Good Manufacturing Practices
GMP – Non negotiable
ISO/TS 22002-1 Section No. and Description
4 - Construction and Layout of Buildings
5 - Layout of premises and workplace
6 - Utilities - Air, Water, Energy
7 - Waste Disposal
8 - Equipment suitability, Cleaning and Maint.
9 - Management of Purchased Materials
10 - Measure for Preventing Cross Contamination
11 - Cleaning and Sanitizing
12 - Pest control
13 - Personnel Hygiene and Employee Facilities
14 - Rework
15 - Product Recall Procedures
16 - Warehousing
17 - Product info. and Consumer Awareness
18 - Food Defence, Bio vigilance and Bioterrorism
Major ones
HACCP new template aligned with FSSC requirement – study to be for process and C&D
Change management – Process , Product ,Supplier ,Equipment ,Personal ,Premises
Category GMP – Specific mandates , operational controls
Unilever Relevant Procedure(s)
UQP-18 Facilities, building design and layout
UQP-18 Facilities, building design and layout
UQP-19 - Utilities, Air and Water
UQP-40 - Disposal and dispensation of non-conforming
product
UQP-17 - Hygienic engineering and maintenance
UQP-34 - Supplier quality approval
- Procurement processes for selection and management of
suppliers
- GMP/ local processes for intake of raw materials
UQP- 21- Prevention of cross contamination
Allergen Standard
Guidence Document for Allergen Management
UQP-20- Cleaning and disinfection
UQP-22- Integrated pest management
UQP-23 - Personnel hygiene and employee facilities
UQP-24 - Rework
UQP-38- Marketplace non-conformance (incident)
management
UQP-32 - Warehouse and transport
UQG-12-52-Capability- technical artwork approval (Part of
functional excellence)
UQG-xx Food defence (still in Draft)
This communication is based on actual GMP assessments

Grouped in following headings

– Commitment
– Consumer safety
– Hygiene & Housekeeping
– Process control
– Change management
– Lab control
– FSSC gap assessment
Visible Commitment
– Communication with Management and Employee
• Periodic updates – circle / meeting / quality boards update / D incident sharing
• Quality posters to be available across factories with details on Quality indicators

– Knowledge and awareness for Operators to own Quality of the operators training
• Specific training is required for line operators to guarantee / own ability to check
• Operator owned quality Production and engineering involved in monitoring and maintaining

– Data integrity and analysis to prioritize critical actions

• Data control in process sheet / log / lab regards to quality monitoring
• Preventive culture - RCA / CAPA rigor ,Process capability improvement
People behavior

• Quality rules
– Hygiene rules not displayed in all areas
– Moustache cover not provided for shop floor and shoe change not always
respected; Pictorial display in each area to be in place with rigor - Refer to New
Hygiene Requirements
– Flow of the people entering production areas must be reviewed and more
controls are requested as seen some non conforming behaviours requested
• Change entry lay out, include shoes cleaner & have a block
system ensuring hand washing .
• Quality data control and report
– Operator log data recording discipline to be improved as do ownership
– Cleaning control report to be periodic and schedule adherence to be improved

– Culture on hygiene and process control by operator must be created via a

specific dedicated training and rules must be evident on boards in production.
 Training Effectiveness

Description :Training management plan is excellent. Factory indentifies training

needs and pre & post evaluation is done through a written test. Effectiveness of
training is questionable in some areas of the factory.
Examples Of Observation: There were evidences that people, despite going
through training, are not aware of the subject or applying the content in
operations.
Corrective Action: Implement tools to identify training effectiveness. Assess
trained people on a periodic basis. Drive training through TPM circles and project
should be assigned for improvement and assessment on the project should be
used to plug the gaps in understanding.
 Procedures

Description:- Factory has procedures, but they are not controlled centrally. It was
also found hand written procedures, with no number or tracking records.
Management of procedures needs significant improvement.

Examples Of Observation: Batch card and process compliances mandated by CQA

and communicated by the factory quality team to the operations team by there is
no audit trail available with the quality team to ensure the latest
procedure/formulations are followed.

