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SECTION 4

Certification Process

1. SCOPE OF THIS DOCUMENT


This document explains the process of certification under the Q Mark Voluntary
Certification Scheme for Food products (hereinafter referred to as the Scheme) and
lays down the requirements that shall be followed in order to obtain, operate and
maintain the Certification.

2. OBJECTIVE
The objective of this document is to regulate the operation of the Scheme and
promote uniformity in its operation and the interaction between the Certification
Bodies (CBs), the Food Business Operators (FBOs) seeking product certification and
the Q Mark Certification Scheme Owner.

3. SCOPE OF CERTIFICATION
3.1 The scope of Q Mark Voluntary Certification Scheme for Food products covers
Packaged Food Products and Commodities as per the requirements specified in the
Certification criteria. The criteria cover 5 levels, which also forms the basis for
certification.
3.2 For the purpose of certification the product categories as applied by FSSA for the
purpose of issuing licences to the Food Business Operators shall be used.
3.3 The certification shall be granted only to those FBOs who have a valid FSSA licence
and shall be restricted to the processed packaged product categories up to the Level
of the category (hereinafter referred to as product(s)) as covered in the licences
issued by the FSSAI and those applied for by the FBO for certification.

4. Q MARK CERTIFICATION SCHEME REQUIREMENTS


4.1 In addition to the requirements specified in the Certification criteria as relevant to the
level applied/certified for, the following requirements specific to Q Mark Certification
scheme shall also apply.
4.1.1 Internal Quality Assurance Protocol (IQAP) - FBO shall develop an Internal
Quality Assurance Protocol (IQAP), for describing the controls over the process and
the product at various stages of production from raw materials, through processing
and dispatch, the hygienic conditions , good manufacturing practices for ensuring the
consistent production of packaged processed food products that meet the specified
certification criteria. Based on a detailed assessment of IQAP by the Certification
Bodys Audit team, during stage 1 audit, regarding its appropriateness and adequacy
for the food product under evaluation and discussions with the FBO, this document
shall be finalised. The FBO shall be required to comply with the same and the IQAP
shall also become a part of the certification agreement. The essential elements that
should be in the IQAP are given in Annex B. The IQAP shall be maintained as a
dynamic document and the FBO shall review and amend the same, if required, as
and when the certification criteria undergo modifications and revisions, whenever the
FBOs processes and/or manufacturing facilities under go changes. FOB shall inform
the certification body about changes in its processes and facilities and changes in the
protocol.
4.1.2 Availability of In-house testing facilities The FBO shall have in-house testing
facilities for conduct of all in-process testing required for ensuring appropriate
process controls and as described in the agreed Internal Quality Assurance Protocol
(IQAP). In addition, the FBO shall also have in-house testing facilities for all other
tests on raw materials and finished products, where the use of external test
laboratory is not feasible considering the frequency of tests to be performed as
described in the agreed Internal Quality Assurance Protocol (IQPA) and the final
product release requirements.
4.1.3 Determination of the Risk classification For the purpose of operation of the Q
Mark certification scheme, a risk classification of the FBOs for specific food products,
shall be carried out based on the system described vide the document The risk
based classification system for food businesses. The risk classification as described
in this document is required to be used as the basis for many activities as relevant to
the Q Mark scheme for certification of food products. These cover manday
estimations, auditor competence and qualification, determination of surveillance
frequencies and the frequencies for drawal of factory and market samples. The FBO
is also required to evaluate the risk their business and products present to the
customer as per document on Risk Classification and based on this develop an
Internal Quality Assurance Protocol (IQAP), identifying the processes that need to
be controlled for ensuring quality and safety of food products, defining the requisite
control over them, establishing a monitoring mechanism and keeping records as
evidence of compliance.
4.1.4 Approval from the scheme owner for use of Q Mark - The Q Mark for Food
Products is owned by the Scheme Owner. The FBO who wishes to use this mark on
his product shall be required to obtain formal approval from the scheme owner for the
use of the mark only after they have been assessed to be compliant to all the
scheme requirements by a Certification Body approved by the scheme owners. Only
the Certification Bodies who are approved by the scheme owner are permitted to
evaluate and certify the Food Business Operators for use of Q Mark on their
products. The prerequisite for approval of the certification bodies by the scheme
owner are accreditation by NABCB against ISO/IEC 17065:2012 and the Q Mark
Scheme specific requirements as contained in various sections of the Q Mark
scheme documents. Initially for a limited period Certification bodies approved under
QCI approval scheme shall also be eligible for approval under this scheme. The
Certification Body shall apply and get approval for use of Q Mark by the FBO certified
by them from the scheme owner for Q Mark.
4.1.5 Certification Agreement The certification agreements describes the terms and
conditions which the FBO is required to abide by after he is granted the certification.
The agreed IQAP shall also be part of the Certification agreement between the FBO
and the Certification Body. Since the Q mark scheme bestows self marking rights to
the certified FBO, he is required to pledge his commitment to implement the agreed
IQAP for ensuring conformity of products and processes to the Certification Criteria
and the Scheme requirements on a continuing basis. The details of the requirements
have been covered vide clause A.4.1.2 of the document Certification Body
Requirements section(Section 7) and the format for certification agreement are also
required to be available on the approved Certification Bodys website. The
Certification Agreement shall also cover requirements with respect to use of
certificates and marks of conformity on the products by the FBO.

5. CERTIFICATION PROCESS
5.1 Application
5.1.1 The certification body shall provide the applicant Food Business Operators (FBOs)
with an up-to-date detailed description of the evaluation and certification procedures,
and the documents containing the requirements for certification, the applicants rights
and the duties of suppliers of certified products (including fees to be paid by
applicants and suppliers of certified products).
5.1.2 The above information along with the application format shall be made available on
the CBs website.
5.1.3 CB may design its own application format for the Q Mark Voluntary Certification
Scheme for Food products, however while designing of the form it shall ensure that
at least the following information is obtained.
a. The general features of the FBO, including its name and the address of its
physical location; contact details; legal entity status; its functions and relationship
in a larger corporation, if any.
b. Details of the valid licence/registration issued under FSSA along with details of
the product categories up to the Level of the category covered.
c. The product(s) to be certified and as on the valid FSSA licence/registration. In
case the application is for a proprietary product(s), this information shall clearly
be included in the application.
d. Information about judicial proceedings relating to its operations/product, any
proceedings by any Regulatory body or suspension/cancellation/withdrawal of
any relevant certifications/approvals under any Regulations.
e. The Q Mark Level (as described in Certification criteria document) against which
certification is being sought.
f. The details of requirements against which label claims are made as well as any
other requirements as per the criteria for certification against which certification is
sought by the FBO.
g. General information about the applicant FBOs activities, description of
production processes, details of manufacturing facilities, technological context,
facility layout, food safety systems, its human and technical resources (Internal
as well as external, contracted, etc), number of shifts of operation, information on
in-house laboratory, if any, accessibility to external testing facilities.
h. The controls exercised by the applicant FBO for ensuring product conformity to
the requirements described in the relevant certification criteria, including Internal
Quality Assurance measures/plan.
i. Information concerning all processes outsourced by the applicant FBO that have
potential to affect conformity to requirements. If the FBO is outsourcing or intends
to outsource such processes then the information regarding what processes
being outsourced / being planned to outsource, the name and address of the
outsourced organization, the FSSAI licences/registration it holds, the basis on
which they are approved by the FBO, the controls FBO exercises / plans to
exercise for controlling the quality (including safety) of such materials, etc, is
required to be submitted at the application stage itself.
j. In respect of Level 2 above, additional information regarding whether the FBO is
HACCP or food safety system certified which includes HACCP as an intrinsic
part, if yes, under which accreditation. In case the FBO is not certified as above
then information regarding number of HACCP studies, number of personnel
(internal external) handling food, as separate total employed in the organization
(Clause ..), type of product and intended use, pathogen reduction process,
intended user (consumer).
k. In respect of levels 3 and above, additional information regarding Basic/India
GAP certified operator/suppliers/farmers from whom the FBO is sourcing , along
with the details of name and location, scope of certificate, validity of certificate
and the issuing authority. In case the FBO is sourcing from Global Gap certified
operators/suppliers/farmers then complete information as stated above.
l. In respect of levels 5, additional information regarding the FBOs system in
respect of Social responsibility and environment requirements as specified in the
certification criteria. In case the FBO is already certified to ISO 14001 or OHSMS
standards, then information with respect to the relevant certification along with
copies of the certificates.
m. Test report(s) from an independent accredited laboratory, clearly indicating
compliance to all the parametric requirements relevant to the product(s) applied
for.
n. All other information considered essential for manday estimations and
determining auditor competence.
5.1.4 The prospective applicant organization shall declare whether it has been an
applicant/certified under this Scheme with or by any other certification body, and if
yes then shall provide the previous evaluation reports to the new certification body.
The certification body may verify the information provided by contacting the previous
certification body.
5.1.5 Certification is granted only against the current relevant certification criteria. The
certification body shall review all applications for the above and ensure the same.

