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An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that...

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An Expert’s Insight & Tips on Facing FSSAI/FDA Audits
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Page 1: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

An Expert’s Insight & Tips on Facing FSSAI/FDA Audits

Page 2: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Sr. No. Index Pg. No.

1. About the Author 2

2. Chapter 1: What is FSSAI, FSSA & FSSR ??? 3

3. Chapter 2: Offences & Penalties under the Act, 2006 6

4. Chapter 3: Powers of FSSAI 11

5. Chapter 4: Rights of a Food Safety Officer (FSO) 13

6. Chapter 5: Rights of the Consumer 15

7. Chapter 6: Rights of the Food Business Operator 18

8. Chapter 7: What should you do in case of a 20

Complaint?

9. Chapter 8: Types of Audit 26

10. Chapter 9: Preparation Before an Audit 28

11. Chapter 10: How to Face a FSSAI / FDA Audit 31

12. Chapter 11: Post Audit Actions 33

13. Conclusion 35

Page 3: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

About the Author: Ashwin Bhadri is the Head of Business

Relations for Equinox Labs. He is a Graduate

from University of Austin, Texas. He Majored in

Chemistry and Computer Science and followed

by an MBA in Marketing.

He is also a Certified Food Auditor and has

completed the Global Food Safety

Management Program from Cornell University.

For the last 9 years he has developed his Expertise in Hygiene &

Food Safety. He works with many top brands to help them develop

Food and Water Safety Programs and Corporate Compliance Policies.

He has been featured in many Newspapers and News Channels.

He has trained over 10,000 people on Food Safety Implementation

and FSSA Compliance. He consults over 500 Companies on Food

Safety Compliance and Employee Health and Safety.

For more information visit: http://in.linkedin.com/in/ashwinbhadri

Page 4: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 1: What is FSSAI, FSSA & FSSR?

By now, I believe every Food Business Operator (FBO) in the

country must have acquainted himself with FSSAI (Food Safety

Standards Authority of India), the regulatory body governed by the

Ministry of Health & Welfare that is responsible for implementation

of Food Safety & Standards Act (FSSA), 2006 in India. I understand

that this book is more on 'How to deal with Food Safety Officers

(FSO) who would audit your facility' & how to understand the audit

process in general but, it is also essential to understand the body that

governs you, its powers, the rights that you have as a FBO, the rights

of an FSO and the Consumer. So, the first few chapters would actually

be a prelude to the actual crux of the matter.

The Food Safety Standards Bill was passed on the 23rd

August 2006

by the parliament. As we are all aware that initially an Act is known as

a Bill & only once it has been passed by the parliament, it comes to

be known as a law that needs to be abided by. This Act also aims to

establish a single reference point for all matters relating to food

safety and standards, by moving from multi-level, multi-

departmental control to a single line of command. To this effect, the

Act establishes an independent statutory Authority – the Food Safety

and Standards Authority of India with head office at Delhi.

Page 5: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

The Government of India established the body as mentioned earlier

under Food Safety & Standards Act, 2006 known as the Food Safety

Standards Authority of India, which we all know as FSSAI. Food Safety

and Standards Authority of India (FSSAI) and the State Food Safety

Authorities shall enforce various provisions of the Act. The

Chairperson and Chief Executive Officer of Food Safety and Standards

Authority of India (FSSAI) have already been appointed by

Government of India. The Chairperson is in the rank of Secretary to

Government of India.

FSSAI was created with the aim of to lay down standards based on

science to regulate all FBO’s involved with food or beverage, viz.,

manufacturers, relabels, importers and businesses dealing with

storage, transportation, sale & distribution of any kind food. Basically

everyone in the food chain.

The Act goes on to take under its purview various Central Acts like

Prevention of Food Adulteration Act, 1954, Fruit Products Order,

1955, Meat Food Products Order, 1973, Vegetable Oil Products

(Control) Order, 1947, Edible Oils Packaging (Regulation) Order 1988,

Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control)

Order, 1967, Milk and Milk Products Order, 1992 & any other order

issued under the Essential Commodities Act, 1955 (10 of 1955

Page 6: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

relating to food). What this means is that you no longer have to go

through the pain of obtaining multiple licenses if you fall under any of

these Acts. However, the Weights & Measures Act, 1976 still remains

solely by itself and does not come under the purview of FSSAI.

