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2.2 Documentation Requirements

YES NO N/A REMARKS
2.2.1 General
2.2.1- Does the Senior Management authorized and signed food
02 safety and quality policies?
2.2 Documentation Requirements
YES NO N/A REMARKS
2.2.2 Control of Records
2.2.2- Is there a documented evidence that policies and procedures
01 have been reviewed at least annually?
2.2 Documentation Requirements
2.2.3 Control of Records YES NO N/A REMARKS
Is a documented, record control procedure developed to
control and maintain records that ensures:
2.2.3-
a) maintenance of a master list of records?
01
b) procedure for food safety and quality records accuracy,
2.2.3-
legibility and review, or as required by applicable laws and
02
regulations?
2.3 Regulatory Considerations YES NO N/A REMARKS
Is there a documented process and procedure to ensure
2.3-01 accuate information for labelling provided to McDonald's
System(Merlin Supplier File) ?
2.3.1 Management of the Regulatory Process YES NO N/A REMARKS
2.3.1- Is there a documented and reviewed regulatory management
01 policy/process in place?
Is there a documented training provided to personnel
2.3.1-
responsible for managing the regulatory compliance and
02
inspection process?
Is there a documented training provided to personnel
2.3.1-
responsible for managing the religious and other label
03
certification process?
Is an up to date and reviewed list of contacts maintained to
facilitate the notification of McDonald's and other relevant
2.3.1-
personnel (regulatory, internal crisis team, etc.) in the event of
04
the crisis potentially affecting product conformity or regulatory
compliance?
Is a documented procedure in place to notify McDonald's when
2.3.1- any site documentation related to the manufacture or provision
05 of McDonald's products has been provided to regulatory
authorities?
2.3.1- A copy of the same document made available to McDonald's
06 upon request?
Is there a documented procedure in place requiring that
2.3.1- duplicate samples be taken by the supplier in the event that
07 any sample of McDonald's product (in-processed of finished) is
taken by regulatory officials?
2.3.1- Does a procedure include a requirement/ arrangements for
08 notifying McDonald's in the event of any such occurrence?
Does a procedure include a requirement that McDonald's is
2.3.1-
consulted prior to making a decision on further testing or
09
disposition of any duplicate sample taken?
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3.1 Management Commitment YES NO N/A REMARKS

Is there a defined organizational structure, reporting
3.1-01 reationships and job functions for those employees that can
affect product quality and safety?
3.2 Food Safety and Quality Policies YES NO N/A REMARKS
Is there an established and implemented food safety and
3.2-01 quality policy with alignment to the company's vision and at
least reviewed annually?
3.6.1 Review Input YES NO N/A REMARKS
Does the manageemnt review input includes McDonald's
3.6.1-
feedback(including complaints from the restaurants and -
01
customers)?
4.2 Key Elements of the Crisis Management Plan YES NO N/A REMARKS
Is there identification and risk categorization of potential crisis
4.2-01
and full assessment of business risks to supply chain?
4.2-02 Do the contingency plans included alternate product sourcing?
Is the lead incident manager and spokeperson and their back
4.3-03
ups identified?
Is there a procees to contact McDonald's in event of potential
4.3-04 direct or indirect brand impact inlcuding release of any related
communications to the public, regulators and media?
Is there a defined process for root cause analysis and initiation
4.3-05 of documented corrective/preventive action after crisis eas
resolved?
Is there a documented root cause analysis and systematic plan
4.3-06 using appropraite tools where predetermined questions were
answered?
4.3 Requirements for Contingency Plan YES NO N/A REMARKS
Is contingency supplier reviewed with and approved by
4.3-01
McDonald's?
Does the contingency supplier meet McDonald's foods safety
4.3-02
and quality system requirements?
4.3-03 Are records of review and approval documented?
Are contingency plans reviewed with McDonald's and
4.3-04
documented?
Is there a process to identify and verify sources and delivery of
4.3-05
alternative raw material supply to meet pertinent standards?