5.2 Application Review The CB shall undertake an Application Review of the


Application received from the FBO, as per their documented procedure for ensuring
the following ; The review of application shall cover the following aspects:

a) the information about the FBO and his facilities and the product to be certified
is sufficient for the conduct of the application review and the subsequent
certification process;
b) any known difference in understanding between the certification body and the
FBO is resolved, including agreement regarding certification criteria;
c) the scope of certification sought is defined;
d) the means are available to perform all evaluation activities;
e) the certification body has the competence and capability to perform the
certification activity.
f) To determine the risk the FBO presents to its customers, based on the
guidance as provided vide the document The risk based classification
system for food businesses (Section 5).
g) To determine the time required for conduct of the audit (Stage 1 and Stage 2
as well as surveillance audits). This shall be done in accordance with the
CBs documented procedure for determination of audit time, which shall be
established based on the requirements described in Annex A to this
document.
h) To determine and nominate an audit team, evaluator and the technical
reviewer competent for the certification scope applied for. This shall be done
in accordance with the requirements specified in the document Certification
Body Requirements (Section 7).
The procedure for conducting the application review, shall clearly describe the
process for application review, responsibilities and the competence of personnel
performing the application review.
5.2.1 Based on the review of applications for certification, deficiencies observed, if any,
shall be informed to applicant FBO within a reasonable time. Records of review shall
be maintained. In case the information about the applicant FBO and the product to be
certified, as provided by the applicant, is not complete/sufficient for the purpose of
conducting an application review then the CB will have procedure for obtaining
additional information. The information thus received shall be recorded along with
other information already received.
5.2.2 Only applications found to be completely filled and supported with all documents
sought shall be accepted and registered in order of receipt with a unique
identification number, acknowledged and records maintained.
5.2.3 Antecedents of the applicants shall be checked in relation to the Scheme. If the
FSSAI licence/registration has been suspended / cancelled for a product or the
factory during the last one year, the application from the same FBO shall not be
entertained.
5.2.4 Applications from FBOs who have earlier either misused the Q Mark, or have been
implicated / convicted by the court, or whose earlier Q mark certificate was cancelled
because of violation of terms & conditions/misuse of Q Mark certification mark shall
not be registered within three years of conviction/strictures by the court/cancellation
of the certificate by any CB.
5.2.5 Applications from organizations found to be misusing the Q Mark, while their
application is being processed for grant of certificate, shall not be processed any
further, and rejected after a due notice of 15 days. Fresh applications from them shall
be treated as per clause 4.2.4 given above.
5.2.6 Requests for grant of certificates from ex applicants shall be processed like a fresh
applicant and the entire procedure for grant of certificate be adhered to subject to
clauses 5.2.3, 5.2.4 and 5.2.5 above.
5.2.7 The CB shall clearly identify the responsibilities and establish internal time lines for
responding to enquiries from prospective FBOs, application review and feedback to
FBOs as well for registration of application and these shall be reasonable as per the
activities involved in the relevant process step.

5.3 Preparation and Planning for Initial Evaluation


5.3.1 Prior to undertaking the site visit, the certification body, through the members of its
nominated team shall undertake certain offsite activities as part of preparation and
planning stage. These are:
a) Study of all the information received and request for additional information, if
required.
b) Examination of the licences issued by the regulatory body (FSSA) to identify the
product category up to the Level of the category as applicable, under
certification and other information contained therein.
c) Study the product and identify suitable product standard and the regulatory
requirements. This exercise shall also be carried out in respect of Raw
Materials/input materials used by the FBO for the product category, since many
of the contaminants and additives, etc, used will be governed by the relevant
regulatory requirements.
d) In case of proprietary products based on information contained in the FSSA
licence/registration and the application made by the FBO to FSSAI and the
information provided by the FBO, study and identify the product requirements.
e) Based on the above study prepare a checklist for requirements to be verified
and audited during the onsite audits. If required, make modifications in generic
GMP/GHP checklist (Annex 3). This modification can continue based on the
observations made in stage 1 audit.
f) Prepare an audit plan for stage 1 audit.

5.4 Initial Evaluation


5.4.1 Initial site Audits - The visit to the site(s) of the FBO where the activities related to
the product/processes to be covered under the scope of accreditation take place is
an important component of the evaluation activities. In case of Q mark the site visit
shall cover both inspection (including test witness) and audit activities and for the
sake of uniformity all site visits will hence forth be referred as Audits and the
personnel involved as auditors and Technical experts.
5.4.1.1 Initial Audit shall generally be carried out by a competent evaluation team in two
stages. Both the Stage 1 and Stage 2 audits shall take place at the FBOs site.
However, in cases where as per manday estimation carried out in accordance with
the requirements specified in Annex A, the initial evaluation mandays work out to less
than 3 mandays, the stage 1 and stage 2 audits may be combined and a single stage
audit be conducted.
5.4.1.2 The information gathered during stage 1 audit shall be used for making adjustment in
audit time and/or audit team competence for stage 2 audit, as necessary.
5.4.1.3 Timings and date of Initial site audits shall be fixed in consultation with the applicant
FBO ensuring that production processes representative of normal operations will be
open for witnessing during the planned audits. The duration and plan for Initial site
audits shall be provided to the applicant.
5.4.1.4 The audit plan covering the relevant audit objectives shall be prepared and
communicated to the FBO well in advance. The composition of the audit teams shall
also be communicated to the applicant organization for identification of conflict of
interest if any. If required by the FBO sufficient background information in respect of
the audit team members shall be provided for this purpose. Any objections to the
team by the applicant shall be examined on merit.

5.4.1.5 Stage 1 Audit - The Objectives of stage 1 audit shall be:


a) To evaluate PRPs/hygienic and sanitary conditions and practices and their
appropriateness and adequacy on a continuous basis vis--vis the products,
processes and risk category.
b) To evaluate whether the controls over incoming material, in process and
finished products have been identified, established in the Internal Quality
Assurance procedure/plan as submitted by the FBO and are appropriate and
adequate for ensuring continued conformity over the products
characteristics/parameters as defined in the relevant Certification Criteria.
c) To evaluate if the internal audits and management review are being planned
and performed and that the customer complaint redressal system and the
system for approval of raw material/input material suppliers and procedure is in
place.
d) To evaluate the adequacy of FBOs established systems with respect to HACCP
and traceability requirements as described in the Certification criteria for
Level 2.
e) To evaluate the adequacy of FBOs established systems with respect to
sourcing and purchase from Basic GAP or India GAP certified farmers,
maintenance of traceability in respect of sourced raw material, etc for levels 3
and 4 respectively.
f) In respect of FBOs, with existing certifications to different systems for food
safety like HACCP and FSMS and sourcing from farmers complying
with/certified to good agricultural practices like Global GAP, etc, from NABCB
accredited CBs, the certification will be taken as evidence of conformity to
applicable requirements of the certification criteria. In case the FBO is holding a
valid and current certification to ISO 14001 or OHSMS from NABCB accredited
CBs, the same shall also be taken as evidence of conformity to applicable
requirements of the certification criteria. However the facility of the FBO shall be
subjected to an evaluation for the other requirements of the Certification Criteria.
g) To prepare an audit plan for stage 2 audit.
5.4.1.5.1 Internal Quality Assurance protocol (IQAP) -During the stage 1 audit the Audit
team shall carry out a detailed assessment of the Internal Quality Assurance
protocol submitted by the FBO for each of the product(s), regarding its
appropriateness and adequacy. Based on this assessment and the discussions
the FBO, shall finalize the IQAP. The essential elements that should be in the
IQAP are given in Annex B. The applicants consent to comply with the finalised
IQAP shall be obtained. The IQAP is a dynamic document and the FBO shall
review and amend the same, if required, as when the certification criteria undergo
modifications and revisions, whenever the FBOs processes and/or
manufacturing facilities under go changes. FOB shall inform the certification body
about changes in its processes and facilities and changes in the protocol.
5.4.1.5.2 Deficiencies observed with respect to the certification criteria during the Stage 1
evaluation shall be informed in writing to the applicant.
5.4.1.5.3 The Stage 2 evaluation by certification body shall take place only after necessary
actions on the identified deficiencies have been taken and confirmed by
applicant. The CB may seek documentary evidence or organize an additional
onsite visit, if necessary, to verify the implementation of corrective actions.