The Food Safety & Standards Authority of India introduced the Food

Safety & Standards Regulations (FSSR) in 2011 which brought the

entire law into effect, making it mandatory for every FBO to procure

a license, depending on their annual turnover. The licensing system

was further split into Central & State, again depending on the annual

turnover & production capacity. Through this the FSSAI decentralized

its powers to State Level making it easier for its implementation.

Page 7: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 2: Offences & Penalties under the Act, 2006

When I first read this part of the law, I couldn’t help but

recollect some infamous people and the incidents that led to it, viz.,

the Panipuri “Pee-in-puri” incident, IIT- Powai food poisoning. I

remember that the penalty imposed on the Panipuri vendor was a

mere night behind bars & a fine of Rs. 1,000, & in the case of the IIT

incident, the caterer was suspended only to be probably recruited

back again or to find himself working elsewhere. Today with the

addition of the imprisonment clause in case of any violations of any

of the provisions of the Act, FBO’s are more cautious.

While deciding the quantum of penalty, the Adjudicating

Officer or the Tribunal, as the case may be, shall take the following in

to consideration:-

(a) The amount of gain or unfair advantage, wherever quantifiable,

made as a result of the contravention. For instance – In case a milk

supplier adulterated the milk before he supplied it to various sectors,

the profit that he individually & the profit he gained through the

other sectors would be quantified and the penalty would accordingly

be imposed.

Page 8: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

(b) The Amount of loss caused or likely to cause to any person as a

result of the contravention,

(c) The repetitive nature of the contravention,

(d) Whether the contravention is without his knowledge, and

(e) Any other relevant factor,

OFFENCES PENALTIES

Substandard food Fine that may extend to 5

lakhs

Misbranding Fine that may extend to Rs. 3

lakhs

Misleading advertisement Fine that may extend to Rs. 10

lakhs

Food containing extraneous matter Fine that may extend to Rs. 1

lakh

Page 9: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Any non compliance with the Penalty not exceeding 2 lakhs

provisions of this act and regulations

or as directed by the FSO

Unhygienic / Unsanitary conditions Fine that may extend to Rs. 1

lakh

Possession of Adulterant not injurious Not Exceeding Rs. 2 lakhs

to health

Possession of Adulterant injurious to Not exceeding Rs. 10 lakhs

health

Contravention of any of the Fine may extend to Rs. 2 lakhs

provisions of Act for which a penalty

is not defined

Unsafe food but does not cause 6 months imprisonment with

immediate injury a fine of Rs. 1 lac

Page 10: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Unsafe food causing non- grievous 1 year imprisonment with a

injury fine of Rs. 3 lakhs &

compensation of up to Rs. 1

lakh in case of injury.

Unsafe food causing grievous injury 6 years imprisonment with a

fine of Rs. 5 lakhs &

compensation of up to Rs. 3

lakhs in case of grievous

injury.

Interfering with seized goods Imprisonment that may

extend to 6 months with a fine

that may extend to Rs. 2 lakhs

Providing any false information Imprisonment that may

extend to 3 months & a fine

that may extend to Rs. 2 lakhs

Obstructing or Impersonating an FSO Imprisonment that may

extend to 3 months & a fine

that may extend to Rs. 1 lakh

Page 11: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Operating without a license Imprisonment that may

extend to 6 months & a fine

that may extend to Rs. 5 lakhs

Well, I don’t want to scare you but caution you against what you

can be pulled up for. Having said this, it is equally important you

know your rights, the rights of the FSO & consumer so that you not

only safeguard yourself, but are informed about the law & system

that governs you.

Page 12: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 3: Powers of FSSAI

FSSAI has been mandated by the FSS Act, 2006 for performing

the following functions:

- Formulate the regulations to lay down guidelines so that a

certain set of standards can be enforced equitably across all

sectors. The guidelines have been devised keeping in mind

the standards followed globally.

- Guiding & providing procedures for the accreditation of

certification bodies that certify food safety management

systems of various food businesses.

- Laying down procedures and guidelines for accreditation of

laboratories and notification of the accredited laboratories.

- To provide scientific advice and technical support to Central

Government and State Governments in the matters of

framing the policy and rules in areas which have a direct or

indirect bearing of food safety and nutrition.

- Collect and collate data regarding food consumption,

incidence and prevalence of biological risk, contaminants in

food, residues of various contaminants in foods products,

identification of emerging risks and introduction of rapid

alert system.

