and its storage and dispatch to be documented
Training programs needed to the personnel as per manufacturing processes and
processing of training as per these documented requirements to be ensured
Handling of customer complaints on the products and its mechanism to be
documented
Ensure that all the requirements of the respective standard is addressed in the
manual. To ensure this it is better to prepare a matrix indicating the requirements on
the one side and compliance documents in the manual can be given
Normally the following procedures will be documented irrespective of the standard
being implemented.
• Document control
• Control of records
• Recruitment of personnel
• Training of personnel
• Management review meeting
• Internal audits
• Handling customer complaints
• Corrective action
• Preventive action
• Handling of potentially unsafe product / non conforming product
• Verification & validation
Raw material and finished product specifications has to framed
Procedure for supplier evaluation
eFresh Portal made an effort to prepare a Food Safety Manual Structure based
on HACCP guidelines, which is generic and the same can be considered as a first
step towards preparation of the Food Safety Manual and incorporating the
requirements as applicable in individual case.
SAMPLE
British Retail Consortium Manual
BRC Global Standard for Food Safety (issue 5),
January 2008
INDEX
Section
Title
Index
Control and confidentiality
Distribution list
Amendment status
Company Profile
1
Senior Management
improvement
2
The Food safety Plan-HACCP
3
Food Safety and Quality Management System
4
Site Standards
5
Product control
6
Process control
7
Personnel
Glossary of terms
Commitment
and
continual
MANUAL AUTHORISATION
This BRC manual pertaining to Food Safety Enhancement Program has been prepared and established for
effective controlling of the food safety hazards. The authority issue and changes to this Manual rests with the
Management Representative who is designated as HACCP Coordinator/ of the company.
Any change to the contents of this manual is guided and made according to the SOP – Document Control
procedure. The minor changes incorporated are highlighted through italics in the document and whereas major
changes through a revision note.
The MASTER COPY of the manual rests with Management Representative and whenever changes are required in
the manual it will be discussed in the Management review meeting and will be updated in the manual accordingly
by Management representative (MR) of the company.
This CONTROLLED COPY of the manual will be distributed as per the executives identified in the distribution
list.
Date:
Distribution List
Copy No.
Distributed to
Role in HACCP System
1
Management representative
HACCP Coordinator/Team Leader
2
Manager QA
HACCP team Member
Amendment List
S.
No.
Document / Topic Title
Page No.
Revision No. and
Date
Revision
Description/
Reason
Note: Amendment Record pertaining to BRC manual shall be maintained as per the above format by HACCP Food safety
Team Leader and verified by HACCP Food Safety Team from time to time and details regarding amendments shall be
intimated during MRM to the Top Management.
INTRODUCTION:
Of the company……………………………………
INFORMATION ON THE OPERATOR:
Sl no
Particulars
Details
1.
Name and Address of the Company
& Manufacturing facility
2.
Year of Establishment
3.
PFA Reg. No.
4.
Factory Reg. No.
5.
No. of Shifts
6.
Exemptions granted in relation to
Food Safety
7.
Details of the market
8.
Statutory
and
Requirements
Regulatory
SCOPE OF APPLICATION:
The British Retail Consortium Global Standard for Food Safety Systems described in this manual is applicable to
the M/s.XYZ, Hyderabad for
“The Procurement of raw materials, Storage, Processing, Packing, Storage and Dispatch of finished
product”.
The scope also covers other functions of the organization like maintenance, engineering and housekeeping,
training etc.
All the manufacturing processes such as Receipt of Raw Material and Packaging Materials, Storage, Processing,
Packaging and Dispatch are carried out in the same location & form a part of the scope of the British Retail
Consortium Global Standard for Food Safety Systems system.
Receiving: Management will ensure procurement of appropriate raw material from reputed primary production /
reputed suppliers and transported to the factory premises with adequate care.
Storage: Organization ensures to store raw materials systematically with traceability and in appropriate
conditions.
Processing: By following Good Manufacturing Practices (GMP) / Good Hygiene Practices (GHP) in the
production area, all operations are focused to ensure food safety. This includes cleaning sanitation, personnel
hygiene, waste management and pest control etc.
Packing: Organization packs the finished product in food grade packaging material by trained staff in hygienic
condition.
Dispatch: Dispatch of the finished product in clean and hygienic condition at ambient temperature.
All the steps like procurement of raw material, storage & manufacturing processes such as cleaning, packing,
storage and dispatch are carried out in the same location and forms a part of the scope of HACCP system.
The HACCP system elements such as Product Information, Process Information, Hazards, Risk and Control
Measures, Critical Control Points, Standards and Critical parameters, Monitoring of Critical Process limits,
Corrective actions, Verification and Documentation are carried out for all product groups.
Section 1: Senior Management Commitment and Continual Improvement
The Top Management is fully committed to the implementation of the requirements of the Global
Standard for Food Safety by making provision for adequate resources including effective
communication, systems review and actions taken to effect continual improvement. Opportunities
for improvement are identified, implemented and fully documented
1.1
The senior management is providing the required resource both human and financial for the identified
process as per quality management system and the food safety plan.
1.2
Systems are established for clear communication and reporting to General Manager by Food safety Team
Leader who monitors the compliance with the Global Standard for Food Safety and reports the effective
compliance regularly.
1.3
Food safety and quality objectives have been established at each functional level and are documented,
monitored and maintained. The food safety and quality objectives are periodically reviewed. Refer: Food
Safety and Quality Objectives
1.4
Issues related to safety and legality of the products are identified and addressed through review meetings.
Actions related to these identified safety and legal issues are recorded in Management Review Meeting
minutes.
1.5
General Manager of the company is responsible for conducting such reviews. Refer: Management review
meeting minutes
1.6
The review is conducted at an interval of 6 months to ensure critical evaluation of the food safety plan and
the HACCP system’s suitability, adequacy and effectiveness.
1.7
The review process includes the evaluation of
•
Internal, second party and third party audits
•
Previous management review documents, action plans, and time frames
•
Customer performance indicators, complaints and feed back
•
Incidents, corrective actions, out-of-specification results and non conforming materials
•
Process performance and deviation from defined parameters
•
Reviews of the HACCP based system
•
Developments in scientific information associated with the product in scope
•
Resource requirements
1.8
Records of management reviews are comprehensively documented and retained.
1.9
The decisions and actions agreed within the review process are effectively communicated to appropriate
staff, and actions implemented within agreed time scales. The records are updated to show when actions
have been completed (Refer record of Management Review meeting minutes).
1.10
The current issue of the Global Standard for Food Safety is available with HACCP Team leader.
1.11
The certification to the Global Standard for Food Safety is maintained by the company by effective
timescale planning to ensure that certification does not expire.
1.12
The General Manager of the company ensures to attend the opening and closing meetings of the audit for
Global Standard for Food Safety certification.
1.13
The company’s Director and or General Manager ensure that non-conformities identified at the previous
audit against the Standard are effectively acted upon.
Section 2: The Food Safety Plan-HACCP
The company’s food safety plan is on the basis of HACCP system which is systematic,
comprehensive covering all products and processes. In the preparation a thorough analysis of
activities has been done. The plan is fully implemented and maintained. The plan is made based on
the Codex Alimentarius HACCP principles. Wherever applicable reference to legal requirements,
codes practice or guidelines are provided.
2.1
The HACCP Food Safety Team—Codex Alimentarius Step 1
2.1.1
The HACCP plan is developed and managed by a multi-disciplinary food safety team that includes
Quality Assurance, Production, Maintenance, Stores, Commercial and other relevant functions such as
Personal and Purchase. The team members have specific knowledge of HACCP and relevant knowledge
of product, process and associated hazards.
2.1.2
The Quality Assurance Manager is nominated as the HACCP team leader who has sufficient experience
and competence in understanding the principles of HACCP and its applications.
2.1.3
The HACCP Food Safety Team has adequate HACCP training. The company has sought external
expertise for training and documentation of Food Safety system. The day to day management and control
of activities are fully controlled by HACCP team leader and team.
2.1.4
As a part of senior management Executive Director and or General Manager is fully committed for
implementing and reviewing the Food Safety System by HACCP team.
2.2
Describe the Product –Codex Alimentarius Step 2
2.2.1
The HACCP Food safety team has defined the product and its related processes.
2.2.2
The information to conduct hazard analysis is collected by the following sources:
•
•
•
•
•
•
The latest scientific literature
Historical and known hazards associated with the product
Relevant codes of practice
Recognized guidelines
Food safety legislation of the product in destination countries
Customer requirements
The information thus collected is maintained, documented and updated. The details of references and
information are available with HACCP Food Safety Team.
2.2.3
The Product Characteristics developed gives detailed description of the product including relevant
information on food safety. The product information contains
•
•
•
•
•
•
•
•
•
•
•
Composition of raw materials, ingredients, recipe
Origin of ingredients
Physical properties ( their impact on food safety)
Chemical properties( their impact on food safety)
Treatment and processing methods
Packaging system
Storage and distribution conditions
Target safe self under prescribed storage and usage conditions
Instructions for use
Potential misuse
Traceability
2.3
Identify Intended Use—Codex Alimentarius Step 3
2.3.1
The Intended Use of the product is described by considering
•
Target group of Consumer
•
Suitability of the product for vulnerable groups of the population e.g. infants, elderly, allergy
sufferers.