Correction Action:- Centralized the procedure management to be done by

factory quality team. Numbering all procedures in the factory is critical to ensure
traceability on procedures. Create procedures that are missing and validate
them..
 Action / Improvement Plans

Description: Action and Improvement plans are quite superficial and not always
identify the Root Cause of the issue. Internal Audit system is in place, with more
than 200 points to be covered. It is done monthly hence it becomes a mechanical
exercise instead of an improvement tool.
Examples of Observation: Consumer complaints due to foreigner matters are
recurrent. Audit records, including assessor comments and actions plans exists
but are incomplete to very high number of areas covered in a short span of time.
Corrective Action: Create robust action/improvement plans using TPM tools.
Internal audit records, including action plans to close gaps, responsibility and
timelines. Internal audit must be a tool to make sure the factory improves. Divide
internal audit on feasible items i.e 70/80 points per month.
Internal Auditing

Currently no internal process audit carried out for site

Examples of gaps:
•No schedule to carry out process audit of plant.
•Site doesn’t get audited centrally for QMS standard.

Recommendations:
•Design format to carry out process audit.
•Make a schedule of audit and ensure timely completion of audit.
•Track on non conformance and give time line and responsibility for closure of gaps.
Training

Currently no system and it is under process of development.

Examples of gaps:
•No training schedule available.
•No process to give licence to operate to new workmen.
Recommendations:
• Need to carry out gap analysis in skill level for all workers/executive/managers.
•Casual workers need to check for medical.
•New (permanent/casual) workers given induction training and must be given licence to
operate.
•Need to make schedule for training.
•Class room training need to be given to workmen and effectiveness of training need to be
checked.
•Maintaining training module for all topics on quality.
Consumer Safety
-- HACCP plan must be reviewed and understood:
• Number of CCP reduced to focus on critical real risks with robust monitoring
• Verification , validation and audit program properly developped
• CCPs displays evident in process steps with critical limits , monitoring and CAPA
---Design in lign with GMP
• Storage conditions to be specvific based on temperature / contamination /Pallets
• Equipment capability hold time / detection / accuracy in place
---Allergen / Rework in lign with GMP
• Guidlines issued by R&D to be followed
---Hygiene risk assessment and actions taken
• Addition of RM No copntamination from outers
• Spill collection water dripping from hoses collected in trays / hoses etc

• It is important that operators understand the meaning of CCP - reduction of CCP’s key
HACCP
DESCRIPTION
The HACCP plans are not correctly defined and do not meet global requirements.
Examples of gaps:
• HACCP study not carried for new setup.
• CCP are not properly identified and displayed in Food & HPC.
• Records are not maintained for CCP monitoring.
•Needs timely revision of HACCP study to capture the changes if any.
•Flow diagrams to be further developed, covering process from receipt of RM/PM to
dispatch.

Recommendations:
•Start monitoring the CCP as per old version of HACCP study.
•Carry out HACCP study for all process line to identify risk and to put control measures.
•Give training to employees on HACCP.
•Proper display of CCP at point of monitoring with critical limit and monitoring and
corrective action.
 Allergen Management

DESCRIPTION:- As per Unilever guidelines mustard flavour and mustard flour are
allergens and these materials are used in mayo formulation. But we have not
identified these as allergens based on design HACCP study and factory has not
validated these as allergen.

EXAMPLES OF OBSERVATIONS:- Mustard flavour and mustard flour are used in

mayo operation. It was also not mentioned in HACCP study of the factory.

CORRECTIVE ACTION:- Follow the allergen management guidelines , design

appropriate management program for implementation and training.
 HACCP Study

DESCRIPTION:- The HACCP study which was done earlier was not adequate and
detailed eg.-ingredient hazard analysis, Flow diagram, understanding of CCP,
processing method and implementation.

EXAMPLES OF OBSERVATIONS:- In new ketchup bottle line online bottle

inspection was not considered as CCP. Sparkle filter in sugar area and mayo line
were treated as CCP which needs to be considered as QCP.

CORRECTIVE ACTION:-Review whole HACCP study and update including

implementation and training.
 Foreign Matter Controls

DESCRIPTION:- In our jam line consumer complaint trend shows maximum

complaints are related to glass piece and insect as a foreign matter. At present we
have manual controls system to inspect online bottles and there is no control at
end of line.