Page 13: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

- Creating an information network across the country so that

the public, consumers, Panchayats etc receive rapid, reliable

and objective information about food safety and issues of

concern.

- Provide training programmes for persons who are involved

or intend to get involved in food businesses. - Contribute to the development of international technical

standards for food, sanitary and phyto-sanitary standards.

- Promote general awareness about food safety and food

standards.

Page 14: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 4: Rights of a Food Safety Officer (FSO)

Before you actually understand the audit process, I think you

should be informed about what are the rights the FSO (or food

inspector / auditor) in order to protect your interests. Clause 38 of

the FSS Act, 2006 enlists the rights or as stated the functions of the

FSO.

- Collection of sample of any food that is in contravention

of the provisions of the Act

- Inspect your premises

- Reimburse the cost of the article of food taken from a

consumer for testing shall be paid at which it was sold to

him.

- Destroy any article of food that has been seized if found

to be unfit for consumption

- Issue a notice for an inspection by a police officer (with a

search warrant)

- Give a notice in writing of his intention

Page 15: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

- Request the FBO to provide sterile bags or containers for

collection of samples, if necessary

- The sample will be correctly marked & sealed and the

signature/thumb impression of the FBO taken.

- The sample will be divide in 4 parts

1 part to the Food Analyst

2 parts to the Designated Officer (safe custody)

1 part to the Accredited Laboratory (on request of the FBO)

- In case the results of the both laboratories varies then a

sample from the Designated Officer will be sent to a Referral

laboratory and those results will be considered as final.

- The Designated Officer has to submit the sample for analysis

within 1 day.

Understanding your rights as an FBO also goes hand in hand with

what I have discussed above and this will be discussed in the

upcoming chapter.

Page 16: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 5: Rights of the Consumer

Consumer is King!!! Customer is King!!! This is very true for all

businesses. For a Food Business Operator, the Consumer & the

Customer should not be considered a King…. But a GOD! You need to

take as much care of the Consumer as you would take of your deity.

The new law empowers your Consumer with a lot of Power.

He has the right for Safe and Wholesome Food. If he doesn’t get

Safe and Wholesome Food, he has many tools at his disposal to

ensure that the Food Business Operator that didn’t give him his

right, gets punished.

The Consumer has the following tools at his disposal:

1) FSSAI Hotline: This is a hotline run by FSSAI where a

Consumer can call and register a compliant anywhere in the

Country. FSSAI will note his complaint and pass it along to

the local enforcing body to investigate.

To make this even better FSSAI runs a Reward Scheme, that if

the Consumer who registers a complaint, and it is found to

be true, then the Consumer will be rewarded Rs. 500. Don’t

think of quitting your day job and start registering complaints

for a living just as yet, because, if FSSAI finds you abusing this

Page 17: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

rule for personal gain, you could be penalised Rs. 1,00,000/-.

2) Local FDA: The Consumer can also lodge a complaint with

the local FDA, which will trigger a visit or a raid based on the

nature of the complaint.

3) Media: This is a very powerful tool which can be used by the

consumer. Media is always hungry for news that its readers

would love to read. If a Consumer finds a worm in your

food, and if decides to go to the media, then you will have a

long month ahead of you, trying to convince your customers

that your food is worm free. Remember one thing about

Media; it’s a double edged sword. If it can make you

famous, it can also make you bankrupt. So tread very lightly

when a consumer is threatening to go to the Media.

4) Consumer Guidance Society of India: This is also a tool

available to the consumer. If your case is taken to them, they

do have a lot of influence in the government and can become

a big problem for you, if you have done something wrong.

Page 18: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

The Consumer has become more powerful than ever before

and your need to understand that and respect that. In the years to

come you will perceive the Consumer as a much bigger threat to your

business than FSSAI or FDA.

Page 19: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 6: Rights of the Food Business Operator

Now that you have read about the rights of the FSO and the

Consumer, I want you to know your rights. This is very important,

because if you don’t know your rights, people can take advantage of

that.

Firstly when a person comes to audit or inspect your

premises and he tells you that he is from FDA or FSSAI or any other

local body, ensure that you ask him for an ID card. Please check this

carefully but respectfully.

Once you ascertain the auditor is genuinely from FSSAI or FDA,

and then let him continue the audit. During the Audit all the Non

Compliances that get raised, can be discussed at the end of the audit. If

you think that your process is right, you can try to make him see your

point of view. If you can prove to him that your way of doing things can

keep the food safe, he may remove that Non Compliance.