2.4
Construct a Process Flow Diagram – Codex Alimentarius Step 4
2.4.1
The flow diagram is prepared to cover the process of the product. It covers all aspects of the food process
operation within the HACCP scope –raw material selecton through processing, storage and distribution.
The below mentioned aspects are considered for construction of the flow diagram:
•
•
•
•
•
•
•
•
•
•
Plant and equipment layout
Raw materials including utilities and other contact materials
Utilities and other contact materials – water, packaging
Sequence and interaction of all process steps
Out sourced processes and subcontracted work
Process parameters
Potential for process delay
Rework, reuse and recycling
Low/high risk and clean/dirt area segregation
Finished products, intermediate/semi-processed products, by-products and waste
2.5
Verify Flow Diagram – Codex Alimentarius Step 5
2.5.1
The HACCP food safety team verifies the accuracy of the flow diagram on site. The daily and seasonal
variations are considered and evaluated. The verification records are maintained.
2.6
List All Potential Hazards Associated with Each Process Step, Conduct a Hazard Analysis and
Consider any Measures to Control Identified Hazards – Codex Alimentarius Step 6, Principle 1
2.6.1
The scope of the HACCP Paln is confirmed by the HACCP Food safety team. The team list all the
potential hazards that are reasonably expected to occur at each step in relation to product, process and
facilities which may not be controlled by existing Pre requisites. The list also includes hazards
•
that are present in the raw materials,
•
those introduced during the process or surviving the process steps
•
allergen risk; and
•
preceding and following steps in the process chain
2.6.2
The HACCP food safety team conducts hazard analysis by identifying the hazards which need to be
prevented, eliminated or reduced to acceptable levels. This HACCP study is based on the risk
assessment. In conducting hazard analysis, the following factors have been considered.
•
Likely occurance of hazard
•
Severity of the effects on the consumer safety
•
Vulnerability of those exposed
•
Survival and multiplication of microorganisms of concern
•
Presence or production of toxins, chemicals or foreign bodies
•
Contamination of raw materials, intermediate/semiprocessed product or finished product
•
Potential for adulteration/delibrate contamination
Risk Assessment: Hazard Analysis (Risk)
•
•
FS Team Members shall identify, analyze and evaluate all potential hazards (biological/microbiological,
chemical/ physical) that can have adverse effect on the safety of the food product.
- The likely occurrence of hazards and severity of their adverse health effects
- The qualitative and/or quantitative evaluation of the presence of hazards,
- Survival or multiplication of microorganisms of concern,
- Production or persistence in foods of toxins, chemicals or physical agents, and
- Conditions leading to the above.
The hazard analysis process is for identifying hazards, determining the risks and control/ reduction of the
risk is the risk management.
RISK MANAGEMENT PROCESS
Hazard Identification
Resp: FS Team Members
- shall list all hazards and define its characteristics
(Refer Hazard Analysis worksheets)
Hazard Analysis (Risk Assessment)
Resp: FS Team Members
- shall estimate the magnitude of the risk
Risk Control / Reduction
Resp: FS Team Members
- programme
- control measures(Refer Hazard Analysis worksheets
•
Hazard analysis serves to identify the potential sources and specific points of contaminants by analysis of
each step in the food manufacturing process. Hazard analysis shall be applied at all points from incoming
material inspection to consumer.
•
Hazard Analysis has been conducted by the Food Safety Team based on the Flow Diagrams. Methodology
followed for arriving a hazard is as follows:
- Number all steps in the flow Diagrams
- Verify each step of flow Diagrams for possible physical/chemical and Biological/Microbiological
hazards
- Assess the likelihood of the hazard
- Asses the consequence / severity of the incident.
- Based on the above, level or risks have been evaluated. All the risks are included with the help of
group discussions by Food Safety Team and other associates from relevant areas.
-
The likely occurrence of the identified hazard, evaluated quantitatively, in terms of Very High,
High, Medium or Low and likelihood of occurrence, as follows:
LIKELIHOOD/ PROBABILITY
CONSEQUENCES/
SEVERITY
RISK / LEVEL
Improbable (eg. 5- 10 years)
1
Rarely
Unlikely (eg. yearly)
2
Minor (eg. Light injuries etc.)
1
5-6/Low
Occational (eg. Monthly/4-6
Monthly)
3
Likely (eg. Weekly/Monthly)
4
Medium (eg. Injuries, stomach
pain, uneasiness )
2
Major(eg. Illness,
Hospitalization)
3
Critical (eg. Death, Permanent
disability)
4
7-9/ Medium
Frequently (eg. Daily/ Weekly)
5
1-4/very Low
DETERMINATION OF RISK AND SEVERITY OF HAZARDS
1. Probability of occurrence
Very High
> automatically happen
High
> Likely to happen
Medium
> could happen
Low
> Not likely to happen
2. Severity of each hazard
Critical
> Will frequently result in unsafe product
Major
> Will likely result in unsafe product
Medium
> May result in unsafe product
Minor
> Will not result in unsafe product
10-12/ High
15-20/Very High
Determination of significance
SEVERITY
MINOR
MEDIUM
MAJOR
CRITICAL
PROBABILITY
LOW
XXXXX
XXXXX
/////////////////////////////
/////////////////////////////
MEDIUM
XXXXX
XXXXX
/////////////////////////////
/////////////////////////////
HIGH
XXXXX
/////////////////////////////
/////////////////////////////
/////////////////////////////
VERY HIGH
/////////////
/////////////////////////////
/////////////////////////////
/////////////////////////////
SIGNIFICANCE:
XXXXX
NO:
////////////////
YES:
Risk / Hazard Assessment
•
The severity of the hazard’s adverse health effects, evaluated quantitatively, in terms of critical, major or
minor impact severity, as follows:
•
The risk rating, in quantitative terms (arrived at by multiplying the probability of occurrence with the
severity of impact), and the classification of the identified hazard into significant or non-significant
category based on the risk-rating factor. A risk rating of 10 or above indicates that the control measure is
required to control the identified hazard.
SEVERITY
PROBABILITY
LOW
(unlikely)
2
MEDIUM
(occasionally) 3
HIGH
(Likely)
4
VERY HIGH
(Frequently) 5
MINOR
1
MEDIUM
2
MAJOR
3
CRITICAL
4
5
9
10
12
7
10
12
15
9
12
15
17
12
15
17
20
•
An explanation / justification for the risk rating arrived at, together with the general control measures in
place for that risk.
•
A risk level of below 10 is generally considered as permissible and the routine OPRP’s and PRP’s are
sufficient to control the hazard.
It is the process of evaluating the magnitude of a risk and deciding whether or not it is acceptable. Risk is
the combination of the likelihood (probability) and the consequences (severity) of a specified hazardous
event occurring.
To evaluate the risk, likelihood and consequences should be estimated. The organization has adopted the
following model for risk analysis for identification of significant hazards to ensure food safety.
2.6.3
The HACCP food safety team identify the control measures--One are more control measures with
synergitc effect necessary to prevent, eliminate or reduce the hazard to acceptable levels. Justification
for acceptable levels in the finished product for each hazard is determined and documented.
2.7
Determine the Critical Control Points(CCP) – Codex Alimentarius Step 7, Principle 2 .
EXAMPLE OF DECISION TREE TO IDENTIFY CCPS
2.7.1
2.8
Whether the particular step / process (Risk rating above 6) is a CCP is ascertained with the help of
Decision Tree vide CCP determination and Justification. The CCP are determined by the above
decision prevent, eliminates and / or reduces the hazard to acceptable levels for production of safe
product. If a hazard is identified at a step where control does not exist, the product or process is
modified at that step, at an earlier or later step, to provide a control measure.
Establish Critical Limits for each Critical Control Point (CCP)– Codex Alimentarius Step 8,
Principle 3
Refer: HACCP PLAN: [example of CCP]
CCP Number:
CCP Step
Description:
Significant
Hazard:
CCP Controller:
Limits
Critical Limits:
Product
temperature
Not more than
12.5° C
Action Limits:
Product
temperature
12.3° C
Target Value:
Product
temperature 12.0°
C
1
Step no. 1
Receiving raw material
Bacterial pathogens
Hazard Type:
Raw material Temperature
Control Measures
Control
Monitoring and Records
What: Incoming material
temperature check
How: Calibrated hand held
thermometer
When: Every lot
Where: Receiving section
Who: Stores Supervisor
Record Name: Incoming
material inspection report
Corrective Actions and
Records
1. On Product:
Check if product temperature
is within acceptable limit of <
12.5°C and if yes then no
problem.
If no, then reject product.
Who: Stores Supervisor
Record Name: Incoming
material inspection report
Recorded By: Receiving Incharge
B
C
P
Manual monitoring of chilled
raw material temperature of
every lot.
