Senior Management commitments:

Time/ Agenda:
Duration

20 minutes Senior management introduction (Organisation charts)

15 minutes Personal Hygiene.

10 minutes Documentation review.

Tea Break 15 Minutes.

20 minutes Interviewing Responsible person.

20 minutes Audit open reports.

20 minutes Audit closing reports.

Date: 12/02/2023 Time: 09:30am.

Venue: Personal Hygiene.

Agenda:

The requirement for personal hygiene at sites producing materials for direct food contact with
food or other hygiene sensitive products shall be documented and communicated to personnel.

Ref 6.1:
Senior Management Team:

Job Title: Name: Role in Team:

Managing Director Tom Bob Chairman

Operational Manager John Kerry Operating reporting.

Quality Manager Ned Tiernan Food safety and quality reporting.

Shift Manager Thomas Kilduff Planning schedules and operating.

Maintenance Charlie Kiernan Services and Engineering reporting.

Human Resources Mark Nugent Resource reporting.

Manager

Quality office Date of

Audit: 12/02/2023
Audit Location:
Auditee(s) : John Kerry Auditor(s) : Naveed Iqbal

1
 Reference: 6.2 Personnel Hygiene
BRC
Issue 6
Clause No.:
ISO 9001:15
Clause No.:
All non-conformances identified
at previous Internal Audit of Yes___/N____ Signed: _
these clause(s) have been Naveed Iqbal______________________
closed off?

Methods of sampling: Below all relevant evidence is attached to the audit.

Visual/Observed document check completed. And
Observation X interview all relevant field competent persons.
Documentation X
All non-
Interview X

Results
Item Description
OK NC Remarks
6.2.1 The requirement for personal hygiene at X Personal Hygiene procedure and policy
sites producing materials for direct food in place. Observed all notice board,
contact with food or other hygiene information available to all employees.
sensitive products shall be documented
Site induction in place and observed.
and communicated to personnel. This
Policies attached as evidence to the
shall include as a minimum the following
audit in details.
instructions:
Wrist bands, wrist worn devices or
watches.
Jewellery not to be worn on exposed parts
of the body, with the exception of a
wedding ring or wedding alert jewellery.
Fingernails shall be kept short and free
from nail, varnish.
False nails and nail art are not to be worn.
Excessive perfume and aftershave not to
be worn.
Compliance with the site’s requirements
shall be checked routinely.

6.2.2 Hand washing shall be performed on the
entry to production areas and at a
frequency that is appropriate to minimise
the risk of product contamination
X Hand wash station and procedure
observed and part of site induction.
Hand wash station evidence photos
attached to the audit.
Hand wash sign in place.
Hand wash soap/ hand sanitiser
dispenser in place, evidence photo
attached.

6.2.3 Personal items and belongings, including X Mobile not in use policy in place and
personal mobile phones, shall not be observed. Observed policies on notice
taken into production areas without the board. Locker provided and observed.
permission of management.

6.2.4 The site shall use risk assessment to X Recommendation: updated

determine the procedures and written
Major
instructions necessary to control the use
and storage in production and storage
areas, to minimise the risk of product
contamination.
questionnaire to be completed. There
was no correct procedure for Risk
Assessment, and no evidence of RA
been introduced to relevant department.
No control of storage area in the
production.

3
6.2.5 Where visitors cannot comply with comply
with site hygiene controls, suitable control
will be put in place ie use of gloves
X Site Induction was observed part of site
hand hygiene and correct PPE.
GMP checklist attached to the audit.
Hand hygiene and relevant signage
phots attached to the audit report.

6.2.6 All cuts and grazes exposed skin shall be X Plaster log sheet in place and observed.
covered by an appropriate coloured Plaster log sheet attached to the audit
plaster that is different from the product report as evidence and correct dated.
colour. These shall be issued and First Aider list is observed on all notice
monitored when people are involved in board.
work with materials intended to come into
First Aid station checked and observed
direct contact with food or other hygiene
on different location on site.
sensitive products. Where appropriate, in
addition to the plaster a finger stall or
glove shall be worn.

