Audit Report - SINCE 1864 / BRC, FSSC 22000 AND ORGANIC … · 2019-07-23 · Henceforth the internal Audit calendar is revised and the audits are spread across the year. Revised

Intertek Certification Ltd10a Victory Park, Victory Road, Derby, DE24 8ZF, United Kingdom

F002 English Food 7 Template issue 9 28/7/2017F103-20-BRC Food Report Format

Page 1 Report No. 091A1304001 Auditor: Harshad Karulkar

Audit ReportGlobal Standard for Food Safety Issue 7: July 2015

1.Audit Summary

Company name Swani Spice Mills Pvt Ltd BRC Site Code 4451668

Site name Swani Spice Mills Pvt Ltd

Scope of auditProcessing (Cleaning, grinding/ milling, crushing, blending, Roasting) of spices, oil seed, botanicals and herbs and packing in high density polyethylene, poly-laminated , Polywoven, kraft paper, gunny bags or corrugated cartons..

Exclusions from scope NONE

Justification for exclusion NA

Audit Finish Date 2018-04-11

Re-audit due date 2019-04-16

Voluntary modules included

Modules Result DetailsFSMA Preventative Controls and FSVP Preparedness

Passed

Choose a module Choose an item

Choose a module Choose an item

2. Audit Results

Audit result Certificated Audit grade A Audit type Announced

Previous audit grade A Previous audit date 2017-04-10

Fundamental 0Critical 0Major 0

Number of non-conformities

Minor 07




3.Company Details

Address A 189/190, MIDC, Industrial Estate, TTC, Opp Village Khairne, Thane Belapur road, New Mumbai 400705, India

Country India Site Telephone Number

+912241268001

Commercial representative Name

Mr.Harjiv Swani Email [email protected]

Technical representative Name

Mr. Vinayak Chondekar Email [email protected]

4.Company Profile

Plant size (metres square)

<10K sq.m No. of employees

51-500 No. of HACCP plans

1-3

Subcontracted processes Yes

Other certificates held FSSC 22000: 2010, Organic, SEDEX, Rainforest Alliance.

Regions exported to EuropeAsiaNorth AmericaAfricaNoneChoose a region

Company registration number

10013022001931

Major changes since last BRC audit

NONE

Company Description

Swani Corporation has been established in 1956. The group is one of the oldest exporters of Spices, Sesame Seeds, Psyllium, and Botanicals Herbs & Foodstuff from India. Swani Spice Mills Pvt Ltd is the present unit located in Mahape Industrial area near New Bombay. The present unit within this facility structure is operational since 1992 & has 4005 square meters built-up area. The Processing plant uses Buhler cleaning / grinding lines & colour sortex technology. Company also procures dried products such as dehydrated onions & garlics, black & green pepper, senna leaves which are not processed onsite but supplied to the customer if required. The unit also has own Laboratory for physical and analytical testing.




The Plant HACCP Certified since Jan 2004 & ISO 22000:2005 certified since September 2008. The unit operates in 2 shifts and a work force of 125 personnel per shift. Company has produced almost 10500 tons of finished product last year. The company does not wish to disclose it’s present turnover. The material is supplied to various markets and clients in Japan, Europe, USA, Canada, South Africa, Australia, New Zealand & Argentina. Company has been certified to BRC since few years & is not using BRC Logo on their product or packaging other than promotional material and visiting cards.

5.Product Characteristics

Product categories 15 - Dried food and ingredientsCategoryCategoryCategoryCategoryCategory

Finished product safety rationale Products have low moisture content around 10% and are shelf stable material at ambient temperature.

High care No High risk No Ambient high care No

Justification for area Raw material is received, handled and stored in dry form. Moisture levels are around 10%. All material & handling area is identified as low risk area & product is meant to be used as an ingredient to cooking process at customers end. Processing activity comprising of cleaning, grinding, blending or roasting activity. After packing the finished goods are fully enclosed and not vulnerable to foreign body or microbial contamination. Applicable areas have been identified by the site based on HACCP principles and decision tree with appropriate food safety controls and also as per directives from the competent authority. Controls are in place to identify & restrict movement of personnel and material between all areas.

Allergens handled on site SesameMustardSulphur dioxide and SulphitesCeleryChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergenChoose an allergen




Product claims made e.g. IP, organic

Organic

Product recalls in last 12 Months No

Products in production at the time of the audit

Cumen seed whoe lot no 930, Ground chilly Lot PO no 110917, Corriander powder 998, Chopped chilly flakes lot no 945.

6.Audit Duration Details

On-site duration 20 man hours Duration of production facility inspection

10 man hours

Reasons for deviation from typical or expected audit duration

NONE

Next audit type selected Announced

Audit Duration per day

Audit Days Audit Dates Audit Start Time Audit Finish Time

1 (start date) 2018-04-09 09:30 18:00

2 2018-04-10 09:45 18:15

3 (end date) 2018-04-11 09:00 17:30

Auditor (s) number(s) Names and roles of others

Auditor Number 168088 Harshad Karulkar

Second Auditor Number N/A

Present at auditNote: the most senior operations manager on site should be listed first and be present at both opening & closing meetings (ref: clause 1.1.9)

Name / Job Title Opening Meeting Site Inspection Procedure Review

Closing Meeting

Harjiv Swani - Director X X




Chetan Kaul – GM Operations X X X X

Vinayak Chondekar – Plant Head

X X X X

Purshottam Kote – Production Officer

X X X X

Deepak Desai – Hygiene officer X X X X

Rajesh Patel – Maintenance manager

X X X X

Purshottan Kore – Production Manager

X X X

Nilesh Pawar – Maintenance Eng

X X X X

Anant Kokate – Material manager

X X X

Sonika Putto – QA Technical manager

X X X X

Umesh M Veedu – AM HR X X X

`Kedar Kavekar – Systems Manager

X X X X




Non-Conformity Summary Sheet

Critical or Major Non Conformities Against Fundamental Requirements

No. Clause Details of non-conformity Critical or Major? Anticipated re-audit date

Critical

No. Clause Details of non-conformity Anticipated re-audit date




Major

No. Clause Details of non-conformity CorrectionProposed preventive action plan (based on root cause analysis)

Evidence provided document, photograph, visit/other

Date reviewed Reviewed by

Minor

No. Clause Details of non-conformity Correction Proposed preventive action plan

(based on root cause analysis)


Date reviewed

Reviewed by

1 3.2.1

Document identification for label control register as per the company’s system was not evident.

Document identification for the label control is established.

Although label issuance is being recorded in the register, it was not under document control.

Now onwards all the label control entries and return of labels will be under document control. Appropriate training of the concerned person is conducted and the format is included in the System.

Training Record for label control awareness and documentation.

Documented format of the label control.

2018-04-30 Harshad Karulkar




2 3.4.1

The program of internal audit is scheduled two times and not throughout the year.

The Internal Audits will be spread out throughout the year & appropriately documented.

Earlier we were doing internal audit once in a year and frequency of which has been revised to twice in a year, additionally GMP-GHP audits are being done on monthly basis. But the internal audits are not spread throughout the year due to inadequate interpretation of the BRC clausal requirements.

Henceforth the internal Audit calendar is revised and the audits are spread across the year.

Revised Internal Audit Calendar.

Training record against the BRC Internal Audit Clause 3.4 2018-04-30 Harshad

Karulkar

3 3.5.4.3

Contract made with Microtrol by site as an service provider was not evident.

Contract made with Microtrol is available and documented.

The contract with Microtrol was with Head Office and could not be produced during the Audit due to miscommunication. Henceforth the relevant contracts will be kept ready at the site.

To ensure the compliance of the requirements, the training for Head Office representatives handling the contract of such outsourced activities, is planned on 5th of May in conversation with the Management.

Contract with Microtrol

Training Plan-E-mail.


4 4.7.2

Hygiene clearance for maintenance activity conducted for Destoner screen on 28th March & 30th August for sieve was not recorded in the

Hygiene clearance activity of maintenance activities conducted, is recorded, documented and verified by the concerned authorized person.

Although each maintenance activity is followed by hygiene clearance at the shop floor, but the offline maintenance of accessories which are rectified in workshop, was not covered under formal hygiene clearance, due to lack of awareness.

Training on Maintenance clause (4.7) for Maintenance Team which includes Hygiene clearance and its importance is





breakdown record. conducted and its evaluation is conducted as well.

Training records

Record of Hygiene Clearance

5 4.11.5

Microbiological checks as recorded to capture cleaning performance do not reflect trends in the specific harbourage points as identified.

Identified harborage points will be checked for Microbiological load and recorded in the same format as (Swab Analysis Record QA-MIC-F-07)

As per existing routine, swabs were being taken from random points. In addition to that, as a part of continual improvement & based on the difficulty level for effective cleaning, the harbourage points were identified. These Harbourage points and the document were still under review at the time of audit.

Post audit to confirm the microbiological load of the harbourage points vs other points, the line study was carried out. And 10 points were checked and tested for TPC, Y&M & Coliforms.

The results are found to be comparable during this study.

Similar studies will be conducted periodically to confirm the Harbourage points and complete the document review.

Swab Test Results of Harbourage points.

Swab Results of Routine Points.

Changeover checklist before & after


6 5.4.2 The most recent Vulnerability risk

The Vulnerability risk assessment is reviewed

Vulnerability Assessment of Coriander Group is done but not been done Vulnerability 2018-04-30 Harshad




assessment review was not completed to reflect product groups being sourced for possible risk of adulteration and substitution such as imported coriander.

and completed for all product groups including imported coriander for possible risk of adulteration and substitution.

separately for imported coriander because we considered that it is being covered under the above said category because of inadequate interpretation. Hence the risk associated with the imported coriander is completed and documented. And going further any other imported material will be assessed and documented.

Assessment

Risk assessment

Supplier’s FSSC certificate.

Training record on Vulnerability Assessment

Karulkar

7 6.2.2

Accounting of those labels which are extra, returned or damaged after their application is not reflecting on the label control register.

Document identification for the label control is established and labels which are extra/returned or damaged are recorded in the same register.

Although label issuing was recorded in the register, it was not under document control, due to lack of awareness.

Now onwards all the label control entries and return, damaged labels are recorded. Appropriate training of the concerned person is conducted and the format is included in the System.

Training Record for label control awareness and documentation.

Documented format of the label control.


Comments on non-conformities




Voluntary Modules Non-Conformity Summary SheetCritical


Major



Date reviewed

Reviewed by







Minor



Date reviewed

Reviewed by




FSMA Module Non-Conformity Summary SheetCritical


Major



Date reviewed

Reviewed byMinor

No. Clause Details of non-conformity Correction Proposed preventive action plan (based on root cause analysis)


Date reviewed Reviewed by




1 117.130(a)

Risk of radiological hazards is not clearly documented as part of Imported coriander consignments although declarations supporting its safety are maintained.

Risk Assessment is revised with the inclusion of imported coriander and additionally declaration from the supplier regarding the radiological hazard is maintained.

Risk Assessment of Coriander Group is done but not been done separately for imported coriander as we considered that it is being covered under the above said category. Hence the risk associated with the imported coriander is completed and documented. And henceforth any other imported material will be assessed and documented.

Risk assessment

Declaration from the supplier

Supplier Documents






F002 English Food 7 Template Issue 9 28/7/2017F103-20-BRC Food Report Format


Detailed Audit Report

1. Senior management commitment

1.1 Senior management commitment and continual improvement

Company is fully committed to the implementation of the requirements of the Global Standard for Food Safety and to processes which facilitate continual improvement of food safety and quality management. Adequate resources and team are provided for maintenance of quality management.

Company has established Quality and Food Safety Policy (P-01 Rev:03, dated 2013/2/2) is documented Signed by Director Operations Mr.Harjiv Swani.

Food Safety Policy is communicated to the staff by displaying the Food Safety Policy at prominent places in the production and administrative office entrances.

Company’s management has established 3 Objectives which are documented and communicated during each management review meetings. These are tracked on monthly / quarterly basis and status recorded for review. Company has established objectives such as. Minimum of 10 hours of training per employee on food safety, Reducing customer to 50% from 22 last year. Reduce the product rework to 50% from last year quantity of 55 tons.