5.4.1.6 Stage 2 Audit - The Objectives of stage 2 audit shall be:


a) To verify compliance to the applicable certification criteria, including labelling
requirements and witness the production processes covering as many products
applied for as possible. Also to verify compliance to the IQAP agreed during the
stage 1 audit. This would generally involve, detailed inspection of the facility,
verification of process controls being exercised to ensure Product quality (safety)
and conformance to regulatory requirements, verification of compliance to
relevant GMP/GHP and HACCP requirement, where relevant, verification of
documents and records, and interviews with personnel involved in various
relevant activities.
b) Drawal of samples for testing in an independent laboratory. Samples shall be
drawn from each product category (up to the Level as mentioned in the FSSA
licence) offered for certification, ensuring that they are representative of normal
production capability and is typical of production. They should be selected by the
certification body from the factory (e.g. production, stock) in a manner that
ensures that the impartiality of selection and the integrity of the sample is not
compromised. While drawing sample from the factory, the certification body shall
ensure that an appropriately packed and sealed counter sample from the same
batch is retained at the FBOs premises as a reference sample.
c) To verify adequacy of testing facilities in respect of the in-house tests carried out
by the FBO, if any and also to verify competence of testing personnel and by
witnessing testing of representative number of sample(s) in the laboratory of the
FBO.
5.4.1.6.1 Any non conformities observed during Stage 2 audit, with respect to the
certification criteria shall be informed in writing to the applicant for taking
necessary action. The non conformities shall be classified as Critical, Major or
Minor depending on their severity.
a) Critical Non conformity A non conformity shall be classified as critical if the
findings and gaps observed do not assurance that the FBO will be able to
produce the a safe food product on a continuous basis.
b) Major Non conformity A non conformity shall be classified as Major when a
finding or a gap points towards isolated instances of reduced assurance with
respect to production of a safe product. that the FBO assurance of reduced
assurance A non conformity is classified as Major when it relates directly to the
quality (including safety) of the product and the FBOs capability to produce a
product that would conform to the certification criteria. A number of minor NCs
(say 7 more) on the same aspect shall be clubbed together and raised as single
major NC.
c) Minor Non conformity All other gaps and non conformities shall be classified
as Minor. These shall generally be related to other implementation issues which
do not directly affect either the safety of the product or the FBOs capability to
produce a product conforming to the certification criteria.
5.4.1.6.2 In case of a Critical NC the certification body shall reject the application for all the
products covered by the non conformity, based on final evaluation of the case.
Whereas in case of Major and Minor NCs the certification body shall allow the
FBO certain predetermined time to upgrade their system to a level that shall be
as per scheme requirement.
5.4.1.6.3 In case of major and minor NCs the FBO shall carry out root cause analysis and
inform the same along with correction and corrective actions, within a period of
one month or 3 months respectively. All non-conformities are required to be
closed before initial certification through verification of adequacy of the correction
and corrective actions. All Major non-conformities, shall invariably require a
follow-up audit.
5.4.1.6.4 Actions to be taken in case of failure of samples on independent testing have
been described in clause 5.9 of this document.
5.4.1.7 The audit report The audit reports for stage 1 and stage 2 shall clearly provide
evidence and conclusions about the fulfilment of the audit objectives as described
above and shall contain sufficient detailed information regarding conformity with all
the relevant certification requirements, including the Certification Criteria. The
Certification Body shall develop appropriate report format(s) and report writing
guidance document to ensure that the report provides, adequate and complete
details for ensuring appropriate, evaluation, review and decision in respect of grant of
certification.

5.4.2 Independent testing of samples The Certification Body shall draw product
samples from the FBOs site as per their documented procedure for ensuring the
following aspects :
a) Care shall be taken to ensure that sample is drawn in such a manner so as not to
contaminate the product while sampling and packing.
b) Packing and sealing of the samples shall be such that the product integrity is
maintained for its intended shelf life.
c) The samples shall be clearly identified with their name and type, batch
identification and suitable identification to enable traceability to the applicant and
the initial evaluation visit.
d) As far as feasible the identity of the sample with respect to its Brand name, and
the name of manufacturer as depicted on the original packing, shall be masked.
e) Draw samples in quantities adequate to facilitate their testing for all requirements
specified in the Criteria.
f) If the product is affected by the conditions of temperature, handling and storage,
then care shall be taken to ensure that the sample is drawn and maintained
under those conditions for testing its conformity to specified criteria.
g) Samples of food products drawn for independent testing shall be forwarded to an
NABL accredited testing laboratory for ascertaining conformance to specified
criteria. The specified criteria, product details including label claims if any shall be
clearly mentioned and communicated to the testing laboratory. The samples(s)
shall be duly coded and as far as possible, the identity of the manufacturer shall
be hidden as far as feasible. The sample(s) shall be so despatched that they do
not get damaged and or contaminated, undergo deterioration, and the product
integrity is maintained.
5.4.3 Final Evaluation
5.4.3.1 The purpose of this process step is conduct an evaluation of all the information
gathered through the process steps of Stage 1 and stage 2 audits and the results of
independent testing to ascertain if all the process steps as described in the
certification process leading to grant of certificate have been fulfilled and if the
evaluation confirms the capability of the FBO, for producing the relevant food product
(s) complying with the requirements described in the relevant certification criteria.
5.4.3.1.1 The final evaluation shall ensure the following:
a) The availability of all relevant manufacturing and processing equipment required
for the production/manufacture of the relevant food product.
b) Availability of authorized and/or adequate power and water supplies, where such
supplies are required for manufacturing and testing.
c) Availability of adequate test facilities for conduct of tests as per the agreed IQAP
and the requirements specified in the Certification criteria. The facilities may
include in-house facilities and/or NABL accredited external laboratory. In case, if
the FBO is planning to get part/full parameters tested in an external lab then the
FBO should be able to demonstrate to CB AT that it will still be able to meet the
requirements specified in Agreed IQAP, with respect to frequency of testing and
availability of external reports, where the tests results are necessary for approval
of raw materials/intermediate materials and finished products, before they can be
released for the next stage.
d) Availability of Competent and qualified personnel for production and testing of
Food product(s) as relevant.
e) Evaluation regarding conformity of the product(s) and raw/intermediate material
wherever specified, with parameters/ requirements of the certification criteria.
f) Acceptance from the applicant FBO for following the Internal Quality Assurance
Protocol, for the products for which product certification is being sought.
g) Necessary documentation for proof of legal entity and authentication of premises
of manufacture where certification is being sought.
h) Acceptance from the applicant for other certification requirements like the fee,
Brand name declaration, etc. A Brand Name declaration shall be obtained from
the applicant indicating the Brand names the manufacturer intends to use on
product(s) covered under the Q Mark certification scheme before the final review
and decision.
i) Verification of implementation of corrective actions and closure of all NCs raised.
j) Any other requirements prescribed by the Certification Body.
5.4.3.1.2 Based on the evaluation as above, recommendations for proceeding to next step
(independent review and decision making) shall be made. In case the evaluation
indicates that some requirements of the certification criteria or the certification
scheme have not been met and then these need to be completed and evaluated
before proceeding to the next step.
5.4.3.1.3 The final evaluation shall be carried out by a competent personnel, duly
authorised for this function. The team leader designated for the conduct of Initial
Evaluation may also be authorised for this activity.
5.4.3.1.4 Records of final evaluation along with all supporting documents and reports shall
be retained at least for the period of two certification cycles.

5.5 Review
5.5.1 An independent review shall be carried out by person(s) or a committee having the
relevant competence. The responsibility for review function, shall however be that of
the certification body.
5.5.2 The Criteria for review shall be documented. It shall be based on the product
requirements as specified in Certification Criteria and the certification scheme and
process requirements as stated in this document.
5.5.3 Any information on which a review and decision is based which comes from any
source other than the evaluation process, for example complaints, information
received from regulators (like FSSAI), etc, should be made known to the applicant or
supplier along with information on the evaluation process. The applicant or supplier
should be given the opportunity to comment on it.
5.5.4 Nonconformities, which raise any doubt as to the conformity of the product must be
corrected and the correction verified by the certification body (by site visit or other
appropriate forms of verification) before certification is granted. The nonconformities
and their resolution should be documented and made available for the purpose of
review.
5.5.5 The records of review shall be retained and shall provide adequate confidence that
all relevant aspects were examined prior to making recommendations.
5.5.6 The recommendation for certification decisions, whether positive or negative shall
justify and document the basis for the same.