Verification and Records
What: Product temperature
records; Thermometer
calibration records; cross check
product temperature when lot is
received.
How: Periodic cross check of
product temperature and
Calibration certificate &
frequency of calibration of
thermometer.
When: Record review every
week
Where: Receiving section
Who: Production Head
Record Name: as above.
2.8.1
For each CCP, the appropriate critical limits are defined in order to identify clearly if the process is in
or out of control and if the identified acceptable level of the food safety hazard in the finished product
is likely to be exceeded. Critical limits are measurable wherever possible (e.g. time, temperature, pH)
and the rationale for their establishment is clearly documented. The HACCP food safety team has taken
into account relevant legislation or codes of practice when establishing critical limits.
2.8.2
Criticls limits based on subjective data such as visual inspection are supported by clear guidance or
examples.
2.8.3
The HACCP food safety team has validaed all the established CCPs and provides the documented
evidence to show the control measures selected are capable of consisently controlling the hazard to the
level specified by the critical limit.
2.9
Establish a Monitoring System for each Critical Control Point – Codex Alimentarius Step 9,
Principle 4
Refer: HACCP Plan
The HACCP food safety team has established a monitoring system for each CCP to ensure compliance
with critical limits.
2.9.1
Each defined CCP is kept under control. The monitoring system is able to detect loss of control of
CCPs and wherever possible information is provided in time for corrective action to be taken. The
below mentioned monitoring system, as applicable, to keep CCPs under control is used:
•
online measurement (if applicable)
•
offline measurement (if applicable)
•
continuous measurement, if required.
2.9.2
where discontinuous measurement is used, the system ensures that the sample taken is representative of
the batch of product,if applicable
2.9.3
Records associated with monitoring CCPs are signed by the person responsible for the monitoring and
verified, as appropriate, by an authorised person.Appropriate records are maintained including details
date and result of measurements carried out.
2.10
Establish a Corrective Action Plan – Codex Alimentarius Step 10, Principle 5
Refer: HACCP Plan
2.10.1 The HACCP food safety team has specified and documented the corrective action to be taken when
monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend
towards loss of control. This also includes the action to be taken by nominated personnel-HACCP Food
safety Team Leader with regard to any products that have been manufactured during the period when
the process was out of control.
2.10.2 Documented procedures are established and maintained for the appropriate handling of potentially
unsafe products to ensure that they are not released until confirmed as suitable for release.
2.11
Establish Verification Procedures – Codex Alimentarius Step 11, Principle 6
2.11.1 Verification Procedure is established to confirm that the HACCP plan is effective. The verification
activities includes:
•
internal audits
•
review of records where acceptable limits have been exceeded
•
review of complaints by enforcement authorities or customers
•
review of incidents of product withdrawal or recall.
2.11.2 Verification results are be recorded and communicated to the HACCP food safety team
2.12 HACCP Documentation and Record Keeping – Codex Alimentarius Step 12, Principle 7
2.12.1 The records and documents are maintained to implement the system and to demonstrate its effective
functioning.
•
Reference Documents
•
Cleaning and Sanitation Documents.
•
Pest Control related Documents.
•
Validation and Verification Document.
•
Preventive Maintenance Program.
2.13
•
Personnel Hygiene & training
•
Records related MRM, Internal Auditing etc
•
Records as per the HACCP plan
Review the HACCP Plan
2.13.1 The HACCP food safety team ensures that procedures exist to review the HACCP plan prior to any
changes which may affect product safety. Review of HACCP Plan is carried out when there is a ,
•
change in raw materials or supplier of raw materials
•
change in ingredients/recipe
•
change in processing conditions or equipment
•
change in packaging, storage or distribution conditions
•
change in staff or management responsibilities
•
change in consumer use
•
developments in scientific information associated with ingredients, process or product.
Appropriate changes resulting from the review are incorporated into the HACCP plan, fully documented
and validated.
2.13.2 Irrespective of any of the above changes, the HACCP plan is reviewed annually once and records are
maintained.
Section 3. Food Safety and Quality Management System
3.1
Food Safety and Quality Policy
Refer: Food Safety and Quality Policy
FOOD SAFETY POLICY
Policy statement:
The Food Safety Team in M/S.XYS Company is committed to serving food to its guests prepared under hygienic
and safe conditions.
Our Food Safety Practices shall:
•
•
•
•
•
•
•
Ensure that only Trained and Skilled staff are inducted into the kitchen
Reflect Food Safety Standards in relation to safety practices, premises and equipment standards
Reinforce consistent food safety practices in the service
Aim at providing Safe and Hygienic food
Reduce the risk of potential food-borne illnesses
Comply with legislative requirements while maintaining a flexible approach to meet the best
practices
Reflects continual improvement in the Food Safety Standards.
This commitment to Food Safety Policy will be demonstrated by the management conforming to Food Safety
Management System based on BRC requirements and the following objectives as mentioned in the table on the
next page.
FOOD SAFETY AND QUALITY OBJECTIVES AT FUNCTIONAL LEVELS FOR THE PERIOD OF
2011-2012
S.NO
FUNCTION
OBJECTIVE
RESPONSIBILITY LEVEL
(Functional Heads)
1
HR
To give employees, a minimum
Manager QC
of one training program in a
month in handling, processing,
and serving of the safe food.
2
Purchase / Stores
Nonconforming input materials
not more than 5% per supplier of
the total consignment per month
Manager Stores
3
Production /
Manufacturing
To bring down the wastage of the
Executive Chef
food to 5 % of the total
production.
4
Quality Assurance
Customer complaints: Not more
than 5% per month
Manager Production
The company’s Food safety and Quality Policy is developed, documented and established by
Director duly authorized -signed and dated. The policy is reviewed for suitablity and adequecy
once in a year during Management Review Meeting.
3.1.1
The policy states the company’s intention to meet the obligation to product safety, quality, legal
requirements and its responsibility to customers. It states commitment for review and continual
improvement. The importance of meeting statutory, legal and customer requirements are communicated to
all levels of staff by the Management through display boards and training programs. The policy
requirements are understood and accordingly implemented by all concerned staff and key personnel.
3.2
Food Safety and Quality Manual
BRC Manual is the Food Safety and Quality Manual which describes the requirements of the
Global Standard for Food Safety. These requirements are implemented, reviewed once in six
months and revised if necessary.
3.2.1
This manual contain or make references to the Standard working procedures SOPs, work sheets, working
methods and practices, which are used to meet the requirements of the Standard.
3.2.2
This manual and related document is readily available to the key staff. The copy holders are given in
Distribution List of the manual.
3.3
Organisational Structure, Responsibilities and Management Authority
Refer: Refer Organization Chart from HACCP manual
The company has an organizational structure, which ensures that the job function, responsibility
and reporting relationship of all personnel, whose work affect the product safety, agility and quality
are clearly defined and documented.
3.3.1
The organization structure demonstrates the structure of the company.
3.3.2
The levels of responsibility and accountability are clearly defined for key staff in product quality, safety
and legality.
3.3.3
Whenever specified staff is on leave either replacement is given by the person having equal subject
knowledge on the specific work
3.3.4
The description of general duties / work instructions are made available at the place of work and
communicated to all the staff involved with the activities related to product safety, legality and safety.
3.3.5
A suitable system has been developed to collect all information related to legislative requirement of the
product, Quality and Food safety issues, scientific and technical developments, industrial code of practice
applicable to the country of origin / sale.
Organization Chart
Managing Director
Production
Manager
Electrician
Plant
Operators
Maintenance in
charge
Microbiologist
Supervisor
Supervisor
Manager
Procurement
Manager QA
Supervisor
Hygiene
Supervisor
Highlighted is the HACCP team
Stores in
charge
HR
Manager
Ripening shed
in charge
3.4
Contract Review and Customer Focus
Customers requirements and expectations with regards to product safety and quality are identified
based on direct interactions and feedbacks. The procedure clearly defines the method, roles and
responsibilities of the process and personnel.
3.4.1
The Marketing Department is responsible for communications with customers and has an effective system
for communication via e-mails, telephone and software for order processing.
3.4.2
Customer requirements relating to the development, specification, manufacture and distribution of product
are defined through specification and approvals of the contracts prior to the release of orders. It is ensured
that these requirements are fulfilled. If specification are not formally agreed upon, the order clearly
mentions the approval for acceptance of the product as per companys specification by the customer.
3.4.3
Depending on the contract/agreement period, the customers’ needs and requirements are reviewed. Any
changes to the existing agreements or contract are agreed by the marketing department upon approval of
Director and communicated to the Production, Quality Assurance and other appropriate departments.
3.4.4
Customer satisfaction index is established to monitor the customer satisfaction levels and communicated
to appropriate staff.
3.5
Internal Audit
The company audits those systems and procedures which cover the requirements of the Global
Standard for Food Safety to ensure that they are in place, appropriate and complied with.
3.5.1
Audits are scheduled based on the risk assessment with minimum of 6 months intervals. Their scope and
frequency is established or modified based on the risk associated with the activity.