Meetings are conducted each month and Management review meetings once in 6 months. Objectives are set annually. All review meetings are attended by senior members of the team including Directors. Each month company undertakes a HACCP review meeting which collates information pertaining to various related issues being compiled and discussed in management review meetings. This meeting addresses essential points such as previous MRM, review of policy & objectives, verification, system update, changes if any, performance review, emergency situation, accidents, third and second party audits, customer satisfaction, customer feedback complaints, incidents, review of HACCP system, resource requirements, nonconforming material and review of existing system. Last review meeting in 7 th April included all requirements & discussions. All details are recorded in the File no TL-F-05 Management review meeting.

Last meeting was on 7 th April attended by 17 personnel from various departments. Demonstrable meeting program organised regularly on monthly basis through HACCP Meetings. Last meetings were on 20.2.2018.

Food safety team includes 8 members towards implementation of food safety plan. Mr. Vinayak Chondekar is the FSTL. Other members are from production, quality, machine room, electrical, sanitation areas. Ref Doc: HACCP Team composition in page 26 FSMS Manual M01.

Company is approved under factory Act and FSSAI registration. All Spice industry applicable technical & legal requirements are obtained from these bodies which monitor and ensure compliance. Company has an original copy of BRC Food standard with them.

Recertification due date is 16 April the audit is conducted before the due date on 9 April.

The Plant Head and GM Operations & Food Safety Team leader attended the meetings.

Root causes of 7 minor non-conformities identified at the previous audit against the Standard have been effectively addressed to prevent recurrence




1.2 Organisational structure, responsibilities and management authority

Clear organisational structure and lines of communication are available to enable effective management of product safety, legality and quality.The Organisational chart, Responsibility and Authority of Food Safety team members are documented in Manual. With reporting structure covering all the departments. The Managing partner and Unit manager are the Top Management. All departments are reporting to Unit manager. The food safety, legality and quality responsibility allocated to general Manager. Documented Organisational Chart is available in BRC manual M-01/Annex 5. Checked Job Description for all HODs and all key positions. Their responsibilities and authorities are defined in M-01/Annexure-05.Company has established Roles & responsibilities for each role with their intended work profile for the core team. This is a part of Manual as Annexure 4 and same are communicated to personnel during joining. Company issues job profiles to all key persons each year. Could review job responsibility of Systems Manual M-01/Annex04 effective date 1/10/2015. The deputy to this function as identified is QA Manager.

Details of non-applicable clauses with justification

Clause reference

Justification

NONE

2 The Food Safety Plan – HACCP

Documented HACCP study is available. HACCP Team is multidisciplinary that includes 08 members from those responsible for Quality, Production, Engineering, QC, Store. The HACCP team is trained on HACCP principles. Team Leader is Mr. Vinayak Chondhekar & Deputy identified is System Manager Kedar Kavekar. Team has undergone BRC and haccp trainings externally.All products and processes covered are defined in HACCP plan. Product groups managed by the company are spices, botanicals and herbs.

The company has identified various pre-requisites. These are identified and established in terms of various procedures in HACCP manual (documents) such as procedures for pest control, Trainings, purchasing, Laundry services, allergen control, housekeeping and hygiene, Maintenance etc. Verified PRP M-02 ver 03 11-2013.

Full description of the products is developed, which includes all relevant information on food safety e.g. composition, product characteristics, preservation method, Labelling instructions origin, biological & physical-chemical properties, packaging and delivery methods, storage & distribution requirements, shelf life, preparation requirements before use, distribution control, labelling requirements and acceptance criteria. Shelf life of the final product is Min 12 months. Product is stable at ambient temperature & humidity conditions. Product is packed primary in PP bags then HDPE / Kraft paper bags. Refer to Product Description Hulled seasame seeds 99.95% purity ver 11 dated 17dec15 Doc no SS-PS-HSS Variety o1.All Information pertaining to update of hazard analysis is collected, maintained, documented and updated. HACCP plan is based on the detailed study of following such as Scientific literature, Customer requirements. Government notifications FSSAI requirements, Codex guidelines.

The intended use of all products is defined and is a part of Product description in the HACCP Manual. All products are ingrediants to be added in products and to be fully cooked by general public before consumption. For cooked product it is to be heated and consumed. This is part of each product




description.

Flow diagrams are constructed & they include all the processing steps within the scope. The equipment, sequence and interaction of all steps in the operation, raw materials, ingredients, utilities in contact , intermediate products entering the flow, operating parameters , where reworking and recycling take place, where end products, intermediate products, by-products and waste are released or removed.

Flow charts are documented (Cleaning: PFC-CD-04, grinding Line-01: PFC-GL-01, grinding Line-02: PFC-GL-02) PFD for Goods receiving, Fumigation, cutting/grinding, blending, Roasting ,magnet and metal detection, packing ( bags),inspection and dispatch,

HACCP food safety team has verified the Process flow diagrams onsite on 15.2.2018 by core team personnel.

The HACCP food safety team has identified and recorded all the potential hazards including physical, chemical and biological those are reasonably expected to occur at each step-in relation to product, process and facilities which may not be controlled by existing prerequisites. This includes hazards present in raw materials, those introduced during the process or surviving the process steps, and allergen risks. It also takes account of the preceding and following steps in the process chain.

In hazard analysis all possible hazards (physical, chemical, biological/microbial) which need to be prevented, eliminated or reduced to acceptable levels have been identified .Consideration has been given to likely occurrence of hazard, severity of the effects on consumer safety, vulnerability of those exposed, survival and multiplication of micro-organisms of concern, presence or production of toxins, chemicals or foreign bodies, contamination of raw materials, intermediate/semi-processed product, or finished product. A detailed step wise risk analysis conducted for each process and product. Necessary information from competent authority has been collated and guidance taken to develop these controls.

Justification for acceptable levels of hazards is developed from Executive instructions by the competent authority and US & EU directives as applicable.

For each hazard that requires control, control points are reviewed to identify those that are critical. This is based on a logical approach and is facilitated by use of a decision tree.

Company has identified 1 CCP: Metal Detection as per identified sensitivities at each process step.

CCP1 at metal detection where all products passing through the cleaning or grinding lines pass through a metal detector of identified sensitivities.

Critical limits are established based on USFDA and guided by machinery and customer requirements for the process.

All activities are cleaning and grinding activities of spices and herbs and have one common CCP which is metal detection at 5 identified locations in Cleaning line, grinding line 1 / 2 / 3, stripping line 1. CCP1 Metal detection is Metal detector the sensitivity for Grinding line 1 is FE 1.5 mm, Non-Fe 1.8 mm and SS of 2.2 mm whereas in GL2, GL3, Cleaning line is Fe 1.19 mm, NFe 2.0 mm, SS 2.5 mm are identified and monitored.

Ref Doc: List of identified CCP for each product type as a part of HACCP Manual and individual Haccp plan forms.

Monitoring system is established for each CCP by direct visual checks on lot sizes by passing all material through an inline metal detector.




The Food safety team has considered the control measures necessary to prevent, eliminate or reduce the hazard to acceptable levels. Consideration is given to using more than one control measure. Justification for acceptable levels in the finished product for each hazard is determined and documented.Ref. Doc: CCP Plan M-01/Annex03(CD) & (GL1).

In case of deviation being found corrective actions is defined for each CCP. For CCP Metal fragments it is re-passing and investigating source of metal. Finished goods are re-segregated and repassed through the metal detector.

The HACCP food safety team has conducted validation for the identified CCP using data as provided by Metal detection equipment manufacturer and in line with USFDA studies. This was last done by Sesotec on 1-4-2018 for model no rapid various FS120. The metal detectors are also calibrated last on 8 th Dec 2017.

Appropriate records are maintained and are signed by the monitoring person. The functioning of metal detector is checked periodically on each line by passing test pieces & recording it on daily production report Cleaning Line PD-F-01 and GLine-01. F02 ,G line 02 -PD-F-03.

CCP records are verified for each lot & recorded lot wise. Can verify for Lot no SS/930 on the day of the audit first at 9.15 then at 11.45 am as per frequency.

HACCP Food safety team conducts HACCP review annually or as and when required due to changes in the processes if any such as changes in raw material, ingredients, process parameters, changes in scientific development. HACCP review was last conducted on 12.09.2017.


Clause reference

Justification

NONE

3. Food safety and quality management system

3.1 Food safety and quality manual

All processes and procedures to meet the requirements of this Standard has been documented to allow consistent application, facilitate training, and support due diligence in the production of a safe productCompany has established Food safety management Apex Manual M-03 Ver 1 2018Food Safety Management System Manual M - 01 ver 03 Rev 05 Dated 7.12.2015.HACCP Study M-01/Annex, PRP M-02 ver 03 1-1-2013 All manuals are authorised and signed by Managing Director.A master list is documented and available. This describes the distribution. Refer to Master List of distribution TL-F-02.Procedures and work instructions are legible, unambiguous & in regional as well as English language and sufficiently detailed. Work instructions towards GMP are also displayed at entrances. This includes




pictorial instructions.

3.2 Documentation control

Company has effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use.Company has established Document control procedure TL-S-S-01, Master list of documents (TL-F-02) and records are available for verification. The method of identification is described as a part of the procedure. Eg TL-S-01 stands for team leader and S for SOP and 01 is serial number.

Document identification for label control register as per the company’s system was not evident. One minor NC (1) has been raised against 3.2.1.

3.3 Record completion and maintenance

Site maintains genuine records to demonstrate the effective control of product safety, legality and quality. The Quality & HACCP Manual are implemented. Distribution of which is part of SOP and Formats for each department. Housekeeping general cleaning procedure HK-S-01 is the SOP and records are HK-F-01 is the house keeping checklist cleaning Div basement. Records are maintained for a period of 2 years which over the shelf life of 1 year.

3.4 Internal audit

Company verifies the effective application of the food safety plan and the implementation of the requirements of the Global Standard for Food SafetyCompany has established an Internal audit schedule TL-F-06 Rev-01 dated 01/7/2017. Internal audit programme & schedule is evident as per procedure. This audit schedule covers 12 different areas to be covered in two days of a year.

The program of internal audit is scheduled two times and not throughout the year. One minor NC (2) has been raised against 3.4.1.

There are 5 internal auditors. Internal auditor training records are available for auditors. Most of the internal auditors have undergone trainings as a Lead Auditor.Internal audits are conducted using an Audit observation sheet TL-F-09 is used and guidance is taken from BRC individual clauses. Both conformity as well as nonconformity are captured. Audit conducted in July 2017 on Production Department by systems manager has identified 10 minor NCs. These were closed and recorded on Internal Audit Non-conformances TL-F-09. Similarly audit observations can be seen on July 2017 towards audit of HR department.

Organisation conducts routine quality inspections to ensure factory environment is clean and maintained appropriately. This is recorded on PRP audit checklist T-L-F-13. Equipment and production areas are checked routinely. These are recorded in House Keeping Checklist Cleaning Division, Basement, Processing area etc. This is done once in a month last done on 20 th March 18.

3.5 Supplier and raw material approval and performance monitoring

3.5.1 Management of suppliers of raw materials and packaging

Company has effective supplier approval and monitoring system is in place to ensure that any potential




risks from raw materials (including packaging) to the safety, authenticity, legality and quality of the final product are understood and managed.Company has also established a supplier approval program. All chemicals raw material and ingredients have undergone hazard analysis and risk assessment before acceptance. This includes packaging material, allergens, physical & chemical contamination. Supplier approval procedure in terms of Management of Purchased material PU-S-01 & Approved vendor list maintained. The risk assessment for raw material group and packaging material is in the form of hazard and risk analysis. Company has established a supplier approval system. All products are purchased from suppliers from various centres handling and supplying spices, herb and botanicals. For initial purchases post commercial discussion the supplier ‘s material is evaluated and checked for raw material compliance as per specification. A purchase team comprises of management involvement towards evaluation of supplier. This is done for 3 consecutive consignments. If material is not complying then it is rejected depending on degree of noncompliance. If it is accepted on all 3 supplies then the suppliers are made to fill a guarantee in the form of Supplier approval form. They are also visited by marketing department and premises audited. Most purchases are from known suppliers having historical. Company maintains a list of 200 plus suppliers.All supplies are either from organic certified farms or traders which defined market yards. All raw materials are spices, botanicals, oilseeds these sourced from farms or traders or markets. Approved suppliers are agents coordinating directly with the source farms or markets of consolidation from where raw material is sourced from. Information is maintained through unique sources & channels of companies having ability to trace material to points of consolidation.All material is accepted only as per established criteria. There are no exceptions to be followed clause 3.5.1.4 is not applicable.