4.3-06 Is McDonald's approval of these arrangements documented?

Is there a process to identify and verify sources and delivery of
4.3-07
alternative packaging supply to meet pertinent standards?
4.3-08 Is McDonald's approval of these arrangements documented?
Is aprocess in place to identify and verify sources and delivery
4.3-09 of alternative finished product supply to meet pertinent
standards?

4.3-10 Is McDonald's approval of these arrangements documented?

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5.1 Facility Security and Food Defense YES NO N/A REMARKS

Do all employees receive facility and food defense training as
5.1-01
part of new hire orientation and at least once a year?
Is appropriate information verified in accordance with local
5.1-02 laws and regulation prior permisiion to work for temporary or
permanent employee?
Is there prompt conducted once a suspected or actual breach of
5.1-03
security occurs?
Is there a detailed, document investigation report prepared and
5.1-04
kept for future reference?
5.2 Good Manufacturing Practices YES NO N/A REMARKS
Is there an internal GMP assessment performed (at least twice
5.2-01
a year)?
5.2.1 Personal Hygiene and Practices YES NO N/A REMARKS
5.2.1- Is there a documented food safety and food hygiene training
01 faciltiy based on Codex and country regulations?
Is there a written hygiene policy in place that inlcudes hand
5.2.1-
washing, hand sanitation and prevention of cross
02
contamination?
Is there monitoring and documentation for the concentrations
5.2.1-
of sanitizing solutions for hands, feet and other uses to ensure
03
they are prescribed by manufacturers for efficacy?

5.2.1- Is there employee glove policy that inlcudes procedures for

04 type of gloves used and their control?
5.2.1-
Is the glove use based on risk assessment?
05
Is there an established and documented uniform cleanliness
5.2.1- policy including restrictions on wearing uniforms, shoes and
06 other specialized clothing when exiting work area that are
based on risk asessements ?
Is there a food consumption policy in place that restricts eating,
5.2.1-
drinking and tobacco use in processing, packaging and
07
surrounding areas?
5.2.1- Does the food consumtion policy covered online sensory
08 analysis giving clear direction?
5.2.1-
Is there established health policy?
09
5.2.1- Are procedures developed to mange employee heatlh issues
10 including illness and communicable diseases?
5.2.2 Employee Training YES NO N/A REMARKS
Is the employee training program includes:
5.2.2-
a) tarining needs analysis for each position?
01
5.2.2- b) HACCP, GMP, policies and requirements, including statutory
02 where applicable?
5.2.2-
ac) defined qualification of trainers?
03
5.2.2-
d) process to train personnel on system documents?
04
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5.2.2 Employee Training (Cont.) YES NO N/A REMARKS

5.2.2-
e) induction and refresher training?
05
5.2.2-
f) evaluation of training?
06
5.2.2- Is the training conducted in appropriate language and
07 organized to facilitate employee understanding?
5.2.3 Facility and Grounds YES NO N/A REMARKS
5.2.3- Is the annual inspection of the functionality of the water
01 system documented and available fro review?
5.2.3-
Are paint minimized and in good condition?
02
5.2.3-
Are cracks, crevices and openings completely sealed?
03
Is there white or light line with reasonable width drawn along
5.2.3-
the internal wall in the storage area, chiller and freezer to
04
reveal presence of rodent activity?
5.2.3- Are discharge and overspill from processing go directly into the
05 drain rather than on the floor?
5.2.3- Are drainage designed to flow away from high risk areas and
06 maintained to minimize risk of product contamination?
5.2.3-
Is there no condensation present?
07
5.2.3-
Is there an established glass and brittle policy?
08
5.2.3- Is there handwash reminder signs and exhaust is vented
09 outside?
5.2.3-
Are lockers suitably designed to disallow inappropriate use?
10
5.2.3-
Is high and low risk operations effectively segragated?
11
5.2.3- Are tools in high risk areas dedeicated to the area or
12 decontaminated upon entry?
5.2.3- Is there a program in place to maintain traceability of waste
13 streams?
5.2.3- Is there a designated quarantine and/or salvage area that is
14 fully segragated from usable stocks?
5.2.3- Is the waste water system does not have a negative impact on
15 food safety or quality?
5.2.5 Equipment and Utensils YES NO N/A REMARKS
Is there a sanitary storage provided for non- fixed equipment
5.2.5- such as utensils, buckets, funnels, scoops, flexible hoses and
01 pipe fitting to protect against contamination of product and
allergen cross- contact?
Are motors, pumps, gearboxes and tank agitators designed to
5.2.5-
prevent contamination of ingredients, product or packing
02
material?
5.2.5- Are pipes free of dead ends, cross connection or back-
03 siphonage and submerged inlets?
5.2.5- Do forklifts have non marking wheels to maintain sanitation on
04 the floor?
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5.2.5 Equipment and Utensils(Cont.) YES NO N/A REMARKS