3.5.2
The internal audits are carried out buy the audit team who are trained and competent. It is ensured that
they do not audit their own area of work or have direct influence on the operation over the section, which
is audited.
3.5.3
Records of internal audits are maintained to ensure that the conformity / non-conformity are clearly
identified and verified.
3.5.4
The results of internal audit are brought to the attention of the personnel responsible for that activity. The
corrective actions and time scales for implementation are finalized and agreed.
3.5.5
The completions of the corrective actions are verified by the HACCP Food Safety Team Leader or
Director or General Manager upon the agreed date.
3.5.6
The records of all scheduled internal audits and associated action and audit reports are maintained to
demonstrate compliance and to ensure non-conformities can be identified and verified.
3.6
Purchasing – Supplier Approval and Performance Monitoring
All purchasing processes that are critical to product quality, safety and legality are controlled to
ensure that products and services procured confirms to defined requirements.
3.6.1
Purchase describes the procedures adopted for supplier approval and continual assessment program.
These continual assessments are done based on risk assessment.
3.6.2
The procedures also cover the criteria for assessment and standards for approval. The assessment may
cover one of the following forms of monitoring performance.
•
In house verification.
•
Verifying certificate of analysis.
•
Through suppliers inspection reports.
The supplier’s assessments include evaluation of HACCP systems, product safety information, traceability
and legislative requirement.
3.6.3
The procedure also describes how exceptions are handled. E.g. use of products and services when audit or
monitoring is not undertaken.
3.6.4
Based on the new supplier performance during the trial period, further decision on ongoing supplier
performance monitoring is decided.
3.7
General Documentation Requirements
Documentation Control
Through Control of Documents procedures the company ensures that all documents, records and
data critical to food safety management, legality and quality are in place and effectively controlled.
3.7.1.1
All documents in use are properly authorized and correct version is ensured.
3.7.1.2
Documents are legible and unambiguous and sufficiently detailed to facilitate correct application by
appropriate personnel and accessible at all times.
3.7.1.3
Reason for changes and changed details critical to product quality, safety & legality and procedures
recorded.
3.7.1.4
The procedures address controls available in identification and removal of obsolete documents and
replacement with updated version.
3.7.2
Specifications
Company’s specifications have been developed and cover
1) Raw material including Packing material
2) Finished products
3) Intermediate semi-processed products; and
Any other product or service that could affect integrity of the finished product.
3.7.2.1
It is ensured that the company’s specifications are adequate, accurate and match with relevant safety
and legislative requirements.
3.7.2.2
It is ensured that the manufacturing instructions comply with recipes as detailed in agreed customer
specifications and implemented.
3.7.2.3
Customer specification if any are formally agreed and authorized by relevant parties. If the
specifications are not formally agreed then suitable steps are initiated to get approvals.
3.7.2.4
The specifications are reviewed once a year or whenever changes are carried out to ensure adequacy
and correct status.
3.7.2.5
Specifications and/or their contents are accessible to relevant staff.
3.7.3
Record Completion and Maintenance
Records are maintained to demonstrate the effective control of product safety, legality and quality.
3.7.3.1
While preparation of records genuinely and legibility is ensured, approved by authorized person
retained in good condition for defined time period.
3.7.3.2
Alterations in the record are authorized by appropriate persons and justification for alteration is also
recorded by the authorized person.
3.7.3.3
The procedure for control of records explains collection reviewed maintenance storage and retrieval of
all records related to product safety, legality and quality.
3.7.3.4
The retention time for documentation and record is based on the shelf life of the product and to
consider the extended shelf life at customer end (e.g.) freezing.
3.7.3.5
Any legal and customer specific requirements relevant to record retention is taken into account.
3.8
Corrective and Preventive Action
Corrective action procedures have been established to investigate the cause of the non conformity
against standards, specifications and procedures that are critical to product safety, legality and
quality.
3.8.1
The corrective actions are accurately documented in corrective action reports clearly indicating person
assigned and accountable.
3.8.2
Corrective actions are implemented to prevent further occurrence of non-conformity.
3.8.3
Corrective action plans related to safety, legality and quality of products are agreed by personnel who are
responsible and accountable for the areas of control. These personnel also verify and report to satisfactory
completion of the corrective action planned.
3.8.4
The completion of corrective actions are monitored and recorded to ensure their effectiveness and
completion within an appropriate timescale.
3.9
Traceability
Suitable traceability system has been developed. This system has the ability to trace and follow all
raw materials including primary packing material from source through all stages of processing and
distribution of finished product to the customer.
3.9.1
Identification of raw materials including primary and any other relevant packaging and processing aids,
intermediate/semi-processed products, part-used materials, finished products and materials pending
investigation, are adequate to ensure traceability.
3.9.2
The system is tested once a year to ensure traceability can be determined from raw material to finished
product and vice versa. It includes quantity check/ mass balance. Traceability records are maintained.
3.9.3
If there is a requirement to ensure identity preservation within supply chain, e.g. Use of logo then
appropriate control and testing procedures are established. Relevant test records are available at HACCP
Food safety Team Leader.
3.9.4
When rework or reprocess is carried out, then traceability is maintained. In addition, the company
demonstrates that this does not affect the safety or legal status of the finished product, e.g. ingredient
declaration, allergy information or identity preservation.
3.10
Complaint Handling
Suitable system for management of product related to complaint is established.
3.10.1 All complaints are recorded, investigated and the results of the investigation recorded.
3.10.2 Immediate corrective actions are initiated for customer complaints depending on the seriousness and
frequency of the problem. Suitable replies are given to the customer based on the root cause analysis.
3.10.3 As a part of data analysis, the complaint data is analyzed to initiate preventive actions and part of on going
improvements related product safety, legality and quality.
3.11
Management of Incidents, Product Withdrawal and Product Recall
Plans and procedures have been developed to effectively manage incidents, product withdrawals
and product recalls.
3.11.1 The company has procedures designed to manage effectively incidents and potential emergency situations
that impact food safety, legality or quality and have effective product withdrawal and product recall
procedures in place. This includes consideration and contingency planning for business continuity and
product withdrawal or recall in the event of the following:
•
disruption to key services such as water, energy, transport, staff availability and communications
•
events such as fire, flood or natural disaster
•
malicious contamination or sabotage.
3.11.2 Emergency preparedness procedure provides the guidance to relevant staff regarding type of event that
would constitute an incident or emergency situation that impacts food safety, legality or quality. Such
incidents reported are recorded.
3.11.3 Emergency preparedness procedure includes the follwing details:
•
identification of key personnel constituting the incident management team with clearly identified
responsibilities
•
an up-to-date list of key contacts, e.g. incident management team, emergency services, suppliers,
customers, certification body, regulatory authority
•
a communication plan including the provision of information to customers, consumers and regulatory
authorities in a timely manner
•
details of external agencies providing advice and support as necessary, e.g. expert laboratories,
regulatory authority and legal expertise
•
product withdrawal and/or recall procedures
•
corrective action and business recovery.
3.11.4 The procedure for incident reporting, product withdrawal and product recall are made in such a way that
they can operate for any product at any time. While developing these procedures, the possible product
stock, logistics involved, the recovery, storage and disposal of the recalled product is also considered.
These procedures are reviewed once in a year and if necessary revised / updated. In line with the
corrective and preventive action procedures, the incidents, recall, product returns and withdrawals are
analyzed and corrective and preventive actions are initiated
3.11.5 Mock drills are conducted once a year to test the effectiveness of product recall / withdrawal procedures.
The results of the mock drill is retained and reviewed for necessary improvements.
3.11.6 The Executive Director ensures that results of this test is used to implement improvements as necessary.
3.11.7 In the event of a product recall, the certification body and appropriate authority is informed in a timely
manner.
Section 4: Site Standards
4.1
EXTERNAL STANDARDS
The factory site is located, constructed, designed and maintained so as to prevent contamination
and enable the product on of safe and legal products.
4.1.1
Consideration is given to local activities and environment, which can have adverse impact on the product,
and control measures are taken to prevent product contamination, if applicable. Whenever such measures
are taken, then these are reviewed to ensure they continue to be effective e.g. dust or odor control.
4.1.2
The external areas are maintained in good order. An unwanted growth like weeds and shrubs are
periodically checked and removed. The condition of the site is included in the internal audit process.
4.1.3
Suitable drainage systems have been constructed and maintained. All the drainage systems lead to the
Effluent Treatment Plant.
4.1.4
External traffic routes, under site control are paved and maintained in good repair to avoid contamination
of the product.
4.1.5
The building fabric are maintained to minimise potential for product contamination, e.g. pipe work are
appropriately sealed to prevent pest entry, ingress of water and other contaminants.
4.2
Security
Measures are in place to maintain site security and ensure only authorized staffs have access to
production and storage areas.
4.2.1
Access to the site by employees, contractors and visitors is controlled and a visitor reporting system is in
place.