EXAMPLES OF OBSERVATIONS:- Manual online inspection of bottles is not

adequate. Source of foreign matter ingress are fillers and capper

CORRECTIVE ACTION:-Putting X-ray machine at the end of line and bottle online
inspection through EBI machine, covers above open bottle area
Hygiene and Housekeeping
-- System to monitor hygienic condition
• Routine and Non routine risk assessment to be in place for assessing gaps /CAPA
• Internal assessment system user freindly checklist / specific / detailed /each section
---Cleaning control to proactively address issues
• Drain control to be in place
• Cleaning schedule for each place / specifc
---Pest cvontrol to have a written detailed plan
• Outside periphery to be well protected
• Openings protected specifc / no cross over / insect protection
---C&D regime to be as per GMP , product specific and part of HACCP flow
• Experts validation to be ensured and recommendations fulfilled
• Verfication after C&D specific focus given on difficult to clean / COP / filler areas

• The cleaning procedure system must be totally reviewed and trained and it has to
cover all the areas of the factory from the buildings to equipment and process
lines.
Need improvement in pest management
Hygiene Design Continuous.....

DESCRIPTION: Currently certain parts of the plant do not meet the required standards for hygienic
design as stated in the Liquids GMP & P & ES guidelines .

Examples of gaps:
•Lots of dead end are found in Mixer & relevant hardware.
•There are a number of used & unused inlets on the mixers which cannot be cleaned via the spray balls.
•No dedicated Transfer pump is provided for transferring the product from Side pot.
•Cleaning through existing no of spray balls seems to be an issue for effective cleaning.
•High Shear Side pot for Carbopol Dispersion is found to be Pitched blade turbine.
•Sample valves installed on line are not hygienic design
•Position of bellows seems to be an issue for weight accuracy.
Hygiene Design
Recommendations:
•A detailed Dead end audit needs to be carried out & action needs to be drawn in terms of cleaning
frequency , mitigation & method of cleaning.
•Mixer drain ability must be improved upon installation of drain value in the recirculation loop . Pipe
work must be sloping and any dead areas removed.
•Buffing needs to be carried out on most of the welding places to remove the crevices.
•Any unused inlets must be removed and cleaning for hard to reach areas must be reviewed.
•Need to provide an inline slot strainer at the mixer Bottom.
•Need to provide additional spray balls in Side pot.
•Need to provide a dedicated transfer pump for transferring the product from side pot.
•High Shear side pot stirrer to be replaced from PBT to Cowl type.
•Sampling valves need to be changed to hygienic design.
•Position of below need to be corrected.
•Most of the Mixer & Side pot hardware are not aligned with the P & ES guidelines. Need to make an
action plan to correct the same.
Pest Control
Pest control needs to be improved.
Examples of gaps:
•Ant, fly and insect observed inside production area of food & HPC.
•Entry door to production hall is without air curtain.
•No proper closure of gaps in door.
•Loading and unloading areas are not having any protection against pest entry.

Recommendations:
•Required detail pest control audit of plant through pest control agency and closure of gaps.
•Provision of mesh/mosquito net for all openings to production hall including exhaust fan.
•Air curtain and strip curtain as required to every entry point.
•Tracking of pest effectiveness and giving feedback to pest control agency for corrective
action.
•Tracking shelf life of UV light used inside insecticutor.
 Cleaning & Disinfection
Examples of gaps:
•The COP washing areas do not meet the required standard and is dirty.
•Equipment is rinsed with a cold water hose – this is carried out on the floor.
•Some of the mixers & side pot have high level of product/ raw material deposits even after completing
sanitization.
•Plant is not completely drainable observed water accumulation in PP plant post sanitization.
•Product residue observed in pipeline post sanitization.
Recommendations:
• Separate room needs to be build, as Sanitization room, for cleaning equipment.
•There must be clear segregation of clean and dirty equipment with clear indication of its status.
•New equipment such as wash baths and draining stands is required.
•Cleaning of the mixers must be improved. Review the usage of external cleaning companies and
chemicals. Need to determine best practice procedures for cleaning and disinfection dip pipes and vents.
Help required from external teams.
•Need to identify the position as a coldest place in recirculation loop, Side pot, Transfer line for thermal
Stickers.
•Proper attention to be given for dead ends. The nature of the plant design dictates that the majority of
equipment needs to be dismantled, cleaned out of place and then re assembled.
 Cleaning & Disinfection

DESCRIPTION
Cleaning & Disinfection follows the existing systems & procedures, but the critical
review of cleaning results must be strengthened

EXAMPLES OF OBSERVATIONS
• The Mayo tank, strainer and subsequent piping were not clean and the Mayo
hopper cleaning approach was very artisanal
• The floors are very frequency cleaned, but the action does not lead to the
required cleaning result due to ineffective cleaning approach and/or cleaning
chemicals and utensils

CORRECTIVE ACTION
Critically review existing cleaning procedures, involve cleaning experts (inside and
outside Unilever) and re-train all operators on detailed execution
 Hygiene Cross Contamination
DESCRIPTION
The routing of people leads in several (production) areas to cross contamination from
‘dirty’ to ‘clean’ areas.