Are incompatible materials such as raw and cooked products
5.2.5-
stored separately under conditions to prevent cross-
05
contamination and allergen cross- contact?
Is there a program in place to avoid ingredient cross
5.2.5-
contamination that constitute either a safety issue or cause
06
sigificant customer dissatisfaction?
5.2.5- Are all containers for work-in-progress and finished product
07 clearly identified?
5.2.5- Is there a procedure implemented for control of brushes and
08 other utensils used for cleaning food contact surfaces?
5.2.5- Are welds on food contact surfaces smooth and in good
09 condition?
5.2.5-
Are excess lubricants removed after equipment was serviced?
10
Does the documented preventive maintenance program
includes:
5.2.5-
a) how the equipment maitenance is manage?
11
5.2.5- b) master preventive maintenace schedule including a process
12 tot rack overdue/ open work orders?
5.2.5-
c) schedule including the frequencies and status?
13
5.2.5- d) process to track effectiveness of maintenance performance
14 as input for program improvement?
5.2.5- e) specified and maintained detailed training records and core
15 skill requirements?
5.2.5- f) maintained predictive, preventive, routine, corrective and
16 emergency maintenance and post maintenace inspection?
5.2.5- g) procedure to reconsile machine parts and tools after repairs
17 and before start up?
h) written and implemented plan for the internal audit of the
5.2.5-
preventive maintenance to ensure compliance and continual
18
improvement?
5.2.5-
Is there detailed and current calibration records maintained?
19
5.2.5- Is there a master calibration schedule to track calibration status
20 against established frequencies?
5.2.5- Is there a documented process in place to ensure training of
21 the personnel responsible for the calibration?
5.2.6 Pest Management YES NO N/A REMARKS
5.2.6- Does the Project Manager has the necessary subject knowledge
01 or experience to manage pest control?
5.2.6- Is there a certified pest control operator employed to identify
02 presence of pests for targeted monitoring and control?
5.2.6- Is there a copy of current license for each pest control operator
03 registered?
Is there policy governing appliaction of residual insecticides
5.2.6- only in non- production areas and during non- production
04 hours to protect contamination of foods, food contact surfaces
and product contact material?
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5.2.6 Pest Management (Cont.) YES NO N/A REMARKS