5.6 Certification Decision


5.6.1 Certification decision shall be the sole responsibility of the certification body and the
decision shall be taken by its internal person(s) competent for the job provided they
have not been involved in the process of evaluation of the FBO.
5.6.2 The person(s), who take(s) the decision on granting/withdrawing certification within
the certification body shall have a level of knowledge and experience sufficient to
evaluate the information obtained from the evaluation process and the review
recommendations. Review and the certification decision may be completed
concurrently by the same person (s).
5.6.3 Only persons (s) employed by the CB or on long term (3 - 5 years) full time contract
with the CB shall be entrusted the responsibility of certification decisions.
5.6.4 The certification Body shall grant certification for product(s) after ensuring complete
compliance to the Certification Criteria and certification scheme and certification
process requirements (refer clause 4 of this document) and all non conformances
have been addressed. There shall be no conditional grant of certification of
product(s).
5.6.5 Impartiality and absence of conflict of interest shall be ensured before entrusting the
task of certification decision making.
5.6.6 In case based on the evaluation the Certification Body decides, not to grant
certification to all product(s), few or any of the product(s) applied for , then it shall
notify the FBO of a decision not to grant certification, and shall identify the reasons
for the decision. If the FBO expresses interest in continuing the certification process,
the certification body can resume the process for evaluation from the process as
described from clause 4.4 onwards.

5.7 Certification Documentation


5.7.1 On grant of certification, the Certification body shall inform the FBO and issue a
Certificate, uniquely identified, which shall include the following information:
a) the name and address of the certification body.
b) the name and address of the FBO and the address of the site certified.
c) the effective date (the date on which certification is granted, which shall not
precede the date on which the certification decision was completed) and the
expiry date of certification. The date of granting, shall also include date of
extending or renewing the certification, if applicable.
d) the expiry date or recertification due date consistent with the recertification cycle.
e) the scope of certification including products categories certified (up to the Level
mentioned on the FSSA licence) and the certification criteria (Levels, etc) against
which the certification has been awarded. Reference to the certification criteria
document shall include issue number and/or revision, used for evaluation of the
certified FBO and the products.
f) Any other information required by the certification criteria used for certification.
g) In the event of issuing any revised certification documents, a means to
distinguish the revised documents from any prior obsolete documents.
h) The formal certification documentation shall include the signature of the
individual(s) of the certification body assigned such responsibility.

5.7.2 Formal certification documentation shall only be issued after, or concurrent with, the
following:
a) the decision to grant or extend the scope of certification (see 7.6.1) has been
made;
b) certification requirements have been fulfilled;
c) the certification agreement has been completed/signed. The contents of the
Certfication agreements have been detailed in the Document Certification Body
requirements (Section 7) and are also required to be made available on the
website of the Certification Bodies operating this scheme, as well as in any
information set provided by the Certification body to its prospective clients.
5.7.3 The Brand names of the Food products certified shall generally not be mentioned on
the Certificate document or any other document intimating grant of certification.
Name of the product as given on the FSSA licence shall be mentioned on the
certificate document or any other document intimating grant of certification.
5.7.4 The certificate for product certification shall be for a maximum period of 3 years from
the date of decision to grant the product certification.
5.7.5 The certification decision as intimated to the FBO, shall clearly inform the certified
FBO, that the final approval from the Scheme Owner of Q Mark for using the Q Mark
on their products, will be required and that they can only start using the Q Mark on
their product after receiving the same. It is the responsibility of the concerned
certification body to obtain this approval based on the decision taken on certification
of the relevant FBO. The certificate shall be handed over to the FBO by the
certification body, only on receipt of the approval from the Scheme owner. Details of
these aspects are contained in the document Certification Body requirements
(Section 7)

5.7.6 Directory of certified FBOs as well as Food products


5.7.6.1 The certification body shall maintain and make publicly available on its website,
directory of valid certifications that as a minimum shall show the name, relevant
certification criteria (normative document), scope and geographical location (e.g. city
and country) for each certified FBO and validity of certification.
5.7.6.2 The information maintained by the Certification Body on its website shall also help
the user to get readily the following information about the certified products:
a) identification of the product;
b) the standard(s) and other normative document(s) to which conformity has been
certified;
c) identification of the certified FBOs and other details like address, etc.
5.7.6.3 The Certification Body shall also display suitably on its website the names of FBOs
under suspension and those whose certificates have been cancelled.
5.7.6.4 Apart from the information made available on its website the CB shall also have a
provision and system for confirming validity of a certificate on request.
5.7.6.5 The CB shall have a procedure for frequent updating of the information on its
website.

5.8 Surveillance Evaluation


5.8.1 The CB shall conduct a surveillance evaluations of certified FBOs, with the last
surveillance evaluation during the certification cycle being treated as the renewal
evaluation. The minimum number of surveillance evaluations determined on the
basis of the FBO Risk category have been detailed in the Table below. These shall
be planned over uniform intervals of time during the certification cycle.

FBO Number of SURVEILLANCE AUDITs


Risk
Normal Reduced Increased
Categor
y Announce Unannounce Announce Unannounce Announce Unannounce
d d d d d d
Low 3 1 3 0 4 1
Medium 3 2 3 1 4 2
High 4 3 4 2 5 3

At the time of initial certification the Certification Body shall draw out the dates for
surveillance which shall be at spaced at uniform interval . There after the dates for
announced surveillance shall be informed to the FBO, with clear instructions that if
the surveillance does not take place within the stipulated date, with a maximum grace
period one month based on valid ground, beyond which, the delays shall lead to
suspension of the certificate. The certification body shall also ensure that the
unannounced audits also take place within the stated date with a grace period of
maximum one month with valid justification.
5.8.2 The frequencies as stated in the table above under the column Normal as assigned
to a FBO based on his risk classification shall be used until a compliance history can
be established by the certification body. The outcome of audits over a period of a
defined time period (say one certification cycle) will help the Certification Body to
establish a compliance history that may allow the adjustment of audit frequency as
per those prescribed under the columns Reduced and Increased in the table
above. While making adjustment in surveillance audit frequencies the certification
body shall record the justification for the same.
5.8.3 The mandays for surveillance assessment shall be as those stipulated in Annex A.
5.8.4 The surveillance audit shall be carried out onsite at the FBOs certified premises. The
objectives for this audit shall generally be the same as Stage 2 audit objectives,
unless the FBO has informed of any changes in its product profile, processes or
systems. In that case, extra time, commensurate with the changes, shall be built in to
the audit time estimated as per Annex A. There may also be cases where after
reaching the site of the FBO, it may be discovered that there have been changes and
not informed to the certification body. In these cases the Audit team shall estimate if
any extra time is required and build the same in to the audit process after
consultations with the certification body, or make additional visits. In case the FBO
has asked for inclusion of new products in their certificate, then the surveillance audit
may be used for carrying out the audit for inclusion of the product categories, after
estimating additional time required for carrying out the audit and also after
determining the audit team competence.
5.8.5 In respect of announced audits, the audit plan shall be prepared in advance and
forwarded to the FBO along with names of the audit team members and their role in
the audit.
5.8.6 In cases where the FBO is certified to a number of products under the under the
same certificate, certification body shall plan for surveillance evaluation with a view to
covering all the product(s), during the certification cycle, through independent testing
of factory samples and market samples. The certification body shall draw more
samples of products registering higher volumes in production and of higher risk
classification.
5.8.7 For Food products certified, the certification body shall ensure that as a minimum at
least the number of samples as listed in Table given in clause 5.8.12 shall be drawn
from the factory for independent testing.
5.8.8 During the surveillance audit, the auditor shall as a minimum check and report on the
following;
a) Compliance to the requirements of the certification criteria and other requirements
of Certification Process.
b) Status of hygienic conditions as well as GMP (all details as per the guidance
provided in Section 6.
c) Compliance to the Internal Quality Assurance Protocol. The auditors shall also
ascertain the continued adequacy of the IQAP in the event of any changes
observed.
d) Handling and disposal of non conforming products
e) Actions taken on discrepancies observed during the previous evaluation, failure of
samples if any reported and informed to the manufacturing unit;
f) Draw samples for testing in independent laboratory.
g) Draw samples for factory testing and witness a sample of tests to ensure
continued competence of the laboratory test facilities and testing personnel.
h) The continued availability of the manufacturing machinery and test equipment
and changes since the previous evaluation. In the event of changes the auditor
shall ascertain if they are adequate for control of processes and testing of the
products.
i) Information on production of Food Products and the names of consignees to
whom Food Products marked products have been despatched for the purpose of
market sampling.
5.8.9 If any non conformities are observed, the same shall be categorized as Critical, Major
or Minor as per the description given in clause 5.4.1.6.1. The non conformity report
shall be provided to the FBO in writing, generally on site, for root cause analysis,
correction and corrective action. Details of the same shall be reported in the
Surveillance evaluation report.
5.8.10 In the event of Critical NCs the certification body shall decide about immediate
suspension. In respect of other NCs the NCs shall be handled in the same fashion as
described in clauses 5.4.1.6.1 to 5.4.1.6.3 above.
5.8.11 If any surveillance evaluation announced or unannounced results in an infructuous
visit due to any reason, and neither the production is witnessed nor products drawn
for testing either in the factory or for independent testing, the CB shall conduct
another surveillance evaluation. Such additional evaluations may be charged to the
certified unit as decided by the Certification Body.