EXAMPLES OF OBSERVATIONS
• The routing of people working in the production area to and from the weighing area is
via the Raw Material storage area.
• Final product is transported by fork lift to the Finished Products storage by people from
the operation (and sometimes by people from the storage area) and without hygienic pre-
cautions they return into production (like when entering production via the changing
area).
•There is also two-directional movement of people between the 2 raw Material Storages
and production hall without preventative hygiene precautions

CORRECTIVE ACTION
Construct barriers between the production hall and the storage areas (RM&FG) to stop
two-directional movement of people from ‘dirty’ and ‘clean’
Water Treatment
DESCRIPTION :Chlorinated water is the method used for treating process water. Design changes to the
system are required to be fully compliant with GMP standards.
Examples of gaps:
• No interlock is there in the entire chlorination Plant.
• Water could potentially remain stagnant in the current system as there is no ring main
provided for Chlorination water loop.
• No system is available for recording Chlorine PPM & pH of the water batch .
• Life of UV light is not being monitored
• Pasteurized water not used in PW for colour preparation.
Recommendations:
• Design changes to the system are required to prevent water being allowed to stagnate.
• In the event of an interlock Chlorine PPM & pH needs to be interlocked with the process.
• Chart recorder needs to be put for recording Chlorine PPM & pH of water going to process.
• Use of Chlorination plant must be reviewed to ensure that treated water is not allowed to
stagnate and system must be capable of being fully drained and disinfected.
• Bypass provided for UV treated water must be removed and shelf life of UV light need to be
monitored
• Need to maintain back washing record for filtration system.
Material Storage & Handling

Examples of gaps:
•No QC status on lot as QC hold/QC rejected/QC pass.
•Poor lot code identification of lot
•FIFO found missing for RM/PM.
•Material found kept touching to wall.
•Improper segregation of rejected material.

Recommendations:
•Maintaining bin card for storage material for easy identification.
•Requisition note and issue slip and material return note to be followed.
•Clear demarcation on lot giving status.
General House keeping
DESCRIPTION
General housekeeping is poor and needs improvement.
Examples of gaps:
•Cob webs found inside manufacturing area
•Bird dropping and feathers found inside spread manufacturing area.
•Use of thread, cello tape can lead to FM contamination.
•Spillages observed in chilled drum, noodle silo, mill shop-floor
•Dirt and duct observed in production area.
•Drains are found uncleaned, needs immediate attention.
•Maintenance tools found scattered across mixer floor in HPC plant

Recommendations:
•Proper schedule for cleaning drain and ensure disinfection of drain once in week.
•Identification of entry point inside production and getting it plugged.
•Work permit should include removal of all maintenance tool post completion of work.,
need to be signoff by concern operator.
•Proper collection tray to collect spill over product and removal of same on time.
•Proper cleaning schedule for general house keeping with records.
 Hygiene & Housekeeping High Risk
DESCRIPTION
In the production hall, adjacent areas and outside the buildings on site, many unnecessary
and obsolete materials are present. Also many floors are unnecessary wet from product
spillages during cleaning, from leaking taps/ equipment or from not well connecting pipes to
drains. Also drains are dirty and several of unhygienic design
EXAMPLES OF OBSERVATIONS
• Running water over the floor at the bottle rinse area and many places in mixing and filling
areas
•Diluted mayo product leaking on the floor instead of the waste bin during cleaning
• Chaotic and very dirty scrap yard (stored obsolete equipment as well as many other waste
e.g. half empty jam bottle, trousers, engineering utilities, undefined metal, carton, plastic
materials as well as glass. High amount of insects at stagnant pool of water at the unhygienic
sorted waste area
CORRECTIVE ACTION
Create a culture of dry and clean floors proportional to the activity. Immediately
remove all obsolete materials from site and re-organize the waste handling area
Process control
-- Design interlocks to assure consistency
• Process and filling interlocks to assure dosing / parameter accuracy
• Double filters to ensure appropriate cleaning and maintanence
---Critical process parameter to be listed / trained and monitored
• Trending charts to be in place either through recorder or SPC charts
• RCA / CAPA for any deviation
---Operator responsibility to be well drafted
• Work instructions to be in local language well understood
• Operator logas have peiodic monitoring parameter with std range matchd with TTD
---JH /PM pillar regime well integrated for quality requirements
• Q components to be identified with frequency and method to monitor
• Post and pre maintanence specific checkpoints for contamination avoidance
• Calibration of critical equipments to have internal and periodic external checks

• SCADA / DCS /Pasteurization / Water treatment systems to be fully audited and

reviewed for compliance
 Process Control
Description :

• Variation in fill temperature for ketchup and Jam observed (lower than
recommended).

