Santas Manual

Denise Robitaille
About the Author

D
enise Robitaille is the author of numerous books on various quality topics.

She is an internationally recognized speaker who brings years of experience
in business and industry to her work in the quality profession. In November of 2005,
she was recognized in Quality Digest as one of the Drivers of Quality. Denise is
a member of U.S. TAG to ISO/TC 176, the committee responsible for updating the
ISO 9000 family of standards. She is also a RABQSA certified lead assessor, an ASQ
Certified Quality Auditor, and a fellow of ASQ.
As the principal of Robitaille Associates she has helped numerous companies in diverse fields to achieve
ISO 9001 registration and to improve their quality management systems. She has conducted training
courses for thousands of individuals on such topics as corrective action, management review, auditing,
document control and implementing ISO 9001.
Denises books include: The Corrective Action Handbook, The Management Review Handbook, The
Preventive Action Handbook, Root Cause Analysis: Basic Tools and Techniques, Document Control and
Managing Supplier-Related Processes. She is a regular columnist for The Auditor newsletter and is the
author of numerous articles.
Look for a special 25% off discount code on all Paton Professional books at the end of this story.
2007, 2009 Denise Robitaille. All rights reserved.
Introduction
S
anta decided it was about time for him to bring more control to the toy manufacturing and delivery
processes at the North Pole. The elf population has increased dramatically, and there are more and
more children to be served. There has been a proportionate increase in the amount of outsourcing due
to several factors.

Recognizing the need for a balance between preserving tradition and addressing consumer safety
laws and environmental protection protocols, Santa initiated processes to ensure continued customer
delight as well as unquestioned safety. This has evolved into a massive project encompassing updated
designs of all the perennial favorites like dolls and sleds and teddy bears. Even with the outsourcing of
21st century gadgetry, theres still a lot of work to keep the elves busy.

Santas Workshop had been outsourcing more of the electronic gadgets and games that kids love.
Rather than sending thousands of elves to universities and trade schools to increase their knowledge of
emerging technologies, it was decided that it made more sense to have the experts make the toys and to
procure them for holiday gift-giving.

Qualifying thousands of suppliers ensures that toys and games continue to reflect Santas commitment
to quality and joy. Hundreds of elves are involved in pre-qualification, supplier audits, developing
improved process documents for the outsource suppliers, and establishing adequate inspection and
acceptance criteria documentation.

Santa became aware of the ISO 9001 standard several years ago and immediately recognized the
value it could bring to the North Pole operation. He has slowly been developing his quality management
system (QMS) with the help of a crackerjack team. Before the production season gets into full swing,
Santa would like to have Santas Workshop registered to ISO 9001.

In preparation for the pre-assessment audit, Santa has sent his organizations quality manual, core
procedures, master document list, and a sampling of other documentation for a document review. It
does not include all the documents.

Enjoy a bit of holiday whimsy as we present the quality manual and core procedures for Santas
Workshop. See if Santas documentation is adequate and if it will pass a registrars assessment. Pick
up a few tips and a fresh perspective on documenting your own QMS from the jolly fellow at the
North Pole.
Santas Workshop
Quality Manual
A pproved:
Santa Claus, President
10/24/09
Date:
Contents
Introduction................................................................................................................................... i
Cover Page with Approval...................................................................................................... ii
Quality Policy............................................................................................................................... 1
Organizational Chart.............................................................................................................. 2
Interrelation of Quality Processes................................................................................. 3
Monitoring and Measurement Activities Flowchart............................................. 4
Management Responsibilities and Review..................................................................... 5
Overview of Quality Management Review.................................................................... 7
Quality System.............................................................................................................................. 8
Quality Objectives...................................................................................................................... 8
Allowable Exclusions.............................................................................................................. 9
Revision History............................................................................................................................ 9
Master Document List............................................................................................................. 10
Documents of External Origin.......................................................................................... 12
QP 4.2.3 Document and Data Control............................................................................... 13
QP 4.2.4 Control of Records................................................................................................... 16
QP 7.4.1 Supplier Qualification and Monitoring........................................................ 17
QP 8.2.2 Internal Auditing....................................................................................................... 21
QP 8.3 Control of Nonconforming Material............................................................... 23
QP 8.5.2 Corrective Action...................................................................................................... 26
QP 8.5.3 Preventive Action....................................................................................................... 27
Reindeer Care Schedule ........................................................................................................ 30
WI 7.3.7 Design Change Control........................................................................................... 31
Santas Workshop Quality Manual
Quality Policy
Santa and his elves are committed to providing gifts that fulfill customer-specified
requirements and to operating within a quality management system that conforms
to the requirements of ISO 9001. We are committed to improving our products and
processes to ensure continued ability to be the premier provider of gifts during the
holiday season. We are all responsible for quality.
Normative References
Holiday season refers to the period from mid-December until early January that is traditionally
associated with the Christmas holiday. However, Santas Workshop provides gifts to children of any
and all denominations, cultures, and ethnicities.
Customer-specified requirements are defined as those described in childrens letters, made while sitting
on Santas knee or expressed through comparable communiques. Included in the specification are
parents inputs as to appropriateness, which may override child (herein occasionally referred to as
customer) requests. Further, children have been previously advised that the delivery of gifts is subject
to their status on Santas NICE list. It is understood that inclusion on the NAUGHTY list prohibits
delivery of gifts or proportionately decreases quantity delivered.