O.K. =
Meets
Requirement NC =
Nonconformity / One non-conformity. Explained in
Need remark, and more in details below.
Improvement
Findings:
(6.2.1) OMS B4 details all requirements pertaining to personal hygiene and PPE.
This is reviewed and trained out to all staff annually. This includes separate requirements of B4-J
that provides supplementary advice around jewellery and communication to staff.
This is reissued each year by the QSE Manager and posted in communal locations.
Staff PPE is reviewed and assessed by the line manager every 2 weeks.
Any issues are reported and resolved as required.
(6.2.2) Handwashing signs are in place at entrance to production and required upon re-entry.
(6.2.3) Personal items documented within procedure.
Personal items audited as part of OMS B4-7 reviewed by line manager.
(6.2.4) Risk assessment completed within quality dashboard and considerations taken within first
aid requirements.
(6.2.5) Gloves are provided and available to all staff/ visitors if nail varnish is worn or other
requirements cannot be fulfilled.
6.2.6 Blue plasters are available to all first aiders and are issued based on plaster control log.

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 Question/Requirement Objective Evidence Dates Auditee

When last staff last training completed 12/02/23 -all 12/02/2023 Ned Tiernan.
training completed? departments.one of the staff training
record attached to the audit.
If it is reissued each Notice board in Facilities areas is used Re-issue Ned Tiernan.
year and posted in for all posters. was dated
communal locations posted facilities notice board – Visual on
what was the date of check was completed by auditor. 10/02/2023
reissue? 
Where did you check it
was in place? 
Where are staff PPE PPE record was checked, attached 12/02/2023 Thomas Kilduff.
issues reported and completed PPE check below.
resolved – what (GMP checklist).
evidence do you have
that this is done? 
Where is the Handwash is located at the entrance to 12/02/2023 Ned Tiernan
handwash located and main production areas, handwash signs
show me the photos is attached below.
handwashing signs? 
When was the risk Excel Risk Registered reviewed, and a 12/02/2023 Ned Tiernan
assessment shot is shared below as evidence.
completed? 
Can you show me a Plaster log control reviewed for 12/02/2023 12/02/2023 Thomas Kilduff
plaster control log? completed (John Nicholas) staff member.
Visual observed First multiple station
provided. Log sheet evidence attached
below.
AUDIT RCA:

Personal Hygiene.
Non-Conformance: 6.2.4
12/02/2023
Report Date:
Naveed Iqbal
Prepared by:

1. Background: (Audit objectives and scope)

Review of personal hygiene requirements

2. Audit Results: (Summarize the audit findings, total number of CAR issued and
descriptions of NC)
One non-conformance noticed.
No evidence procedure in place the safe use of storage facilities
in production.
There was no correct procedure for Risk Assessment, and no
evidence of RA been introduced to relevant department. No
control of storage area in the production.

CAR 1 Requirement of standard / procedures:

Set a safe use of storage procedure need to be in place.
ROOT CAUSE:
Need to identify as control point on quality control documents.
Questionnaire to be completed.
Quality Manager did not introduce the Risk assessment excel
sheet to relevant department.
Which will further shared with line manager. And train the staff
with the correct procedure in place.
The Quality Manager did not update the documents with the
changes.

Details of Non-Conformity Identified:

Risk assessment completed within quality dashboard and
considerations taken within first aid requirements.

Corrective Action Plan: Person Quality Officer

Responsible
1 Months review

Due Date 12/03/2023 Completed

Date

7
 Verified by:

Action Effective CAR Closed Out

YES NO Date: TBC
Highlight as
appropriate

(6.2.1) OMS B4:

OMS B4 details all requirements pertaining to personal hygiene and PPE.
Purpose
 To establish and maintain a system of Good Manufacturing Practices within SaicaPack Dublin
and to ensure a safe and clean working environment for employees.
 To supply our customers with a product which is free from any physical, chemical, or biological
contamination, which may render the product unsafe or present any form of risk to the end user.