5.8.12 Market samples


5.8.12.1 As part of surveillance activity, samples of certified products shall be purchased
from the market or procured from organized consumers and tested in NABL
accredited laboratories for ascertaining compliance to requirements of the
Certification Criteria.
5.8.12.2 The CB shall during the certification cycle draw at a minimum the specified
number of samples from the market, for each of the products under certification, over
uniform intervals of time, as per details given below:

FBO Risk Number of Market samples


Category

Low 3
Medium 4
High 6

5.8.12.3 In case where the unit is manufacturing a number of varieties in a product


category then the certification body shall attempt to draw the market and factory
samples in a manner so that all varieties are covered in factory and market sampling
within a certification cycle.
5.8.12.4 Market samples shall be drawn in the original packaging and product integrity
shall be ensured by the certification body.

5.9 Dealing with failure of samples reported in independent laboratory reports -


Failure of sample of certified food product, drawn from the factory or the market, to
comply to requirements of the certification criteria, shall be communicated to the
certified FBO for investigation, root cause analysis and proposed correction and
corrective actions within 15 days of intimation. The Certification Body shall respond
to the proposed corrective actions within 5 days and the manufacturer shall
implement the corrective actions within one month from acceptance of the corrective
actions by the Certification Body.
5.9.1 Depending on the nature of the failure reported, the CB shall decide on one or more
of the following;
a) Draw additional samples of the product manufactured around the same time
from the market.
b) Organize for an additional surveillance audit and evaluation immediately.
c) Increase the frequency of surveillance audit and evaluation.
d) Increase the number of market samples.
The certified FBO shall be informed of the decision taken.
5.9.2 When the failure of the sample is in requirements relating to microbiological
parameters, adulterants, Contaminants, Toxins and Residues the Certification Body
shall advise the certified FBO to:
a) Stop despatches of the failing Batch if stocks are available either at the site or
in their warehouses;
b) Recall the failing Batch from the market;
c) Identify all Food products manufactured with same raw material, or those
manufactured during the same time under similar controls, and examine their
production and quality records of the failing Batch and retest the Reference
samples of these Batches in the custody of the Manufacturer; or
d) Suspend the certification for the specific product in which failure has been
observed, till adequate and effective corrective actions are taken.
5.9.3 Based on the satisfactory demonstration of root cause analysis and corrective
actions to prevent such reoccurrences in future, the decision to revert back to the
normal operation of certification shall be taken by the Certification Body. Testing of
fresh samples of the specific product manufactured after implementation of corrective
actions may be one of the mechanisms of satisfactory demonstration. Based on the
root cause analysis the FBO may decide to increase the internal controls described
in the IQAP. Evaluation of adequacy of the revision in IQAP and output of the
relevant changes may be another means of satisfactory demonstration. Based on the
specific situations the certification body shall decide the appropriate actions and
record the justification for the same.

5.10 Suspension
5.10.1 The certification body shall issue instructions to the certified FBO for suspension of
certification for the product category certified (up to the level mentioned on the FSSA
Licence / Registration) when:
a) any sample fails to conform to requirements relating to microbiological
parameters, adulterants, Contaminants, Toxins and Residues.
b) 2 consecutive samples, from the factory or market, as determined by date of
manufacture, fail to conform to the requirements of the product requirements
other than microbiological parameters, adulterants, Contaminants, Toxins and
Residues;
c) Unsatisfactory performance as adjudged during the process of evaluation on
account of any one or combination of the aspects stated below:
i. Serious failures in compliance to GMP/GHP requirements during a
surveillance.
ii. Non implementation of Internal Quality Assurance Protocol, like testing not
performed as per the frequencies described in the IQAP on a continuous
basis and which create serious doubts regarding quality (and safety) of
samples going in to the market.
iii. Failure to take actions by the FBO, when the serious gaps/non
compliances observed in the IQAP of the FBO.
iv. Repeated failure to take actions by the FBO in respect of Major NCs, with
in the time limit prescribed or Major raised on the same issue in
consecutive (3 ) onsite audits.
v. Non availability of testing and or key manufacturing personnel and
absence of alternate arrangements.
vi. Failure of a sample in the requirements as lifted in b) above.
d) Unsatisfactory hygienic conditions of serious nature observed during a
surveillance audit, which does not give confidence that the FBO has been able to
produce and sell safe product.
5.10.2 The certification body shall issue due notice of at least one week for suspension of
certification to the manufacturing unit. In case of serious failures mentioned at 4.12.1
a) and d) above , the notice may not be required.
5.10.3 On receipt of instructions for suspension of certification, the certified FBO shall
suspend using Q mark on relevant food product(s) being manufactured by them with
immediate effect. In case of suspensions due to sample failure the FBO shall not use
the Q Mark on the relevant food product category. The manufacturing unit shall be
advised to undertake a root cause analysis and identify the necessary corrective
actions for resolving the same.
5.10.3.1 When certification is suspended, the certification body shall require that, during
the period of suspension, the certified FBO makes no misleading claims and should
advise relevant existing and potential purchasers regarding the status of certification,
and ceases to use the certification mark on the products manufactured since the date
of notification of suspension. A certification body shall ensures that the FBO has
have procedures in place to ensure that a defective certified food product that gave
rise to suspension of certification is recalled.
5.10.4 While under suspension, the certification body shall ensure that despatches of
certified Food Products to the market/customer are withheld until the product in
stock has been reassessed for conformity to the criteria and the product already
despatched shall be recalled. The manufacturing organization shall reassess the
quality of the products in stock and the CB shall verify this reassessed stock for
conformity to the certification criteria before allowing its despatch.
5.10.5 The information about the suspension and withdrawal of certification shall be made
publicly available by the Certification Body on its website.
5.10.6 The certification body shall revoke suspension only when ;
a) Corrective actions have been taken and verified by the certification body.
b) Reports of Samples of Food Products manufactured after corrective actions, both
during factory and independent testing confirm compliance to Criteria
requirements.
c) Please also see details given in clause 5.9 and 5.10, in respect of suspensions
based on failure of Factory/market samples in independent testing.
5.10.7 Suspension shall not exceed a period of six months. The FBOs inability to resolve
issues relating to suspension within this period shall lead to cancellation of
certification.

5.11 Renewal of certification


5.11.1 The certification shall be renewed at the expiry of 3 years validity period. However
the renewal process and the renewal of certification decision shall be taken on or
before the certificate expiration date. In order to achieve the same the certification
body shall send the Renewal notice to the certified units at least four months prior to
expiry of certificate validity period.
5.11.2 The FBO shall apply for renewal in the prescribed format along with fee, if any
prescribed by the CB at least 3 months before expiry of the certification.
5.11.3 The onsite surveillance audit conducted towards the end of third year and before the
expiration of the certificate shall be considered as surveillance cum renewal audit.
The objectives of this audit will be a combination of stage 2 and surveillance audits,
unless there has been any changes in product and process requirements, which
would then also require assessment of the FBOs revised processes, controls and
systems.
5.11.4 The certification body shall review the performance of the certified unit who has
sought renewal of the Certificate, with respect to compliance to certification criteria
during the entire certification cycle, prior to a decision on the renewal of the
certificate. The review shall essentially be based on the following:
a) Surveillance and renewal evaluation reports for the audits carried out during the
certification cycle. The NCs raised and the satisfactory resolution of the issues
raised and their effectiveness.
b) Handling and disposition of non conforming products
c) Test reports for samples drawn from the factory and the market,
d) Any suspension of certificate during the previous validity period;
e) corrective actions taken
f) complaints if any received,
g) Adverse information from stakeholders and regulators, if any.
5.11.5 The review shall be conducted by competent person (s) designated for the job.
5.11.6 The decision for renewal of certificate shall be taken by the competent personnel
authorised for the same, based on the satisfactory performance of the certified FBOs
as revealed through the review process.
5.11.7 The certification body shall not renew certification with conditions for compliance to
be verified subsequently. There shall be no conditional renewal of certification.
5.11.8 When performance of the certified unit is not satisfactory, the certification body shall
withhold the renewal of the certificate to the certified FBO clearly stating the reasons
and give time for effecting corrective actions. The verification and decision on
renewal should be taken within 3 months of the certification expiry date.
5.11.9 The corrective actions shall be verified generally on site unless the Certification Body
can verify the same off site prior to considering for renewal of certificate. The
justification for off site review shall be recorded.
5.11.10 The renewal shall be effected from the date of the expiry of the previous certificate
and the intervening period shall be treated as period of suspension and clearly
stated on the Certificate. The manufacturing unit shall not claim certification or use
the Certification Mark during this period.
5.11.11 In case the manufacturing unit does not complete satisfactorily actions within three
months, the certificate shall stand expired from the date of expiry of previous
validity.
5.11.12 When a certificate is not renewed, it shall expire at the end of validity period.