Organizational Chart
Santa Claus
Elfin Director
of Toy Design
Senior
Purchasing Elf
Master Elf
of Toy
Production
Outsourcing
contract
supervisory elf
Receiving/
inventory
Toy
production
Chief
Financial
Officer
(Mrs. Claus)
Steward of
letter-sorting
elves
Sleigh and
reindeer
maintenance
Elf training

Interrelation of Quality Processes
Customer
request
approved
Yes
Refer to
engineering
No
Manufacture
in-house?
Review design:
revise if needed
Purchase from
approved
outsource
Supplier
on approved
list?
No
Initiate
approval
process
Yes
Refer to
engineering
Placer order
with approved
supplier
Check parts
inventory
Purchase
materials
Receive and inspect
materials
No
OK?
No
Put in stock
Finished
goods?
To finished goods
stockroom
Contact supplier
refer for possible
corrective action
Component/
materials
stockroom
Issue
materials to
manufacturing
Manufacture
toys
Prep sleigh and

reindeers
Pull inventory/
stock sleigh
Inspect
Deliver toys

Monitoring and Measurement Activities
Monitoring and Measurement

Activities
Audits
Improvement
initiatives
Process
monitoring
Customer
feedback
Internal audits
Corrective action
Production
performance
Complaints
2nd and 3rd-party

audits
Preventive action
Scrap rate
Supplier
performance
Nonconforming
material
Analysis
Management
review
Letters to Santa
Market research

Management Responsibilities and Review

Our commitment to quality, and to the fulfillment of specified requirements and adherence to the
ISO 9001 standard, is articulated in Santas Workshop Quality Policy.

This policy is displayed prominently throughout the North Pole and communicated to all elves. The
quality policy is presented at meetings, printed in newsletters, and explained as part of the training for
new hires.

Executive management is responsible for defining and communicating the quality policy. Further,
executive management is responsible for ensuring that the quality management system (QMS) is
established, understood, implemented, and maintained throughout the organization. Organizational
chart and process flowcharts have been developed, indicating authority, responsibility, and interrelation
of processes.

Santa Claus has ultimate authority for all aspects of the organization and the QMS. He ensures
there are adequate resources for the management of the organization and the maintenance of the QMS,
including provision of resources relating to training, equipment, communication, and infrastructure.

Santa Claus is the sole authority in the decision of gift selection and gift giving.
Mrs. Claus serves at the ISO management representative. She ensures the establishment, definition,
and implementation of the QMS. Further, she is responsible for ensuring the awareness of customer
requirements throughout the organization. She ensures that information relative to the QMS and key
performance indicators are analyzed and available to executive management. She participates in
management review. The ISO management representative is responsible for:
Overseeing/maintaining the QMS
Initiating actions that prevent the occurrence of nonconformities
Assisting operations by recommending solutions to problems
Coordinating data and records for management reviews
Participating in supplier assessment and monitoring
Baking cookies for the elves

Mrs. Claus also serves as the chief financial officer, responsible for financial matters and oversight
of administrative staff. She supervises the team of elves responsible for opening and sorting childrens
letters to Santa.

The master elf of toy production is responsible for managing toy manufacturing processes.
Responsibilities include:
Overseeing all aspects of toy production, inspection, packaging, inventory, and maintenance
Participating in the dispositioning of nonconforming material
Assisting in development of plans and objectives
Management of quality control lab

Staff training and personnel development (except administrative staff)
Contributing to corrective action activities
Initiating actions that prevent the occurrence of nonconformities
Monitoring and analysis of relevant key performance indicators
Participating in corrective actions, preventive actions, and innovation initiatives

Responsibility for various functions within the QMS and the authority to perform or approve certain
activities are delegated by the executive management to managers and elves in supervisory roles.
Responsibilities are identified in the appropriate documents.

