T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.

CONTENTS

1. Welcome to the Training Module .......................................................................................... 2

2. Today’s Topics .......................................................................................................................... 2

3. Purpose .................................................................................................................................... 2

4. Learning Objectives ................................................................................................................ 2

5. Audit Duration Requirements ............................................................................................... 2

Course ID 004 Transcript ID T.004

Course Title The Certification Process – Version 1.0
Specific Requirements –
Audit Duration
Linked to On Boarding Program Date 11-Feb-2021

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

1. WELCOME TO THE TRAINING MODULE ON THE

CERTIFICATION PROCESS, SPECIFIC REQUIREMENTS
RELATED TO AUDIT DURATION.
This training is complementary to the Scheme Training Modules and is based on FSSC Scheme
Part 3 and ISO/TS 22003 – Annex B.

2. TODAY’S TOPICS
In this module we will be covering the following topic related to the FSSC 22000 Scheme:

1. Audit Duration Requirements

3. PURPOSE
The purpose of this training is to provide the Licensed Partners with the principles of determining
the audit duration for the different FSSC 22000 audit types.

The information covered in this module, is intended to provide support to FSSC Scheme Managers
and CB personnel involved in calculating audit duration.

4. LEARNING OBJECTIVES
Upon completion of this module, you should:

• Understand the principles of audit duration calculations.

• Be able to calculate the audit duration for the different audit types.

5. AUDIT DURATION REQUIREMENTS

Slide 6 – Audit Duration Requirements

The correct calculation of the audit duration is a key element to ensure that the auditor has enough
time to conduct a thorough audit, covering the Scheme requirements. Before going into the detail
of how to calculate the audit duration for a FSSC 22000 audit, it is important to understand some
key principles:

• The CB shall calculate the audit duration based on the information gathered from the
organization’s application and following the requirements of ISO/IEC 17021-1, ISO/TS
22003 (Annex B) and FSSC 22000 Part 3.
• The duration of an audit day normally is eight (8) hours; the effective audit duration does
not include a lunch break (unless in contradiction with local legislation - IAF MD5).

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

• The audit duration calculation for FSSC 22000 shall be documented by the CB, including
justifications for reductions or addition of time based on the minimum audit duration.

Slide 7 – Audit Duration Requirements

• The audit duration shall be stated in auditor working hours indicating effective audit time
based on the audit plan. Deviations to the audit duration and audit plan shall be recorded
(including motivations);
• The audit duration does not include planning, reporting or travel activities, only actual
auditing time;
• The audit time duration only applies to auditors who are fully qualified, registered FSSC
22000 auditors; The time of technical experts or trainee auditors does not count towards
audit duration.
• Additional time needs to be allocated where translators are being used to allow for an
effective translation process during the audit.

Slide 8 – Audit Duration Calculation

When calculating the FSSC 22000 audit duration, the following formula is used:

Ts + TFSSC = = {TD + TH + TMS + TFTE} + TFSSC

Ts is audit time based on ISO/TS 22003: 2013 calculation in Annex B where:

TD = the basic audit time, in days linked to the category

TH = Number of audit days for each additional HACCP study, so if only 1 HACCP study then
TH=0

TMS = number of audit days for absence of certified MS

TFTE = number of employees

The Ts cannot be less than 1 day in all instances.

The TFSSC is the additional FSSC time and are calculated as follows:

i. 0.5 auditor day (4 working hours) when the company has less than 250 FTE and 1 or 2
HACCP studies.
ii. 1.0 auditor day (8 working hours) when the organization has 250 FTE or more; or 3
HACCP studies or more.

TS + TFSSC results in the initial audit time, so for Stage 1 and Stage 2.

Now the Surveillance audit time can be calculated, namely (one third of initial Ts audit duration) +
TFSSC.

Re-certification audits – (two thirds of initial Ts audit duration) + TFSSC.

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

The exact audit time as calculated can be used OR where rounding is applied, it can only be
applied upwards to the nearest half day. Please note that rounding is not mandatory, but if
rounding is applied, the time can only be rounded upwards, not downwards.

Slide 9

We are going to look at an example to demonstrate how to calculate the audit time based on the
table in Annex B of ISO/TS 22003.