5.12 Cancellation
5.12.1 Certification body shall cancel the certificate when;
a) Certified unit contravenes the terms and conditions of certification and provisions
of Q mark certification scheme like repeated failures of samples, suspension of
certificate beyond the stipulated period, inadequate corrective actions, lack of
compliance to IQAP, misuse of Q Mark(s), etc.
b) Repeated non-compliance of certified food products to the certification criteria
and the inability of the corrective actions taken to ensure compliance, or if the
proposed plan for corrective actions is likely to take considerable time, beyond 6
months for implementation.
5.12.2 Certification body shall cancel the certificate at the request of the certified unit, if the
operation(s) in the certified units premises can no longer be carried due to reasons of
natural calamities such as flood, fire, earthquake etc, lock out declared by the
management, or closure of business operations etc.

5.13 Changes affecting certification


5.13.1 When the certification scheme introduces new or revised requirements both in
Certification criteria and Certification process requirements that affect the FBO, the
certification body shall ensure these changes are communicated to all FBOs. The
certification body shall verify the implementation of the changes by its FBOs and
shall take actions required by the scheme.
5.13.2 The contractual agreement with the FBO shall have clearly defined clause which
shall make it makes mandatory for the certified FBO to agree to implement the
changes in his processes and product, necessitated by the changes in above
requirements.
5.13.3 Following decision on, and publication of, the changed requirements, the Certification
Body shall verify that each certified FBO makes any necessary adjustments within
such time as, in the opinion of the certification body, is reasonable, unless the
Certification Scheme owner itself has decided the time lines. The verification may
involve steps like onsite re-audit/evaluation, retesting of samples in an independent
laboratory, evaluation, review and decision and issuance of issuance of revised
formal certification documentation to extend or reduce the scope of certification, etc.
In case the changes necessitate changes in IQAP, then the certification body shall
also review and approve changes and make necessary revision in the Certification
agreement to reflect the revised IQAP. The records shall provide justification for
choice of activities chosen for the purpose verification of changes.
5.13.4 The certified FBO shall also be bound by the certification agreement to inform the
Certification Body about changes initiated by the FBO; including changes in process
and product design, changes in technology of manufacturing, changes in IQAP, etc;
which have the potential to affect the Product compliance to the certification criteria.
Based on the nature of changes informed, the Certification Body shall decide the
verification activities, which may include the activities as stated in clauses 5.4.1.4
5.4.1.6 and all other process steps, as relevant.
5.13.5 Change of location/Ownership/Name
5.13.5.1 The certified FBO shall inform the CB of any change in the location of the
manufacturing unit.
5.13.5.2 On receipt of such information, the certification body shall issue instructions to
the certified FBO for suspension of certification with immediate effect.
5.13.5.3 The manufacturing unit shall be subject to an onsite audit and evaluation at the
new site like an Initial Evaluation of an applicant.
5.13.5.4 If the evaluation is satisfactory, the Certification Body shall transfer the Certificate
to the new location and the FBO with its manufacturing unit at the changed location
shall be permitted to affix the Q mark to the Food products produced therein.
5.13.5.5 The CB shall endorse the change of premises on the Certificate.
5.13.5.6 In the event of change of Ownership, the organization shall provide necessary
documentary evidence. The new management of the organization shall submit its
acceptance to the agreement for with the Certification Body, Internal Quality
Assurance Protocol and payment of fees. The same process shall be followed as and
when an existing applicant undergoes a change in management. Such changes shall
not call for a visit to the production site.
5.13.5.7 In case of change of Name, the manufacturer shall inform the change in the
name to the CB supported with documentary evidence, and if satisfied the CB shall
endorse the Certificate in the new name.

5.14 Extension of scope This shall cover inclusion of additional criteria like label claim
in level 1 of the criteria as well as additional requirements as relevant to the next
level in the certification criteria and product varieties with in the product category as
governed by the individual FSSA licence, if relevant.
5.14.1 The FBO shall be required to make a formal application for the purpose of inclusion
of additional product categories.
5.14.2 The process steps of receipt of application information and application review,
planning for audit, determination of competence of auditors and others like for
evaluation, review and decision making functions shall be the same as that for initial
(certification) evaluation. The audit time and the time for related activities like
planning and preparation, initial and final evaluation and decision making shall
suitably be estimated based on the guidance provided in Annex A and the time as
evaluated at the initial certification stage.
5.14.3 Extension of scope of certificate for inclusion of additional product categories. Shall
be done only after:
a) ascertaining that the certified FBO has required equipments and machineries;
test facilities as relevant; systems, processes and human resources and
competencies; Internal Quality assurance Plan and competence for
manufacturing/processing of the new product categories in accordance with the
certification criteria and certification scheme requirements as contained in the
Certification Process requirements (Section 4) and the Certification Body
requirements (Section 7). The above aspects shall be assessed by a competent
auditor / audit team through a site visit. This site visit could be combined with a
surveillance / recertification audit or a special audit organized for the purpose.
In cases where extension covers migration to another level in the certification
criteria, the certification body may decide to add additional steps like offsite
evaluation and documentation review, etc.
b) Conformity of the sample of food product drawn from the factory/market to the
certification criteria requirements, when tested in an independent lab.
5.14.4 The process of extension of scope shall undergo the same process steps of
evaluation, review and decision making as in case of initial certification based on the
results of onsite audit and test results from independent laboratory.
5.14.5 The extension of scope shall be clearly mentioned in the certificate document along
with its date of inclusion for avoiding any misrepresentation or misinterpretation.
Irrespective of the date of inclusion, the validity of the Certificate shall remain
unchanged.

5.15 Certification Fees


5.15.1 A fee to be charged to the FBOs for various activities of the Q Mark certification
scheme, without any discrimination between units, geographical location, size of the
unit.
5.15.2 The CBs fee structure shall be publically accessible and also be provided on request.
5.15.3 CB shall notify and obtain consent to its fee structure from the organizations prior to
grant of certification. As and when the fee undergoes a change, the same shall be
communicated to all including applicants and the manufacturing units certified under
this scheme of certification for their acceptance.

5.15.4 Records
5.15.4.1 The certification body shall have a documented policy and documented
procedures in respect of the retention of records to demonstrate that all certification
process requirements have been effectively fulfilled.
5.15.4.2 The certification related records shall be retained for two certification cycles. If
required by law or any regulation relevant to the products certified, like FSSA, etc,
then the records shall be retained for longer period in accordance with the relevant
regulation.
5.15.4.3 The certification body shall keep records confidential. Records shall be
transported, transmitted and transferred in a way that ensures confidentiality is
maintained.
5.15.4.4 If the certification scheme involves complete re-evaluation of the product(s) within
a determined cycle, records shall be retained at least for the current and two more
cycles. Otherwise, records shall be retained for a period defined by the certification
body.
5.15.4.5 The certification records shall include records for all FBOs, including all
organisations that submitted applications, and all organizations evaluated, certified,
or with certifications suspended or withdrawn/ cancelled. The records of certification
of FBOs shall include the following:
a) Application information and results of application review and mandays estimation
and team competence records;
b) Audit planning and preparation records, audit plans and other related records;
c) justification of the methodology used for sampling and justification for auditor time
determination
d) Records of Stage 1 and stage 2 audit reports and related records; Test reports
from independent laboratory;
e) Initial and final evaluation records, Records of verification of correction and
corrective actions;
f) Records of review and certification decisions; committee deliberations and
decisions, if applicable;
g) Certification agreement;
h) Certification Documentation (certificate, etc), including scope of certification;
i) Records of complaints and appeals, and any subsequent correction or corrective
actions;
j) Related records necessary to establish the credibility of the certification, such as
evidence of the competence of auditors, technical experts, evaluators, review
personnel, evaluators and decision makers, etc, as relevant;
k) Any other records as relevant to the certification process, in order to provide
confidence that the certification scheme requirements (clause 4) were complied
with.