The senior purchasing elf is responsible for processes relating to supplier qualification and monitoring
and purchasing activities. Responsibilities include:

Qualification of suppliers
Oversight of negotiations and control of outsourced processes
Purchase order approval
Monitoring and analysis of supplier and subcontractor performance

The elfin director of toy design is responsible for the design and development of toys manufactured
by Santas Workshop. Because most of the toy designs are established, most of the design work involves
revision to existing toy designs. Responsibilities include:
New toy design
Supervision of engineering staff
Revision of existing design to address:

Availability of improved materials
Technological innovation
Improved manufacturing capabilities
Safety and statutory requirements
Changes in the marketplace
Newly discovered colors

Overview of Quality Management Review

Management review of the quality system consists of an assessment of the quality management
system (QMS) based upon information, data, and reports on various functions and activities. These
records and data, furnished by the process owners and supervisors, are retained with the records of the
management review. The information may be in summary form.

Records of management review are retained. Aspects of the QMS, which are reviewed, include:
Internal audit reports

Corrective actions and preventive actions
Customer feedback
Supplier performance
Measurement of identified processes and elements of the system
Resource requirements
Nonconforming materials reports
Follow-up actions from previous reviews
Changes that could affect the quality management system
Opportunities for improvement

The review encompassesas appropriate to each meetingthe following activities:
1. Review of open items from previous meeting

2. Review of customer feedback:

Letters to Santa
Complaints
Market research
Other
3. Presentation of statistical analysis, such as process and production data, nonconforming material
reports, scrap rates, equipment failure/downtime, and supplier performance
4. Review summary of internal audits performed since last management meeting
5. Review of quality policy and objectives
6. Equipment issues
7. Training issues
8. Suggestions
9. Action to be taken

Quality System

The scope of the quality management system is the design, manufacture, and distribution of gifts
during the holiday season.

Santas Workshop operates its quality system by a set of defined procedures and processes identified
in the Master Document List. Adherence to these documents ensures fulfillment of customer-specified
requirements and conformance to the requirements of ISO 9001.

Quality planning is incorporated into the appropriate procedures, work instructions, and other
documents. These plans may relate to product design, processes, equipment, inspection, training, and
continual improvement, and reflect consideration for interrelation and sequence of processes.
Quality Objectives

Santas Workshop establishes quality objectives relating to product, performance, and the attainment
of organizational goals. These are defined and communicated in various forms, as appropriate to the
function and objective.

Management ensures that appropriate metrics are established for measuring and assessing the
organizations fulfillment of these objectives.
Documents
and Procedures

Allowable Exclusions

The following ISO 9001 requirements are excluded from the scope of Santas Workshops quality
system.
ISO 9001 reference
Requirement
Justification for exclusion
7.5.1 Control of
Santas Workshop excludes
It does not provide any
service provision
from this section any language
after-market services.
and/or requirements that relate

to post-delivery activity.
Revision History
Revision
Date
Nature of change
5/23/09
Initial release
2/14/09
Added description of
responsibilities for senior
purchasing elf
10/24/09
Included normative
references on page one
10

Master Document List
Procedures
Number
Title
Rev. Level
Rev. Date
--
Quality Manual
10-24-09
QP 4.2.3
Document and Data Control
11-6-09
QP 4.2.4
Control of Records
6-12-08
QP 6.2.2
Training
11-22-08
QA 6.3
Equipment Maintenance
10-17-09
QA 7.3
Toy Design
11-6-09
QA 7.4.1
Supplier Qualification and Monitoring
10-17-09
QA 7.4.2
Receiving and Inspection
10-17-09
QA 7.5.1
Toy Manufacturing
6-29-08
QA 7.5.5
Toy Packaging
9-13-09
QA 7.6
Control of Measuring & Test Devices
5-30-10
QA 8.2.2
Internal Auditing
11-6-07
QP 8.3
Nonconforming Material
6-12-09
QA 8.5.2
Corrective Action
9-29-08
QA 8.5.3
Preventive Action
9-29-08
Number
Title
Rev. Level
Rev. Date
WI 6.3.1
Reindeer Stable Maintenance
9-13-09
WI 6.4.1
Christmas Tree Decoration
10-05-10
WI 7.4.3
Receiving of Subcontracted Toys & Gifts
8-05-10
WI 7.3.7
Design Change Control
11-6-09
WI 7.5.1.1
Dolly Construction
6-25-07
WI 7.5.1.2
Wagon Assembly
7-18-08
WI 7.5.1.3
Rocking Horse Fabrication
7-18-08
WI 7.5.1.4
Teddy Bear Assembly
8-29-09
WI 7.5.1.5
Sled and Toboggan Manufacture
8-05-10
WI 7.5.1.6
Chemistry Kit Assembly
8-05-10
Work Instructions
11