5.2.6- Are external bait station and/or traps loacted between 13-30
05 meters apart or as advised by the PCO?
Are external bait station inspected by a PCO(local equivalent) at
5.2.6-
least once per month and findings are documented and
06
trended?
5.2.6- Are internal traps and glue boards inspected at least weekly
07 and findings are documented and trended?
5.2.6- Is there retained detailed records of pest control inspections,
08 recommendations and necessary actions undertaken?
5.2.6- Is certified pest control operator contacted for the application
09 of any restricted use of pesticides?
5.2.6- Is there a copy of label indicating the name and application
10 instruction for all pesticides on site to be maintained on file?
5.2.6- Does the Safety Data Sheets written in local language and easily
11 accessible?
5.2.6- Is the obsolete pest control chemical disposition procedure in
12 compliant with pertinent local regulations?
5.2.7 Contractors and Visitors YES NO N/A REMARKS
Is there a written policy to require all contractor, temporary or
5.2.7-
permanent employee to receive company GMP and facility
01
training before being authorized to work on site?
Are all contractors employed working on site are appropriately
5.2.7-
identified to reflect their identity, GMP training status and
02
access rights?
5.2.7- Are all GMP training documented and maintained on file for
03 minimum of two years as per regulatory requirements?
Is there a written policy stating that visitors shall be escorted in
5.2.7-
the facility and not given independent access rights or left
04
unaccompanied?
5.2.8 Water, Air and Gas Quality YES NO N/A REMARKS
5.2.8-
Is there description of sources of water on site?
01
5.2.8-
Is there water treatment process description?
02
Are all water/ ice in contact with food or food contact surfaces
5.2.8-
are potable, from an adequate source safe and of adequate
03
sanitary quality based on test records?
5.2.8-
Does the potable water standard based on local government?
04
Is there a routine monitoring program and test parameters to
5.2.8-
ensure the water, ice or steam that come into contact with
05
either product or equipment conform to the above standards?

5.2.8- Is there monitoring records to confirm conformance with

06 potable water standards?
5.2.8- Are water and ice potable and tested at point of use to ensure
07 safety and quality?
5.2.8- Is there back-siphonage protection devise present and
08 functioning on all water lines and hoses?
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5.2.8 Water, Air and Gas Quality (Cont.) YES NO N/A REMARKS
5.2.8- Based on the risk assessment, does the air flow and air quality
09 managed based on the nature and processed of the product?
Does air in contact with product, packaging or food contact
5.2.8-
surfaces filtered to remove particles of 50 microns or larger and
06
does not contain, dirt, oil, water and other contaminants?
5.2.8- Does air filter used to treat air reaching product contact
07 surfaces located as close to the point of use as practicable?
5.2.8- Based on risk assessment, is the air dried to reduce the
08 bacterial growth in the system?
5.2.8-
Are the water traps inspected and maintained?
09
5.2.8- Is there a schedule in place to inspect and change the air traps
10 and filters?
5.2.8- Are gases in contact with food, including beverages or food
11 contact surfaces are food-grade quality?
5.2.8- Based on risk assessment, is the air monitoring conducted to
11 minimize contamination?
5.2.8- Does record of air filter change maintained as part of the
12 facility maintenance program?
5.2.9 Cleaning and Sanitation YES NO N/A REMARKS
5.2.9-
Is there a cleaning master schedule in use?
01
5.2.9- Is the master cleaning schedule internally audited on regular
02 basis to verify compliance?
Is there documented compliance to the cleaning and sanitation
5.2.9-
schedule, inlcuding corrective actions procedures fro
03
incomplete or inadequate sanitation?
5.2.9- Is there verification of the effectiveness of the cleaning and
04 rinsing procedure documented?
Is there a letter from the supplier is on file to verify the
5.2.9- compliance of the cleaning/ sanitizing agent with local
05 regulations for food contact surfaces and safe use in food
processing facility?
5.2.9- Are equipment and structural "overheads" such as lights, pipes,
06 brims and vent grids listed for cleaning?
Is there a process in place to ensure suitability of use of any
5.2.9-
piece of equipment that has not been used for over 4 hours
07
after last sanitation and based on risk assessment?
5.3 Good Laboratory Practices YES NO N/A REMARKS
Does the laboratory use approved official test methods or
5.3-01
methods that have been validated?
Are controls in place to ensure accuraccy and precision of all
5.3-02
results?
5.3-03 Are the test methods documented and followed?
Does the scope of laboratory testing inlcudes quality, chemical,
5.3-04
microbiological (including pathogens)?