Example: Category C, 150 FTE, no existing MS, 3 HACCP plans

Ts= {TD + TH + TMS + TFTE}

= 1,5+1+0,25+1,5

= 4,25

TFSSC = 1 day because of the 3 HACCP plans

Audit duration initial audit = 4.25 +1 = 5.25 days (1.5 days Stage 1 + 3.75 days Stage 2) – the division
of Stage 1 and 2 audit time can be divided differently, but generally the Stage 1 audit is 1/3 and
the Stage 2 = 2/3 of the initial time.

To calculate the Surveillance time = Ts/3 + TFSSC = (4.25/3) + 1 = 1,42 + 1 = 2,42 days – round to 2,5
days

Recertification time = Ts/3*2 + TFSSC = (4.25/3*2) + 1 = 2,83 + 1 = 3,83 days – round to 4 days

Slide 10 – Minimum Audit Duration

Based on the fact that the Ts cannot be less than 1 day, the minimum basic FSSC 22000 audit
duration is 1.5 - 2 days for all audit types depending on the FSSC additional time (refer Part 3 of
the Scheme , clause 4.3.1 b);

HOWEVER, for categories C, D, I and K the minimum audit duration shall always be 2 days;

The following exemptions apply to the minimum audit durations:

For organizations with simple processes, having 5 FTE or less and maximum 1 HACCP study,
further reductions are allowed, but the total time Ts+ TFSSC shall be minimum one day for all audit
types.

For organizations in category C, D, I or K that have simple processes, less than 20 FTE and
maximum 1 HACCP study, further reductions are allowed to a minimum audit duration of 1.5 days
for all audit types.

For subcategory A, ISO/TS 22003:2013 states a minimum audit duration of 0.5 days, the minimum
FSSC 22000 audit duration for this category shall be 1 day.

Where any of the exemptions above are applied, the CB shall ensure that the audit duration allows
for an effective audit, covering the full FSSC 22000 requirements.

Slide 11 – Multiple functions across more than one site

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

There are also instances where the same organization has multiple functions across more than
one site. In this section we will look at head office functions and off-site activities.

For organizations where some functions pertinent to the certification are controlled by a Head
Office separate to the manufacturing site(s), the minimum time shall be 0.5 auditor day (4
working hours) to audit the functions pertinent to the certification at the Head Office.

When the responsible person from the Head Office attends the audit at manufacturing site, no
extra audit time is calculated.

A maximum of 20% audit time reduction can be allowed for each of the single manufacturing sites
belonging to the group where the shared functions are controlled by the (off-site) Head Office.

The 20% audit time reduction is applied to the minimum audit time (Ts) as per ISO/TS 22003:2013,
Annex B and not to the Tfssc. Take care that the combined time of the HO audit and the site audit
still meets the minimum duration requirements linked to the relevant category.

The audit duration is therefore calculated for each of the sites, and the 20% reduction may be
applied to the Ts.

Slide 12 - SEPARATE HEAD OFFICE – CALCULATION EXAMPLE

Recertification audit – Producer of CO2 gas for the beverage industry.

1 HACCP, certified to ISO 14001, 20 FTE office personnel, site is linked to head office that is
responsible for Human resources and sales.

Calculation:

2/3 (TD+TH+TMS+TFTE) + TFSSC

= 2/3 (1.5+0+0+0.5) +0.5

=1.3+0.5 = 1.8 man-days

On-site time for the HO is 0.5 man-days. Because functions are being audited at the HO for this
organization, a 20% reduction can be given on the TS, so 80% x 1.3 = 1 man-days + 0.5 (TFSSC) =
1.5 man-days. Take note that the minimum duration for an organization in category K is 2 man-
days. In this case the requirement is met when the HO time is added, so 1.5 + 0.5 = 2 man-days

The HO audit is conducted first, followed by the site audits within a maximum timeframe of 12
months.

Every site linked to the head office shall have a:

• separate audit,
• separate report and
• separate certificate

The Head Office cannot receive a separate certificate, but are referenced on the site certificate
with wording such as:

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

“This audit included the following central FSMS processes managed by (name and location of Head
Office): (describe FSMS processes audited at the Head Office)”

Slide 13 – Multiple functions across more than one site – Off site activities

To qualify as an off-site activity, the following requirements apply as per Scheme Part 3, §5.2.2:

Where one manufacturing or service process is split across more than one physical address, all
locations may be covered in one audit provided that the different addresses are:

• part of the same legal entity,

• under the same FSMS and
• that they are the sole receiver/customer of each other.