Training Guides
Number
Title
Rev. Level
Rev. Date
TG 6.3
Stable Cleaning
6-25-06
TG 6.4
Christmas Caroling
1-29-10
TG 7.5.1.1
Department Store Santas
11-03-09
TG 7.5.1.2
Woodshop Elf Level I
6-25-06
TG 7.5.1.3
Woodshop Elf Level II
6-25-06
TG 7.5.1.4
Woodshop Elf Level III
6-25-06
TG 7.5.1.5
Machine Shop Elf Level I
7-06-09
TG 7.5.1.6
Machine Shop Elf Level 1I
7-12-09
TG 7.5.1.7
Machine Shop Elf Level 1II
7-12-09
TG 7.5.1.8
Sewing and Needlework Basic Skills
6-25-06
Other Documentation
Category
Location or Owner
Comments
Toy specification
Blitzen drive
Santas flight plan
On Kringle drive
Access restricted
Calibration schedule
On Dancer drive
Old revs archived
Audit schedule
Rudolph drive
Old revs archived
Production schedule
Master elf of toy production
Printed weekly; updated daily
Naughty/nice lists
Santa
On Kringle drive. No one but Santa .

has access to these lists.
Reindeer care instructions
Master reindeer custodian;
Revise based on condition and health
and schedules
on Comet drive
of individual reindeers
Production routers
Prancer drive
Shop steward elves authorized to revise
Purchasing/outsourcing
Senior purchasing elf with input from
documents
outsource supplier
Record retention matrix
ISO rep
IT backup and security
On Dancer drive
Access limited to IT elves
protocols
12
Form Number
Form Name
Rev.
F5.6
Agenda: Management Review
F6.3.1
Reindeer Care Schedule
F7.4.1
Vendor Self-Assessment
F8.3.1
Nonconformance ID tag
F8.3.2
Material Review Board (MRB) Record
F8.5.2
Corrective Action Form

Documents of External Origin
Number or Name
(if applicable)
Category
Location/Owner
Comments
ISO 9001: 2000
QMS standard
ISO Rep
Revision by issuing
body
(various)
Equipment manuals
Master elf of toy

production
(for reference only)
Consumer
Product Safety
Commission
(CPSC) regs
Safety/statutory
requirements
Elfin director of
toy design
Accessed from official

CPSC Web site
Olafs Care
and Grooming
of Ruminants,
Second Edition
Reindeer care
Master reindeer
custodian
OSHA documents
Safety protocols
Safety elf
MSDS sheets
Material safety
Production area
The Corrective
Action Handbook
Guidance for
problem solving
Two copies in Kringle

Memorial North Pole
Library. One copy
each production and
purchasing.
Re-order from Paton

Professional
The Preventive
Action Handbook
Guidance for
managing risk and
potential problems

Memorial North Pole
Library. One copy
each production and
purchasing.
Re-order from Paton

Professional
The Management
Review Handbook
Guidance on strategic
planning and
management issues

Memorial North Pole
Library. One copy
each production and
purchasing.
Re-order from Paton

Professional
Document
Control: A
Simple Guide
to Managing
Documentation
Guidance on how
to keep track of
Santas Workshop
documentation

Memorial North Pole
Library. One copy
each production and
purchasing.
Re-order from Paton

Professional
On shared drive
13

Number or Name
(if applicable)
Category
Location/Owner
Comments
Root Cause
Analysis: Basic
Tools and
Techniques
Guidance on
problem-solving
investigation

Memorial North Pole
Library. One copy
each production and
purchasing.
Re-order from Paton

Professional
Managing
Supplier-Related
Processes
Guidance on
purchasing,
outsourcing, and
monitoring suppliers

Memorial North Pole
Library. One copy
each production and
purchasing.
Re-order from Paton

Professional
PROCEDURE: QP 4.2.3 Revision: B

Document and Data Control
Approval:
Santa
Quality Approval:
Mrs. Claus
Date:
11/6/09
Date:
11/6/09
1.0 Purpose
This procedure defines the establishment of a system to approve, control, review, and maintain the
documentation that relates to Santas Workshop.
2.0 Scope
This encompasses QMS documentation, including the quality manual, procedures, work instructions,
production documents, specifications, manuals, and documents of external origin. Some documentation
is generated and maintained electronically.
3.0 Procedure
3.1 The ISO management representative is responsible for developing and implementing a plan for
the control, storage, and maintenance of documents and data relative to the quality system. Quality
procedures are reviewed by the ISO management representative prior to implementation to verify that
they comply with established procedures, statutory requirements, and the ISO 9001 standard.
14