Prior to the entry into the production or storage primeses, vistors has to fill the required details in the
Visitor’s Declaration Form
4.2.2
Staff are trained in site security procedures and encouraged to challenge unidentified or unknown visitors.
The visitors are provided with the apron and visitor’s pass which is later handed over to the Security at
the main entrance.
4.2.3
Measures are in place to maintain site security and to ensure only authorised staff have access to
production and storage areas via designated access points. Areas are assessed according to risk; sensitive
or restricted areas are defined, clearly marked, monitored and controlled.
4.2.4
Based on risk assessment, procedures are in place to ensure the secure storage of all materials including
ingredients, packaging, chemicals and equipment.
4.2.5
Procedures are in place to ensure that finished product is held under secure storage and transportation
conditions, e.g. tamper evident packing, contractual handling agreements.
4.2.6
Site is registered with and approved by Mr.XYZ.The Registration Number is …………………
4.3 Internal Site Standards
4.3.1
Layout, Product Flow and Segregation
Premises and plants are designed, constructed and maintained and procedures put in place to
control the risk of product contamination and to comply with all relevant legislation.
4.3.1.1
The process flow from intake to dispatch is arranged in such a way that the risk of product
contamination is minimized.
The process flow is well documented in the Process Flow Diagram referred in this manual.
4.3.1.2
Segregation of products (If required) takes into account the flow of product, nature of materials,
equipment, personnel, waste, airflow, air quality and utilities provision.
4.3.1.3
Facilities for cleaning and washing of housekeeping equipments and containers and general purpose
cleaning are adequately segregated from all production areas.
4.3.1.4
Premises allow sufficient working space and storage capacity to enable all operations to be carried out
properly under safe hygienic conditions.
4.3.1.5
Cleaning and inspection of areas and equipment are aided by the avoidance of obstructions and where
appropriate the provision of adequate space.
4.3.1.6
Temporary structures constructed during building work or refurbishment, etc., are designed and
located to avoid pest harbourage and potential contamination of products.
4.3.1.7
To avoid the risk of growth of pathogenic microorganisms, finished products are segregated from raw
material and other processing areas. These high risk areas are designed and maintained under high
standard of hygiene. Hygiene controls related to personnel, ingredient, equipment, packaging and
environment are in place to prevent contamination of product by microorganisms.
Packing area in the main building, Raw material ware house, Packaging material ware house and
finished goods ware house are well segregated.
4.3.1.8
The processing methods are developed to reduce the potential physical, chemical or microbiological
contaminations and risks.
Physical contaminations are controlled by manual check at the time of receiving.
Chemical and microbiological contaminations are controlled by
procuring raw materials from the approved suppliers
RO treatment to process water
Proper machinery (like closed pipelines, no leakages etc)
Fabrication-Raw Material Handling, Preparation, Processing, Packing and Storage Areas
The fabrication of the site, buildings and facilities are suitable for the intended purpose.
4.3.2.1
Walls
4.3.2.1.1
The Walls are designed, constructed, finished and maintained to prevent the accumulation of dirt,
reduce condensation and mould growth, and facilitate cleaning.
4.3.2.2
Floors
4.3.2.2.1
Floors shall be designed to meet the demands of the process, and withstand cleaning materials and
methods. They shall be impervious and maintained in good repair.
4.3.2.2.2
The Drainages are designed and maintained suitably to minimize risk of product contamination /
product safety. Drains from laboratories are kept in such a way that they do not present a risk to
the products.
4.3.2.2.3
The Floors are built with sufficient slope to cope up with the flow of any water towards drainage
where applicable.
4.3.2.3
Ceilings/Overheads
4.3.2.3.1
Ceilings and overheads are designed, constructed, finished and maintained to prevent the
accumulation of dirt, minimise condensation and mould growth, and facilitate cleaning.
4.3.2.3.2
Where suspended ceilings are used, adequate access to the void is provided to facilitate cleaning,
maintenance of utilities and inspection for pest activity.
4.3.2.4
Windows
4.3.2.4.1
Where windows are designed to be opened for ventilation purposes, they are provided with mesh
to prevent entry of pests.
4.3.2.4.2
Glass windows are paneled and prevented from breakage by providing hooks and made shatter
proof by poly-lining
4.3.2.5
Doors
4.3.2.5.1
Doors in the raw material stores, processing, packing and product storage areas are either kept
closed or provided with curtains to prevent pest entry.
4.3.2.5.2
Doors are in good condition and easy to clean, where required.
4.3.2.6
Lighting
4.3.2.6.1
Adequate lighting is provided for all work areas.
4.3.2.6.2
All bulbs and tube lights, including those on pest-o-flash units, in the high care zone, are protected
by shatterproof plastic covers
4.3.2.7
Air Conditioning/Ventilation
4.3.2.7.1
Adequate ventilation and extraction is provided in product storage and processing environments to
prevent condensation or excessive dust.
4.3.2.7.2
Wherever filtered air is required, the blowers, exhaust fans and the filters used for this purpose are
adequately maintained.
4.3.2.7.3
The entire material movement is either by manual, fork lifts, and trolleys.
4.4
Utilities
All utilities to and within the production and storage areas are designed, constructed, maintained
and monitored to control the risk of product contamination.
4.4.1
All water used as processing aid in the production unit or for equipment or plant cleaning is potable and
pose no risk of contamination. Water used for toilet and washing is also from the bore wells and the
storage tanks are protected and cleaned periodically to minimize any risk of contamination.
4.4.2
The quality of water, air and compressed air that comes into contact with food or packaging is regularly
monitored to avoid risk to product safety or quality.
4.5
Equipment
Equipment are suitably designed for the intended purpose and used so as to minimize the risk of
contamination of product.
4.5.1
All equipments shall be properly specified before purchase and tested and commissioned prior to use.
4.5.2
The layout and positioning of equipment is made in such a way that there is adequate access in and around
them for ease of cleaning and servicing.
4.5.3
Certificates of conformity or other evidence are available for equipment in direct contact with food to
confirm its suitability for use, e.g. conveyor belts.
4.6
Maintenance
A system of planned maintenance is in place covering all items of equipment and plant, which are
critical to product safety, legality and quality.
4.6.1
Equipment, including fixtures and fittings, are maintained in such condition as to minimise the risk of
product contamination.
4.6.2
Whenever new equipment is commissioned, based on the risk assessment, suitable preventive
maintenance instructions are developed and implemented.
4.6.3
During maintenance and cleaning operations, sufficient controls are maintained to avoid product
contamination and to ensure the safety or legality of product is not affected.
4.6.4
In addition to any planned maintenance programme, where there is a risk of product contamination by
foreign bodies arising from equipment failure, the equipment are inspected at predetermined intervals,
inspection results documented and appropriate action taken.
4.6.5
Where temporary repairs are carried out, , packing, binding wires, etc., they are controlled to ensure the
safety or legality of product is not affected. As soon as possible, they are made permanent.
4.6.6
Contractors involved in maintenance or repair activities are under the supervision of a nominated person.
4.6.7
Maintenance work is followed by hygiene clearence procedure-House Keeping activity, recording that the
product contamination hazards have been removed from the machinery and equipment. On completion of
maintenance work, care is taken to clean and make free from contamination hazards.
4.6.8
Materials used for equipments and plant maintenance such as lubricating oil and paints, that may pose a
risk by direct or indirect contact with raw materials, intermediate and finished products, is ensured that
they are suitable for intended use.
4.6.9
Engineering workshops are controlled to prevent risk of contamination to the product.
4.7
Staff Facilities
Staff facilities provided is sufficient to accommodate the required number of personnel, and are
designed and operated to minimise the risk of product contamination. Such facilities is maintained
in good and clean condition.
4.7.1
The changing facilities for staff, visitors and contractors are located in such a way that after changing the
personnel has direct entry into the production, packing or storage areas without recourse to any external
area.
4.7.2
The workers who work in raw material handling, processing, preparation, packing and storage area are
provided with sufficient size storage shelves to accommodate all personal items.
4.7.3
The workers are provided with storage shelves so that outdoor clothing and other personal items are stored
separately from work wear.
4.7.4
Suitable and sufficient hand washing facilities are provided at the entry points of the production areas. The
facilities include,
•
sufficient quantity of water at an appropriate temperature
•
liquid soap
•
single use towels or suitably designed and located air driers
•
appropriate instructions for use .
Where high-risk products are handled, the following additional requirements are provided:
•
water taps with hand-free operation
•
hand disinfection
4.7.5
Toilets are adequately segregated from production, packing and storage areas and do not open directly into
these areas. The facilities include,
•
sufficient quantity of water at an appropriate temperature
•
liquid soap
•
single use towels or suitably designed and located air driers
•
appropriate instructions for use.
4.7.6
Smoking is not permitted inside the factory premises.
4.7.7
No food consumption is permitted in the processing and packing areas. Suitable provision is made for the
storage of food brought onto the premises by staff in clean and hygienic state.
4.7.8
If catering facilities are provided, it shall be suitably controlled to prevent contamination of product.
4.7.9
Tea and refreshment is served in the designated area and waste generated is appropriately disposed.