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5.3 Good Laboratory Practices(Cont.) YES NO N/A REMARKS

Does the laboratory testing which has food safety implications
5.3-05 (i.e. pathogen, toxicological, residue or chemical testing)
certified by accreditation bodies (ISO. A2LA, CNAs etc.)

Does the non-standard methods (e.g. customer specified

5.3-06 methods) has systematic validation performed and
documented?
5.3-07 Does documented records current and fit for use?
Is there a process in place to verify internal and / or customer
5.3-08
specified methods are followed?
Does laboratory technicians receive new hire/ induction
5.3-09
training and annual on-going training?
Is there a proficiency testing conducted with either the
5.3-10 company corporate laboratory or a certified external
laboratory?
Are there documented test results and retained records for
5.3-11 two(2) years, or per local McDonlad's or regulatory
requirements, whichever is longer?
Are chemicals, reagents and/ or media are adequately labeled
5.3-12 with information on name, chemical concentration, use-by-
date?
Does the laboratory workflow designated to minimize cross-
5.3-14
contamination?
5.3-15 Does sample preparation allows control of sample integrity?
Is there in place calibration and maintenance program for all
5.3-16
laboratory devices ?
Is there a maintained masterlist of equipment requiring
5.3-17
calibration and maintenance?
5.3-19 Do persons/positions responsible for calibration defined?
Does equipment accuracy acceptance and rejection levels are
5.3-20
defined, documented and followed?
5.3-21 Is there an identification system for laboratory equipments?

5.3-22 Is calibration activity performed in-house?

Is there a documented calibration and maintenance

5.3-23
instructions for equipment calibrated and maintained in house?
Is there an evidence for the annual calibration of equipments
5.3-24
(stickers, documents, etc.)?
Do internal calibrations(quality control checks) have current
5.3-26
SOP's?
Is there participation on external proficiency program at least
5.3-26
twice a year for all test parameters within the scope?

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5.4 Material Handling, Storage and Transport YES NO N/A REMARKS

Is there a process in place to provide supplier with periodic
5.4-01
performance feedback?
Is there record keeping procedures for all incoming raw
5.4-02
materials?
Is there program in palce to specify minimum remaining shelf
5.4-03
life at receiving?
Is there control of research and development raw materials in
5.4-04
process or production samples?
Is reasonable care taken to prevent detoriation and spoilage
through appropriate measures that may include monitoring
5.4-05 and maintaining required temperatures, humidity and/ or other
controls and taking appropriate corrective actions if those
parameters are exceeded?
Are policies and procedures in place on ensuring security of
5.4-06 inbound and outbound shipments by the use of tamper evident
seals?
Does the organization have protection methods to assure the
5.4-07
transport security for "Less Than Truck Load" (LTL) shipment?
Are in place transportation security measures in full compliance
with McDonald's DQMP (Distribution Quality Management
5.4-08
Program) and/ or applicable regulatory requirements,
whichever is more stringent?
Is a procedure in place to handle inbound couriers and goods
when seals are missing or broken; broken original seals are
5.4-09
documented, verified by the parties involved, traceable and
replaced with suitable seal/lock?
Is there a clearly documented policy on acceptance of returned
5.4-10
goods?
Is procedure in place for handling of returned goods to prevent
5.4-11 contamination and allergen cross contact to themselves, the
facility and other products?
If product testing is critical to safety, is there an in place test or
5.4-12
hold program/policy implemented and documented?
5.5 Holding Non-Conformance YES NO N/A REMARKS
Is there a test and hold system implemented fro finished
5.5-01
goods?
Are inspection records reviewed before finished goods are
5.5-02
released for every delivery?
6.1 HACCP Systems YES NO N/A REMARKS
Does the corrective action plans include the control of product
6.1-01
since the last acceptable check?
6.1.2 Physical Contamination Control YES NO N/A REMARKS
6.1.2-
Is there a documented glass and hard plastic policy in place?
01
6.1.2- Is a documented loose item control policy/ program in place to
02 prevent the potential product contamination?
6.1.2- Are utensils and tools properly stored and responsibility for
03 stock control is defined?
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6.1.2 Physical Contamination Control(Cont.) YES NO N/A REMARKS