3.2 The ISO management representative maintains a master document control list, which lists the
quality manual, quality procedures, and other relevant documents. For the quality manual and
quality procedures, the list includes the date of the most current revision and the revision level.
3.3 This procedure identifies the personnel authorized to access, revise, and make copies of the
documents. Care is taken that access is limited to qualified personnel to prevent proliferation of
uncontrolled documents or to avoid unintended use.
3.4 The master copies are stored electronically on the shared Rudolph drive. Approval is indicated by
electronic signature of authorized personnel and date stamp. A distribution list is maintained of
hard copies that have been distributed.
3.5 Changes to documents must be reviewed by the same function/organization that performed
the original review and approval. The designated function/organization is authorized to access
pertinent background information for the purpose of the review and approval.
3.6 When a document is changed, the authorized person verifies that obsolete hard copies are retrieved
and replaced with the most recent revision. Unless otherwise indicated, all copies of obsolete
documents are destroyed. Should there be a need to retain an obsolete document, all copies are
clearly designated as obsolete.
3.7 In the event of a change to a controlled document, the nature, date and revision level (when
appropriate) is indicated as follows:
Documents
Revision level and history
Bill of materials
On the document; date code and revision
Blueprints/drawings
On the drawing; by revision level. Multiple revisions available

on Engineering Blitzen drive.
Quality Manual and procedures
At the end of the document
Production routers
Date on new rev.; older rev. with annotated changes archived on

Production Prancer drive
Additional documentation
As appropriate to the nature of documents. (Process owners

ensure rev. level and history are accessible.)
3.8 The ISO management representative or the supervisor of a department or function is responsible
for ensuring that all authorized personnel are trained in the control, maintenance, and storage of
15

controlled documents and data. Further, appropriate revisions of controlled documents are made
available at all locations where they are required.

It is the responsibility of authorized personnel to verify that they are in possession of the most
current revision of a document.
3.9 The following departments/personnel are responsible for document control and maintenance:
Documents
Responsible personnel/department
Quality Manual and
ISO management representative
procedures
Production routers
Naughty/nice lists
Santa Claus
Toys specifications
Elfin director of toy design
Purchasing/outsourcing
Senior purchasing elf
documents
Reindeer care
Master reindeer custodian
Additional work instructions
Senior elf manager of relevant processes
3.10 Functions having responsibility for the control, maintenance and/or access of documents of
external origin such as standards, specifications and statutory requirements are identified on the
master document list.
3.11 Electronic documentation maintained and protected in accordance with information management
system (IMS) protocols described in IMS work instructions. The system is backed up on a regular
basis. A copy of the back up is stored off-site
3.12 Santas Workshop has identified forms that need to be controlled and listed them on the master document
list. Other forms, templates and charts may be utilized, but need not be numbered or controlled.
3.13 Quality procedures and work instructions are regularly reviewed for continued applicability and
accuracy as part of scheduled internal audits. Revisions are made if required.Revision History
Revision History
Revision
Date
Nature of Change
6/12/08
Initial release
11/6/09
Added documents of external origin to master .

document list
16

PROCEDURE: QP 4.2.4 Revision: A
Control of Records
Approval:
Santa
Quality Approval:
Mrs. Claus
Date:
6/12/08
Date:
6/12/08
1.0 Purpose
The purpose of this procedure is to define the system by which quality records are controlled and
maintained.
2.0 Scope
The scope of this procedure is Santas Workshop records that provide evidence of fulfillment of
specified requirements. Control covers identification, collection, indexing, access, filing, storage,
maintenance, and disposition of the quality records.

3.0 Procedure
3.1 Records verify and substantiate the implementation and effectiveness of the QMS and the
fulfillment of customer-specified requirements.

