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CONFIDENTIAL APPROVED TRAINING PARTNERS CQI and IRCA Specimen Examination Paper for FSSC 22000 Food Safety Management Systems Lead Auditor Training Courses (PR360 & PR368) Please write your name and the date in the space below. Name: Date: THESE SPACES ARE FOR OFFICIAL USE ONLY Section

Marker 1

Marker 2

Pass mark

Maximum

1

5

10

2

10

20

3

15

30

4

15

30

Total

63

90

Name of Marker

Confirmed

Result

This examination is closed book. •

A clean copy of ISO 22000 and a bilingual dictionary are the only items permitted for reference.

•

Electronic devices, including laptops and mobile phones, are not permitted into the examination room. Exceptions may be granted to delegates with special needs. Any such arrangement must be with the prior written agreement of the Approved Training Partner and shall include a record of appropriate precautions that will be taken to ensure the fairness and security of the examination process and examination questions.

CQI and IRCA Specimen exam paper FSSC 22000, July 2019. Amended for use on certified course xxxx operated by ATP xxxx Page 1 of 31

Information for delegates The examination paper is in four sections. Attempt all sections and all questions. The time allowed is two hours. There is no additional time allowed for reading the examination paper. 90 marks are available. To pass you must achieve at least 63 marks (70%), and you must achieve at least 50% in each of the four sections. The maximum marks for each question, or part of a question, are shown in brackets. Your answers must be written on the sheets supplied. Please avoid writing in the margins; these are for the markers. Write on the reverse side of a page if necessary. Additional loose sheets will not be accepted. All references to ISO 22000 and FSSC 22000 refer to the latest issue. Examination technique Time management is very important in the examination. For guidance, the average time available is: a) Reading the examination instructions – five minutes b) Section one – fifteen minutes c) Section two – twenty minutes d) Section three – forty minutes e) Section four – forty minutes Total time available – two hours (120 minutes) Allow enough time to read each question properly. Make sure you understand what is being asked for before starting to write your answer. Where appropriate, the action verb that indicates the depth of answer required by the question – explain, list, describe – is printed in bold. You should ensure you understand the meaning of these terms (see below). Full marks will not be awarded for a list if an explanation is required. Conversely, it is a waste of time to provide a detailed explanation if the question asks for a list. Action verb

Meaning

describe

depict in words

explain

give a clear account of

outline

give the most important features of (less depth than explain or describe)

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give

provide without explanation (used normally with the instruction to ‘give an example (or examples) of ....’)

list

provide a list without explanation (bullet points)

identify

select and name

define

provide a generally recognised or accepted definition

state

a less demanding form of ‘define’ or where there is no generally recognised definition make (something) ready for use or consideration

prepare

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Section one – five questions worth two marks each – maximum 10 marks 1.1

ISO 22000 identifies an “operational PRP” as one of the control mechanisms in a food safety management system to ISO 22000. Explain, in your own words, your understanding of what is meant by “operational PRP”. (2 marks)

1.2

Give two reasons why it is necessary to control elements of an organisation’s FSMS, such as a Hazard Analysis, developed externally. (2 marks)

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1.3

Perishable food products are normally stored at low temperatures. Give two reasons for this. (2 marks)

1.4

Principle 1 in HACCP is the conduct of a hazard analysis. List four possible outcomes of this activity. (2 marks)

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1.5

The FSCC 22000 certification scheme claims to have benefits not found in other private certification schemes. Outline two of these benefits for FSSC 22000 certified organisations. (2 marks)

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Section two – four questions worth five marks each – maximum 20 marks 2.1

You are the audit team leader conducting an FSMS stage one certification audit on site by yourself in an organization. At the initial meeting, you are presented with a top-quality leather laptop case containing the FSMS documentation. During lunch, the FSMS manager indicates that the case is a gift for you to retain after the audit. Describe how you would respond to this situation. (5 marks)

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2.2

During the opening meeting of a certification audit, the client introduces an attendee as an external consultant who has helped with the implementation of the ISO 22000 system and conducted some internal auditor training for the company. Explain how you, as audit team leader, would react to this information, giving five examples of issues raised. (5 marks)

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2.3

During the presentation of findings at a closing meeting, the laboratory manager indicates that she is not happy to accept a minor nonconformity raised in her department. She considers that it is really an opportunity for improvement and asks for the finding category to be changed. Explain how you, as audit team leader, would respond to this request? (5 marks)

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2.4

a) The FSSC scheme has the category of “Critical”, “Major” and “Minor” nonconformities. Explain the difference between these categories. (2 marks)

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b) Identify the category of the nonconformity in the three examples shown from an audit of a tuna processing plant. State whether they are “Minor” (MI), “Major” (MA) or “Critical” (CR) in the Category box: (3 marks) Description

Category

1

After a nonconformity being raised in packing and labelling area, the corrective action put in place has involved acquisition of new equipment but here was no evidence of review of the hazard control plan

2

Two of the six workers on the production line were not wearing the mandatory head covering

3

A worker was seen replacing product onto the production line after it had fallen onto the floor

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Section three – three questions worth ten marks each – maximum 30 marks

3.1

You are conducting a third party audit at the Krystalwater Bottling Company. The next item is a meeting with the Chief Executive, to focus on food safety policy and management commitment. Prepare a checklist with a minimum of ten points which you need to cover during the interview. State the relevant ISO 22000 clauses. (10 marks)

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3.2

(a) Describe four differences between an accreditation process and a certification process in the context of a management system. (4 marks)

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(b) You are the audit team leader of a team of three auditors conducting a third party audit of a soft drinks company over two days. The audit process is subject to witnessed evaluation by a representative of the accreditation body who has chosen to accompany a member of your audit team. The food safety team leader complains that this auditor has raised fifteen nonconformities during the first day, many of them being of a very minor nature. Identify six actions you would take as audit team leader in this situation. (6 marks)