6.1.2- When loose items are used, are they reconciled at the end of
04 the production shift?
6.1.2- Are missing items (e.g. utensils and tools) recorded and
05 immediate action take as per policy/ procedure?
6.1.2- Is the use of wood not allowed in production areas, including
06 wood handled euipments and tables/ benches?
Does the loose item control program includes the control of
6.1.2-
maintenance parts and tools including verification that food
07
contact zones have been cleared prior to release to production?

Does the program includes control of maintenance parts and

6.1.2-
tools inlcuding verification that the food contact zone have
08
been cleared prior released to production?
Are sifter, sieves and scalpers for flour and other finely divided
6.1.2-
ingredients checked at least once a week to identify issues and
08
correct it on a timely manner?
Is there daily inspection of reject materials conducted and
6.1.2-
source of possible impact upstream of process are investigated
08
and documented?
6.1.3 Chemical Product Control YES NO N/A REMARKS
6.1.3-
Is there in place and implemented chemical control program?
01
6.1.3- Are primary and secondary containers for non-food chemical
02 accurately and legibly labelled?
6.1.3- Is the chemical approval program audited periodically for
03 effectiveness?
6.1.3- Is the functional eye wash located on areas where chemicals
04 are used and stored?
6.1.3- Is there a secondary containment in place for chemical stored
05 on site?
6.1.3- Is there a spill control program in place with relevant
06 procedures for the clean up and disposal of chemicals?
6.1.3- Are persons handling chemicals trained and are trainings
07 documented?
Is there disposition procedures of nearby raw materials,
6.1.3-
packaging and finished goods that maybe affetced by chemical
08
spills?
6.1.3- Is there an approved chemical list that include SDS reference,
09 storage locations, intended use and area of use?
6.1.3- Is there a map that identiifes all approved chemical storage and
10 work in progress locations?
6.1.4 Microbiological Product Control YES NO N/A REMARKS
Does the facility identify all microbiological hazards in its
6.1.4-
HACCP plans and implement control measures to reduce or
01
eliminate those hazards?
Are microbiological contamination control measures validated,
6.1.4-
documented and implemented for any known and potential
02
microbiological hazards?

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6.1.4 Microbiological Product Control YES NO N/A REMARKS

Are control measures reviewed whenever there are changes to
6.1.4-
the product, processes or when a new hazard is identified in
03
the industry?
Does the facility have a written program established that
6.1.4-
describes how condensation is controlled to prevent the
04
potential for microbial contamination for unsanitary surfaces?

Does the facility actively inspect for signs of condensation and

6.1.4- implement immediate corrections and long term corrective
05 actions that address the root- cause, whenever condensation is
identified?
6.1.4- Is any product potentially contaminated with condensation
06 properly dispositioned?
6.1.4 Microbiological Product Control
YES NO N/A REMARKS
6.1.4.1 Environmental Monitoring Program
Does the facility identified microbiological hazard of concern in
6.1.4.1-the plant environment, including high risk points of potential
01 cross- contamination, to ensure target indicator organisms are
monitored?
Does the appropriate program established, implemented and
documented in compliance with applicable laws and
regulations include:
6.1.4.1-
a) target microorganisms and testing frequencies?
02
6.1.4.1-
b) procedures for identifying sample locations and zones?
03
6.1.4.1-
c) procedures for handling and collecting samples?
04
d) corrective action plans for investigation/ root cause analysis,
6.1.4.1-
sampling escalation and product disposition when positive
05
trends are reported?
6.1.4.1-e) records for the test results, investigations, corrective actions
06 and preventive actions maintained?
6.1.4.1-f) analysis of the results by the qualified individual on a routine
07 basis to identify potential trends?
6.1.4.1-
g) training for proper techniques and sampling of samples?
08
6.2 Testing YES NO N/A REMARKS
Is there a documented food and food ingredients testing
6.2-01 covering program micrbiological, chemical and physical testing
to meet McDonald's and applicable laws and regulations?