3.5.2 Raw material and packaging acceptance and monitoring procedures

Controls on the acceptance of raw materials including packaging ensure that these do not compromise the safety, legality or quality of products.Company has established Raw material receiving criteria which are monitored for each lot by the Quality department. This involves visual, physical and organoleptic checks. Raw material sampling plan QA-SCH-02 is documented for 42 individual products. This comprises of receiving tests which are visual and lab tests for specific aspects. The procedures are implemented Records are maintained for compliance against established quality criteria of all material during acceptance.Ref Doc : Raw material analysis QA-F-01 & In process – Daily analysis record seed cleaning & Grinding division.

3.5.3 Management of suppliers of services

All service providers are appropriately assessed and any risks presented to food safety, legality and quality have been evaluated to ensure effective controls are in place.Company utilises services of various service providers for specific activities such as ETO treatment (Mircotol). Pest control by Pest Control M Walshe, Waste management contractor for process waste (Om Sai) & packing material (Kedar traders) . These services are documented and contract maintained. Transport for inward is by Suppliers themselves. Refer to Control of outsourced activities and service providers PU-S-01.The approval re-approval is based on quality, pricing and accuracy of service.Service contracts are maintained for activities conducted. Contract made with Pest control operator. Certificate is provided by Pest Control M Walshe & Microtol towards ETO treatment service provided for closed product. Contract made with Pest relief India dated 1 April 2018 PRI/FUM/001 for raw material & container fumigation.




3.5.4 Management of outsourced processing and packing

There is only one outsourced process step which is applicable if a customer requires the same to be conducted which is ETO treatment of already packed finished product.Company conducts ETO treatment for packed finished products through a service provider Microtol. All customers are aware of this process step by provision of stickers on products and certificates of activity undertaken. Company has documented a Control of outsourced activities and service providers TL-S-09. The service provider gives a certificate of ETO treatment which is again cross checked by conducting internal microbial record. Certificate of sterilisation dated 31 July 2017 for 2 types of products undergone ETO treatment being maintained for lOT NO soss-17/18 231-1. The lot is again tested for microbial counts on 10 th July with no microbial results #6065.

The service provider is monitored company representatives visit and audit the outsourced services provider & monitoring records are maintained. A supplier assessment questionnaire is maintained on 12 th Oct 2016. For activities such as Irradiation, Pest control. Certificate of service obtained from Microtol.

Company evaluates all the products on return and records are maintained by the quality department. The lot of SS 231-1 of Nigella Seeds was tested for microbial on 10 th July 2017 found to be meeting all microbial levels.

Contract made with Microtol by site as an service provider was not evident. One minor NC (3) has been raised against 3.5.4.3.

3.6 SpecificationsCompany sources spice based products and is approved for handling these products by the competent authority. In accordance to the requirement company has developed raw material, packaging and finished product specifications documented.Company has established Specifications for Raw material and finished goods. These are documented in the form of Criteria which include raw material acceptance organoleptic and microbial standards. Ref Doc: Finished Goods Product Specifications for individual product eg For raw material Coriander specifications are established eg Corriander whole SS-RMS-RW-1, Coriander Seed Splits SS/RM/SAP/221 & For finished product it is Coriander Powder product code SS-526 & Cinnamon coarse SS-PS-Cinnamon 04. Manufacturing instructions and process specifications as well as quality criteria are established.Ref Doc: Standard Operating procedure for individual Process Volume 2.Specifications are agreed with customers and accordingly distributed to various personnel in the production and quality control department. Can evaluate a contract finalised for turmeric powder and hulled sesame seeds with customer PO 993 dated 29 March 18 where in company has accepted customers specification of prodcut. The same information is available in terms of a sales contract.Specifications are documented in the HACCP Manual and maintained with department heads or communicated to customers. They are provided to customers as an agreement being part of an agreement. Over and above this specification are reviewed for regularly. Curry powder hot was last reviewed on 16 th Nov 2017.

3.7 Corrective and preventive actions Company intends to use Information from identified failures in the food safety and Quality management system to make necessary corrections and prevent recurrence.Company has documented a Procedure of capturing nonconformities in terms of a Corrective Action Procedure. They identify major areas in Process based inspections, customer feedback, internal audits and Hygiene inspections. The observed Nonconformities are identified and actions to be taken are documented a clear list of Non-conformities is identified with responsibility of various departments. Corrective Action Procedure TL-S-10 is documented. It defines the kind of deviations, corrections and corrective actions to be taken in case of deviation. There has been no such occurrence were safety or legality of product has been compromised.




3.8 Control of non-conforming productCompany ensures that out-of-specification product is effectively managed to prevent release.

All raw materials if not meeting acceptance criteria or all finished products not meeting customer specifications are defined as Non-confirming products. Company has established a documented procedure for managing non-conforming products. They have also established quality criteria for finished goods, identifying material / batch concerned if not meeting the criteria. Holding in isolated area, responsibility for disposal. Responsibility defined with General Manager Operations and QA Manager. Company provides COA which ensure that product specifications are met.

Ref Doc: Control on non-confirming product QA-S-07 & refer to Non-confirming product record QAF-08 maintained for Fennel seeds Lot no SS-915-9 on 3-4-2018 for high moisture content.

3.9 Traceability

The site can trace all raw material product lots (including packaging) from its suppliers through all stages of processing and dispatch to its customers and vice versa. Identification of raw materials and y packaging is incorporated in terms of system. All raw material is spices herbs and botanicals are allotted a Lot no on the basis of running serial number. Work in process material is allotted same number along with the truck number it is received in. Further at the finished product step SAP based final lot number is allotted. The system is being followed for each batch of material. Ref. Doc : SOP for Batch identification and traceability QA-S-05.Company has conducted own testing of traceability on 15 th July 2017 for Lot SS-879 Celery seed whole powder Lot Qty 25000 kgs this could be traced to 2 raw material Lots such as PO-110163 & PO-110123 received on 17 TH June and 8 th June of 20,000 kgs each. Balance quantity of 15,000 kgs was used towards production of 2 lots of 14000 kg & 800 kgs with 200 kgs wastage.

During the audit Traceability was tested for Product: Chilli Powder PO 110917 for size 30 mesh received form truck number a KA-17-C-0531 received on 5 th April and qty was 7790 kgs. This was processes in B shift on 7 th April till 9 th April A shift total quantity handled & packed 7500 with a loss of 290 kgs. Also tested traceability for raw material Corriander seed whole Lot PO-110007 qty 13650 kgs received on 4 th September and dispatched on 22 September with final lot ono SS-385-10 by clubbing it in 2 other lots were mixed & 2 more consignments were exported. Raw materials are received from farmers, traders and processing factories. Approval of suppliers has been carried by testing 3 consecutive lots. For main products based on risk company has intiated traceability checks of 14 suppliers. Eg Sai Agro supplying turmeric company tested the traceability where in lot no 110796 was checked for its source to place of consolidation as Basmat mandi.Traceability is maintained for all lots including rework which is regrinding for size, re-cleaning for improved purity etc.

3.10 Complaint handling

Customer complaints are handled effectively and information used to reduce recurring complaint levels.Complaints are recorded, investigated and appropriate actions taken. Quality Assurance Manager handles complaint after receiving from H.O marketing manager. Root cause analysis is conducted and records maintained. Ref Doc: Procedure for Handling of Customer Complaints QAS -04. Complaint data is maintained and is analysed appropriately. Data is available with Marketing Head and General Manager Operations. The analysis is documented and about 15 complaints have been received in 2017 and this is has reduce to 22 in 2016. Complaints are pertaining to chemical and particle size & foreign matter which have gone down.

3.11 Management of incidents, product withdrawal and product recall




The organisation has documented procedures to manage possible incidents. The team is located on site all the time given the activity on site.Company has documented an Incident Management Procedure designed to facilitate timely actions in case of incidences and report and manage them. Have identified fire, power shutdown, Accidents, flood, communication failure , vehicle breakdown. An incident management team is documented which comprises of 4 persons with responsibility and communication details. Ref Doc: Management of incidents and Emergency preparedness TL-S-06.Company does not supply any material directly to customer only withdrawal is applicable. Company has identified and documented a team comprising of 4 members along with their contact details, responsibilities of actions to be taken during a situation needing withdrawal as identified. If there is any food safety issue then recall or withdrawn can be initiated. Contact details and communication plan is for each is available. 4 major areas for contacting customer, legal, internal traceability and overall approval to initiate are identified. Ref Doc: Product withdrawal and Recall procedure QA-S-08.Product mock recall is tested by the company once in a year which includes activities and timing of results. Initiated on 19.12.2017 for Fenugreek Powder Lot No SS-267, Reply was received on next day from Client. Details of results of test have been recorded & location and status of lots can be reconfirmed. There has been no recall for the sites products. Clause 3.11.4 is not applicable.

3.12 Customer focus and communication

There are no customer specific policies applicable on site clause 3.12. is not applicable.


Clause reference

Justification

3.5.1.4 All material is accepted only as per established criteria specified in the Specification file. There are no exceptions clause 3.5.1.4 is not applicable.

3.11.4 There has been no recall for the unit clause 3.11.4 is not applicable.

3.12 There are no customer specific policies applicable on site clause 3.12. is not applicable.

4. Site standards

4.1 External standards The site is of suitable size, location and construction, and maintained to reduce the risk of contamination and facilitate the production of safe and legal finished products. Site is located in TTC Industrial area with a well-defined boundary and free from any possible contamination. Site boundaries are clearly defined boundary wall. External areas and grounds are concretised and maintained in good order.Building fabric is of permanent nature and mostly does not allow any pest entry.

4.2 Security

Site has walled premises with entry and exit monitored through an appointed security agency. All external persons are supervised through company personnel presence.




Company continues to control entry in the premises and has appointed a security agency NSF Security services to control access in the premises . Raw material and product Hazard Analysis is conducted to incorporate possible routes of contamination during handling. Workers Movement & product flow map is established. Access to personnel is restricted and controlled.The security risk assessment is documented in the form of common risk assessment which also covers security as a topic M-01/Annex 02.All personnel have to pass through the gate and a visitor’s gate pass system is followed.Company uses underground storage for untreated water and after treatment water is pumped to the top floor for storage for distribution. All water opening points are locked. Process does not require use of water. Factory site is registered by competent government authorities such as Maharashtra Pollution Control Board, FSSAI & Factory license no 10013022001931 valid till 22 nd May 2018 for the identified premises.Facility is also registered with the Spice Board and hold a certificate as an exporter cert no ML/REG/S976/2017 valid till 31.8.2020.Maharashtra Pollution Control Board consent MPCB/SRONM-11/CONSENT/1609000196 valid till 31 st march 2019.

