Documentation
Structure
1. Interactive communication
2. System management
3. HACCP principles
4. Prerequisite programs
Communication along the food chain is
essential to ensure that all relevant food safety hazards are identified and
adequately controlled at each step within the food chain. This implies the
importance of communication between organizations between both upstream and
downstream in the food chain. Recognition of the organization’s role and the
position within the food chain is essential to ensure effective interactive
communication throughout chain in order to deliver safe food product to the end
user (ISO 22000, 2005).
The Standard defines six types of
documentation within a quality management system:
A food safety policy and objectives; a food
safety manual (optional);
Documented procedures as required by the standard;
Prerequisite programs
Documents required by the organization to
ensure effective planning, operation and control of processes;
Records required by the standard.
However, the amount of documentation will
depend on:
The size of the organization, place in the
food chain and types of activities; the risk involved; the complexity of
processes and their interaction; the competence of personnel. A document is virtually anything that
provides information. It may be a record, procedure, specification, drawing or
report. The information may be presented on paper, magnetic tape, electronic,
computer disc, photograph, master samples or a combination of these.
In those areas where the Standards call for
“documented procedures”, one would expect to find information set out in
formally, meeting the criteria set out for relevant activity. The flexible approach of the Standard is
intended to enhance the implementation, maintenance and improvement of the
system. This being the case, management should decide upon structure and format
of the documentation that is needed to support the food safety management
system. The nature and extent of the documentation should depend upon, and
meet, the needs of the organization.
Documentation
in the Context of Food Industry
An organization with an existing quality
management system should not need to rewrite all of its documentation in order
to meet the requirements of ISO 22000:2005. This is particularly true if an
organization has structured its system in the way it operates effectively,
using a risk based management approach. In this case, the existing
documentation may be adequate and can be simply referenced in the revised food
safety manual (optional) or even in the procedures.
An organization that has not used a risk
based management approach in the past will need to define its processes, their
sequence and interaction as required by the ISO 22000 Standard. Thus an
organization must be able to carry out risk assessment (Hazard Analysis) with some
streamlining and/or consolidation of existing documents, in order to simplify
its system.
Organizations
preparing to implement a FSMS
Based on the ISO 22000:2005
requirements mentioned in the standard, regardless of size, type of activities
performed or the place in the food chain; the organization must comply with
o
Food Safety Policy
o
Food Safety Objectives
o
Mandatory Food Safety Procedures
o
Prerequisite Programs
o
Hazard Analysis
o
HACCP Plan
o
OPRAP Plan
o
Work Instructions
o
Specifications/Records/Reports/Check Lists/Guidelines, etc.
However, the standard did not
request to have a Food Safety Manual. But it is much easier and very systematic
to have a manual, which can be used as the main document with reference and
links to all other documents. According
to the gap analysis results and the ISO 22000:2005 requirements, each and every
document must be designed considering the effective implementation and
maintenance. It was very important to maintain document linkages as well as the
identification of which process required documents and where they should be
applied and the way of managing them and the responsibilities and even the
distribution as mentioned in the standard.
The following six step process can
be adapted as a standard record documentation system development initiative
with reference to the ISO 30300:2011 that are needed for the effective
operation of the system.
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvements
In order to claim conformity with ISO 22000:2005,
the organization must provide evidence of the effectiveness of the HACCP plan
and food safety management system. As noted above, this may not necessarily
depend on documented procedures or records, except where these are specifically
required by ISO 22000:2005. Organizations, particularly small organizations,
may be able to demonstrate compliance without the need for extensive
documentation or by adapting externally developed combinations of control
measures when the similar industries in existence.
The Food
Safety Policy and Objectives
Food Safety policy
The food safety policy should define top
management’s commitment to comply with requirements and to continually improve the
effectiveness of the food safety management system.
An effectively formulated food safety
policy should:
Demonstrate top
management commitment to food safety and the provision of adequate resources
for its achievement;
Promote a
commitment to food safety at all levels in the organization; be consistent with
the organization’s overall business policies;
Be consistent with
the vision of the organization’s future;
Enable food safety objectives
to be understood throughout the organization; address continual improvement and
consumer safety;
Food safety policy
is a framework for establishing and reviewing food safety objectives.
In establishing the
food safety policy, top management should consider:
The expected level
of consumer safety;
The needs of other
interested parties;
Opportunities and
needs for continual improvement; Resources required and;
Contributions of
suppliers and partners;
Food Safety Objectives
Food safety objectives
are a link between the policy and the commitment to continual improvement. The
organization’s objectives should be:
Established during the
planning process; set at each relevant function and levels;
Measurable and
consistent with the food safety policy;
In establishing food safety objectives,
management should consider:
The current and
future needs of the organization and the markets served;
Current product and
process performance;
The levels of food
safety of all interested parties;
Actions arising
from management review.