You should show him only relevant records. In case he asks

you your turnover or any other sensitive data, you will need to show

him only one piece of documentation that satisfies that criteria. You

don’t have to open up all your books to him. Also while showing him

records; he has the right to see records which are pertinent to food

Page 20: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

safety and FSSAI Compliance. He can’t ask you to for records which

don’t have anything to do with food safety or FSSA Compliance.

When he raises Non Compliances, which he will, do ask

him against which clause that Non Compliance is being raised

against. This will force him to ensure that he is raising the right

number of Non Compliances.

When a Customer comes to you with a Complaint, if you

think that there is something fishy, you can ask him to produce a

receipt, to prove that he has actually purchased your product.

Before asking him about this, please ensure that you do issue a

receipt or a bill with every purchase.

The Last but not the least, is your right to Recall food. In

case you find out that your food is tainted, you have the right to

recall it. You need to be sure what will trigger a Recall. Do ensure

that your Food Safety Management System (FSMS) plan has a Recall

plan attached to it, so as to ensure that when you need to recall

your product, you have all the procedures, protocols and formats in

place. You may never need to use this, but it is best to be prepared.

It’s like buying Life Insurance, you hopefully never need to use it

immediately, but it is always better to have it.

Page 21: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 7: What should you do in case of a Complaint?

If you are lucky the complaint comes directly to you, and

does not go directly to the Authorities.

When the Customer Complaints to you, you are in the best

possible position to close the complaint satisfactorily and

discreetly. You will get 3 types of Complaints.

1) Minimum Risk Complaint: This is the best kind of

Complaint that you will get. It is something minor like:

- Hair in Food

- Stone in Food

- Water smells funny

These Complaints need to be handled quickly and closed

on the spot. Ensure that your staff is trained to appease

the Customer, so that he doesn’t create a scene or

launch a Complaint with FSSAI / FDA or worse … Media.

This kind of complaint should be closed by offering that

particular item / dish for free, a certain discount on the bill

or a free dessert. Ensure that your staff is empowered to

take these decisions and also ensure that these small

complaints get noted and a root cause analysis is done.

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Even a small matter should be discussed with the

staff internally and a permanent solution should be

implemented so as so to ensure that it doesn’t repeat

again.

Things NOT To Do

Never argue with the Customer about the matter. That

will only make the matter worse for you.

If a Customer Complaints, you should in an apologetic

manner, let them that it will be looked into immediately. If

there is a GAP, then offer a complementary dish or

discount or dessert, which ever fits.

2) Moderate Risk Complaint: This is a more serious

complaint and should be handled by the Owner or a

senior member of the Business. The Complaints would be

like:

- Food Poisoning

- Dysentery or Diarrhoea

- Vomiting

If a Customer calls or visits you and tells you that they

experienced any of the above symptoms after eating at

Page 23: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

your location or taking away food from your location,

you need to address it seriously.

Step 1: Note down their complaint. Ask them which

food item they consumed and when.

Step 2: If that batch of product is still in your location,

draw 2 samples of the same and have 1 sample sent to a

NABL Accredited Lab for Food Pathogen Testing. The 2nd

sample should be labelled correctly and stored in a

refrigerator.

Step 3: When the food testing results come back, check

if the sample failed. If the sample passes, do let the

Customer know about it. If the sample fails, you need to

inform the Customer about it and offer a small

compensation. Please ensure that this is a monetary

compensation and not a meal voucher or a free meal at

your location. (Would you want to eat at a place where

you got food poisoning??? I know I wouldn’t… and I

haven’t)

Page 24: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Note: If you get more than 1 complaint about a particular

batch of food, or a batch with a common ingredient, then

you may want to initiate a Food Recall. (Read Chapter 6).

3) High Risk Compliant: This type of complaint should

be handled by the Owner for the Company. These

Complaints would be :

- Customer is Hospitalised due to Food Poisoning

- Customer dies from Food Poisoning (Rare

but possible)

In case a Customer complaints, that due to eating at your

location or your food product, they had to be hospitalised

or their near and dear one died from food poisoning, then

you going to face a whole new level of trouble.

Here are the following steps which you need to take

immediately.