4.3 Layout, product flow and segregation

The factory layout and movement of personnel is designed to allow logical flow of material. These are complying relevant legislation by undergoing audits by competent authority and are provided an approval for export.Plan of site has been established and areas demarcated for handling of raw material, pre-processing, processing, grinding Only Low risk area is identified. Ref Doc: Plant Lay out M-02 / Annexure 03.Site plan and movement system provide designated access routes for personnel in individual sections (Cleaning & Grinding) facility with wash rooms, hand wash stations, raw material cleaning area and packing area. Product flow is unidirectional and equipment controlled. personnel movement is designed for individual sections.Ref Doc: Plant Lay out M-02 / Annexure 03.All external visitors are made to follow company code of conduct and supervised throughout their movement in the facility. Facility employs staff who is allotted specific and defined work. Workers are supervised and trained in specific work instructions and potential product contamination before commencing work. Maintenance activity is supervised. Ref Doc: Visitors Declaration TLF-10.Movement of personnel, raw materials, packaging and waste does not compromise the safety of products. Effective procedures are in place to minimise the risk of the contamination of raw materials, intermediate/semi-processed products, packaging and finished products in Low risk areas.There is no high risk area only low risk area is identified.There is no High care area applicable on the manufacturing site. Clause 4.3.6 is not applicable.There is no ambient high care area on the site, clause 4.3.7 is not applicable.Premises of the area are large and sufficient working place is available taking in to consideration the volume of the activity possible on site.There are no temporary structures which as a part of design may allow pest harbourage. Clause 4.3.9. is not applicable.

4.4 Building fabric, raw material handling, preparation, processing, packing and storage areas

Permanent facility with panel and frame construction has been provided designed to avoid any possible external influence. Mostly Walls are finished and maintained to prevent accumulation of dirt or contamination. Floors are tiles and hard to stand the demand of the process and impervious in nature. Use of water in the process is very minimal to no use. Drainage where needed for floor wash water are adequately sited, designed and maintained to minimise risk of product contamination and not compromise product safety. Machinery and piping are arranged in such a way that process waste water goes directly to drain. Only low risk areas are applicable in all premises. Ceilings and overheads are constructed, finished




and maintained to prevent the risk of product contamination. All suspended ceilings in anteroom area are adequately controlled. Windows are sealed and exhaust fans screened.

All glass windows are filmed. Doors are maintained in good condition. All opening and chutes are kept closed at all times to prevent entry of pest. Sufficient lighting is provided for facilitating correct operation and other processes such of sanitation, maintenance, inspection etc. All tube lights are protected.

Exhaust fans are provided for air ventilation. Based on risk analysis only low risk areas are applicable in the site.

4.5 Utilities – water, ice, air and other gases

Facility does not use water in any process. Air is used for movement of product in the Buhler lines used for cleaning and grinding lines.There is not direct use of water in processing or product contact. Sufficient quantities of water are available and provided for hand washing. Water is analysed externally once in 12 months and once in a year and internally once in 15 days. Water analysis report MISC-17-10-016327 dated 30.10.17 by Geochem Laboratories for IS 10500 Standard is maintained. Internal microbiological testing is also conducted once in a month recorded on Water Analysis record QA-MIC-F-05 last done on 15 th March 18 for coliforms. For use of water in the hand wash areas and indirect cooling of roasting lines a water distribution plan MNT-F-37. There is no use of non-potable water on site. Clause 4.5.3 is not applicable.Air pressure is used for moving material which is in powdered form this is monitored. Air quality is checked for microbial levels internally once in a quarter last done on 23 Jan 18 for 4 locations such as Vibroshifter 1 / 3 / Bin 2 and Shifter 2 for TPC, Yeast and moulds. Tis is recorded on Air sampling records QA-MIC-F-08.

4.6 Equipment

All food contact equipment is either SS 304 or packing material such as PE lined paper or PP woven bags. Contact material are cleaned and maintained adequately. Materials suitable for handling spice products are provided in accordance to industry acceptance.All equipment is made from SS and utensils are made of plastic designed and placed suitably.Production facility equipment involves use of cleaning equipment and grinding equipment. These are designed appropriately for spice handling by equipment manufacturer BUHLER. This involves use a combination of SS and MS. Company conducts swab analysis for judging adequacy of the equipment at all times. Ref Doc: Equipment swabs conducted recorded in Swab Analysis Record QA-MIC-F-07 maintained on 25 th Jan for 6 equipment & 2 hand surfaces.

4.7 Maintenance

Company has a maintenance team of 11 persons with a responsibility of keeping all important machinery and equipment maintained. Company has documented a Preventive maintenance schedule, maintenance system, equipment list. Daily & Monthly maintenance is conducted. Equipment are segregated as per individual divisions. Cleaning division involves 20 major equipment, Grinding GL1 has 6, Strip Mill 6, GL2 has 6 and GL3 has 8 equipment, strip has 4 and Roasting has 4 there are 5 other utility devices which are identified for maintenance.

Ref Doc: Preventive maintenance schedule (Monthly & Daily) cleaning division / Grinding Division MNT-SCH-02. In addition to planned maintenance all equipment are attended whenever need arises. A maintenance complaint register MNT-R-01 is maintained.

Hygiene clearance for maintenance activity conducted for Destoner screen on 28 th March & 30 th August for sieve was not recorded in the breakdown record. One minor NC (4) has been raised against 4.7.2.




There were no temporary repairs found on site. All equipment related activity was appropriately maintained. All breakdown is also attended do and recorded in Maintenance complaint register. Hygiene clearance acceptance is recorded each time as taken from Production manager Destoner screen was faulty on 28 th March, 30 th August sieve broken on shifter. Micronizer on GL1 was broken on 24 th march and hygiene clearance taken.

Only low risk areas are applicable on site. There is no product contact directly with the product in any machinery by the lubricating oil or grease. Clause 4.7.6 is not applicable.

Engineering work shops are not connected to production areas.

4.8 Staff facilities

Staff facilities comprise of staff changing and hand cleaning points provided before entry to each of the section of cleaning section and grinding lines. Designated changing facilities are Provided before entry to the cleaning, grinding sections with foot cover stations, lockers and Hand disinfection areas.

Storage facility is sufficient to accommodate all personal items of personnel working in respective areas. Storage facility is of 2 types comprising of personnel items and used clothing racks.

Separate cabinets for personnel items and used clothes are provided in each entry to production area. Only low risk area is identified and applicable for the unit. Clause 4.8.4 is not applicable.

High care area is not applicable. Clause 4.8.5. is not applicable.

Hand washing facilities are provided at entry point to production. Water at ambient temperature Is provided; liquid soap and hand dryers are provided with advisory signs to undertaken necessary action. Toilets are segregated and do not open directly in to the production or storage area with basins, soaps and hand wash facility is provided. Most of them are part of changing area.

Smoking is not allowed in the campus. Clause 4.8.8 is not applicable. Company has provided designated area in the premises for consumption of food. There is no catering and cooking on site. Clause 4.18.10 is not applicable.

4.9 Chemical and physical product contamination control

Raw material handling, preparation, processing, packing and storage areas

Separate Storage areas are provided for managing and handling chemicals which are required to be used on site. All raw material and ingredients have undergone hazard analysis and risk assessment before acceptance for possible physical microbial & chemical contamination.

4.9.1 Chemical control

Storage areas are provided for managing and handling of dry and wet chemicals which are required to be part of the processing ingredients.All raw material and ingredients have undergone hazard analysis and risk assessment before acceptance. Manufacturing activity does not involve addition of any chemicals, preservatives and ingredients. Raw material is spices which undergo cleaning and grinding, roasting as applicable. Equipment or product contact surfaces are cleaned by using dusting or air and no chemicals are added in the process at any




point except fumigation of raw material.There is no use of strongly scented chemicals which may affect the product integrity. Clause 4.9.1.2 is not applicable.

4.9.2 Metal controlAll raw material have undergone hazard analysis and risk assessment before acceptance. Company has established Sharp Metal Policy. Metal removal is CCP. Knives are used for opening raw material bags and are adequately controlled. Needles are used for stitching bags and usage is monitored. Ref Doc: Needle, Knife and scoop inventory including loose nuts and bolts are monitored and are a part of the Production Report PDF-02 , Knives issuance is recorded as a part of Production Report Grinding Division PDF-04.

Each day one piece is issued and returned back. All packaging material being used such as bags are staple free and only glued cartons are use. Office area is segregated from production area.

4.9.3 Glass, brittle plastic, ceramics and similar materialsProcess does not use glass for packaging or in equipment’s or product contact. All the glasses on windows, lightings etc are protected against breakage with proper lining and covering. Most glass is windows and tube lights which is protected and monitored. A glass policy has been established to declare the company’s policy on the use of glass and brittle policy.

Glass, wood & brittle plastic Policy P-02 is documented in the Food Safety Management System Manual.

A glass breakage procedure HK-S-07 is documented which details actions and provides instructions such as quarantining product, cleaning, inspection , responsibility and disposal of affected material.

Ref Doc: Glass Identification Record MNT-F-04. Last checks on 17 th March 2018 identified 146 locations.

4.9.4 Products packed into glass or other brittle containersThere are no products packed in glass or brittle containers. Clause 4.9.4 is not applicable.

4.9.5 WoodThere are no products packed in glass or brittle containers. Clause 4.9.4 is not applicable.

4.10 Foreign-body detection and removal equipment

4.10.1 Foreign-body detection and removal equipmentThe working ambience, surroundings, tables and equipment where material is exposed is so designed so that possible contamination will be reduced or avoided.

All raw material and ingredients have undergone hazard analysis and risk assessment before acceptance for physical, microbial & chemical contamination. Metal detection is an identified CCP for each batch of products. CCP plan as a part of the CCP & OPRP Plan part of HACCP Study M-01/Annex.

Location of the metal detectors is in 5 locations. In 3 Grinding lines viz GL1,GL2 & GL3 & 1 in Cleaning line & 1 in strip mill. In the GL1 line the sensitivity of the metal detector is Fe 1.50 mm NFe 1.80 mm SS 2.20 mm. In all other locations the sensitivities of these metal detectors are of Fe 1.19 mm, NFe 2.00 mm SS 2.50 mm. All locations are immediately before packing of each bag.

All material is passed inline through the metal detector. If there has been detection of metal or rejection of pouches the same is recorded and investigated. Actions to be taken are recorded. Trends of CCP monitoring results are discussed in each management review meeting.




4.10.2 Filters and sieves

Sieves are used in the process line with sizes as per individual product and customer requirements. Company maintains a stock of 20 meshes for individual sizes of 20 / 25 / 30 / 40 and 8. Records of checks are maintained. Ref Doc: Production Report Grinding Division GL01. Installation of respective sieves is a part of record keeping in the production report. Eg 20 # Mesh size on sifter no 1 in grinding line 2 was inspected for damage on 26 th March at 7.10 am and then at 10.00 am pm for Dhania Roast powder packed.

4.10.3 Metal detectors and X-ray equipmentThe working ambience, surroundings, tables and equipment where material is exposed is so designed so that possible contamination will be reduced or avoided. All raw material and ingredients have undergone hazard analysis and risk assessment before acceptance for physical, microbial & chemical contamination. Metal detection is an identified CCP for each batch of products. CCP plan as a part of the CCP & OPRP Plan part of HACCP Study M-01/Annex.Location of the metal detectors is in 5 locations. In 3 Grinding lines viz GL1,GL2 & GL3 & 1 in Cleaning line & 1 in strip mill. In the GL1 line the sensitivity of the metal detector is Fe 1.50 mm NFe 1.80 mm SS 2.20 mm. In all other locations the sensitivities of these metal detectors are of Fe 1.19 mm, NFe 2.00 mm SS 2.50 mm. All locations are immediately before packing of each bag. All material is passed inline through the metal detector.If there has been detection of metal or rejection of pouches the same is recorded and investigated. Actions to be taken are recorded. Trends of CCP monitoring results are discussed in each management review meeting.

4.10.4 MagnetsMagnets are used in many locations. Cleaning line uses 3 magnets , GL1 has 3 magnets , GL2 has 5 and GL3 has 5 magnets , 2 magnets in Kibbling section in identified Locations .Ref Doc : Process Flow chart for cleaning and Grinding lines. 03 Magnets in Cleaning section. Company has its own guaze meter and conducts checks quarterly checks for all magnets. There are totally 18 magnet locations which are checked for strengths using a calibrated gauss meter. Eg Gauss meter D20B was calibrated on 26 Feb 2018 and used to calibrate all the 18 locations recorded on magnet strength record eg Magnet on GL-3 Bin no 02 had an average strength 4272.