Scope
 Good Manufacturing Practices are to be adhered to by all employees and any other persons
present on these premises who are not employed by SaicaPack Dublin.

Responsibility
 It is the responsibility of the Quality Manager to ensure that all Shift/Department Managers are
familiar with the Good Manufacturing Practice policy.
 It is the responsibility of the Shift/Department Managers along with the assistance of the senior
management, to ensure that all existing and new employees in each department are familiar with
the Good Manufacturing Practice policy through thorough induction training (see PMS 6.2
‘Human Resources’).

Procedure:

Smoking
As SaicaPack Dublin is a major supplier to the food and beverage and pharmaceutical industry, smoking
and vaping are not allowed on the production premises or the carrying of smoking material on site as it is
a fire hazard and there is the possibility of contamination of product.
Smoking and vaping are strictly prohibited in all manufacturing areas, office areas and external areas
inside the site perimeter. (Except for the designated smoking area)
Any individual caught smoking or vaping on site will be disciplined. Smoking is only to occur during
allocated breaks within the designated smoking area. A smoking committee will be formed to control the
use of the smoking area and report misuse.

Pest Control
[See also OMS- B1 ‘Pest Control’]
SaicaPack Dublin are committed to safeguarding its premises against the intrusion of rodents, birds,
crawling/flying insects.
All doors and windows to the external of the factory must be kept closed where possible.
Any doors or windows, which need to be kept open, must be protected with fly screens to prevent the
intrusion of pests.
Any maintenance regarding proofing of premises against pest intrusion must be carried out by the
maintenance as soon as possible after being highlighted by the pest control company.
Any damage to the premises, which may introduce the risk of the intrusion of pests must be reported to
the Departmental Managers/Quality Manager immediately so that corrective actions can be
implemented.
All incidents of pest infestation are to be reported to the supervisor in charge. The incident is to be
reported to the Quality Department as soon as possible.

Jewellery Policy

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The wearing of heavy jewellery, wrist bands/devices/watches, necklaces and bracelets on the factory
floor is prohibited.
Jewellery including piercings shall not be worn on exposed parts of the body, except for a plain wedding
ring, wedding wristband or medical alert jewellery. Continuous loop sleeper earrings are permitted to be
worn.
The wearing of a plain (no inset stones) wedding ring/band is permitted.
The wearing of a medical band is permitted, this is to be communicated to the relevant departmental
manager.
The wearing of wristwatches is prohibited as it introduces a risk of glass entering the production chain.
Watches including fitness watches are prohibited.
Any individual caught wearing prohibited jewellery on site will be disciplined.

Housekeeping Procedures
[See also OMS B2 ‘Cleaning Procedures’]
Each Area Manager is responsible for the upkeep of all production areas.
Machine operators are responsible for ensuring that their workstations are always kept tidy.
General cleaning duties will be carried out by the pertinent personnel outlined on the cleaning schedules.
Cleaning schedules reports shall be collated weekly by the Quality Department. All Shift/ Department
Managers shall be accountable to the Manufacturing Manager as to the accuracy & completion of said
reports.
As part of housekeeping requirements regular checks shall be made by management to ensure that all
WIP cartons, lacers, shrink-wrap and outers are kept on pallets and off the ground at all times.

PPE
Protective clothing as supplied by SaicaPack Dublin to all production employees. This clothing must be
worn at all times in the production areas.
Hair nets must cover all hair and ears i.e. front, back and sides.
Sweaters, t-shirts and trousers issued must be worn on the premises at all times.
The wearing of this protective clothing outside of SaicaPack Dublin is prohibited. The only exception to
this rule is for ‘trouser bottoms’ which can be worn outside within the grounds of the factory perimeter. All
protective clothing must be kept segregated from normal clothing during transport and storage.