3.2 Quality records facilitate management review and provide historical reference that may assist in
trending analysis, performing root cause analysis, and developing corrective action plans.
3.3 Records are maintained in a manner that promotes identification, accessibility, and preservation
from damage or deterioration. Records are readily accessible and stored in conditions that guard
against damage and deterioration. Records that are stored electronically are similarly protected.
3.4 Supervisors ensure that elves provide clear and legible records. Further, personnel are trained in
the correct storage, maintenance, and retrieval of records.
3.5 Santas Workshop has identified records that need to be controlled and defined the method of
retention in the record retention matrix.
3.8 Santas Workshop complies with statutory requirements for retention and storage of records
relating to product safety.
17

Revision History
Revision
Date
Nature of Change
6/12/08
Initial release
PROCEDURE: QP 7.4.1 Revision: D

Supplier Qualification and Monitoring
Approval:
Bigelow, senior purchasing elf
Quality Approval:
Mrs. Claus
Date:
6/12/08
Date:
6/12/08
1.0 Purpose
This procedure establishes activities relating to the selection, qualifying and monitoring of suppliers
and outsourced processes that affect Santas Workshops ability to supply product that conforms to
specified requirements.
2.0 Scope
This procedure encompasses the purchase of materials used in the manufacturing process and finished
products such as electronic toys and games
3.0 Vendor qualification procedure

3.1 Santas Workshop maintains an approved vendor list (AVL) for vendors, suppliers, and subcontractors who provide services and products that directly affect the workshops ability to furnish
quality toys, games, and gifts.
3.2 Vendors are selected based on their ability to meet specified requirements in a timely manner and
who demonstrate an unwavering commitment to the highest levels of quality.
3.3 Additional control is required of those organizations to which Santas Workshop outsources the
design and manufacture of specific games and toys. Such controls may relate to documentation,
special requirements, specific acceptance/verification criteria, periodic audits, and furnishing
inspection/test records. These additional requirements are defined, as appropriate, in the contract
with the outsourcing organization.
18

3.4 The manner of qualifying and monitoring suppliers is detailed in the supplier classification and
qualification chart found in this document.
Supplier Classification and Qualification

Suppliers are grouped into classes for determining method of qualification, selection, and evaluation.
The following classes have been established:
Class
Product/service
Criteria for
selection
Method of
qualification
(may be one or more
methods)
Method of monitoring
(as appropriate to
category)
1.
Outsourced
processes,
including
fabrication of
toys, games,
and gifts
Training of
department
store Santas
Ability
to fulfill
requirements
Delivery
On-site visit
(After initial visit
may accept copy
of certification to
recognized QMS
standard)
Delivery
Receiving records
Certificates or final
inspection reports
Nonconforming
material reports
Response to corrective
action requests
2.
Raw
materials and
components
Reindeer food
Ability
to fulfill
requirements
Delivery
Copy of certification
to recognized QMS
standard
Customer/associate
recommendation
Historical
performance
Delivery
Receiving records
Certificates or final
inspection reports
Nonconforming
Material Reports
action requests
3.
Services such
as calibration,
testing, and
veterinary care
Ability
to fulfill
requirements
Availability
Copy of certification
to recognized
standard (Ex: ISO
17025)
Customer/associate
recommendation
Historical
performance
Assessed at time
service is delivered
(observations noted
in supplier file, by
default only, record
of failure to provide
specified service)
action requests
19
Class
Product/service
4.
Machine parts/
supplies
Criteria for
selection
Price and
delivery
Method of
qualification
(may be one or more
methods)
None
Method of monitoring
(As appropriate to
category)
By default only;
record of late delivery
or incorrect/defective
material
3.5 Criteria for removal from the approved vendor list (AVL) includes, but is not limited to:

3.5.1 Recurring defects
3.5.2 Repeated failure to meet required delivery
3.5.3 Failure to respond to vendor action requests
3.5.4 Poor workmanship
3.5.5 Making the elves cry

3.6 Disqualification of a supplier is recorded and communicated in the purchasing database.
3.7 Quarterly analysis of on-time delivery is conducted for top suppliers by volume as determined by
purchasing personnel. Additionally, occurrences of late deliveries that have affected production
and/or the ability to meet customer requirements are recorded on a case-by-case basis, when
deemed appropriate by purchasing personnel.
3.8 Self-assessment forms are to be sent out to new suppliers as soon as possible, but no later than
forty-five days after generation of initial order. Failure to respond to a request for self-assessment
results in banning from Santas Nice List and removal from the AVL.
4.0 Forms
7.1 F7.4.1 Vendor Self-Assessment
Revision
Date
Nature of Change
6/12/08
Initial release
3/06/09
Removed description of purchasing activities to separate

procedure
20
6/12/09
Added chart to better explain process
10/17/08
Added 3.8 dealing with response to request for self-assessment

PROCEDURE: QP 8.2.2 Revision: A
Internal Auditing
Approval:
Santa
Quality Approval:
Mrs. Claus
Date:
11/6/07
Date:
11/6/07
1.0 Scope
This procedure covers internal quality audits.
2.0 Purpose
This procedure defines the establishment, implementation, and documentation of the internal auditing
process as an appropriate method for evaluating the effectiveness of the quality system as it relates to
the organizations ability to meet customer requirements.
3.0 Related Documentation