Is there a current McDonald's shelf life study guide and

6.2-02
completed testing as evidence to show shelf life compliance?
6.3 Food Allergens and Sensitivities YES NO N/A REMARKS
Is there revalidation done if there are changes process/
6.3-01
product/ sanitation occur?
Is there any written corrective actions implemented to address
6.3-02
any deficiencies?
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McDonald's SQMS v. 4.4 (Additional Requirements) July 30, 2020

6.4 Traceability YES NO N/A REMARKS

Are documented policies and procedures in place to ensure
that all ingredients, finished product and packaging (inner and
6.4-01
outer) can be traced throughout the entire history from
production to distribution?
Is there a one-step-up and one-step-down traceability with the
6.4-02
ingredients providers along the entire food chain?
6.4-03 Are all coding information legible?
Are all McDonald's requirements on coding, labeling and
6.4-04
graphics been met?
Does the product recovery program able to locate 100% of any
6.4-05
given finished product within three hours?
Does the facility conduct training and mock recovery exercises
6.4-06 at least twice a year and included tracking of raw amterial and
packaging (inner and outer)?
7.1 Vendor Requirements YES NO N/A REMARKS
Is there a process in place to work with vendors to close any
7.1-01
gaps via corrective/preventive action plans?
7.4 Sensory Attributes and Evaluations YES NO N/A REMARKS
Does the organization demonstarte understanding of "critical
7.4-01 to product quality attributes" based on the training provided by
McDonald's Quality Centers and/or qualified individuals?
Is there a program in place to conduct sensory evaluation for
7.4-02 products(s) manufactured aligned with McDonald's Quality
Centers and Quality Leads?
Is there a documented process in place to demonstrating
7.4-03
product performance at McDonald's restaurants?
Is product sensory tests performed by trained persons prior to
7.4-04
release of a production run?
Is full product sensory evaluations of products performed by
7.4-05 trained panelists on a periodic basis comparing products
against target or in-house reference samples?
7.4-06 Is it documented and available for review upon request?
Does McDonald's Quality Centers current sensory tools,
7.4-07 product specific evaluation forms (scoresheets) and SOPs used
for evaluation?
Is there a defined process for selection of in- house reference/
7.4-08
targets?
Are evaluation results effectively communicated to McDonald's
7.4-09 market QS or global QS leads and action taken for continuous
quality improvement?
7.5 Process Validation and Capability YES NO N/A REMARKS
Does the facility established parameters within which the
7.5-01
production line is expected operate?
Does process control and monitoring established and
7.5-02
implemented?
Is trend data available to demonstrate that process is producing
7.5-03
products within the established parameters?

Internal Audit Checklist - Mcdonald's SQMS v. 4.4 Additional

Requirements (12)
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McDonald's SQMS v. 4.4 (Additional Requirements) July 30, 2020

