Professional Documents
Culture Documents
Certification Process
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.
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.
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.
5.4.2 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.
5.7.2 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)
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.
Low 3
Medium 4
High 6
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.
5.12 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.
5.14 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.
5.15.4 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.
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.2.1 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
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
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
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:
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:
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:
3.7 The IQAP shall be developed as per format provided as Annex A to this document.