• Differences observed between temperature displayed at SCADA vs actual

temperature of the product in holding tank/filling hopper.
Impact: Low temperature fill may lead to consumer complaints related to
spoilage / microbiological contamination in the product.

Corrective Actions:

- Interlocking between SACAD and fill temperature. Automatic controls to

be in place to ensure- No fill at low temperature (< 85 deg C).

- Training to be provided to all the shift operators on the seriousness of

product safety requirements and fill temperature.

4
 Process Control

Description:

• Black scum layer was found on the surface of sugar solution stored in the sugar
syrup holding tank (No acceptable). This was due to transfer of sugar syrup through
the bypass line

Impact:

- Impact on product quality with respect foreign body and sensory attributes

Corrective Actions:

- The bypass line provided before the sparkler filter must be removed and should be
used only incase of CIP.

- Entry from RM and FG store to the process area must be closed. There must be
restricted entry only for authorized personals.

4
 High Risk

Process Control

Description:

• Hygiene requirements for the pulp preparation is not met.

• Hot water flushing after every 8 hrs not followed for pulp blending tank and
Impact: line.
transfer
- Issue with respect to microbiological contamination.
- Consumer complaints issues.

Corrective Actions:

- Trend analysis to be conducted based on the SOP recommended for aseptic pulp
handling system to establish the cleaning/flushing frequency.

- Hot water flush must be started for the pulp blending line.

- Required hardware modification to be done to facilitate hot water flushing.

4
Process Control
Examples of gaps:
• Process parameters are not well defined in the batch Card
• Counter sign. of Shift Incharge in the batch sheet for correct weighment and addition of claim
ingredients & CCPs was not available.
• Batch sheets are not completely filled.
• No Segregation of High Risk from allergen, Low Risk, Hazardous from non Hazardous Raw
material.
• No system interlock available for critical process.
Recommendations:
• All the process parameters are need to defined well in the batch Card ( i.e. Temp, Pressure,
RPM etc).
• Provision of process interlock to make system mistake proof.
• Counter Sign of Shift Incharge in the batch Sheet is must & only after his confirmation operator
is allowed to transfer batch from Mixer to Holding Tanks.
• All Batch sheets should contain start & end time, all process parameters, final results of the
batch & get it signed by the Shift Executive at the end of Shift.
• Revalidation of Micro Sensitive Raw material needs to be carried out as per GMP guidelines.
• Material needs to be segregated & stored based on risk classification.
 Fill temperature compliance High Risk

DESCRIPTION : Product fill temperature for product microbiological safety to be

85 c as per specs - CCP . This was widely deviated in spot checks in Jam and
Ketchup lines

EXAMPLES OF OBSERVATIONS : 1. New filler hopper RTD installation / interlock

pending 2. Temperature gauge maintenance issues 3. Interlock in existing fillers
are bypassed to manual mode in operation 4. Frequent start / stop operation
leading to stagnant material 5. Operator/QC log not recording deviation

CORRECTIVE ACTION : 1. All filler hopper temperature probe should have RTD
probe and temperature interlock with the filler ,manual bypass to be controlled
only in case of CIP 2. Start stop operation SOP to be framed / implemented on
removing appropriate number of bottles 3. QC operators checking frequency till
stability to be more and appropriate values recording to be ensured with CAPA
 Process & equipment improvement

• End of line controls

– Checkweigher in end of line
• Cone quality improvement
– Increase the quality awareness on key quality parameter of Cornetto (ex. Wafer Cone
rim to be relooked to reduce the overlap in the top )
– Spray must be better controlled to aver a complete coverage of the cone
– Chocolate spray temperature to be better controlled
• Cup filling quality to be improved
– Lack consistency on product especially for sauce distribution. May be Automatic cup
filling with even sauce distribution to be ensured