4.10.5 Optical sorting equipmentCompany uses SORTEX machine Z series for removing non-material particulate matter. This is inline in the cleaning division. Operating instructions are documented. Company passes all material through the machine and this is verified by the Quality department before final acceptance. Ref Doc : SOP for working of Sortex machine PD-F-03.

4.10.6 Container cleanliness – glass jars, cans and other rigid containersThere is no use of container cleaning equipment clause 4.10.6 is not applicable.

4.11 Housekeeping and hygiene

Facility handles perishable fish and fishery products. All areas are required to be cleaned using running water followed by chlorine wash. Company ensure cleaning of various areas is effectively managed through a team of 20 persons. Premises and equipment’s are maintained in clean and hygienic condition.

Company has documented a general cleaning procedure HK-S-01 & a specific cleaning procedure developed for individual equipment. General cleaning is for all premises except equipment. For equipment company has identified a procedure for Changeover in cleaning and grinding divisions for all the lines. This is combination of effective cleaning and changeover. This removes traces of material in the lines. This is undertaken in between 2 products so that all areas specific to production are addressed and there is not cross contamination to the next product. Detailed instructions towards actions to be taken in sequence for each sub section n of equipment are defined. Eg A documented cleaning schedule HK-




SCH-02 describes the actions to be taken such as applicable areas (24) frequency identified, cleaning methods, cleaning agents, concentrations, responsible persons. Eg Window glass is cleaned on weekly basis by both dry and wet mopping, using colin, responsible person is hygiene officer.

SOP for changeover of the product cleaning division PD-S-02 describes equipment based actions. For each line harbourage points are identified based on risk. In Cleaning div 10 points are identified such Indent cylinder & Elevators.

For all general surfaces cleaning the limits of acceptability is by visual checks. Company has defined specifications for Limits of acceptance of cleaning are part of the swab analysis procedure QA-MIC-SOP-02. There are limits defined for surface swabs, machine swabs, hand swabs, and linen in terms of cfu/plate. For machine swabs alert limits are 10 fcu and action limits are 25 cfu. A swab analysis record QA-MIC-F-07. The records demonstrate compliance through visual checks and microbial swab analysis such as bagging points and LAF Hood as seen on 25 th Jan 2018 with zero CFU readings.

Various points within the equipment have been identified which are checked for effective cleaning during a change over. These points are checked for cleaning during change over.

Cleanliness of equipment or surfaces is checked for cleaning efficiency visually most raw material is in dry powder form having moisture ranging around 8 to 12 %. Surfaces are checked for cleaning efficiency visually and microbial analysis is also conducted for product contact surfaces.

Company has identified line checks for each line which ensure that change over process is successful and new product can be started. Eg House Keeping Checklist Cleaning Div HK-F-01 covering 13 areas, checked by hygiene officer and verified by QA division.

Microbiological checks as recorded to capture cleaning performance do not reflect trends in the specific harbourage points as identified. One minor NC (5) has been raised against 4.11.5.

Cleaning equipment for tables & contact surfaces such as brushes are used. For floor cleaning mops and wipers are used. Equipment is stored separately in an identified extension.

4.11.7 Cleaning in place (CIP)

There is no requirement of CIP in place. Clause 4.11.7 is not applicable.

4.12 Waste / waste disposal

All waste generated is raw material dry spice products, paper & plastic based packaging material.Company discharges dry waste in solid form which are by product from cleaning of spices, oilseeds etc. The solid waste is disposed through a vendor Om Sainath warehouse. This company is dealer and agent in all kinds of grains & cattle feed and plastic waste. All packaging material waste is disposed through this vendor.External waste collection containers and rooms housing waste facilities has been managed to minimise risk. There is no transfer to third party for destruction of waste clause 4.12.3 is not applicable.

4.13 Management of surplus food and products for animal feed

There are no surplus products manufactured which could be sold as animal feed. Clause 4.13 is not applicable.




4.14 Pest ControlCompany has provided enclosed areas with control on entry exit points, control on site through a pest control expert and pest catching devices. There is no major pest infestation activity noticed on site and facility is adequately proofed and controlled to prevent an occurrence.Company has established a pest control contract with PCMW.Ref Doc: Contract no 18/April/MT/39 made on 05.4.2018 valid till 1 year Services undertaken are for Fogging, General infestation & rodent control. for a period of 1 year. Services undertaken for Fogging & General insect control and Rodent control undertaken once in 15 days, Electric Fly catchers are also provided for fly control. The pest control agency as well as pest catching devices using electric flycatchers and glue pads. In addition, company conducts fumigation of material lots which is lot specific activity and not connected directly with pest control and conducted by a different service agency specialised in undertaking it. As per industrial application there are few chemicals used for fumigation & application inside the factory on lots of raw material.

Company staff only monitors the catches in Rodent boxes and electric fly catchers’ guidance is taken from service provider to cover their absence. Clause 4.14.3 is not applicable.Company maintains a map identifying 109 rodent bait stations and 26 fly catcher locations. All traps are numbered and identified. Glue traps for rodent and electric fly killers for flying insects are being used. Responsibility of monitoring of rodent bait stations is with the contractor and for Electric fly catchers is with company personnel. However, there is no use of chemicals or pest control products inside the facility only trap monitoring is practiced. Spraying is undertaken in the external areas of the buildings. This is strictly monitored.Bait stations are robust and secured & placed externally. No toxic compounds are used in the bait boxes only glue pads are used. Fly-killing devices are correctly sited and operational inside the factory. There has been no incidence of infestation found so far which needs immediate attention for additional actions taken.Records for pest control inspections are maintained and actions as required are carried out if recommended.The service provider maintains a General pest control record for each section HK-F-14 for cleaning division where specific areas are covered eg 4 areas non-production are sprayed. Rodent monitoring records are maintained HK-F-12 where each rodent box is checked once in a day.

In cleaning division 4 main operational areas have undergone spraying and fogging. All bait stations are monitored regularly and recorded fortnightly for all the 116 bait boxes. Details of chemicals used is recorded on the General Pest control Record during each visit eg Chlorypyhus 180 ml used for crawling insect activity. Service provider gives a monthly report where in remarks and observations are provided by them to the company. One in a year the service provider gives a survey with observations and suggests actions and closure points. Last such activity was on 13 th July 2017.Results of pest control inspections are maintained for insect catches as well as rodent bait stations for each month. Pest control operator provides a trend of observations and results for each month for rodent, spider, lizard and crawling insect observations and this is used to plan improvements. Trend of pests trapped in monitoring devices are maintained from 2013 to 2018 indication overall reduction. A pest o flash records HK-F-15 captures insect catches in terms of grams of catches which is minimal.Employees understand signs of infestation.

4.15 Storage facilities

Storage of ingredients, in-process product and finished products facilities are suitable for its purpose.Company Stores all material in dry condition. Each section Is provided with finished goods store. There is




no temperature requirement during storage. Packaging materials are always stored away from other raw materials and finished products in a dedicated packaging material store placed on the first floor. Part used and obsolete packaging not found or left onsite.There is no requirement for temperature control, all material is stored in ambient temperature. Clause 4.15.3 is not applicable.There is no requirement to use controlled atmosphere storage clause 4.15.4 is not applicable.There is no external storage clause 4.15.5 is not applicable.Correct stock rotation of raw materials, intermediate products and finished products in storage maintained. Materials are used in the correct order in relation to their manufacturing date and within the prescribed shelf life. There is limited storage of inputs like packing material. Products are manufactured and marketed against Purchase orders .All products are labelled and indicate manufacturing date.

4.16 Dispatch and transport

Procedures to manage transport are in place so that dispatch of the vehicles and containers used for transporting products from the site do not present a risk to the safety, security or quality of the products.All raw material are received only in supplier’s covered vehicles. Condition and all finished goods are dispatched in ambient temperature containers. Vehicle cleanliness and status is recorded prior to unloading Ref Doc : Raw material Analysis Report QA-ANA-F01 Celery seed lot PO no 110904 recorded on 17 th March 2018 from Sethi sons covers vehicle truck details PB46-M-9837 in 400 bags and status of cargo such a lot covered , Infestation , spillage , infestation , integrity checks .All material being received and dispatched/ exported are recorded in a Inward Challan and Outward Challan respectively which captures condition during transport, details of shipment, Packing list, Bill of Lading and invoice for each shipment with set of documents is maintained. Dispatch details are captured in terms of value and volume data as well as a Container Stuffing Report 6948 for Cumin seeds as can be seen in case of CAIU 971090-O to destination KOBE covering condition-based check points. This was loaded on 17 th Feb 2018.

All material is shipped in ambient temperature container. Clause 4.16.3 is not applicable.Company receives raw material from suppliers vehicles loads material in transporters vehicle or shipping line containers. All are subjected to checks of cleanliness. Company has documented procedures for the transport of products containers for dispatch are dedicated loads of containers. Dispatch of finished goods WH-S-06.Transport of containers is through shipping lines, Port handling agent arranges to transfer the container through own trailer to the port.


Clause reference

Justification

4.3.5 High risk Area is not applicable only Low risk area is applicable.

4.3.6 High care Area is not applicable only Low & High risk area is applicable.

4.3.7 Ambient care Area is not applicable only Low risk area is applicable.




4.3.9 There are no temporary structures which as a part of design may allow pest harbourage.

4.4.4 Only low risk area is applicable on site.

4.4.13 Based on risk analysis only low risk areas are applicable in the site.

4.5.3 All Water used in the facility is potable there is no use of non-potable water.

4.7.5 Only low risk areas are applicable on site.

4.7.6 There is no product contact directly with the product in any machinery by the lubricating oil or grease. Clause 4.7.6 is not applicable.

4.8.4 Only low risk area is identified and applicable for the unit. Clause 4.8.4 is not applicable.

4.8.5 High care area is not applicable on site.

4.8.8 Smoking is not allowed in the campus.

4.8.10 There is no catering and cooking on site. Clause 4.18.10 is not applicable.

4.9.1.2 There are no strongly scented or taint-forming materials used in production areas.

4.9.4 There are no products packed in glass or brittle containers.

4.10.6 There is no use of container cleaning equipment.

4.11.7 There is no requirement of CIP in place. Clause 4.11.7 is not applicable.

4.12.3 There is no transfer to third party for destruction of waste.

4.13 There are no surplus products manufactured which could be sold as animal feed.

4.14.3 Company staff only monitors the catches and does not undertake own pest control activities clause 4.14.3 is not applicable.

4.15.4 There is no requirement to use controlled atmosphere storage clause 4.15.4 is not applicable.




4.15.5 There is no external storage clause 4.15.5 is not applicable.

5. Product control

5.1 Product design/development

Product design and development procedures are in place & established considering guidance from competent authority and customer requirements. Company has established SOP for Handling and production of individual products and conducted hazard analysis to consider introduction of hazards if any within the scope of products. Present products are Spices, Herbs, and Botanicals. New products are blends of existing products. A procedure is developed as in Design and Development Procedure R&D-S-01 rev on 13-8-2017 provides guidance to necessary actions when any blends need to be produced. Company regularly conducts R&D work towards manufacture of blends of existing ground spices and this undergoes a customer acceptance for organoleptic, physical and chemical parameters. In 2017 company has developed 4 to 5 blends. Company has recently developed new product Curry Powder comprising of 7 individual spice-based ingredients. All recipes for blended spices are as per customer requirements.

All new products are variants of existing products and are manufactured using identical methods of processing (cleaning & grinding & blending) without any changes to monitoring systems and parameters.

They undergo hazard analysis and approval by the HACCP team. In December Haccp team leader has approved new product developed as per buyer’s sample eg Curry Powder developed for particular customer from Turkey was approved by customer for recipe on 16 th Jan and reanalysed by HACCP team and authorised on 18 th Jan by 4 key members.

Methods of processing and monitoring remain the same and do not need any additional trials or validation to maintain the safety of the products beyond routine review of processes.