Once decided, the objectives need to be
communicated to the appropriate people in a way that they are able to translate
these objectives into their individual contributions. Objectives should be
reviewed periodically and revised as necessary in order to provide current
objectives for continual improvement of the food safety management system.
Food Safety Manual (Optional)
Contents
The food safety manual must clearly define
the scope of the food safety management system where food safety manual
provides an overview of the food safety management system. Each manual will be unique to the
organization but should contain:
Title page;
Table of contents;
Introduction to the organization; Quality
Policy;
The scope of the system, including the
details and justification for any exclusion;
Organization structure (for example charts
and scopes of responsibility);
A description of the interaction of the
processes of the system;
The documented procedures or reference to
them;
Amendment record (if appropriate);
A cross-reference between the
organization’s system and the requirements of the Standard;
(Adapted from ISO 9001:2008)
Role of the food safety manual is to demonstrate
the organization’s ability to operate a food safety management system and impress
the customer or to meet customer requirements while defining and clarifying the
food safety assurance, facilitate change, improve communications, meet international
business requirements, act as a training aid, provide a system of audits and
act as a guide for suppliers. The Standard requires that responsibilities and
authorities and the interrelation between them are defined and communicated
within the organization. One way of
doing this is through organization charts and scopes of responsibility and
these may well be presented in the manual. The lines of reporting of the food
safety team leader, especially in terms of food safety related decisions should
be clearly defined in the organization structure.
Documented Procedures
The ISO 22000:2005 management elements are
handled through mandatory food safety procedures, that consists,
Control of
documents
Control of records
Corrections
Corrective Actions
Potentially Unsafe
products
Withdrawals
Internal
Audits
These procedures are basically identical to
ISO 9001, and compatible with its requirements.
The ISO 22000 FSMS also has procedure/ protocol for emergency preparedness and response, which is inherited from reputed safety standards while identical to ISO 9001. However, some organizations may need documented procedures in other areas covering particular departments, functions, or processes.
Procedures should be written in an agreed
format and the following are typical sections or headings;
Purpose
The objective or intention of the procedure
Scope
Applicability, boundaries
Procedure/method
Who is responsible for the action/control?
What is actioned/controlled and how, (including
how information is processed);
Methods and equipment used
Records to be completed/processed
Where: location.
When: timing, frequency
References
Other documents quoted and those that may
need to be read to understand the procedure.
The documented procedures may be contained
within the food safety manual or in a separate Procedures manual.
These are documents required by the
organization to ensure the effective planning, operation and control of its
processes.
Such documents may include:
Product flowcharts;
Process flowcharts;
organization charts; production schedules; work instructions; operating instructions; Job cards; User manuals; Inspection plans; Test methods and instructions; drawings;
Approved supplier lists; technical manuals;
Manufacturer’s recommendations;
Performance standards;
Prerequisite Programs
However, when you are implementing an ISO 22000:2005
FSMS, initially don’t plan to have all these PRPs in your system, first design
and implement mandatory PRPs initially to observe their performance as a dummy.
When you complete the hazard analysis, validate all the PRPs before
implementation. In this stage you will realize the real additional needs or
modifications to the prepared PRPs, where you can decide exact number and the
control measures according to ISO 22000 FSMS. According to the ISO 22000:2005, the
organization shall establish, implement and maintain PRP(s) to assist in the
following:
Controlling the likelihood of introducing food safety hazards to the product through the work environment;
Controlling
biological, chemical and physical contamination of the product(s) including
cross contamination between products;
Controlling food
safety hazard(s) levels in the product and product processing environment.
The PRP(s) shall be appropriate to the
organizational needs with regard to food safety, be approved by the food safety
team, and their relevance and appropriateness for controlling food safety
hazards shall be included in the hazard analysis (7.4).The PRPs consist of two types:
Infrastructure and maintenance programs
(see 7.2.2);
Operational PRP(s) (see 7.2.3).
When selecting and designing PRP(s), the
organization shall consider and utilize appropriate existing information (e.g.
regulations, customer requirements, guidelines, Codex principles and codes of
practices, national, international or industrial standards) that is relevant
for the design of the PRP(s).
The prerequisite program requirements (recommended
by Codex Alimentarius) are generic which basically designed to cater ISO 22000 food safety
management system/HACCP systems. Thus your establishment will need to ensure
that the criteria in these programs (including regulatory requirements) are
being met within the plant environment as requested by the ISO 22000 standard.
Each prerequisite program is structured according
to the following example:
A Program (e.g. Premises)
A 1 Element (e.g. Building Exterior)
A 1.1 Sub-element (e.g. Outside Property and
Building)
A 1.1.1 Bullet (e.g. Building facility not located
close to any environmental contaminants and the surroundings/ roadways are free
of debris and refuse, adequately drained and maintained to minimize
environmental hazards).
Conduct your final assessment at the sub-element
level for each prerequisite program.
Records