– All the processes must be reviewed in order to introduce the BP available in the
respect of Hygiene principles and product CRQS
 Maintenance control
• Floor /Walls
– Flooring to be even and hygienic
– Crevices in walls to be rectified , Gaps between door and floor to be avoided
• Use Unilever approved engineering solutions
• Temporary fixtures / Repairs
– Tapes usage in insulation joints to be avoided
– Roof opening . Rusting in structure
• Rusting / scales in equipment
– Rusting inside hardening tunnel
– Spray ball scales inside mix vessel and avoiding shadow area due to inadequate spray
– Strip curtain support metal strips rusting
• Old equipments
– Decommissioning of old cold room and old mix tanks
– One of the old mix tank had watersised ice with contamination
• General impression is there is lack of good maintenance control and also on new
implementation the level of refinement is not perfect
Preventive Maintenance
Examples of gaps:
• Effective Preventive Maintenance is gone astray for the Mixer & relevant hardware.
• Equipment Classifications not done for prioritizing Maintenance activities.
• Root Cause analysis not happening for the equipment breakdowns
• LLF activities not identified for critical equipments.
Recommendations:
• Manufacturing equipment required a scrupulous PM Schedule in which detailed activities
need to be mentioned for all critical equipments.
• Equipment classification needs to be carried out for prioritizing Maintenance activities.
• All repetitive breakdown required a root cause analysis by the operating team & maintenance
team jointly.
• LLF activities need to be identified for critical equipments as a pre health check of equipment.
• Inventory needs to be maintained for critical equipments.
• Technical Training needs to impart to Technicians & maintenance team to carried out the job
• Necessary tools & tackles need to be provide to all technicians & fitter.
Calibration

Examples of gaps:
• Frequency of Calibration of all weighing balances is very low . Currently relying only on External
agency Calibration.
• Internal validation of weighing balances are not done by team.
• Calibration & Validation of Temperature gauge, Vacuum gauge, pressure gauge not carried out
Internally.
• Ensure 3party agency carrying out calibration gives traceability to national standard.

Recommendations:
• Make a list of all critical equipment with status of calibration and next due date.
• Put sticker on all calibrated equipment giving detail of calibration status.
• Need to start doing a daily Validation of all weighing balances.
• Need to start doing Calibration & Validation of Temperature gauges, Vacuum gauges, Pressure gauges
internally & start recording it.
Rework & Scrap Management

Rework handling not fully aligned with UL guidelines in HPC & Food. Procedures not in place
can lead to cross contamination, micro contamination or batch scrapping.
Examples of gaps:
•Rework not stored hygienically and there is possibility of FM contamination.
•Rework not properly segregated and no demarcated area for keeping rework.
•No traceability to the rework on shop-floor, QC status missing.
•Rework product addition to new batch is not in the Batch sheet procedure.
Recommendations:
• Update rework SOP as outlined by UL guidelines (GMP) and train as appropriate.
• Keep forward and back word traceability of rework
•Provide designated area for keeping rework material with rework status on every bag.
•Use of colour coded bags for different rework material for easy identification.
Design Change Management
-- Risk management awareness and assurance
• Risk management tools to be used – 4M for EEM /FMEA for EPM to identify risks
• Risk mapping to ensure action mitigation RQS / TRA in all and RAW for high risk
---Manufacturing capability to be proven and established before commercial run
• Capability measure to be part of MPT for UL /Statutory parameters ,part of report
• MPT outcome closed before final sign off
---Change checklist to be used and points complied
• Incoming / SFG/ FG specs updated / tests established /BOM / standards in place
• Changes incorporated in logs / sops / wis and circle meeting training taken
---PCP sign off ensured before startup
• Technology transfer docket / info with all relevant details in place
• First production clearance obtained before despatch

• RA points mitigated , MPT actions closed , Change checklist complied ,PCP sign off
in place before startup for all process , product , packing , supplier , equip
changes
Online Product change management

Examples of gaps:
•Change management protocol not followed.
•Batch code traceability found missing.

Recommendations:
•Formal format need to be maintained for every change over to prevent mix-up.
•Train the operator on change management.
•Product change over checklist need to be followed with formal signoff from QA & production.
•Need to maintain batch code traceability.
Change Management for new formulation & design

Examples of gaps:
• No formal signoff with R & D on batch card.
• No risk analysis for new launches.
• No trial request gets raised for any change.
• OTIF Q not monitored for new launches.