1) Get a Lawyer: Yes, you will need to get yourself a good

lawyer, someone who has experience in Food and Food

Safety Laws. There is going to be a case which you will

have to fight. You will have to prove your innocence (if

you are innocent that is). The new law will put the onus

Page 25: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

of proving that all required food safety norms were

followed during the preparation of the food, unto

the Food Business Operator. 2) Get all Food Safety Documents Ready: You will be

having some documents related to your food safety

process with you. You need to start compiling them

together. This will act as evidence in court. In case you

are not sure about this, please hire a Good Food Safety

Consultant immediately, who can help you with this. This

is a very crucial step, as these are the only documents

which will help prove that you were following Food

Safety Practices. The documents will include your FSMS

Plan, Storage Records, Temperature Records, Cleaning

Records, Health Check up Records, Food Testing Report,

Water Testing Reports, GAP Audit Reports, Pest Control

Records, Training Records, etc.

3) Get the Samples Tested : The Samples that you received

a Complaint about, should be drawn by a external 3rd

Party Lab, in duplicates and one batch of it should be

sent for testing to a NABL Accredited Lab for Food

Pathogen Testing. The 2nd

set of samples should be

labelled correctly and stored in a refrigerator. If these

Page 26: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

samples pass, then they become a great piece of

evidence which help your case. But if these samples fail,

then you will have to evaluate the option of going for

an out of court settlement with the Customer.

Note: We normally recommend that if you are not at

fault, then you should fight the case, because you will

win it, but if you do not have adequate evidence,

then you should go for an out of court settlement.

Page 27: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 8: Types of Audit

There are 3 types of Audits:

1) Scheduled Audits: These are audits in which the FSSAI or FDA

will inform you about the day and time when the Audit

would take place. This rarely happens, but the Government is

working to ensure that over sometime, most of the regular

audits would be scheduled.

2) Unscheduled Audits: These are the audits in which the FSSAI

or FDA officer shows up at your doorstep, unannounced. This

is what normally happens in India, as there is a lack of Food

Safety Officers, so they will visit one area at one time. The

downside of this is that there is no time to prepare your

documentation and your premises for the audit.

The above 2 types of audits are normally done once a year to

ensure that you are complying with all food safety and FSSAI

norms.

3) Raids: These Audits or Raids are based on a specific

complaint or trends in adulteration known to FSSAI / FDA.

When a Customer / Consumer complaints to FSSAI or FDA

Page 28: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

about a malpractice or food safety violation done by a FBO,

this gets recorded and must be investigated. Based on the

seriousness of the Complaint, the time frame of action is

decided by FDA. If the Complaint is minor, like piece of

plastic found in bread, it may not trigger a Raid. But if 5

people lodge a complaint saying that they all eat at a

particular joint and have fallen ill, or if they find worms in

food, etc, this will definitely trigger a Raid. Let’s just hope

that this is not something that will ever happen to you, but

its best to be prepared for it.

Note: A Raid if not published, may not hurt you as much,

but if it gets media attention and if you are a bigger brand,

this will hit you hard, very hard!!! You will have to create a

disaster recovery plan to ensure that your brand name

doesn’t get affected in the long term. You will need to hire a

professional in handling this, so it doesn’t affect your

business in the long term.

Page 29: An Expert’s Insight & Tips on Facing FSSAI/FDA Audits · governs you, its powers, the rights that you have as a FBO, the rights of an FSO and the Consumer. So, the first few chapters

Chapter 9: Preparation Before an Audit

Before you prepare to face an audit, you should know what

the auditor is going to look for. The auditor will look at the following:

1) Infrastructure: The Auditor will look at the Infrastructure

provided by you for the Storage, Preparation and Serving

of Food. The Auditor will see the following:

- Walls, Ceilings, Floor: Are they Clean? Are they

Cracked? Do they need immediate repair? Are there

any pests? Are there any problems which can lead

to food safety being compromised?

2) License: The Auditor will look at your license copy and

ensure that it is up to date and the right kind of license.

He will check what kind of business you are into and in

what capacity, and will check if your license reflects the

same. He may also ask you for other business related

licenses and ensure that they are also OK. You need to

ensure that all your licenses are up to date.

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3) Documentation: The Auditor will also check your FSMS

Plan, and ensure that it covers all the areas required. He

will also check if you are following all the points in the

FSMS Plan. FSMS plan is the first document that every

FBO should have as it lays down the foundation for any

Food Safety Related Activity. The Auditor will also check

if you have all the other food safety related records like

food temperature record, critical storage temperature

records, training records, material storage record,

wastage record, pest control record, etc. These records

need to be up to date and filled by the right person. You

don’t need a highly educated person filling these records,

it just that they must be filled.