4.7.10 Facilities provided for visitors and contractors are as per company’s hygiene norms.
4.7.11 Where an operation involving high-risk products (refer to glossary) exists, personnel enter via a specially
designated changing facility, and follow specified procedures for applying visually distinctive clean
overalls, headwear and footwear.
4.8
Chemical and Physical Product Contamination Control. Raw Material Handling, Preparation,
Processing, Packing and Storage Areas
Appropriate facilities and procedures are in place to control the risk of physical or chemical
contamination of product.
4.8.1
The company has identified the potential risks from chemical, physical or taint contamination based on
risk assessment. The risks are controlled and managed by appropriate control measures.
The areas associated with such risks are
•
Storage
•
Production operation or processes or machinery
•
any maintenance or building work carried out
•
hygiene and cleaning operations
Such Potential contamination from building material and overhead structures are controlled through
regular documented audits and corrective action is taken to minimize risk of product contamination.
4.8.2
4.8.2.1
Chemical Control
Chemical control procedure details the use , storage and handling of non-food chemicals.
The controls includes are
4.8.3
•
Approved purchase
•
Availability of material safety data sheets and specifications
•
If required, confirmed suitability for food use
•
Avoidance of strong scented products
•
Identification of chemicals at all times
•
Segregated and secure storage with restricted access to authorized personnel
•
Use of trained personnel only
Metal Control
4.8.3.1
The documented metal policy provides the control of the use of sharp metal implements including
knives, cutting blades on equipment, needles and wires including suitable controls both into and out of
the factory, and safe disposal.
4.8.3.2
Snap-off blade knives are not to be used.
4.8.3.3
Non-production blades, equipment and tools are not to be left in a position that allows them to
contaminate the product.
4.8.3.4
Where staples or other items are used which are likely to cause contamination in packaging,
appropriate precautions are taken to minimise the risk of product contamination.
4.8.4
Glass, Brittle and Hard Plastic, Ceramics and Similar Materials
4.8.4.1
All glass and brittle material in raw material storage, processing, packing and product storage areas are
listed in a register indicating its locations and checked for damage at specified intervals determined by
risk analysis.
4.8.4.2
Documented procedures for handling glass, brittle or hard plastic, ceramic or other similar materials is
in place and implemented to ensure that necessary precautions are taken. Procedure includes:
4.8.4.3
4.8.5
4.8.5.1
4.8.6
•
list of items detailing location, number, type and condition
•
recorded checks of condition of items carried out at a specified frequency based on risk assessment
•
details on cleaning or replacing items to minimise potential for product contamination.
Documented procedure details the action to be taken in case of breakage of glass, brittle or hard
plastic, which includes glass packaging and similar material based on risk assessment. The action paln
includes the following:
•
quarantining the products and production area that were potentially affected
•
cleaning the production area
•
inspecting the production area and authorising to continue production
•
changing of workwear and inspection of footwear
•
specifying those staff authorised to carry out the above points
•
recording the breakage incident.
Wood
In areas where a risk assessment has identified the potentials for product contamination from wood,
the use of wood is excluded. Where the use of wood cannot be avoided, and the risk is managed, the
condition of wood shall be regularly checked to ensure it is in good condition and clean.
Other
4.8.6.1
Filters, sieves and magnets used for foreign body control are regularly inspected and properly
maintained. Such activities are recorded and investigated.
4.8.6.2
Based on risk assessment, procedures are implemented to minimise foreign body contamination of
packaging during filling operations, e.g. covered conveyors, container inversion and foreign body
removal through rinsing or air jets.
4.9
Housekeeping and Hygiene
Housekeeping and cleaning systems are in place which ensure appropriate standards of hygiene are
maintained at all times and that risk of contamination in minimized.
4.9.1
Documented cleaning schedules have been developed and followed for building, services, plant and all
equipment. Cleaning procedures include the following:
•
responsibility for cleaning
•
item/area to be cleaned
•
frequency of cleaning
•
method of cleaning
•
cleaning materials to be used
•
cleaning records and
•
responsibility for verification.
4.9.2
Cleaning-in-place (CIP) facilities are monitored and maintained to ensure effective operation.
Consideration is given to frequency, cycle time, temperature, chemical concentration and spray ball
location and coverage. CIP have adequate separation from active product lines.
4.9.3
Cleaning and housekeeping is carried out by trained personnel in accordance with documented procedures
and records are maintained.
4.9.4
Cleaning chemicals and equipments are chosen based on
•
fit for purpose
•
suitably identified for intended use, e.g. colour coded or labelled
•
stored in a hygienic manner to prevent contamination
4.9.5
The effectiveness of the cleaning and sanitation procedures is verified and recorded. Corrective actions are
documented.
4.9.6
Cleaning and disinfection procedures are revalidated following building or maintenance work, new
product introduction or changes to equipment.
4.10
Waste/Waste Disposal
There are adequate systems for the collection, collection disposal of waste material.
4.10.1 Systems are in place to avoid the accumulation of waste in production areas and prevent the use of unfit
materials.
4.10.2 Presently there are no legislative requirement for waste / scrap disposal.
4.10.3 The waste / scrap are disposed through approved contractors.
4.10.4 External waste collection bins and containers are clearly marked and controlled to avoid mix up and to
minimize risk. The containers/ bins are
•
clearly identified
•
designed for ease of use and effective cleaning
•
well maintained to allow cleaning and where required, disinfection
•
emptied at appropriate frequencies
•
covered or doors kept closed as appropriate
4.10.5 If substandard trademarked materials are transferred to a third party for destruction or disposal, it is
ensured that third party is a specialist in secure product or waste disposal and provide records of material
destruction or disposal.
4.11
Pest Control
4.11.1 The company is responsible for minimizing the risk of pest infestation on the site.
4.11.2 The company has a contract with a competent pest control organization for regular inspection and
treatment of premises to deter and eradicate infestation. The service contract clearly defines and reflects
the activities of the site.
4.11.3 Pest Control procedures and inspection documentation are maintained. This includes:
•
an up-to-date, signed and authorised site plan identifying numbered pest control device locations
•
identification of the baits and/or monitoring devices on site
•
clearly defined responsibilities for site management and the contractor
•
details of pest control products used and instructions for their effective use.
Detailed records of the pest control inspections, necessary action under taken are maintained.
4.11.4 Bait stations are placed at outer wall of the plant. They are robust, of tamper resistant construction,
secured in place and appropriately located to prevent contamination risk to product.
4.11.5 The pest-o-flash/pheromone are correctly positioned and operations throughout manufacturing operations
and periodically checked and cleaned.
4.11.6 In the event of infestation, immediate action are taken to eliminate the hazard. Action are taken to identify,
evaluate and authorise the release of any product potentially affected.
4.11.7 Detailed records of pest control inspections, recommendations and actions taken are maintained. The
company ensures all of the relevant recommendations made by their contractor are carried out and
monitored. The completion of corrective action are demonstrated by documented evidence.
4.11.8 Results of pest control inspections are assessed and analysed for trends regularly, in the event of an
infestation and annually.This includes a catch analysis from trapping devices to identify problem areas.
Any such problems are suitably rectified.
4.12
Storage and Transport
All facilities used for the storage and transportation of product, movement around the site, and
dispatch of finished product are suitable for the purpose, maintained in good repair and in a
hygienic condition.
4.12.1 Procedures to maintain product safety and quality during storage, loading and transportation are developed
on the basis of risk assessment and implemented accordingly. These may include as appropriate the
following list:
•
controlling temperature
•
cleaning storage areas and vehicles
•
segregating to avoid cross contamination or taint uptake
•
storing materials off the floor and away from walls as appropriate
•
ensuring that vehicles such as bulk tankers are of hygienic design and designated for food use;
putting in place procedures to prevent cross contamination from previous loads
•
vehicle pre-loading and unloading inspection
•
vehicle loading or unloading in covered bays
•
maintaining product security and preventing damage.
4.12.2 Where temperature control is required, the storage area or transport facility are capable of maintaining
product temperature within specification, under minimum and maximum load and under worst case
ambient temperature.
4.12.3 Where temperature control is required, documented procedures are in place to ensure product temperature
requirements are met. This shall include temperature data-logging devices which can be interrogated to
confirm time/temperature conditions or a system to verify and record at predetermined frequencies the
correct operation of refrigeration equipment.
4.12.4 Where storage outside is necessary, items are protected from contamination and deterioration.
4.12.5 Receipt documents and/or product identification facilitate correct stock rotation of goods in storage and
ensures materials are used in the correct order and within the prescribed shelf life.
4.12.6 If the company employs third-party contractors, all the requirements specified in this section are clearly
defined in the contract or the company shall be certificated to the Global Standard for Storage and
Distribution.
4.12.7 Traceability is ensured during storage and transportation. There are clear record of dispatch and receipt of
goods and materials to demonstrate that sufficient checks have been completed during the transfer of
goods. The returned goods from market is stored at an identifed area. The returened material along with
packing material inspected and disposed as appropriate.