Recommendations:
• Proper network planning ensure timely inputs from QA.
•Sharing observation of trial report with team and discussing on way forward.
•Carry out risk analysis (HACCP) for new RM/PM & equipment.
•Start Monitoring OTIF Q for new launches
Lab control
-- Specs compliance tools in place
• Equipments / Methods to comply specs tests requirements
• Inadequacy / gaps in apecs /sap to be resolved
---Capability to measure consistently established
• Calibration /Standaridsation standaards / procedure compliance
• Licence to operate resource in place
---Document and Data control to be deep rooted
• ISO 22000 documentation regime to be followed
• Data audites to be done periodically and CAPA taken
---Results analysis to be done periodically to understand trends and CAPA taken
• SAP /COA data trend to be used and RCA /CAPA planed for key trends
• RRT / Market sample assessment for compartive / capability assessment

• Statutory / Spec updates to be periodic for updating and internal Lab audit to be
undertaken by an expert
Laboratory

Examples of gaps:
• No proper calibration system for instrument
• No back-up record
• Gaps in COA of supplier and gaps FG parameter analysis as per interspec.
• No perfumer in personal wash.
• No incident management.

Recommendations:
• Ensure proper calibration of equipment.
• Maintain back-up record for all kind of analysis.
• Develop effective formal communication system in case of non conformances.
Microbiology

DESCRIPTION: Microbiology check not fully in line with requirement.

Examples of gaps:
•No micro checking is done for process water in HPC.
•No Swab and rinse water check post C & D in HPC.
•Calibration status of autoclave is out of date.
•No incident management.
•No Revalidation of High Risk Raw material before use.

Recommendations:
•Follow the guideline of micro for sampling and testing.
•Use of filtration method for TVC monitoring for process water used for HPC unit.
•Ensure blocking of product if any nonconformance getting observed and carry out
through investigation.
 Quality assurance in process/ lab Medium Risk

DESCRIPTION : Quality and process consistency depend on reducing variability.

There were variation observed in the process parameters /product assessment
results which are not being taken for RCA to close gaps

EXAMPLES OF OBSERVATIONS : 1. CIP swab showed high results on few areas

repeatedly 2. TVC results of some of @ 10% batches are near the brim of spec
limit 3. CIP not fully validated in Ketchup and Jam 4. Random storage sample
showed variation in parameters 5. Process parameters not part of QC audits /
monitoring schedule 6.SCADA not in operation

CORRECTIVE ACTION : 1. Any deviation / near freeze instances to be considered

for RCA and CAPA to address root cause 2. Process parameter should be part of
periodic batch audits 3.Process capability study and subsequent CAPA
suggested for critical parameters 4.SCADA to be fully in place for batch record
and process data monitoring
DNV FSSC gap audits few action points observed
The process owner ( Security personnel ) awareness on the Visitor self declaration health check list not adequate.

The Retention time for the following records can be clearly defined in the document 1) Management review minutes
2) Training records 3) Internal audit records

The following to improve in Food safety objective setting 1) Achieved and Sustained objective to be revisited for the
continual improvement 2) Time limits to be specified for the objectives 3) Specific objective Corporate audit score.

The 4 type of Incident categories has been identified as A,B,C & D but the D category is not defined in the manual.

Uniform understanding between the corporate and the unit level to be established for categorizing the Customer
complaints as High , Medium & Low.

Even though The Management review information are available the Review input & Output not addressed as per
the standard requirement.

The Organogram of the Tea factory not separated out from the other units ( Personal care & cleaning care units ).
PAS 96 : 2010 can be referred as outsource document for the addressing the Clause No : 18 ( Food defense, bio
vigilance, and bioterrorism) of ISO 22002-1 : 2009.

The food safety Emergency Preparedness procedure during FIRE not addressing the cleaning and sanitation
activity to be carried out after the fire fighting.

The PRP verification procedure of the FSMS manual not clearly indicating the Verification planning , purpose,
methods, frequencies and responsibilities for the verification activities and the related records.
The Tea factory Layout not capturing the Common utilities used ( Compressed air ) and the QA Lab
situated above the RM storage area.

Some of the Raw material Specifications like "Garden Tea" and "Product contact material"
specifications are not documented.

The Process Flow diagram not capturing the waste generation and the process details like Magnet
Gauss strength / Sieve size to conduct hazard analysis.