5.16 Complaints and appeals


5.16.1 The certification body shall have a documented procedure for handling of complaints
and appeals.
5.16.2 The procedure for complaint handling shall include complaints from all stake holders,
especially its FBOs as well as customers of its FBOs.
5.16.3 The procedure for receipt and handling of complaints shall be made available to
public on the CBs website and shall also be easily accessible on the website.
5.16.4 Upon receipt of a complaint or appeal, the certification body shall confirm whether the
complaint or appeal relates to certification activities for which it is responsible and, if
so, shall address it. The certification body shall acknowledge receipt of a formal
complaint or appeal.
5.16.5 The certification body shall be responsible for gathering and verifying all necessary
information (as far as possible) to progress the complaint or appeal to a decision.
5.16.6 The procedure shall include the process steps for receiving and recording, evaluating
and establishing validity of the same, investigating and make decisions on complaints
and appeals. The process step shall also include the activities of root cause analysis,
correction and corrective actions.
5.16.7 If the complaint relates to a certified FBO and the certified product supplied by the
FBO, then the examination and evaluation of the complaints shall take in to
consideration the effectiveness and implementation of the FBOs certification system.
The process of establishing validity of the certified product, should generally involve
processes like conduct of additional surveillance activities visit to certified FBOs
premises for special evaluation, testing and evaluation of certified product, against
which the complaint had been received, etc. The decisions on complaint shall then
be based on the result of additional surveillance activities.
5.16.8 The CBs complaint handling process shall document the actions to be taken by the
CB as well as the certified FBO, in case the certified product, against which the
complaint was received was observed to be non-compliant with the specified
requirements. Some of these actions/conditions shall also be included in the CBs
legally enforceable contract with the FBO.
5.16.9 The certification body shall record and track complaints and appeals, as well as
actions undertaken to resolve them.
5.16.10 The decision resolving the complaint or appeal shall be made by, or reviewed
and approved by, person(s) not involved in the certification activities related to the
complaint or appeal. To ensure that there is no conflict of interest, personnel
(including those acting in a managerial capacity) who have provided consultancy for
a FBO, or been employed by a FBO, shall not be used by the certification body to
review or approve the resolution of a complaint or appeal for that FBO within two
years following the end of the consultancy or employment.
5.16.11 Whenever possible, the certification body shall give formal notice of the outcome
and the end of the complaint process to the complainant.
5.16.12 In respect of appeals the CB shall ensure that the individual(s)/committee entrusted
with handling of appeal and its resolution decision shall be independent of the
persons involved in certification related recommendations and decision and their
position in the CB shall be such that it shall not be possible to influence their
decisions with respect to the subject of the appeal.
5.16.13 The procedure shall also have provision for giving a written statement to the
appellant, of the appeal findings including the reasons for the decisions reached and
also communicating to the appellant about the provision for giving an opportunity to
formally present his case.
5.16.14 Based on the presentation made, the individual or a committee appointed for
hearing the case shall take a final decision on the appeal and a formal notice of the
outcome and the end of the appeal process shall be given to the appellant.
5.16.15 The certification body shall give formal notice of the outcome and the end of the
appeal process to the appellant.
5.16.16 The certification body shall take any subsequent action needed to resolve the
complaint or appeal.
Annex A

Q Mark Scheme Minimum Audit Manday estimation

A.1. General

A.1.1 In determining the audit time needed for each site as required in Certification Process
detailed in this document, the certification body should consider the minimum on-site
duration for initial certification given in the Table A1 below.

A.1.2 The minimum time, as indicated in Table A1 includes stage 1 and stage 2 of the initial
certification audit. It is expected that half of the total audit time would be spent in the conduct
of the stage 1 audit.

A.1.3 The minimum audit time for the audit of an FBO is established based on the risk the
FBO presents to its customers, namely High, medium and Low . This minimum audit time is
established for the audit of an FBO processing one product as per Certification Criteria
prescribed for Q Mark level 1, covering all audit activities described in the certification
process. This minimum audit time also includes the activity of verification of existing
certifications with the FBO to different systems for food safety like HACCP and FSMS, and
sourcing from farmers certified to good agricultural practices like India GAP and Global GAP
etc . No additional time has been allocated for verification of existing certifications being held
by the FBO. Initial evaluation shall be carried out in one stage when the minimum audit time
for an FBO is determined as 3 mandays or less.

A.1.4 Where the FBO is involved in processing of multiple products, engaging a large work
force for processing food, has undertaken HACCP studies additional time shall be allocated
for each HACCP study undertaken. A HACCP study corresponds to a hazard analysis for a
family of products/services with similar hazards and similar production technology and,
where relevant, similar storage technology. Likewise where the FBOs processes do not
have any pathogen reduction process, a reduction in the audit time shall be done. However
the minimum audit time for initial certification shall not be less than 2 mandays,

A.1.5 The minimum surveillance audit time for both announced and unannounced audits
should be the same as the audit time allocated for the stage 2 audit of the initial certification
audit time. When the FBO seeks extension in scope of certification during the existing
validity of the certificate, the CB shall determine the FBOs risk categorization, and the
minimum audit time be reassessed depending upon the risk categorization. The subsequent
surveillance audit time for both announced and unannounced audits shall be as per revised
audit manday calculations.

A.1.6 The minimum audit time allocated for a renewal audit prior to expiry of 3 years of
validity shall be the same as the audit time allocated for the stage 2 audit of the initial
certification audit time provided the FBOs risk categorization and the scope of certification
remains unchanged. In case the FBO while seeking renewal applies for a change in the
scope of certification, modify its processes, the FBO risk categorization and determination of
minimum audit time shall be ascertained afresh.

A.2 Calculation of minimum initial certification audit time

A.2.1 Minimum audit time for single site = Basic time for the FBO risk category + Time for
additional products + Time for additional personnel+ Time for HACCP studies - Time for
Absence of pathogen reduction process(es).

Table A1

Risk Basic Additional time for Reduction


categori Onsite in time for
es of Audit
number of number Other Additional Absence of
FBO time*
products of systems time for pathogen
personnel like assessment reduction
HACCP / of process(es)
Food Environment
safety and social
systems responsibility
related
requirements
- Level 5
Low 2 Add 0.5 Add 0.5 Add 0.25 Add 0.5 MD Reduce 0.5
manday for manday manday manday
each each for for every
Medium 2.5 Reduce 0.5
additional employee HACCP
manday
product strength study
High 3 more ----
than 20,
and for
any
multiples
of 20
thereafter

A.2.2 In addition to the onsite audit time as described in the table A1 above following
additional time for offsite activities like Initial evaluation, preparation & planning, final
evaluation & review for certification decision shall be added while determining the total
mandays:
Table A2

Risk categories of Time for activities like Initial evaluation,


FBO Preparation & planning, Final evaluation & Review
for certification decision
Low 0.5
Medium 0.75
High 1.0

A 2.3 A suitable proportion of the time for Preparation and planning stage plus the Final
evaluation and review for certification decision stage, may be added in case of scope
extension audit or any other special audit, requiring these stages. Please see the
certification process document for the details of activities involved in these stages.
Annex B

Framework For Internal Quality Assurance Protocol

B.1 Purpose and scope - FBO is required to develop an IQAP for describing the controls
over the process and the product at various stages of production from raw materials, through
processing and dispatch, the hygienic conditions , good manufacturing practices for ensuring
the consistent production of packaged processed food products that meet the specified
certification criteria.