4.12.8 Documented maintenance and hygiene procedures are maintained for all vehicles and equipment used for
loading/unloading. The records of the measures taken are maintained.
4.12.9 Procedures are in place in the case of vehicle breakdown. All incidents of vehicle or equipment
breakdown are recorded and corrective action documented.
Section 5: Product Control
5.1
Product Design/Development
Product design and development procedures are in place to ensure manufacturing processes are
capable of producing a safe and legal product.
5.1.1
During Product design and development process, HACCP plan is developed to identify potential hazards
and the control measures.
5.1.2
Factory trials are carried out and thorough testing to validate that product formulation and manufacturing
processes are capable of producing a safe and legal product against the proposed shelf life.
5.1.3
Shelf-life trials are undertaken using documented protocols reflecting conditions during storage and
handling throughout shelf life. Test Results are recorded and retained which confirm compliance with
relevant microbiological, chemical and organoleptic criteria.
5.1.4
During new products introduction, the company ensures control of handling requirements for specific
materials.
5.1.5
Purchase Procedures ensures that product packaging conforms to relevant food safety legislation and
specification and is suitable for its intended use.
5.1.6
The Executive Director / General Manager ensures that a system is in place to confirm that labelling of the
product or other forms of customer information meets legislation for the designated country of use and in
accordance with the appropriate product specification.
5.1.7
Where a product is designed to enable a claim to be made to satisfy a consumer group, e.g. a nutritional
claim of reduced sugar, the company ensures that the product formulation and production process is fully
validated to meet the stated claim.
5.1.8
The product design/development process is documented and effectively communi cated throughout the
organisation, to ensure that changes in formulation are adequately assessed for safety and legality.
5.2
Handling Requirements for Specific Materials – Materials Containing Allergens and Identity-preserved
Materials
Where raw materials and finished products require special procedures for handling specific materials
(e.g. material containing allergens or the requirement for identity-preserved status such as Genetically
Modified Organisms, assured organic status or special designated origin) these are in place to ensure
that product safety, legality and quality are maintained.
5.2.1
Material Containing Allergens
5.2.1.1
The company has carry out risk assessment of raw materials to establish the presence and likelihood of
contamination by allergens including approval of raw material specifications. The company has
systems to specify the integrity of the raw material and compliance with specification throughout the
purchasing and supply chain.
5.2.1.2
The company shall identify and list allergen-containing materials handled on site. This shall include
raw materials, intermediate and finished products. Presently, no genetically modified raw materials
containing raw materials are used. If legal requirements warrant additional controls, like declaration,
then it will be established.
5.2.1.3
Risk assessment are carried out to identify routes of contamination and establish documented policies
and procedures for handling raw materials, intermediate and finished products to ensure cross
contamination is avoided. This includes:
•
physical or time segregation while allergen containing materials are being stored, processed or
packed
•
use of identified, dedicated equipment for processing or cleaning
•
all food brought onto site including that by staff.
5.2.1.4
Where rework is used, or reworking operations carried out, procedures are implemented to minimise
cross contamination from allergen-containing materials and ensure the safety, legality and quality of
the finished product.
5.2.1.5
Where a claim is made regarding the suitability of a food for allergy or food sensitivity sufferers, the
company ensures that the production process is fully validated to meet the stated claim.
5.2.1.6
Based on risk assessment, documented equipment or area cleaning procedures are undertaken to
remove or reduce to acceptable levels any potential cross contamination in compliance with finished
product specifications.
5.2.1.7
All relevant personnel, including temporary staff and contractors, are appropriately trained in allergen
handling procedures prior to commencing work and are adequately supervised throughout the working
period.
5.2.1.8
Any non-conformities relating to allergen control are included in the management review process and
may include, as appropriate, internal or external incidents and customer complaints such as labelling
or cross-packing errors. The review process also considers updates or changes in allergen legislation or
scientific information.
5.2.2
Identity-preserved Materials
5.2.2.1
Where identity preserved claim is made and products brought onto site require segregation, the
company carry out a risk assessment of raw materials to specify the integrity of the raw material and
compliance with specification throughout the purchasing and supply chain.
5.2.2.2
Risk assessment are carried out to identify routes of contamination and establish documented policies
and procedures for handling raw materials, intermediate and finished products to ensure cross
contamination is avoided and that controls are in place to maintain identity preserved status.
5.3
Foreign Body Detection
The company shall have appropriate foreign body detection equipment in place and ensure its
effective operation.
5.3.1
Foreign body detection equipment shall be in place unless it can be justified as not necessary. This
justification shall be documented. Detection equipment shall be situated to maximise foreign body
detection within the finished product.
5.3.2
The sensitivity of detection shall be specified and best practice applied with regard to the nature of the
food, the location of the detector and any other factors influencing the sensitivity of the detector.
5.3.3
The metal detector shall incorporate the following based on best practice:
an alarm on a belt stop system
an automatic rejection device which shall either divert contaminated product out of the product
flow or to a secure unit accessible only to authorised personnel
in-line detectors which identify the location of the contaminant and effectively segregate the
affected product.
There shall be documented procedures specifying corrective and investigative action to be taken in the
event of the detection of metal or a foreign body.
5.3.4
The company shall establish and implement procedures for the operation, routine monitoring, testing and
calibration of the metal or other foreign body detectors. This shall include:
frequency and sensitivity of checks
authorisation of trained personnel to carry out specified tasks
documentation of checks
5.3.5
The company shall establish and implement corrective action and reporting procedures in the event of the
monitoring and testing procedure identifying any failure of the metal or foreign body detector. Action
shall include a combination of isolation, quarantining and re-inspection of all product produced since the
last acceptance test of the metal or other foreign body detector.
5.4
Product Packaging
Product packaging is appropriate for the intended use and stored under conditions to minimise
contamination and deterioration.
5.4.1
Certificates of conformity are available for product packaging to confirm its suitability for use.
5.4.2
To avoid cross contamination, Packaging is stored away from raw materials and finished product.
5.4.3
Any part-used packaging materials suitable for are effectively protected before being returned to an
appropriate storage area. Defective packing materials are returned to main packing store for returning to
the supplier / scrapping.
5.4.4
Product contact liners (or raw material/work-in progress contact liners) if used, are appropriately coloured
and of sufficient gauge to prevent accidental contamination where appropriate.
5.4.5
Presently packaging materials do not pose a product safety risk. If required, special handling procedures
are in place to prevent product contamination.
5.5
Product Inspection and Laboratory Testing
The company carries out own product inspection and analyses which are critical to confirm product
safety, legality and quality, using appropriate procedures, facilities and standards which prevent risk to
product safety.
5.5.1
Product Inspection
5.5.1.1
Based on risk assessment, testing and inspection schedules are established to ensure specified product
requirements are met. Inspection and testing methods and frequency are documented.
5.5.1.2
Test and inspection results are recorded and reviewed regularly to identify trends. Appropriate actions
are implemented promptly to address any unsatisfactory results or where trends indicate unsatisfactory
results.
5.5.1.3
Where validation of finished product quality attributes is required, organoleptic tests are carried out
regularly in accordance with specifications and recorded.
5.5.1.4
The company ensures that a system of ongoing shelf life assessment is in place. This based on risk and
includes microbiological and sensory analysis as well as relevant chemical factors such as pH and aw.
Records and results from shelf life tests validate the minimum shelf life period indicated on the
product.
5.5.2
Laboratory Testing
5.5.2.1
When such activity is carried out in house, the laboratory facility shall be located remote from the
manufacturing site.
5.5.2.2
Routine testing laboratories are present on a manufacturing site. The laboratory is located, designed
and operated to eliminate potential risks to product safety. Controls are documented, implemented and
include consideration of the following
•
design and operation of drainage and ventilation systems
•
access and security of the facility
•
movement of laboratory personnel
•
protective clothing arrangements
•
processes for obtaining product samples
•
disposal of laboratory waste.
5.5.2.3
Where tests, which are critical to product safety or legality, are carried out at the out side laboratory,
or subcontractors, then their control and recognition in accordance with the requirements and
principles of ISO 17025 are acertained.
5.5.2.4
The reliability of the lab results are cross checked at least once a year by testing in other laboratories.
This includes:
•
documented testing procedures
5.6
•
ensuring staff are suitably qualified and/or trained and competent to carry out the analysis
required
•
use of a system to verify the accuracy of test results, e.g. ring or proficiency testing
•
use of appropriately calibrated and maintained equipment.
Control of Non conforming Product
The company ensures all out-of-specification product is clearly identified, labelled and quarantined.
5.6.1
Procedures for the control of non-conforming material, indicates the controls adopted, including rejection,
acceptance by concession, or regrading for an alternative use. The details are communicated to all
concerned and authorized personnel to ensure that they are aware of the requirements.
5.6.2
Corrective actions are implemented to avoid recurrence of non-conformance and adequate records are kept
on the action taken.
5.6.3
All non-conforming material are clearly identified and quarantined as appropriate, and handled or
disposed of according to the nature of the problem and/or the specific requirements of the customer.