The Hazard identification to be revisited considering the following When identifying the hazards,
consideration shall be given to a) the steps preceding and following the specified operation, b) the
process equipment, utilities/services and surroundings,c)

Even though the HAZARD analysis is addressed as per the HUL Corporate approved methodology
the mapping of the ISO 22000 requirements to the same by the Food safety team not adequately
understood and expressed.

The CCP / OPRP plan not clearly indication the Corrective actions as per the standard requirement.
The CCP plan not clearly indicating the critical limits and the monitoring frequency are indicated as
yearly eg.Gauss strength of magnet.
Identification of significant hazards to be revisited as the methodology of Significant rating to be
justified with scientific / historical data and the same not recorded.
Even though validation reports are available for the CCP & OPRP the same not supported with
sufficient data.
Additional requirement as per the FSSC 2013 Version not addressed in the FSSC manual.
Control over the outsourced process like "Washing of Uniforms ( Laundry ) " and the "Disposition of
the Non conforming material" ( Waste tea) not adequately addressed.
Strom water drain blocked near the entrance to the Tea factory
The Staff canteen food serving plates sanitation not addressed.
Soap dispenser in the staff dining hall hand wash area not working.
The Gents toilet near the Tea factory entrance do not have any awareness posters insisting on hand
washing practice.
Paint peeling seen near the wall / floor joints in the process hall
Raw material receiving dock seen with some water stagnation due to rain and the floor of the dock
seen with soil and debris potential source for cross contamination
The shed in the Raw material dock worn-out temporally protected with poly sheets potential source
for cross contamination.
The hidden area cleaning to be improved like the false roofing above the Lab cleaning schedule not
available.
The process equipment hygienic design like rough welding / loose nuts & bolts / use of split pins / use
of snap off knife / use of worn out metal bristle brush for cleaning not addressed.
The Access control to the filling hopper weighing load cell doors to be addressed.
The cleaning of the following food processing equipment not addressed adequately 1) Packing
machine filling area below 2) Vibro sieve inspection window acrylic sheet
The machine numbers of the packing machines are misleading as the traceability on the product
running indicate Machine No 26 but the machine board indicate as machine No : 27.
No dedicated Rework area identified and the hazard analysis not covering the same.
Some of the wooden platforms stored in the FG area seen with "wooden borer" potential sign for pest
infestation.
Evidence for FIFO followed in FG dispatch not adequately noticed.
Rain water dripping seen in the FG ware house from the roof potential source for moisture
contamination to the FG.
The Preventive maintenance schedule plan and the actual not meeting for one of the sample audited
for Air compressor filter cleaning / changing schedule.
Scope not defined in food safety management system
Out sourced activity and control on outsoureced activity not mentioned in FSMS manual
Measurable food safety objectives not finalised and mentioned
Management review meeting not done as per FSSC requiremnt
Emergency, Preparedness and Response are not addressed adequately for emergency situations
and accidents that can impact food safety
Description & characteristics of all raw material,ingredients and product contact material not
mentioned as per FSSC requirements
Characteristics of end product not mentioned as per FSSC requirement to conduct the hazard
analysis
HACCP study not conducted as per ISO 2200:2005
Flow diagram not verified and signed by by Food safety Team
Verification planing ,purpose,method,frequencies and responsibilities of all verification activities not
mentioned properly
Evidence of PRP validation not avaliable
ProperPersonal behaviour requirements/policy not avalable and not displayed
High care area not identified and mentioned
Access control system not proper in case of intra department movement and sensitive area are not
identified and mapped
Lot of Paint chipping because of improper paintiong in some area.
Floor chipping observed in some are as few old and damage tiles not repaired
Mesh not provided on some exhaust fan window and Wall repairing not done
Communication matrix for external communication not defined properly in Food safety management
system
Record of inoculation against enteric group of disease not avalable
Display board of Do's and don't not displayed
Improper monitoring of Cleaning program effectiveness
Cover on some Tube light not provide after cleaning or repairing
Some doors and wall having gaps, and few door closure not working properly.
Personal hygiene requirement not avaliable as Hot water facility and auto tap not avalible in hygiene
station and laundry of work wear not as per the standard
Window gaps and unhygienic condition in reqqwork room and gaps in access control system
Drainage system not proper near burner and ETP garden and improper cleaning of drain lines
Cleaning program not documented properly for all plant utensils and equipment
Thank You!