ISO 9001 QMS requirements
Procedure: QA 8.5.3 corrective action
Internal audit schedule
4.0 Responsibilities
4.1 ISO management representative
Prepares and maintains audit schedule
Ensures that auditors are trained
Ensures that audits are conducted in accordance with the audit schedule
4.2 Auditors
Assist in the preparation of audit material
Conduct audits
Write audit report
Follow up on CARs
5.0 Procedure
5.1 All elements of the quality system are audited at least once within a one-year audit cycle. The
audit schedule is prepared and issued covering a one-year time span. Frequency of audits for
21

various processes and activities are reliant on multiple factors, including criticality, results of
previous audits, and changes that could affect the fulfillment of organizational objectives. The
schedule may be periodically updated based upon these factors or other considerations.

5.2 Internal auditors may not audit their own work.
5.3 The auditee is notified in advance of the audit.

5.4 In preparation for audits, auditors assemble required documents. These may include:
Related quality procedures
Related work instructions
ISO 9001 standard
Additional requirements relevant to the process
An audit checklist
Corrective actions from previous audits that need to be verified and closed-out
5.5 Auditors proceed with the audit and keep the auditee informed of observations. Findings are
recorded for later review in developing audit CARs for presentation at the CAR meeting.
5.6 Corrective actions are generated and assigned in accordance with QP 8.5.2.
5.7 An audit report is generated that is used during the management review process to assess the
status and effectiveness of the quality management system.
5.8 The records of internal audits are filed in the ISO management representatives area.
22

PROCEDURE: QP 8.3
Revision: B
Control of Nonconforming Material

Approval: Randy,
Quality Approval:
master elf, toy production
Mrs. Claus
Date:
6/12/09
Date:
6/12/09
1.0 Purpose
This procedure defines the process for identification, documentation, and disposition of nonconforming
material and products.
2.0 Scope
This procedure applies to materials, components, subassemblies, and finished goods.
3.0 Definitions
Nonconforming product: Material, component, subassembly, or finished product that does not
conform to specified requirements. It includes materials and products whose conformance status
has not been determined.
Material Review Board (MRB): The MRB is comprised of the following individuals:
Santa Claus
Senior purchasing elf
Quality control level III elves
ISO management representative
Production group leader elves
Review of an MRB report and disposition of materials may be performed by one or more members.
Each member is authorized to disposition materials and determine the need for further action.
4.0 Procedures
Identification and segregation
4.1 It is every elfs responsibility to identify nonconforming material when it is noticed during normal
work assignments. The nonconformance is identified with the part number, date of detection,
quantity, and description of defect using a nonconformance tag (F8.3.1).
23

4.2 In production processes where there are expected levels of setup scrap and/or failure rates due to variation,
there is no need to separately document and process each occurrence of the same nonconformance.
These products have a predetermined disposition to scrap. Scrap is disposed of in green-colored bins.
Elves have all been trained that material in green bins is not to be used in production.
4.3 Product nonconformances are documented using the MRB form.
4.4 Identification and documentation of defects or other nonconforming conditions are processed as
described in the following chart:
Source/point of
detection
Segregated location
Process
Incoming/receiving
(purchased material
and outsourced
finished goods)
Designated area in
stockroom
Receiving elf logs in receipt of material

QC elf initiates MRB form
Gives form to purchasing
Purchasing contacts supplier, dispositions
material, and records action taken on MRB
form
Purchased material
detected at first point
of use (usually in
production)
Designated area in
stockroom
Production group leader elf logs defective parts

in Vixen database (found on Prancer drive)
Stockroom elves issue replacement
components
Material is segregated in stockroom (small
quantities of items of negligible value may
be discarded)
Stockroom or QC elves check inventory and
verify correctness or segregate additional
nonconforming stock
Any rejected material with a dollar value
exceeding $15 or with a long lead time
requires an MRB form.
QC elves evaluate the material and work
with purchasing and production elves to
determine further action.
24

Source/point of
detection
Segregated location
Process
In-process or at final
inspection
Designated area in
QC
QC level III elf logs defective parts in

Donner database (found on Prancer drive)
Any rejected material with a dollar value
exceeding $15 or with a long lead time
requires an MRB form.
QC elves evaluate the material and work with
production group leader elves to determine
further action.
4.5 MRB members determine appropriate disposition and record action taken on MRB form (F8.3.2).
Nonconformance review and disposition