Details of work wear and rules pertaining to work wear will be detailed as part of OMS B4-3.
All personal must wear the relevant PPE, including Mop Caps, Safety Shoes and Ear Plugs. Personal
handling chemicals must wear gloves and safety glasses. PPE shall be removed upon exit of the site.
Storage of safety shoes and personal shoes will be segregated.
Gloves shall be replaced at first sign of wear and tear.
Office staff and Management must wear protective overcoats, safety shoes, and mop caps when
entering production areas.
Where an employee has a moustache or beard or greater than 1 days’ worth of growth, a beard snood
shall be worn.

Glass Policy
[see OMS B3 ‘Glass Policy’]
Refer to the Glass Policy section of the Operating Manual for glass policy documentation.
Ceramic or glass vessels (cups, glasses, bottles etc.) shall not be permitted in production areas or
facilities areas including the cloakroom. Eating is not permitted on the factory floor.
All employees are responsible for the reporting of glass breakages on site in SaicaPack Dublin to their
Shift/Department Manager.

Safety Policy
Each employee must be issued with a safety briefing when commencing employment with SaicaPack
Dublin.
All employees are responsible for ensuring that they carry out their work instruction in a safe manner,
which limits the risk of danger to themselves and their work colleagues.
Please refer to the Safety Statement for further information.

Personal Hygiene
Protective clothing is issued to each employee and managed in accordance with work wear rules.
Protective clothing and personal clothing shall not be stored in the same locker or locker compartment.
All employees shall be allocated two separate lockers.
Hand wash facilities are situated throughout the factory and at all of the major entrances. All persons
entering the manufacturing areas must wash & dry their hands. Nailbrushes are provided at the hand
wash facilities to aid the cleaning of all personnel's fingernails.
Water of a suitable temperature and adequate facilities will be provided, and hand washing encouraged
particularly in relation to direct food contact.
Hand washing will be completed on a frequency based on risk of contamination.
False nails & nail varnish/ art shall not be used. Fingernails are to be kept short & clean. Gloves shall be
worn if the employee is found to be wearing nail varnish.
False eyelashes are not permitted in production areas.
No excessive makeup is permitted in the production areas.
No excessive aftershave/perfume shall be worn on the production floor.
No food is permitted on the production floor or in locker rooms. All food must be kept in food lockers
located in the canteen.
Minor injuries such as cuts shall be covered with blue self-adhesive plasters only (from first aid box).
This will be monitored by the first aider and controlled via the plaster log.
The Area Manager must conduct a spot check of employees every week to ensure they are complying
with the GMP regulations using the GMP Checklist (OMS B4-7).
Only company issued bottles allowed/clear bottles.

Illness Reporting/ Medical Screening:

Any persons suffering from food poisoning or related illnesses must report this to their shift supervisor.
This person will be stood down from directly handing carton products. Employee Ailment Notification
Policy (OMS B4-2)
If advised to do so, any employee suffering from a food poison illness, must contact their General
Practitioner.
All employees shall be aware of Employee Ailment Notification Policy and should report to their
immediate supervisor or Shift Manager if they are suffering from or have been in contact with any
diseases likely to be transmitted through food (OMS B4-2).

Work Station Maintenance/ GMP

Each workstation operator is responsible for ensuring that his/her working environment is clean, tidy and
in a fit state so as not to present a safety hazard to themselves or other employees. All employees
operate to the ‘Clean as you go’ system.
Any hazards or issues with individual workstations must be reported directly to the Area Manager.
At all changeovers between batches a full line clearance shall take place (ref. Individual Work
Instructions). Before signing for this line clearance the Operator must be satisfied that the working area
is fully clean, tidy and hygienic.
Mobile phones shall not enter production areas without management permission.
Personal items including car keys, music devices, ear phones (including air pods) and all other personal
items shall not enter the production floor and should be stored within the personal locker.