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3.3

a) In your own words, state your understanding of the phrase ‘context of an organisation’ in relation to its FSMS. (2 marks)

b) Give four examples of interested parties who may need to be taken into account in the FSMS of a dairy creamer company. Identify one item of objective evidence to be sought for each example and briefly explain why it is relevant. (8 marks)

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Section four – three questions worth 10 marks each – maximum 30 marks Questions in this section are designed to test your ability to analyse audit situations, evaluate objective evidence and apply knowledge of the audit criteria correctly. Delegates are required to either: •

Complete the nonconformity report template. Marking scheme for a nonconformity: •

For correctly identifying the scenario as a nonconformity

(2 marks)

•

For a clear description of the nonconformity

(3 marks)

•

For correctly quoting relevant evidence

(3 marks)

•

For correctly identifying the relevant ISO 22000 requirement

(1 mark)

•

Overall clarity of the nonconformity report

(1 mark)

Note: if you raise a nonconformity report when there is no nonconformity, 0 (zero) marks will be awarded. OR •

Complete the audit investigation template, clearly stating: •

Your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity (2 marks)

•

How you would investigate to determine conformity or nonconformity, including audit trails you would follow and specific examples of objective evidence you would seek and for what purpose. (8 marks)

Note: If you complete the audit investigation template for a situation where there is evidence that a nonconformity exists, a maximum of 7 marks may be awarded as follows: •

Providing a valid reason why there is insufficient evidence for a nonconformity (2 marks)

•

Providing relevant audit trails as above. (5 marks)

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4.1 – Audit situation one: Chews Bubblegum Limited is certified to ISO 22000 under the scope of “confectionary gum products for the international market”. A third party auditor discovers in the sales department that it has won a contract to develop and produce a new sugarless chewing gum product for children. This is a departure from its normal range of products of breath-enhancing gum for adults. The auditor finds that the company has applied its existing ISO 22000 system to this new line without revising its hazard analysis or hazard control plan. On querying this, the auditor is told that the product specification is not yet fully established and the only products being despatched are being used for market testing by the new customer. The food safety team leader advises that he has been instructed by top management to wait until the customer is satisfied before involving the food safety team in changing the system and formally notifying the Certification Body to include the new product in its scope.

If you think there is sufficient evidence to report your findings as a nonconformity: •

Complete the nonconformity report on the following page.

Or •

Complete the audit investigation template.

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NONCONFORMITY REPORT 1 For correctly identifying the scenario as a nonconformity (2 marks) Description of the nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

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ISO 22001:2018 clause and requirement:

Note: 1 mark for clause and requirement plus 1 mark for clarity of answer OR Complete your answer on the following page.

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AUDIT INVESTIGATION 1 Reason why there is not yet sufficient evidence for reporting nonconformity (Max 2 marks):

Four audit trails you would follow, including, evidence sought and purpose. (Max 2 marks for each audit trail):

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4.2 – Audit situation two: You work for a major supermarket chain and you are carrying out a second party ISO 22000 audit of the main supplier of milk and dairy products. On reviewing the records of their internal audit programme over the last twelve months, you find that 25% of the nonconformities relate to lapses in hygiene procedures. Twenty internal audits covering each area of the company have been conducted during the last year. You note that corrective actions are still outstanding for fourteen findings, half of them dating back more than six months. Corrective actions relating to other areas and activities have generally been closed out within two months. When asked about these results, the Operations Manager states that the facilities budget is very tight due to the economic climate and management are slow to release funds for improving infrastructure.

If you think there is sufficient evidence to report your findings as a nonconformity: •

Complete the nonconformity report on the following page.

Or •

Complete the audit investigation template.

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NONCONFORMITY REPORT 2 For correctly identifying the scenario as a nonconformity (2 marks) Description of the nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

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ISO 22001:2018 clause and requirement:

Note: 1 mark for clause and requirement plus 1 mark for clarity of answer OR Complete your answer on the following page.

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AUDIT INVESTIGATION 2 Reason why there is not yet sufficient evidence for reporting nonconformity (Max 2 marks):

Four audit trails you would follow, including, evidence sought and purpose. (Max 2 marks for each audit trail):

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4.3 Audit situation three: You are auditing the raw material storage and dispensing area of an ice cream manufacturing facility. The area is well organised with dedicated areas for materials awaiting inspections, those approved for use and nonconforming materials. Allergenic products in unopened containers are stored in one area, separate from other materials. Each container is labelled correctly. There is a nearby sign on the wall indicating the area for “Allergens”. There is no indication of physical separation for the different allergen-containing materials, such as egg, milk, nuts and peanuts. The warehouse manager explains that they store liquid products above powdered products, and nut and peanut materials on the bottom shelves. In the dispensing area, there are blue drums into which ingredients have been decanted. They are marked with the name of the ingredient. You observe that some blue drums contain white scoops and others green scoops. The warehouse manager states that the scoop colours are not significant as each scoop is dedicated to the drum in which it appears.

If you think there is sufficient evidence to report your findings as a nonconformity: •

Complete the nonconformity report on the following page.

Or •

Complete the audit investigation template.

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NONCONFORMITY REPORT 3 For correctly identifying the scenario as a nonconformity (2 marks) Description of the nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

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ISO 22001:2018 clause and requirement:

Note: 1 mark for clause and requirement plus 1 mark for clarity of answer OR •

Complete your answer on the following page.

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AUDIT INVESTIGATION 3 Reason why there is not yet sufficient evidence for reporting nonconformity (Max 2 marks):

Four audit trails you would follow, including, evidence sought and purpose. (Max 2 marks for each audit trail):

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THIS IS THE END OF THE EXAMINATION PAPER

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