All products have a shelf life of 1 year at ambient temperature. Shelf life trials are initiated and records are maintained. Shelf life is established based on trials, tests, industry norms and codes of practices for food safety. Shelf life study has been initiated for Fennel Powder produced on 4 th March 2017 and study completed on 8 th April 2018 which is the most recent study. Previously chilli powder lot no SS-230 produced on 13 th Sept 2016 was analysed and completed on 1 st Oct 2017. Checks involved parameters such as moisture, microbiology such as TPC & Yeast mould limits. Which were compliant.

5.2 Product labelling

Product labelling is conducted as per customer requirements considering destination regulations for products meant to be exported.All products handled are bulk bags of not less than 20 kgs. All material is meant for reuse in processing by the customer. Products are labelled to meet legal requirements for the designated country of use and include information to allow the safe handling, storage, preparation and use of the product within the food supply chain or as needed by the customer. As required by customer the label may include details of the company or may mention only a lot number. Can verify label of Fenugreek seed whole of packing 25 kgs production date 2.4.2018 best before 1.4.2019, Lot no SOSS 17-18/745-1 Indent no 112270 having sticker with company name Swani Spice. Whereas also could see another label with only product name (Garlic powder), Net wt 25 kg, prod date 6.4.2018, expiry 5.4.2019 batch no SOSS 17-18/948 & importers brand on label. Traffic (Export) department maintains approvals as received from customer.




Since all material is bulk bags meant to be identified and used by importer the information on the bags is pertaining to basic identification of content. The customer who imports the material provides label proofs in line with local country requirements. The label proofs as well as customer proofs are maintained and available with Export department maintained in the label proof file.

Products are bulk commodities and are not ready to eat products and do not make any specific claims for a particular group of consumers. Clause 5.2.3 is not applicable.All label formats if used are directly received from the customers there is no nomination of external printer or party. Clause 5.2.4 is not applicable.

5.3 Management of allergens

System is in place for the management of allergenic materials which minimises the risk of allergen contamination of products and meets legal requirements. Company handles 4 Allergens, Sesame, Celery, Mustard & Bleached ginger which could be treated with sulphites for bleaching. An SOP for Management of Allergens has been developed. Most products are either sold as individual or as a ingredient in a blended product. Ref. Doc: Allergen Handling Procedure QA-S-9.Company has identified & listed the Allergens such Sesame, Celery, Mustard & ginger for sulphite content. Ref Doc: Allergen handling procedure QA-S-9.

All material being handled is in solid state powders. A change over procedure to handle production after running allergen containing raw material is elaborated. Company is selling only bulk packaged product such as 25 kg to 700 kg all customers. Company is declaring to all clients through own specifications that company product is manufactured in a facility which handles allergens such as above. After each run of product either allergen based or non allergen based a product changeover system is followed. This is towards cleaning and removal of traces of earlier or already run product.Company has conducted risk-based assessment of natural contamination as part of raw material having traces of other allergens. In the last 1-year company has conducted reasonable amount of tests (41) to verify raw material based allergen contamination and results are satisfactory for most material. The testing is validated using ELISA test. This also done in finished goods almost 94 samples where in information is collated.

Allergen Risk Assessment M-01/Annex/02(RAL) Ver 2-12-18 part of Food Safety Management System Manual. Procedures have been established to manage allergens by identification, time segregation during manufacture, change over procedure, restrictions on food brought onto site by visitors or contractors. The types of allergens that are processed are sesame, sulphite containing ginger, mustard & celery. All these allergens are received in whole form and except Sesame all the 3 are converted in to powder after undergoing only cleaning or other operations. Mustard undergoes grinding in blends, celery is cleaned and ground. After processing of these products semen cassia or grinding quality fenugreek seeds which are relatively heavy material is cleaned or ground to reduce or remove traces of pre-existing allergens. This material is only an non allergenic buffer not meant to be used or sold further only discarded. This is acceptable by industrial standards. Ref. Doc: Allergen Handling Procedure QA-S-09.Documented procedure is established and implemented for rework which is refining of cleaning etc. Currently the product is packed as bulk form and sold to re-processers and does not need any warning label. This is purely based on customer requirements. Customer is aware that material is produced is a spice handling facility. All products are labelled for declaration of contents or allergens there is no requirement to include a warning label. Developed by the customer and to be used by the customer. Clause 5.3.6 is not applicable.

There is no special claim made regarding suitability of food or allergy clause 5.3.7 is not applicable.Cleaning procedures are designed to remove or reduce contamination by allergens. After processing of these products semen cassia or grinding quality fenugreek seeds which are relatively heavy material is cleaned or ground to reduce or remove traces of pre-existing allergens. The process is validated and tested using ELISA kit. On 5 th Feb 18 traces of yellow Mustard were checked in turmeric powder and the results we done for 1 product and 3 surface samples having no traces. Similarly, this was done for sesame




seed and black mustard and results were satisfactory.

5.4 Product authenticity, claims and chain of custody

All raw materials are purchased from suppliers with whom Guarantee of supply has been established and are also approved by competent authority as and where applicable.Information on historical and developing threats to the supply chain which may present a risk of adulteration or substitution of raw materials this comes from various routes such as government regulatory body, Spices Board and other agencies such as All India Spice Exporters Forum. Company has documented as vulnerability substitution of fraud risk assessment for source of raw materials (M-01/Annex02) which considers possibility, likelihood and severity of vulnerability. This is kept open for review and more raw materials as incorporated have been added in as on purchased. This was reviewed on 7 Nov 2017 where in few raw material groups was added in.

The most recent Vulnerability risk assessment review was not completed to reflect product groups being sourced for possible risk of adulteration and substitution such as imported coriander. One minor NC (6) has been raised against 5.4.2.

All raw materials are agricultural produce such as spices, oil seeds and herbs which are sourced mostly in whole form and undergo processing activity in company premises. Raw materials are analysed for chemicals for conformity. The company’s major volume is turmeric chilli coriander cumin which is almost 60 % of volume. The other list covers almost a dozen products. The company’s vulnerability risk assessment has identified certain spices at a risk of adulteration in the powder form. Therefore, as a company rule all raw material are purchased in whole round natural. Company is kept informed of developing threats of adulteration through routes of legal competent authorities.

Company also manufactures Organic Spices. The raw material is procured from a certified source and accordingly declared.Purchase of Organic raw material is from a single Organic material supplier which is a sister concern based in Jalor in Rajasthan. The material is not stored on site and procured only when an order is to be processed. Raw Material undergoes production operations and is dispatched against an identified order. Facility maintains purchase records and process traceability of all such lots handled. This constitutes 20 % of all material which is handled. Company has almost 10 suppliers who are certified Organic and who are managed through a team sourcing and managing these supplies.Company maintains sources of such supplies. For each lot sourced the material is tested for pesticide residue over and above farm certification status. Lot no LRM/SSM/12 is clove which is tested for pesticide residues on 27 th Jan 2018 for 127 pesticide residues. Similarly Cumin lot SSM/JALO/ORG/CU/US/30/2017 also tested for pesticide residue. This is done for all Organic lots being sourced.All the farmers from whom the declared Organic material is procured their certicates are maintained. Eg Nutmeg sourced from LRM Spices pvt ltd having cert no NPOP/ORG/SC/1511/2891 & NOP/ORG/SC/1511/2892. And Clove sourced from Apees Organics having cert no NPOP/ORG/SC/11707/001517. All material deemed organic is procured only against an order and no extra material is kept on site. All lots are handled separately at one time on one equipment to avoid possible mix up with Non-Organic material.

5.5 Product packaging

Appropriate product packaging for the intended use and are stored under conditions to prevent contamination and minimise deterioration.Material which is packed is spice ingredient with moistures and oil content less than 10 %. Company is using LDPE bags and paper bags laminated and plain. All packaging material Is procured against certificate of conformity of physical properties. Specifications are provided to the suppliers along with purchase order.




The packaging materials are procured against their suitability for use in food as a part of declaration. List of approved packaging material suppliers containing 9 approved vendors is available for all. Currently they are procuring material from Krishna packers material such as primary contact liners & paper-based bags. These are being tested by company against overall migration test against IS 9845:1998 cert IFS-180331017 for HDPE bags, Cert no IFS-180331017 for multiwall paper bag dated 5.4.2018, LDPE liners IFS-180331015. Contact liners are appropriate and identified by specific size and colour to prevent accidental contamination. All plastic liners are made of PE material and declared by supplier for compatibility with material being handled.

5.6 Product inspection and laboratory testing5.6.1 Product inspection and testing

Microbial and organoleptic Inspection and analyses are carried out which are critical to confirm product safety, legality and quality, using appropriate procedures, facilities and standards.

Company has established a lab undertaking organoleptic, physical and microbiological tests. This is undertaken as a Sampling plan for all material handled. Ref Doc : Raw Material Sampling Plan QA-SCH-02 & Quality manual. In process checks for particle size and purity for whole spices with a frequency of once in a hour. All finished products are tested to meet various identified parameters.

Regular laboratory functioning involves sampling and testing followed by recording of microbial and organoleptic results. Company has an in-house lab capable of conducting physical, chemical, microbial tests which is continuously involved in test for raw material and finished product. Refer to guidance sop Sampling QA-GEN-SOP-10 &

Sampling plan QA-SCH-02 for 43 raw material & 4 product types. All results are recorded in various formats eg QA-ANA-F-01 for raw material QA-ANA-F-02 in seed cleaning and so on.

Company has sampled 41 specific product types and recorded to identify trends of results for various parameters to name a few

Shelf life trials are conducted every 6 months and records are maintained. Ref Doc: Shelf life study has been initiated for Fennel Powder produced on 4 th March 2017 and study completed on 8 th April 2018 which is the most recent study. Previously chilli powder lot no SS-230 produced on 13 th Sept 2016 was analysed and completed on 1 st Oct 2017.

5.6.2 Laboratory testing

Only pathogen confirmation tests are undertaken by the laboratory and live strains of pathogens are not maintained by lab. Microbial testing laboratory is placed onsite but segregated from any direct openings to the production areas. All movement of personnel, material, laboratory use apparel, waste disposal, access etc is adequately controlled during approach and access.The external laboratories are required to have accreditations against ISO 17025. Mostly nationally approved labs are used. Geochem / TUV labs are the approved labs. Company also operates an ISO 17025 scope for certain microbial tests. For pathogens a confirmatory test is recorded on each pathogen specific record. Eg Detection of salmonella QA-MIC-F-09B as seen for cumin seeds Lot no SS381-1 found absent for any pathogen. The analyses conducted in house are based on recognised standard like, AOAC or BAM. The personnel are qualified, trained and are competent to carry out the job. The results are cross verified with external laboratories for their reliability. Last such test was done on Nov 17 for 3 products tested for aflatoxin, moisture, pungency, TPC, curcumin and volatile oils with 6 external labs. Internally reliability is tested for




11 parameters by 11 analysts.

5.7 Product release

Finished products are not released unless results of all agreed procedures have been achieved.QA / technical Manager is authorised for product release after all release protocols. Company has a product release procedure QAS-15.


Clause reference

Justification

5.2.3 Products do not make any specific claims for a particular group of consumers.

5.2.4 All labels if used are directly received from the customers there is no nomination of external printer or party. Clause 5.2.4 is not applicable.

5.3.6 There is no requirement to use a warning label on packs as most material is bulk commodity. Clause 5.3.6. is not applicable.

5.3.7 There is no special claim made regarding suitability of food or allergy.

6. Process control

6.1 Control of operations

Documented procedures and work instructions are part of individual SOP to ensure the production of consistently safe and legal product with the desired quality characteristics, in full compliance with the HACCP food safety plan.The company has controls over process operations. Most operations involve cleaning and grinding activities through a BUHLER line. All operations involve cleaning of spices and grinding as per customer requirements & sizes. Mesh sizes are the necessary controls for all products. Roasting is also conducted for roasted material, such as coriander, fenugreek and Cumin. A standard guidance for Roasting temperatures are documented. Ref Doc: Production Process parameters sheet & Daily Production Report GL01.There is time and temperature monitoring required for basic operations of cleaning and grinding. However, for Roasting of fenugreek seed temperature identified is 170 deg C for period 3.5 hours. Other process monitoring in cleaning section is purity levels checks and in Grinding is particle size checks. There is no requirement to have an inline monitoring device. Only Metal detection is an inline rejection mechanism. Processing conditions remain same only the resultant product is monitored to meet size and purity . Size is controlled Processing equipment such as temperature and pressure devices are calibrated once internally as well as externally. All variations are product specific and equipment can cover the requirements. Ref Doc : Roasting of fenugreek seed temperature identified is 170 deg C for a period 3.5




hours.Backup power generation is provided in case of equipment failures and quality checks are undertaken to ensure there is no contamination to products.