Security (Visitors/Contractors/ Employees)

[Ref: OMS A3‘Control of Visitors/Contractors’]

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No unauthorised personnel are permitted to enter SaicaPack Dublin without approval. All SaicaPack
Dublin management & supervisors have been instructed to challenge unaccompanied visitors.
Delivery and courier personnel must report to either the Incoming Stores Department or the Despatch
Department prior to entering the production area.
All visitors/contractors must be issued with protective clothing and hairnets before entering the factory
floor.
All visitors / contractors entering production areas must be issued with Visitor Security Passes & they
must also sign the Health Questionnaire as acknowledgement of having read same. Visitors shall be
challenged by staff if its believed that they are not complying with the company’s hygiene regulations.
All other instructions outlined on this document apply to visitors/ contractors.

Security Employee: All new employees shall be taken on a tour of the production floor as part of the
induction process to highlight the secure staff entry and exit points, and fire escapes as denoted on OMS
B7-1 Layout Map.

Accidents/Incidents:
All accidents must be reported to Shift Managers as soon as possible after the incident.
A First Aid Report form must be filled in by the attending First Aider. This should be given to the Safety
Officer or the Area Manager.
An accident/incident report is completed for each accident/incident by the Safety Officer/Shift Manager.
The company's Safety Officer is responsible for the maintenance of same.
Upon returning to work after an accident the Department Manager along with the Safety Officer shall
carry out a “return to work interview” and an Accident Investigation

Sharps Policy
[Ref: OMS B5 ‘Sharps Policy’]
Refer to the Sharps Policy section of the Operating Manual for sharps policy documentation. All
employees are responsible for the reporting of breakages or losses of sharps on site in SaicaPack
Dublin.

Entrances / Walkways
All employees shall enter the premises through designated entrances, which are:
a) Facilities / Clock In Entrance
b) Main Side Entrance
c) Despatch Entrance
d) Goods Inward Entrance
e) Reception.
Visitors / Contractors shall enter through Reception at all times (Ref: OMS A3).
All employees are instructed to use designated logical walkways when moving between the different
production areas.
To protect all employees and for health and safety reasons all staff must clock out upon leaving site and
inform their department manager.

Tool boxes
All toolboxes in general use must be central registered on the Toolbox Register (OMS B4-4) and
identified accordingly.
The Quality Department is responsible every quarter for randomly checking all toolboxes on the register
in each department to ensure that all GMP requirements are being met. They shall sign the declaration
section of the Toolbox Register accordingly. Any employee not complying with this directive shall be
subjected to standard disciplinary procedures.
Foreign Bodies:
Staples, Paper clips, bulldog clips, Drawing Pins are not allowed to be used on the production floor, in
stores or dispatch in any circumstances.
All signage in production areas shall be company issued and made of cleanable material.

13
 GMP Checklist
OMS B4-7: Personal items audited as part of OMS B4-7 reviewed by line manager.

GMP (Good Manufacturing Practice) Checklist to be completed by the Shift Manager’s for every shift at an interval
of 2 weeks.

Employee 1 Employee 2 Employee 3 Employee 4 Employee 5

Name: Alan James Patrick Darren

John

Hair Net covering

Yes Yes Yes Yes Yes
all scalp hair

Beard snood
worn (if Yes Yes Yes Yes Yes
applicable)
Full uniform worn
including all PPE Yes Yes Yes Yes Yes
worn correctly

Gloves are clean

Yes Yes Yes Yes Yes
(if applicable)

No makeup Yes Yes Yes Yes Yes

No jewellery
(including
watches), a
Only wedding Only wedding
wedding band No jewellery No jewellery No jewellery
band band
and small hoop
earring are
allowed
No nail
Yes Yes Yes Yes Yes
polish/false nails

No food or drink
Yes Yes Yes Yes Yes
at workstation
Shift Manager Thomas Kilduff complete the GMP checklist. It was make sure, that
the staff is aware of the checklist procedure and follow the correct procedure.
Comments:

Completed By: Thomas Kilduff_________________________ Date: ___12/02/2023________________

(OMS) Training record of one of the employees checked.
Plaster Log sheet Evidence:
Excel Risk Assesment Evidance:
Hand Was Station Evidence: Hand Soap/Hand Sanitizer Evidence:

Evidence of Hand Wash signage: