The
Documentation Process
The
major changes in the standard applied in documentation process, since Annex SL
format has adjusted its wording from documentation and record keeping to
documented information in the recently modified versions of ISO standards.
Hence, at the documentation level, the standard has flatten its controls while
introducing the bare minimum thus, releasing the complete responsibility to the
user, which is one of the best improvements, because standard 3rd
party auditors are crazy and hectic headache to users. They change their
documentation requirements from one audit to another, person to person,
organization to organization if they couldn’t find any minor concerns, but they
mostly ignored major concerns to retain the client. Now company can decide what
documents to be kept, at which format, the way they want to document, and what
documents are really required based on the process requirements, but it doesn’t
mean that company do not require documentation. Thus, there are mandatory
documented information as evidence of proper implementation and maintenance,
which is mentioned in the standard without basically dictating whether it is a
manual or a procedure or a work instruction or something else.
However,
considering the documented information, it still requires much more than it
asked from the food manufacturer where it is best advised to consider the original
documentation model or what we call the documentation pyramid to ease the
development of better FSMS. The company can eliminate the manual, but manual
can be used as an explanatory document of company’s food safety/quality system
which can amalgamate several ISO standards together such as ISO 9001, ISO
22000, ISO 14001, etc. Thus, common Annex SL can be used to setup initial
documents and references to the relevant procedures or secondary documents as
well as system performance documents, while linking several standard together
to build a single company manual. Nonetheless, it also provide the opportunity
to club all the relevant documents to a one place while using them in a
flattened structure.
Considering
the mandatory documented information, the standard still requests to provide
hazard analysis, PRPs, CCPs, OPRPs, hazard control plans, and procedures or
sort of evidence of protocols for the below mentioned areas. In addition, same procedures and activities
are applied to the prerequisite programs and operational prerequisite programs
identified according to the risk levels of the product manufactured.
The
ISO 22000 management elements are handled through mandatory documented
information in addition to the above mentioned areas which consists of;
1. Control of documented information
2. Statutory, regulatory and customer
requirements
3. Communication
4. Product identification and
traceability
5. Emergency preparedness and
response
6. Corrections and corrective actions
7. Handling of potentially unsafe
products
8. Withdrawals and recalls
9. Internal audits
10. Management review
Some
of these procedures are not requested as procedures directly, but as documented
information, but practitioners of ISO 22000 can consider to write them as
procedures since it is easier to upgrade from previous model to the new version
without much documentation work rather than completely revising the existing
system. Nonetheless, some of these requirements are basically identical to ISO
9001, and compatible with its requirements, thus it can be used in harmony if
required. The ISO 22000 FSMS has procedure for emergency preparedness and
response, which is inherited from reputed safety standards while it is also
identical to ISO 9001. The organization and the top management must be prepared
to respond to potential emergency situations and accidents that can impact on
food safety. These can include incidents such as fire, flooding, bio-terrorism
and sabotage, energy failure, vehicle accidents, contamination of the
environment, various types of weather-related events, or the impact of a
pandemic.
Hence,
food safety management system needs to be documented as it requires documented
information. This means that the organization must have, as a minimum, a
written food safety policy and related objectives, the procedures/way of
execution/rules and performance evidence as required by ISO 22000 as well as
any other documented information that might need to ensure the effective
development, implementation and updating of the system. In addition,
organization will not only need to document its policies and procedures but it
also need to have a procedure for controlling its documentation and records,
because food safety management systems will change over time, as will the
people doing the activity. Therefore, one reason for controlling documented
information is to ensure that the individual using the document has the most
recent version of the document. Part of document control ensures that all the
proposed changes are reviewed prior to implementation which determines their
effects on food safety and the impact on the management system.
The
documentation system is still identical to the ISO 9001 which consisted of four
layers in its previous version that has been flatten in the latest revision in
2015. As the organization develops its food safety management system, it has
been advised to carefully document its activities. These will include the
written food safety policy and related objectives, food safety procedures and
the required records as to pervious terminology, even though their names have
been changed to a generic documented information. Further, the scope of the
required documentation has been extended wherever possible. For example, in
establishing your control measures you are required to document your hazard
analysis and hazard assessment, including the decision-making process and the
selection of control measures, whereas decision making process requires
additional categorizations based on two types of logics which require more
information than previous version. Nonetheless, organization will have to have
evidence of documented information on the validation of its system and
verification activities. The work of the food safety team and the management
review also require documentation as it was required before.
Prerequisite
programs were basically developed as part of good manufacturing practices
initially and later-on it was became one of the major components in HACCP,
because most of the system developers wanted to keep lowest number of HACCP
studies in a system where PRPs were used to cover less critical control points
as well as which cannot be measured in real time. In ISO 22000:2005, this uncertainty was
addressed with separating real time immeasurable critical control points in to
operational prerequisite programs, which was not properly segregated in HACCP,
even though later versions of HACCP addressed the issue up to a certain extent.
As it didn’t completely cover the gap until the ISO 22000:2005 was released,
where ISO 22000:2005 version introduced separation through ISO 22000 decision
tree with logical sequence of questions to segregate them. However, most of the
users never understand the complete logic behind it in ISO 22000:2005 and they
compel to use HACCP decision tree, where there was a great disagreement between
many auditors and user to clearly define them. Because, people love logical
trees and select CCPs easily, but distinguishing OPRP had great differences
which was ignorant in many cases.
Considering
the changes in the new version of ISO 22000, it has nominated HACCP plan and
OPRP plan as hazard control plan by clubbing both CCP plan and OPRP plan
together which is a terminological improvement, rather than system, where
standard has struggled to come out of better solution to differentiate,
segregation of CCP and OPRP. But the technical committee has not come out with
a completely successful solution which practitioners can easily understand.
This is one of the major weak points so far in the previous standard, which is
still remains a mystery to average users. When considering the private
standards like FSSC 22000, it is also depend on the ISO 22000, where they have
added additional parameters or streamlined the issues with the ISO 22000, but
never address this part of the misunderstanding to the average user
completely.
Nevertheless,
all prerequisite programs have four common factors which are; address indirect
or less critical food safety issues, cover general programs related to food safety
and it can be applied to multiple production lines. Momentary failure to meet
prerequisite programs seldom results in a food safety hazard. The organization
should use documented information of external origin relevant for food safety
in its various activities, for example in meeting statutory, regulatory and
customer requirements and their interests. The new version has also considered
paperless management situations, where electronic documentation has added as
part of documented information which may be required to comply with regulatory
requirements.
As
a whole, ISO 22000 can be considered as a business management tool which links
food safety to business processes and encourages organizations to analyze
requirements of interested parties, define processes and keep them in control
where it enables integration of quality management and food safety management.
In this way ISO 22000 FSMS is considered as more focused, more coherent and
integrated food safety management system which can satisfy any food safety
statutory or regulatory requirements.
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