6.2 Labelling and pack control

Controls on product labelling activities ensure that products will be correctly labelled and coded. A dedicated packing material store is provided and consumption is tracked.Most packing can be bulk bags of 20 or 25 kg . All bulk bags are supplied to importers for their own use with identification of lots. Company may provide a Lot no of own. As a minimum information such as product name, net wt, date of packing will be displayed on each package. This is order specific as per customer and the packaging material room allots them to the production. Only the packaging for immediate use is available to the packaging activity. For packaging such as paper/plastic or LDPE Liners or woven bags there is not specific requirement which may change from one packing line to the other. Once product contracts are signed along with specifications, checks are carried out before commencing execution of the order. This is also covering labels as identified by importers for art work checks. Most labels are simple identification of lot sizes. Labels which were approved for Garlic powder lot no SOSS 17-18/948 totally 572 labels were printed internally. Track is maintained of damaged quantity or unused labels if any. Precise number.

Accounting of those labels which are extra, returned or damaged after their application is not reflecting on the label control register. One minor NC (7) has been raised against 6.2.2.

Company uses pre-approved labels / stickers on bulk bags and provides them during final packing of material. All material is specific to Cleaning line or 3 grinding lines or roasting / kibbling lie. Packaging material to be used is part of product specifications.There is no online label generation or use of online vision equipment to be used. Clause 6.2.4 is not applicable.

6.3 Quantity, weight, volume and number control

Quantity control & online packing system conforms to customer and a legal requirement in the country where the product is produced and sold is complied.Online checks for quantity verification including weight and grade/size checks are conducted as per the documented procedures, regulatory and customer’s requirements. Each bag is weighed and recorded. Records maintained in finished Product Inspection report. The products are packed conform to the customer requirements and records maintained. There is no requirement to meet bulk or volumetric requirement clause 6.3.2 is not applicable.

6.4 Calibration and control of measuring and monitoring devices

Company demonstrates that measuring equipment are sufficiently accurate and reliable to provide confidence in measurement results.The company has identified equipment used to monitor important control points such as temperature in roasting and air pressure in cleaning and grinding line. Calibration to recognised national standard is being followed. A list of equipment with identification code identifies 55 measuring equipment. Ref Doc: Calibration Schedule MNT-SCH-01 All equipment is checked at a frequency of once in a 12 month which is annually. Calibration is traceable to national standards and results are documented. Eg weighting scale ID 111142092 calibrated on 1.04.2018 cert no SER/012/04/2018 by CAS India & Dig temp controller Micron RD/DTC/-01 cert no CAL/1708-007 by TECHNOCAL Calibrations on 19.8.2017. Pressure Guage CD-PG-02 by TECHNOCAL Calibrations on 19.8.2017 Cert no CAL/1708-007. There are totally 18 magnet locations which are checked for strengths using a calibrated gauss meter. Eg Gauss




meter D20B was calibrated on 26 Feb 2018 and used to calibrate all the 18 locations recorded on magnet strength record eg Magnet on GL-3 Bin no 02 had an average strength 4272. Measuring equipment is being calibrated and traceable to national standards (NABL) same being recorded on the calibration certificate of the equipment. technocal has used Master calibration equipment 447183 which is calibrated to National standards by IDEMI against national standards. Site has quality procedures in place to record actions to be taken when the prescribed measuring devices are found not to be operating within specified limits. There has been no such incidence.


Clause reference

Justification

6.2.4 There is no online label generation or use of online vision equipment to be used. Clause 6.2.4 is not applicable.

6.3.2 The products are packed conform to the customer requirements and records maintained. There is no requirement to meet bulk or volumetric requirement clause 6.3.2 is not applicable.

7. Personnel

7.1 Training: raw material handling, preparation, processing, packing and storage areas

All personnel conducting work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience and qualification.All Employees permanent and temporary are recruited on the basis of their experience in the seafood industry. Personnel are trained and supervised. Organisation has documented a Training calendar QA-TC-01 for the current year this has almost 42 topics. Topics such as GMP GHP, Personnel hygiene, allergen awareness, policy awareness, company rules were planned in January. Similarly, the trainings were executed such as applicable laws, HR Manual, policy, safety on 13 th & 20 th Jan for many batches. Company rules, personal hygiene, HACCP were done on 15 th Feb. Personnel engaged in CCP monitoring such as supervisors are trained for CCP Monitoring. Ref- Training given on CCP awareness and various important topics on 24 Feb 2018 for 14 personnel covering supervisory production staff. Training given by Mr. Kedar between 1730 to 1830 pm. Company has documented competency matrix for 28 positions in the factory. For each of these a competency requirement is document. In case of QA Executive, the required competency is PG in Food technology, Knowledge of 2 to 4 years of experience, trainings required for BRC, FSSC, Analytical knowledge in testing. Personnel are analysed for existing competencies and trainings are provided to improve their capability. Executive R & D was recruited on 6 th Nov and an induction training was provided by different departments. Training given on allergen awareness was done on 19 Feb for totally 26 personnel.Training is conducted and recorded on Training Record QAF-09 which covers date (19 th Feb), No of trainees (17), name of trainer (Kedar Kavekar) their acknowledgement, topics are listed.The company review the competencies of staff and adds in training topics as required. A training assessment is maintained for all personnel after the training & a remark of satisfactory or unsatisfactory result is recorded. On 27 th Aug 2017 training on HACCP, Allergen and BRC was done for 7 persons. The evaluation resulted in measurement of responses by means of a score. All these were in a range of 21 to 24.




7.2 Personal hygiene: raw material handling, preparation, processing, packing and storage areas

Site’s personal hygiene standards have been developed to minimise the risk of product contamination from personnel. Personnel are required to maintain personnel cleanliness and compliance. Documented personnel hygiene policy and communicated to all the employees. Wearing of Jewellery, watches, studded rings is prohibited. Monitoring is done for effectiveness. Ref Doc: Personnel Hygiene Practices & Entry Procedure HK-S-06.Hand cleaning is performed before entry to the production area using soap solution followed by disinfection solution. Personnel are encouraged to report external cuts or injuries, personnel found to have cuts and wounds are not allowed to work in production area. There is no use of blue coloured plaster. Clause 7.2.3 is not applicable.Company does not allow any personnel with plaster in the production area & metal detector does need to check a plaster sample. Clause 7.2.4 is not applicable.Written instructions for control on use of personnel medicine are documented although company does not allow drinking and eating in the production area.

7.3 Medical screeningAll employees including new ones are required to undergo a medical check in the factory once in 12 months which is the basic legal requirement.Company personnel are encouraged to notify in case of any diseases. All personnel are medically checked by a Visiting Doctor annually. Ref Doc: Personnel Hygiene Practices & Entry Procedure.All the visitors and contractors are required to complete a visitor’s declaration. Ref Doc: Visitors Declaration TL-F-10.Documented procedure exists in which all employees need to inform immediately to their supervisor in case of any wounds, burns, cut as well as suffering from any diseases. Periodic checks by a visiting doctor and annual checks are conducted for all employees Rakesh Sharma from production was checked on 29 th Jan 2018 by Dr Pradeep Mahajan and test report from Medi Check hospital laboratory is available.

7.4 Protective clothing: employees or visitors to production areas

Suitable site-issued protective clothing has been worn by employees, contractors or visitors working in or entering production areas. Company provides protective work wear to all the employees including visitors and contractors visiting the production and handling areas. During lunch breaks and tea breaks personnel change in to non-production outfit while leaving production area. Documented policy is established. Workers are provided with shirts having hoods and trousers and masks, cap and shoes. Hygiene & Quality officers are provided with aprons, headgear, mouth mask. Shoes are provided by company for all employees entering in the production area as appropriate.Ref Doc: Personnel Hygiene policy P-03 in English and local language.Suitable clothing sets are provided to all the employees on daily basis. There are no external pockets above the waist and sewn buttons on the uniforms. Hairnets to contain all scalp hair are provided. Company has in house laundering of all protective clothing. Effectiveness of the laundering is verified through swab test and report maintained.Swab analysis for apron & validation of laundry procedure, TPC and Coliform counts were monitored before and after cleaning. Laundry Procedure HK-S-05 defines the procedure to be followed. Swab of laundry washing effectiveness is maintained by the company and recorded on Mircotest result as conducted on 25 Oct 2017 for 2 samples from grinding and cleaning division recorded on Swab Analysis record QA-MIC-F07.Internal laundry in terms of 2 washing machines is provided which conducts daily washing. Ref Doc: Laundry Procedure HSK-05.Only Low risk area is identified clause 7.4.5 is not applicable.Gloves are not provided to personnel clause 7.4.6 is not applicable.There are no items of protective clothing which may require specialised laundering clause 7.4.7 is not applicable.





Clause reference

Justification

7.2.3 Personnel are encouraged to report external cuts or injuries, personnel found to have cuts and wounds are not allowed to work in production area. There is no use of blue coloured plaster.

7.2.4 Company does not maintain sample of any metal detectable plaster as it does not allow personnel to work near products.

7.4.7 Items of personal protective clothing that are not suitable for laundering are not provided.




Module 8 - Traded Goods

Scope

8.1 Approval and performance monitoring of manufacturers/packers of traded food products

8.2 Specifications

8.3 Product inspection and laboratory testing

8.4 Product legality

8.5 Traceability




Module 9: Management of Food Materials for Animal Feed

Scope

9.1 Management Commitment

9.2 HACCP

9.3 Outsourced Production

9.4 Specifications

9.5 Traceability

9.6 Chemical and Physical Product Contamination Control




9.7 Labelling

9.8 Training

Module 11: Meat supply chain assurance

Scope

11.1 Traceability

11.2 Approval of meat supply chain

11.3 Raw material receipt and inspection




11.4 Management of cross-contamination between species

11.5 Product testing

11.6 Training

Module 12: AOECS Gluten-free Foods

Scope

12.1 Senior management

12.2 Management of suppliers of raw materials and packaging




12.3 Outsourced production

12.4 Specifications

12.5 Management of gluten cross-contamination

12.6 Management of incidents, product withdrawal and product recall

12.7 Labelling

12.8 Product inspection and laboratory testing




Module 15 FSMA Preventive Controls Preparedness Module

Item no. Clause Module item Conforms

(Y/N)

Comments

1 117.20 Handwashing areas, dressing and locker rooms, and bathrooms must have adequate lighting.

Y

All areas have adequate lighting whose lux intensity done on 7 th Feb 2018 for 27 different areas. Required minimum ranges from 300 to 500 lux are arrived at.

2 117.37 The water distribution system must prevent backflow from, or cross-connection between, piping systems that discharge waste water or sewage.

Y

Facility does not use water directly in process or handling of spices. Use of water is limited to hand wash stations which are on the ground floor and flow pipes are maintained at the external of the facility. There is minimal chances of any form of back flow. Only other water is the pipe conveying water as a cooling medium to roaster which is a closed loop process between cooling tower and roaster medium.

3 117.40 All food contact surfaces of plant equipment and utensils used in manufacturing, processing, packing, or holding food must be corrosion resistant.

Seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and allergen cross-contact.

Y

All process equipment involving operations of cleaning, grinding, roasting involves BUHLER lines made of SS304 and SS316L which is suitable for this industrial purpose found to be corrosion resistance.

4 117.80 Ice used in contact with food must be manufactured in accordance with the good manufacturing practice (GMP) requirements of 21 CFR § 117.

N/A

Ice is not used in any of the processes. Clause is not applicable.