B.2 Components of an IQAP - An IQAP shall be prepared for every product category and it
shall have the following components:

a) Identification of all applicable requirements as per relevant Certification Criteria


corresponding to Level of Q Mark, including label claims
b) Identification of applicable regulatory requirements
c) Definition of Batch
d) Inspection and testing plan for incoming materials raw materials, ingredients,
water, food contact and packaging material, additives, processing aids etc;
e) Process control plans and Inspection and testing plan for inprocess products
f) Inspection and testing plan for finished products
g) Testing facilities
h) Calibration of inspection and testing equipment
i) Finished Product release system
j) Maintenance of records
k) Handling of non conforming products including rejection raw material, in
process and finished products

B.3 How to develop an IQAP


B.3.1 Identify all applicable requirements as per relevant Certification Criteria corresponding
to Level of Q Mark, including label claims and applicable regulatory requirements and
ascertain the requirements the food products are required to meet.
B.3.2 Determine the risk the FBO business presents to it customers for developing the
controls that would be required and defining them in the IQAP document.
B.3.3 At the very outset the FBO shall based on its production processes define the Batch
as is applicable to their processing facility for every food product processed. For the
purpose of this Internal Quality Assurance Protocol for processed food products /
commodities, a batch (or lot) would be a defined quantity of raw material, ingredients,
packaging material, or food product processed in a single process or series of processes
so that it is expected to be homogeneous. It may sometimes be necessary to divide a
batch into a number of sub-batches, which are later brought together to form a final
homogeneous batch. In continuous manufacture, the batch must correspond to a defined
fraction of the production, characterized by its intended homogeneity. The batch size can
be defined either as a fixed quantity or as the amount produced in a fixed time interval.
B.3.4 The IQAP shall be documented to define the controls over the incoming material, in
process controls and the final processed food products / commodities. The description
of controls shall include identifying the characteristic / parameter is to be controlled, the
step at which to be controlled, the specification value for the characteristic, the frequency
at which to be measured or tested, the method of evaluation of the control, the
acceptance criteria, the responsible functionary who would be responsible for
undertaking the same and the records on which the observed values of controls
exercised would be recorded. The basis for determination of Characteristics, its
parametric values, method of evaluation, frequency of testing and number of sample s to
be drawn along with acceptance criteria shall be stated. A risk based approach to be
adopted while developing the IQAP.

B.3.5 The various aspects to be considered while developing the IQAP Inspection and
Testing Plan for Raw Material and Finished product are as follows;
B.3.5.1 It shall generally be in a table form. An example of the contents of each column of
the table are given below:
B.3.5.1.1 Raw material, Incoming material, Finished product - Under this column identify
and list:
a) For incoming inspection plan - raw materials, ingredients, water, packaging,
processing aids, etc, being received by the FBO.
b) For finished products inspection plan the finished products processed by the
FBO.
B.3.5.1.2 Characteristics / Parameters Under this column:
a) For every material identified in column (1) indicate the characteristics /
parameters that need to be evaluated/ inspected / tested.
b) The list of characteristics / parameters shall as a minimum comply with those
identified for the material / product in the FSSA Regulations and other regulatory
requirements.
c) In case additional characteristics are identified indicate basis for inclusion e.g
customer requirements, regulatory requirements of importing country etc.
B.3.5.1.3 Specified values / parametric values Under this column:
a) Document the values for each of the Characteristics / parameters given in
column (2) for each of the material / product given in column (1).
b) These parametric values shall as a minimum comply with that defined in the
FSSA Regulations.
c) For parametric values for the additional characteristics identified indicate basis/
source e.g customer requirements, requirements of importing country etc.
B.3.5.1.4 Method of evaluation / inspection and testing Under this column, Identify the
method of evaluation to be adopted for measurement of the identified parameter in a
give material / product. e.g
a) verification of COA, COC received with incoming supplies, inspection,
b) testing of few or all characteristics of incoming supplies on receipt,
c) on line inspection of few material like packaging films, RGB for few
characteristics during use;
d) inspection and testing of supplies at the suppliers end prior to dispatch to FBO,
e) Acceptance of certified and or branded material / products without testing,
f) Acceptance without testing of some material / products on the basis of supplier
declaration on quality of material.
g) When testing is used for evaluation indicate
i. Testing methods and its source / reference.
ii. In-house / external test facility.
3.5.1.5 Frequency of test Under this column, determine and document Determine
frequency of inspection and testing for each of the characteristics identified for each of
the material / product listed at (1). Adopt a risk based approach, factors that could be
considered include;
a) Impact of the material / product on the quality of the finished product;
b) Quantities used in the processing of a homogenous production of t finished
product;
c) Size of the consignment received;
d) No of Batches of the material in a Consignment / Lot of the supply received;
Accordingly frequency could be defined as;
a) Every Batch / lot;
b) Every consignment;
c) Reduced frequencies either on the basis of risk or when no failures in the
supplies have been reported over the last X number of supplies, etc.
The frequencies determined shall be technically justifiable.
3.5.1.6 No. of Samples In case evaluation is through inspection and testing, determine
and document under this column, the number of samples to be subjected to inspection
and testing, with respect to the quantities received, Batches / Lots received, consignment
received, with justification. Determine whether composite samples are to be drawn;
Adopt a Statistical tool to determine the sample size.

3.5.1.7 Acceptance Criteria - Determine and document under this column, the acceptance
criteria specially when multiple samples are being subjected to inspection and testing.
Adopt a Statistical tool to determine the Acceptance Criteria. Acceptance criteria could
be described as:
a) All samples to conform;
b) The composite sample to conform to all / identified requirements;
In case of multiple sample indicate both acceptance number and rejection number for the
attribute.
3.5.2 The Layout of the table should be like the one given below:

Raw Characteristi Specified Method of Frequenc No. of Acceptance


material, cs / values / evaluation / y of test Sample Criteria
Incoming Parameters parametri inspection s
material, c values and testing
Finished
product
(1) (2) (3) (4) (5) (6) (7)

3.6 The various aspects to be considered while developing the IQAP Inspection and Testing
Plan for process controls are as follows;

3.6.1 It shall generally be in a table form. An example of the contents of each column of the
table are given below:
3.6.1.1 Process Step - Under this column identify and list the various process steps at
which controls are to exercised for controlling quality and food safety of the food
products being processed by the FBO.;
3.6.1.2 Process Control Characteristics / Parameters Under this column, for every
process step identified in column 1, indicate the characteristics / parameters that need to
be evaluated/ inspected / tested. The characteristics / parameters could be for the
process parameter or for the in-process product parameter / characteristic. either or
both. The list of characteristics / parameters shall as a minimum be such that they
contribute towards meeting the requirements for characteristics/parameters identified for
the finished product in the FSSA Regulations. In case additional process / product
characteristics indicate basis for inclusion e.g technology used, manufacturing process
deployed at the FBO, additional controls applied to address additional customer
requirements, etc. requirements of importing country etc.
3.6.1.3 Parametric requirement Under this column:
a) Determine and document, if the process controls are for controlling the process
or also for acceptance of in-process products;
b) Document the values for each of the Characteristics / parameters for both the
process steps / in process product given in column (2).
3.6.1.4 Method of evaluation / inspection and testing Under this column, identify the
method of evaluation to be adopted for measurement of the identified parameter at a
given process step. e.g Process controls could be verified on line like temperatures,
pressures, flow rates, while in process products would have to be tested for the
characteristic designed to be achieved through the process. This measurement would
indicate whether the process control applied was adequate and sufficient for this step
and for conformance to the requirement e.g pH, acidity, moisture content, refractive
index, viscosity, brix, clarity, physical appearance, TDS, levels of chemicals present etc.
3.6.1.5 Frequency of test - Under this column, determine and document the frequency of
measuring the process controls for each of the characteristics identified for each of the
process steps listed at (1). Adopt a risk based approach, factors that could be
considered include;
a) Impact of the process on the quality and safety of the product;
b) Whether the product is being processed as a Batch process or through a
continuous process;
c) In case of a continuous process if a process control was not achieved how much
time would be required to restore process to normal, and how much non
conforming in process / finished product would have progressed further in the
process line;
d) Whether non conforming in process / finished product can be segregated for
reprocessing, and are facilities for the same available;
e) Whether any subsequent process step can control this process parameter /
characteristics.
3.6.1.6 No. of Samples - In case the process controls are through inspection and testing of
in process products, determine and document under this column, the number of samples
at appropriate steps to be subjected to inspection and testing, with justification. Adopt a
Statistical tool to determine the sample size.

3.6.1.7 No. of Samples - Process Controls are used to control the process and at some
specific steps also for taking decisions on the acceptance of products (read a) under
Column (3). In case the process controls are for acceptance of the in process products,
determine and document under this column, the acceptance criteria . Adopt a Statistical
tool to determine the Acceptance Criteria.
3.6.2 The Layout of the table should be like the one given below:

Proces Process Parametric Method of Frequenc No. of No. of


s Step Control requireme evaluation y of test Sample Sample
Characteristic nt / s s
s / Parameters inspection
and
testing
(1) (2) (3) (4) (5) (6) (7)

3.7 The IQAP shall be developed as per format provided as Annex A to this document.