4) Process: The Auditor will study the process of food

storage, preparation and serving or dispatch. The

following points would be looked at:

- Raw material receiving

- Raw material quality control and storage

- First In First Out (FIFO) for Stored Items

- Preparation Process

- Control points for Sanitization and Temperature

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- Post Cooking Storage

- Dispatch or Serving Process

- Left Over Storage Process

- Recall plan (If needed)

- Complaint Handling, etc

5) People: In any business the quality is controlled by the

people in the process. The Food Business is no exception.

At every Stage it is the people that control the Quality of

the Food Produced. The Auditor will check if they are

aware of basic food safety norms. He may either do that

by talking to them or by observing what they are doing.

He will also ask for the health certificates of all the

people working in your location. This is mandatory as per

the new law and needed as the food handler can easily

pass on a disease or infection through the food to its

recipient.

Now that you know what the auditor will look for you can

be better prepared to handle the audit.

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Chapter 10: How to Face a FSSAI / FDA Audit

Now that you have prepared to face the audit, the

process should be pretty simple.

Before the audit starts, always find out what is the purpose

of the audit. Is it a regular check, or did they receive a complaint.

Because if FDA conducts an Audit or a Raid due to a complaint, they

will look more aggressively for compliance, as there was an active

complaint.

During the Audit always be very patient with the Auditor. If

he raises any non compliance, make a note of it promptly. Always

assure him that you will get it fixed immediately. Every Auditor will

give you advice on what needs to be fixed. If he thinks it’s a big

food safety hazard, he will mark it as a Non Compliance. But if it

doesn’t directly affect food safety, he may put it down as an

observation or he may just mention it to you.

The Non Compliances raised should be against a clause in the

Law. If you think that the auditor is being unfair, then you can ask

him, during the course of the audit or at the end, against which

clause he has given a Non Compliance. This is your right, but I don’t

personally believe in arguing with the auditor about this, as this may

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push him into looking deeper into your audit, which will not end

well for you. If he really decides to go very deep, he will find at least

20 gaps in your system and penalise you for all of them.

The Law says that when the auditor finds a small gap for

the first time, he should issue you an improvement notice. If you

don’t comply with the notice, then a penalty would be applicable.

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Chapter 11: Post Audit Actions

Congratulations! Your Audit is now complete. But don’t

celebrate yet. After every audit you will have to make a list of all the

improvements you need to bring in your organisation and in your

process to ensure that the audit process is smoother the next time.

During every audit many gaps are discovered either by you or they

are made evident to you by your auditor. These gaps need to be

closed within a certain timeframe so as to ensure that your end

product stays safe.

After every audit you have 2 outcomes.

1) You have passed the audits without any Non

Compliances.

2) You have received Non Compliances.

In the first case you need to spend time with your team

and understand improvement points and the timeline to

implement them.

But in the second case you need to take more serious and

immediate action. Whether the audit is by FDA / FSSAI / Internal

Auditor or a 3rd

party Consultant, you need to take the audit findings

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more seriously and ensure that the Preventive and Corrective

Actions are taken quickly and correctly.

I have seen so many FBOs facing an Audit, learning a lot from

the process, but not acting on it.

“Experience is a good school. But the fees

are high.”

In my experience the best way to ensure all this happens is to

allocate each corrective action to a team member and also give him a

time frame to finish it in. Then review on a regular basis to ensure

that the progress is on track.

Over many years of auditing and implementing food safety

systems across the country, I have found the key, the secret of success.

If you want a Food Safety plan to work, you must have 1 single person

in your organization to take charge of this. If there is a single point

responsibility then things get done. If that person knows that if this

doesn’t get done, he will lose his job, then it gets done.

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Conclusion

I think the reason I was inspired to write this book was

that I learnt post the release of my earlier book “13 Steps to Protect

yourself from the Consumer & Regulatory Authorities” that it wasn’t

enough help given to the FBO, who always stands in the line of fire.

Hence, I thought it would be best to armour him still further through

this book. After all, “Ignorance is not always blissful.” I would like to

sign-off with a very thought provoking quote.

“Knowledge & Human Power are synonymous, since the

Ignorance of the Cause Frustrates the Effect.”

- Francis Bacon

To know more about Complying with FSSAI Standards, you can

reach me on [email protected]

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