5 117.110 Where defect action levels (DALs) are established for a food, quality control operations must reduce defects to the

Company has documented acceptance criteria for raw




lowest level possible.

Defect levels rendering the food adulterated may not be reduced by mixing the food with another lot.

Y material. Have also developed specifications for each product & product type to monitor desired specification for each customer. Monitoring mechanism is designed to identify possible adulteration at raw material level to ensure this does not enter process. Company rejects potential material which deems to be adulterated at the point of receipt and does not re-use it. Quality checks conducted in process through sampling are designed to identify quality defects which are variation in specifications. Raw material analysis report maintained by the company for each lot covers monitoring of most specifications as well those parameters which may provide hints of possible adulteration. QA-ANA-F-01 for Fennel seed Lot PO 110817.

6 117.130 (a) The hazard analysis must additionally identify and evaluate the following known or reasonably foreseeable hazards, which are associated with the food or facility:

economic adulterants which affect food safety

environmental pathogens where ready-to-eat (RTE) food is exposed to the environment prior to packaging and the packaged food does not receive a kill step

radiological hazards unintentional adulterants that

affect food safety.

N

Company has conducted hazard analysis for all raw material and processes conducted on site to ensure safe final products are produced this is in the form of Hazard Analysis M-01/Annex 2 (GL-01). This considers physical, chemical, biological and radiological hazards considering purchase of raw material and its processing in to final product.

Further company also conducted Raw material vulnerability risk assessment M-01/Annex 2 which considers adulteration, substitution and exposure of unintentional adulterants raw material to




such factors.

Risk of radiological hazards is not clearly documented as part of Imported coriander consignments although declarations supporting its safety are maintained. One minor NC has been raised against this module.

7 117.130 (b) All identified, known, or reasonably foreseeable hazards must be evaluated to determine ‘hazards that require a preventive control’ (i.e., significant hazards).

Y

As a part of the hazard analysis company has considers all possible hazards are expected to occur at the receipt or handling or processing as applicable to the products under scope such as spices herbs and botanicals. These are toxins, physical and chemical hazards, microbial contaminants or factors which could arise as a result of handling the material.

8 117.135 Establish one or more preventive control(s) for each identified ‘hazard that require a preventive control’ (i.e., significant hazard) such that the control significantly minimizes or prevents the food manufactured, processed, packed, or held by the facility from being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug and Cosmetic Act.

Y

The Food safety team has considered the control measures necessary to prevent, eliminate or reduce the hazard to acceptable levels. Consideration is given to using more than one control measure. Justification for acceptable levels in the finished product for each hazard is determined and documented. Measures and monitoring along with periodic sampling and testing ensures that any form of adulteration does not take place within the facility of the product. The processing does not involve any form of chemical treatment or addition of ingredients. For blended products only, those material which is produced in the facility are used for blending.




Ref. Doc: CCP Plan M-01/Annex03(CD) & (GL1).

9 117.139 Evaluate and update the recall and withdrawal procedure as necessary to ensure it contains procedures and responsibility for the following:

notifying consignees of how to return or dispose of recalled product

conducting effectiveness checks to verify recall is carried out

appropriate disposal of recalled product (i.e., destroy, divert, repurpose).

Y

Company does not supply any material directly to customer only withdrawal is applicable. Company has identified and documented a team comprising of 4 members along with their contact details, responsibilities of actions to be taken during a situation needing withdrawal as identified. Responsibility to inform consignee lies with director operations. If there is any food safety issue then recall or withdrawn can be initiated. However, there is no such incident. Contact details and communication plan is for each is available. 4 major areas for contacting customer, legal, internal traceability and overall approval to initiate are identified. Ref Doc: Product withdrawal and Recall procedure QA-S-08

10 117.145 Establish monitoring activities and a written procedure for each preventive control in a manner consistent with the requirements of BRC section 2.10.

Y

Monitoring system is established for each CCP by direct visual checks on lot sizes by passing all material through an inline metal detector. Monitoring system is followed by recording such results for each day and batch which can be traceable.

11 117.150 Establish corrective action procedures when preventive controls are not implemented in a manner consistent with the requirements of BRC sections 2.11 and 3.7.

Corrective action procedures must be established and implemented when the presence of a pathogen (or indicator organism) is detected as a part of verification activities (i.e., product testing and/or environmental

Y

As a part of hazard analysis company has identified critical control points which are monitored and actions in case of a deviation is defined. For CCP Metal fragments it is re-passing and investigating source of metal. Finished goods are re-segregated and repassed through the metal detector.Presence of microbial contamination and pathogen




monitoring). testing are part of the routine tests. All finished products are tested to meet various identified parameters & Corrective actions initiate if found to be deviating during the manufacturing process. Regular laboratory functioning involves sampling and testing followed by recording of microbial and organoleptic results. Company has an in-house lab capable of conducting physical, chemical, microbial tests which is continuously involved in test for raw material and finished product. Guidance sop Sampling QA-GEN-SOP-10 & Sampling plan QA-SCH-02 for 43 raw material & 4 product types. All results are recorded in various formats eg QA-ANA-F-01 for raw material QA-ANA-F-02 in seed cleaning and so on. Necessary action pertaining to incidence of pathogens is investigated although this is a rare occurrence.

12 117.160 Validate all established process controls prior to implementation of the food safety plan, upon changes requiring revalidation or within 90 calendar days of the first food production.

Validate allergen, sanitation and supply-chain controls as appropriate to the nature of the hazard, control and facility.

Y

Company has been manufacturing the product lines since some years and has standardized the process through their own manufacturing experience supplement by state of the art tested equipment from BUHLER. Customer feedback towards setting expectation and safety parameters is available. Process has been validated and quality checks ensure that deviation of product lines does not take place. The controls are focussed over physical controls of hazards at the processing step through metal detectors, magnets and sieves which are monitored for each




batch being produced.

Critical control points being identified are validated through the assistance from equipment manufacturer.

This was last done by Sesotec on 1-4-2018 for model no rapid various FS120. The metal detectors are also calibrated last on 8 th Dec 2017.

Company has documented as vulnerability substitution of fraud risk assessment for source of raw materials (M-01/Annex02) which considers possibility, likelihood and severity of vulnerability. This is kept open for review and more raw materials as incorporated have been added in as on purchased. This was reviewed on 7 Nov 2017 where in few raw material groups was added in.

Allergen handling and removal process is validated and tested using ELISA kit. On 5 th Feb 18 traces of yellow Mustard were checked in turmeric powder and the results we done for 1 product and 3 surface samples having no traces. Similarly, this was done for sesame seed and black mustard and results were satisfactory.

The validated plans are signed by team members who are trained PCQI. Dr Sonika Putto is also the PCQI and Quality Technical manager.




13 117.165 (a) The PCQI (or authorized designee) reviews the monitoring and corrective action records within 7 days. Where an alternate timeframe exceeding 7 days is used, the PCQI must document justification.

The PCQI (or their authorized designee) reviews the verification records for all preventive controls (e.g., calibration records, product testing, supply-chain audits) within a reasonable timeframe after the record has been created.

Y

All production records and quality monitoring records are reviewed on the same day or maximum next day. Results of monitoring if found to be deviating are discussed immediately with the HACCP team to ensure that compliance is achieved and product is identified. All compliances or issues pertaining to food safety are recorded in monthly meeting.

14 117.165 (b) Where product testing for a pathogen (or indicator organism) or other hazard is used as a verification activity, a scientifically valid and written testing procedure must identify the following:

sampling procedure to include method, quantity, frequency, and number of samples

analytical method laboratory conducting an

analysis corrective action procedure

where a pathogen is detected.

Y

Company has an in-house lab capable of conducting physical, chemical, microbial tests which is continuously involved in test for raw material and finished product. Guidance sop Sampling QA-GEN-SOP-10 & Sampling plan QA-SCH-02 for 43 raw material & 4 product types. All results are recorded in various formats eg QA-ANA-F-01 for raw material QA-ANA-F-02 in seed cleaning and so on. Pathogen testing is part of finished product testing along with other microbial loads. There has not been any incidence of positive pathogen indication.

15 117.165 (c) Where environmental monitoring for a pathogen (or indicator organism) is used as a verification activity, a scientifically valid and written testing procedure must identify the following:

adequate number and location of sample sites

timing and frequency of sampling

analytical method laboratory conducting the

analysis

N/A Facility handles low risk products which are used as an ingredient to cooking operations. There are no products which are consumed directly. There is no customer requirement to monitor environmental pathogen monitoring. Environmental monitoring is not used as an indication of verification. The




corrective action procedure where a pathogen is detected.

clause is not applicable.

16 117.165 Devices used to verify preventive controls must be calibrated.

Y

All equipment are checked at a frequency of once in a 12 months which is annually. Calibration is traceable to national standards and results are documented. Eg weighting scale ID 111142092 calibrated on 1.04.2018 cert no SER/012/04/2018 by CAS India & Dig temp controller Micron RD/DTC/-01 cert no CAL/1708-007 by TECHNOCAL Calibrations on 19.8.2017. Pressure Guage CD-PG-02 by TECHNOCAL Calibrations on 19.8.2017 Cert no CAL/1708-007. There are totally 18 magnet locations which are checked for strengths using a calibrated gauss meter. Eg Gauss meter D20B was calibrated on 26 Feb 2018 and used to calibrate all the 18 locations recorded on magnet strength record eg Magnet on GL-3 Bin no 02 had an average strength 4272.

17 117.180 Identify a PCQI responsible for developing the food safety plan, validating preventing controls, review of records, and reanalysis of the plan.

Document the PCQI’s training or qualifications via job experience.

Y

The site has trained 4 PCQI who are part of the HACCP Team. The responsible PCQI is team leader Vinayak Chondekar who is the team leader and Dr Sonika Putto who is also the PCQI and Quality Technical manager. The training for PCQI was done on 17 th Dec 2016 conducted by FSPCA. The PCQI has relevant experience to understand the process and hazards involved.

18 117.305 All records required by 21 CFR § 117 must include:

the date and time of the activity being documented

signature/initials of individual performing the activity or

Y

All records bear the date and time as applicable with signature of the person signing and lot no being processed.




conducting the record review information to identify the

facility (e.g., name and location)

the identity of the product and lot code where applicable.

19 117.310 The owner, operator or agent in charge of the facility must sign and date the written food safety plan initially and again upon any changes following reanalysis.

Y

The Food Safety plan has been signed by team leader Vinayak Chondekar and is done so whenever it is reviewed. The entire HACCP team is also comprising of top management who are part of the review process.

20 117.315 All documents and records relating to the food safety plan (i.e., all records required by 21 CFR § 117) must be retained at the facility for 2 years after the record is created. Where records are stored offsite, they must be retrievable within 24 hours, with the exception of the food safety plan, which must remain onsite.

Y

All the records are retained for a period of 2 years which one year over the shelf life of the product. All records are stored on site.

21 117.405 Where a hazard requiring a supply-chain-applied control is identified in the hazard analysis, the receiving facility must establish and implement specific supplier approval and verification activities.

Where a hazard requiring a supply-chain-applied control is identified and the control is applied by an entity other than the receiving facility’s supplier, the receiving facility is responsible for verifying implementation of the control.

Y

Company has also established a supplier approval program. This is developed monitored and implemented by the company directly. All chemicals raw material and ingredients have undergone hazard analysis and risk assessment before acceptance. This includes packaging material, allergens, physical & chemical contamination. . The risk assessment for raw material group and packaging material is in the form of hazard and risk analysis.

22 117.420 Supplier approval must be documented before receiving and using raw materials and ingredients.

Verification activities must be conducted before receiving and using raw materials and ingredients on a temporary basis from unapproved suppliers.

Y

Supplier approval procedure in terms of Management of Purchased material PU-S-01 & Approved vendor list maintained. Company maintains as approved vendor supply chain control list.




23 117.430 One or more supplier verification activities (as defined in 21 CFR § 117.410(b)) must be conducted for each supplier before using raw materials and ingredients and periodically thereafter at an adequate frequency.

Y

Raw material testing of each lot conducted internally as a minimum and externally as applicable is conducted and maintained.