7.5 Process Validation and Capability (Cont.) YES NO N/A REMARKS

Does the facility implemented Statistical process Control (SPC)
7.5-04 program to demonstrate process capability or there maybe
alternatives that are equivalent?
Does it explaines the equivalency and substantiate that the
alternative emthods provide evidence that the process is
7.5-05
visible, stable and capable to produce product meeting
specifications?
Is documentation available to show that corrective actions are
7.5-06
taken when process is not in control?
Does it have a process in place to verify that all products are
7.5-07 meeting local laws and regulations, as well as country
destination being exported?
Does SPC program been implemented for process control and
7.5-08
statistical analysis to improve consistency of product quality?
Does the Critical to Quality Manufacturing Control Points
7.5-09 (CTQMCP) in each process been identified for which control is
necessary in order to create consistent finished product?
Does the operator for each prodution line provided with
7.5-10 measurement devices to determine the effectiveness of the
process adjustments made?
Does a target been provided to the operator to center the
7.5-11
process variation around the target?
Are sampling protocols defined and include the number of
7.5-12 samples, sampling frequency, sampling point and degree of
resolution of measurements?
Are realtime control charts used at all identified locations on
7.5-13 processing lines for the critical to quality manufacturing control
points?
Does the operator only makes necessaary adjustments when
7.5-14
process is out of control as indicated by the chart?
Does the CTQCMP operator identified and documented the
root- cause and corrective action taken, when special caues/
7.5-15
incidents (out of control points) are indicated in the control
chart?
Are processes capable to meet product specifications or
manufacturing targets, demonstrated by:
7.5-16 a) control chart with upper and lower limit?

7.5-17 b) real time control charting being used?

7.5-18 c) absence of unexplained out-of-control conditions?

7.5-19 d) data that fits a normal curve?

Is a process in place to update the process sigmas and optimize
7.5-20
the targets with the real time control charts?
Is statistical data used to manage process improvement and
7.5-21
optimize pocesses?
Are increased product quality and consistency, reduction of
7.5-22 waste and cost savings evident as result of process control
implementation?
Internal Audit Checklist - Mcdonald's SQMS v. 4.4 Additional
Requirements (13)
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McDonald's SQMS v. 4.4 (Additional Requirements) July 30, 2020

8.1 Customer Satisfaction YES NO N/A REMARKS

8.1-01 Is there a customer satisfaction program in place?
Are there established key measurements for measuring success
8.1-02
in handling and resolving customer issues?
Are key measurements trending and root cause analysis used
8.1-03
to improved customer satisfaction?
8.1.1 Management of Restaurant and Customer Complaints YES NO N/A REMARKS
8.1.1- Is there a process and procedures in place to manage customer
01 complaints?
Is there a process in place for the Customer Representatives to
8.1.1-
handle and categorize complaints to identify serious issues and
02
trends?
8.1.1- Is the Customer Representatinves formally trained and
03 proficient in complain handling process?
8.2 Verification of the Food Safety and Quality Systems YES NO N/A REMARKS
Does the organization have a formal program in place to
undertake annual (minimum) verification of its food safety and
8.2-01 quality management systems or as required by applicable laws
and regulations and a process to ensure continuous quality
improvement?
8.2.3 Evaluation of Verification Results YES NO N/A REMARKS
Does review of objective trending data confirmed
8.2.3-
improvements achieved have resulted in product quality and
01
safety improvement?
Does the facility has achieved tangible business benefits such
8.2.3-
as improvement in productivity and resource utilization (e.g.
02
reduction in errors, defects, waste)?
OVERALL GMP PERFORMANCE YES NO N/A REMARKS
After the walk thorugh the facility, answer the question:
As a consumer, would you be proud to eat or feed to your
family the prodcuts that come from this facility?
Quantity REMARKS
How many external warehouse(s) for the storage of raw
materials, packaging, in progress products and finished
products does the facility manage (only those housing
materials and products for McDonald's)?
YES NO N/A REMARKS
Do the warehouse facilities have the following quality/food
safety audit standards: GFSI, DQMP, SQMS or other? (Upload
audit records in RizePoint if applicable)
Quantity REMARKS
How many co-packer/external manufacturers does the supplier
use for McDonald's for McDonald's products?
YES NO N/A REMARKS
Do the co-packer have the following quality/food safety audit
standards: GFSI + Addendum, SQMS or other? (Upload audit
records in RizePoint if applicable)

Internal Audit Checklist - Mcdonald's SQMS v. 4.4

Additional Requirements (14)