5.7
Product Release
The company ensures that finished product is not released unless all agreed procedures have been
followed.
5.7.1
A procedure are in place, based on risk assessment, to ensure that only products conforming to
specification are dispatched and released by authorised staff.
Section 6: Process Control
The company demonstrate effective control of all operations undertaken.
6.1
Control of Operations
The company follows validation procedures to verify that the processes and equipment employed
are capable of producing consistently safe and legal product with the desired quality characteristics,
in full compliance with the HACCP food safety plan
6.1.1
All Critical Control Points and specified limits identified through HACCP are transferred into day-to-day
production controls and are fully validated.
6.1.2
Process monitoring such as temperature, time, pressure and chemical properties are established and
adequately controlled to ensure that product is produced within the required process specification.
6.1.3
Process monitoring are carried out by trained staff and documented.
6.1.4
In circumstances where process parameters are controlled by in-line monitoring devices, it is ensured
these are linked to a suitable failure alert system that is routinely tested.
6.1.5
In the case of equipment failure or deviation of the process from specification, procedures are in place to
establish the safety status of the product, prior to release.
6.1.6
Corrective action are taken in the event of deviation of process from specification and recorded.
6.1.7
Procedures are in place to ensure that products are packed into the correct packaging and correctly
labelled with due consideration given to product changeover.
6.1.8
In the event of changes to product formulation, processing methods, equipment or packaging, monitoring
of the specified process are re-established based on HACCP.
6.2
Quantity – Weight, Volume and Number Control
The company operates a quantity control system which conforms to legal requirements and
additional industry sector codes or specified customer requirement in the country where the product
is sold.
6.2.1
The frequency and methodology of quantity checking meet the requirements of appropriate legislation
governing quantity verification.
6.2.2
Where the quantity of the product is not governed by legislative requirements (e.g. bulk quantity), the
product must conform to customer requirements.
6.3
Calibration and Control of Measuring and Monitoring Devices
Measuring equipment used to monitor CCPs and product safety and legality are identified. The
identified measuring equipment are calibrated to a recognised national or international standard. Where
a traceable calibration is not possible, the company will demonstrate the basis by which standardisation
is carried out.
6.3.1
6.3.2
6.3.3
6.3.4
The company has identified measuring equipment used to monitor CCPs and product safety and
legality.This shall include:
•
a documented list of equipment
•
equipment identified and marked in accordance with requirements (e.g. numbered, calibration due
date).
All identified measuring devices are checked and where necessary adjusted:
•
at a predetermined frequency, based on risk assessment
•
by trained staff
•
to a defined method traceable to a recognised national or international standard where possible.
The prescribed measuring and monitoring devices are:
•
prevented from adjustment by unauthorised staff
•
protected from damage, deterioration or misuse.
Procedures are in place to record actions taken when the prescribed measuring and monitoring devices are
found not to be operating within specified limits.
Section 7: Personnel
7.1
Training – Raw Material Handling, Preparation, Processing, Packing and Storage Areas
The company ensures that personnel performing work that affects product safety, legality and
quality are demonstrably competent to carry out their activity, through training, work experience or
qualification.
7.1.1
All relevant personnel, including temporary staff and contractors, are appropriately trained prior to
commencing work and adequately supervised throughout the working period.
7.1.2
Where personnel are engaged in activities relating to Critical Control Points, relevant training and
documented monitoring procedures are in place.
7.1.3
The company has documented programmes covering the training needs of relevant personnel. These
include:
7.1.4
7.1.5
•
identifying the necessary competencies for specific roles
•
providing training or other action to ensure staff have the necessary competencies
•
reviewing and auditing the implementation and effectiveness of training and competency of the
trainer
•
consideration of the delivery of training in the appropriate language of trainees.
Records of all training are available. This includes:
•
name of trainee and confirmation of attendance
•
date and duration of training
•
title or course contents as appropriate
•
training provider.
The company are routinely reviewed for the competencies of staff and provide relevant training as
appropriate. This may be in the form of training, refresher training, coaching, mentoring or on-the-job
experience.
7.2
Access and Movement of Personnel
The company ensures that access and movement of personnel, visitors and contractors shall not
compromise product safety.
7.2.1
Plant layout defines access points for personnel, travel routes and staff facilities.
7.2.2
If required, to allow access through production areas, designated walkways will be provided that ensure
there is adequate segregation from materials.
7.2.3
All facilities are designed and positioned, where possible, so that movement of personnel is by simple,
logical routes.
7.2.4
Contractors and visitors, including drivers, are made aware of all procedures for access to premises and
the requirements of the areas they are visiting, with special reference to hazards and potential product
contamination.
7.3
Personal Hygiene – Raw Materials Handling, Preparation, Processing, Packing and Storage Areas
The company’s personal hygiene standards are documented and adopted by all personnel, including
contractors and visitors to the production facility. These standards are formulated with due regard
to risk of product contamination.
7.3.1
The requirements for personal hygiene are documented and communicated to all personnel. Compliance
with the requirements are checked regularly.
7.3.2
Based on risk assessment, the company has documented its jewellery policy.
7.3.3
Watches are not worn. Jewellery are not worn, with the exception of a plain wedding ring, a wedding
wristband and sleeper earrings (continuous loop). Rings and studs in exposed parts of the body, such as
noses, tongues and eyebrows, are not to be worn.
7.3.4
Hand cleaning is performed at a frequency that is appropriate, based on risk assessment.
7.3.5
Fingernails are kept short, clean and unvarnished. False fingernailsare not permitted. Where visitors
cannot comply, suitable control procedures are in place, e.g. non-handling of product, use of gloves.
7.3.6
Excessive perfume or aftershave not worn.
7.3.7
Smoking (where permitted under law), eating and drinking is permitted in designated areas segregated
from food-handling and storage areas.
7.3.8
All cuts and grazes on exposed skin are covered by an appropriately coloured plaster different from the
product colour and containing a metal detectable strip where metal detection/X-ray equipment is in use. At
present, metal detectable strips are not used but in addition to the regular plaster, a finger stall is worn.
7.3.9
At present, metal detectable strips are not used.
7.3.10 Procedures are in place to control the use of personal medicines to minimise the risk of contamination.
7.4
Medical Screening
The company ensures that medical screening procedures are in place for all employees, contractors or
visitors who will be working in or visiting areas where product safety could be compromised.
7.4.1
The company have a procedure for the notification by employees, including temporary employees, of any
relevant infections, disease or condition with which they may have been in contact or be suffering from.
7.4.2
Where there may be risk to product safety, visitors and contractors are required to complete a health
questionnaire prior to entering the raw material, preparation, processing, packing and storage areas. Where
appropriate, these persons shall undergo medical screening before permission is granted.
7.4.3
There shall be written and communicated procedures for employees, including temporary employees,
contractors and visitors, on action to be taken in the case of infectious disease from which they may be
suffering or have been in contact. Particular consideration should be given where product safety may be
compromised. Expert medical advice shall be sought where required.
7.5
Protective Clothing – Employees or Visitors to Production Areas
Suitable company issued protective clothing are provided to employees, contractors or visitors
working in or entering production areas.
7.5.1
Based on risk assessment, the company has documented and communicated to all employees, contractors
or visitors the rules regarding the wearing and changing of protective clothing in specified work areas, e.g.
high-risk and low-risk areas. This includes policies for wearing of protective clothing away from the
production environment, e.g. removal before entering toilets, use of canteen and smoking areas.
7.5.2
Protective clothing is made available:
•
provided in sufficient numbers for each employee
•
of suitable design to prevent contamination of the product
7.5.3
Clean and dirty clothing are segregated and controlled to prevent cross contamination.
7.5.4
Laundering of protective clothing is outsourced using defined and verified criteria to validate the
effectiveness of the laundering process, or by an approved contracted and audited laundry. The
effectiveness of cleaning is monitored. Washing of workwear by the employee is not allowed.
7.5.5
Where there is the risk of contamination, smoking and eating while wearing protective clothing is not be
permitted.
7.5.6
All scalp hair are fully contained to prevent product contamination.
7.5.7
Based on risk assessment, snoods for beards and moustaches are worn to prevent product contamination.
7.5.8
Suitable footwear are worn within the production environment.
7.5.9
If gloves are used, they are replaced regularly. Gloves are suitable for food use; of a disposable type; of a
distinctive colour intact, and do not shed loose fibres.
7.5.10 For operations involving high-risk products all visibly distinctive protective clothing (including footwear)
are applied when entering, and removed when leaving, the high risk area and stored in a designated
changing area.
Section 8: Glossary of Terms
BRC
British Retail Consortium
SOP
Standard Operating Procedure
FSP
Food Safety Plan
ANX
Annexure
FSTL
Food Safety Team Leader
PROD
Production
QA
Quality Assurance
WI
Work Instructions
GMO
Genetically Modified Organisms
CIP
Cleaning In Process
COM
Commercial
MKT
Marketing
PRP
Pre-Requisition Programmes
CCPs
Critical Control Points