Storage facilities at another location shall also be included in the same audit provided they meet
the requirements mentioned above.

For the calculation of additional audit time for off-site activities linked to the organization, there
are two options:

• A 50% audit time reduction of Ts may be applied for each additional site OR
• The parameters of the off-site activities shall be included in the audit calculation and travel
time between locations shall be included in the audit plan.

The Tffsc still needs to be added for off-site manufacturing activities.

For off-site storage: At least 0.25 auditor day (2 working hours) additional audit time shall be added
to the FSSC 22000 audit time for each off-site storage facility.

Cross docking is considered as an off-site activity which is covered by FSSC Part 3, section 5.2.2
with the exclusion of the last phrase of section 5.2.2, 1, which is the requirement regarding the
sole receiver/customer relationship. The requirements including audit duration calculations
related to off-site activities may be applied for cross docking. Transshipment is not covered in this
requirement.

Slide 14 – FSSC-Quality, Transition audits and Transfer audits

We are now going to look at the requirements for calculating the audit duration for FSSC-Q,
Transitions audits and transfer audits.

FSSC-QUALITY: the following applies.

The audit time for the ISO 9001 part of the audit shall be calculated using IAF MD 5.

The audit duration for the integrated FSSC 22000 and ISO 9001 audit shall be based on IAF MD
11:2019, section 2.2, to which TFSSC shall be added.

TRANSITION AUDITS – FROM ISO 22000/GFSI RECOGNIZED SCHEME

Minimum FSSC 22000 audit duration shall be two-thirds of the initial certification audit time, with
a minimum of 1 auditor day (8 working hours plus TFSSC as defined in §4.3.1.)

The transition audit shall result in an FSSC 22000 certificate with a validity of three (3) years.

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

Transition to FSSC 22000-Quality is only possible when the organization has a valid ISO 22000 or
FSSC 22000 certificate AND a valid ISO 9001 certificate. In this case, the audit duration is two-thirds
of the initial combined audit time (see 4.3.5.) plus TFSSC.

TRANSFER AUDITS

Follow the requirements in IAF MD2 to conduct the pre-transfer review and based on the outcome
decide whether or not the certificate may be transferred. Once the certificate has been
transferred, then the next audit duration is calculated for either the surveillance audit or the
recertification audit using the FSSC calculation. In cases where a transfer is not possible or not
approved by the CB, then the organization is treated as a new client and a Stage 1 and 2 audit is
required.

Slide 15 – Audit Duration for Multi-site certification

Multi-site certification (including sampling) is only allowed for the following food chain
(sub)categories:

A – Animal Farming

E – Catering

FI – Retail/wholesale

G – Storage and distribution

When applying multi-site certification all requirements of IAF MD 1 shall be met, except:

Paragraph 6.1.3 (size of sample). This IAF MD 1 paragraph shall be replaced by the ISO/TS
22003:2013 sampling regime paragraph 9.1.5.4.

Paragraph 7.3: For audit time calculation see 4.3.3 where the same principles for a Head Office
can be used for the central function.

Slide 16 – Audit Duration for Multi-site certification - sampling

The sampling requirements as set out in ISO/TS22003: 2013, paragraph 9.1.5.4 shall form the basis
for determining the sample size.

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T.004 | The Certification Process (Specific Requirements) - Audit Duration Transcript V1.0

In addition, the risk categories and performance of the sites shall be considered and might result
in an increase in the sample size.

Where sites are added to the group, an audit is required before adding them to the certificate –
either as a special audit or as part of the annual audit.

Once every 3 years, the annual audit shall be conducted fully unannounced as set out in Part 3,
section 5.4.1, including the central function and the site audits.

Slide 17

Thank you for attending this training. I hope you found the information useful, and please read
the Scheme, Annex 1, and ISO documentation carefully to ensure you meet the Scheme
requirements.

<< END>>

History Log

Date Version Change Author

11/02/2021 1.0 First version Elsabe Matthee

FSSC 22000 | February 2021 8 of 8