4.6 Based on the outcome of the MRB, nonconforming products may be:
Reworked to meet the specified requirements
Regraded, with or without rework, for alternative applications
Scrapped
4.7 Action taken is recorded on the MRB form.
4.8 Reworked products are inspected to verify that they conform to the same requirements as originally
specified. The manner and scope of inspection are prescribed in the rework instructions. Records
of re-inspection are noted on the rework production router.
4.9 The member of the MRB who dispositions material recommends if corrective action should be
initiated. Additionally, MRB members review and analyze reports to detect trends and identify the
possible need for corrective and preventive actions.
Revision History
Revision
Date
Nature of Change
6/12/08
Initial release
6/12/09
Added chart to better explain process
25

Corrective Action
Approval:
Santa
Quality Approval:
Mrs. Claus
Date:
9/29/08
Date:
9/29/08
QP 8.5.2 Corrective Action

Identify problem
Evaluate situation
Take appropriate
action
No
Monitor for
recurrence
CA
required?
Repair defect
Quarantine inventory
Contact vendor
Scrap material
Yes
Take corrective
action
Assemble team
Conduct root cause
analysis
Develop plan of
action
Close out
Implement plan
No
Yes
26
Did it
work?
Assess results
Revision
Date
Nature of Change
6/12/08
Initial Release
9/29/08
Added notation for appropriate actions

Preventive Action
Approval:
Santa
Quality Approval:
Mrs. Claus
Date:
9/29/08
Date:
9/29/08
1.0 Scope
This procedure encompasses documentation and activities related to identifying and eliminating the
causes of potential of product and process nonconformances.
2.0 Purpose
The purpose of this procedure is to describe the manner in which Santas Workshop addresses potential
problems and nonconformances through various preventive actions.
3.0 Procedure
3.1 Preventive actions are generated based on the identification of a potential problem and the
determination of probability, magnitude, and criticality. As the opportunity to address potential
problems varies depending on the nature of the product or process, the criteria for determination
and the decision to initiate preventive action is the responsibility of top management or the process
owner.
3.2 The justification to initiate preventive action is derived from a multitude of sources including, but
not limited to:
3.2.1 Market input
3.2.2 Procedural requirements
3.2.3 Trends analysis/performance data
3.2.4 Reports from air traffic controllers
3.2.5 Internal audit
3.2.6 External (third-party) audit
3.2.1 Management review and recommendation
3.3 Preventive actions may be:
3.3.1 Specific procedures or processes
3.3.2 Requirements or steps within a procedure or process
3.3.3 Unique initiatives or projects
27

3.4 In each instance the preventive action will reflect consideration of the potential risk, an evaluation
of the need for action, development and implementation of an action plan, a mechanism for
verifying effectiveness, contingency for record retention, and inclusion in management review.
3.5 In the case of unique initiatives, a Preventive Action Initiative form is generated. In other instances,
the action taken and the record of results is reported to supervisors and top management in a
manner that is appropriate and reflective of similar verification and review processes.
3.6 The chart below illustrates the origin, documentation and method of reporting various preventive
actions that are conducted.
Preventive
action
To prevent
Defined
in what
procedure,
process, or
requirement
Verification
of
effectiveness
Records
Method of
reporting to
management
Equipment
preventive
maintenance
Equipment
failure
Various
maintenance
manuals
Internal
audits,
periodic
monitoring
by supervisor
Various
maintenance
forms
Results
analyzed
(including
cost) and
summarized
for management review
Reindeer
wellness
program
Sick
reindeers on
Christmas
Eve
Various
Performance
during dryruns and on
Big Night
Reindeer
Care
Schedule
form F6.3.1A
Detailed
reports once
a week,
summarized
for
management
review
Min/max
inventory
levels
Material
shortages,
late deliveries
to customers
MRP
database
Daily
production
meetings
Inventory
database
Data
summarized
and
reported, if
appropriate,
during
management
review
28
Preventive
action
To prevent
Defined
in what
procedure,
process, or
requirement
Verification
of
effectiveness
Records
Method of
reporting to
management
Electronic
data backup
Loss of data
IT backup
and security
protocols
Management
review
On electronic
back up
media
Not required
unless there
is a problem
Safety
program
Injury, scrap,
liability
issues
OSHA
manuals
Number of
accidents &
injuries
Supervisor
accident
reports
Not required
unless there
is a problem
Other
preventive
action
initiatives
Addressing
potential
problems not
identified
through
established
processes
QP 8.5.3
Unique
to each
preventive
action
initiative
Unique
to each
preventive
action
initiative
Regular
part of
management
review
3.7 Determination of the appropriate elf to be assigned responsibility for a preventive action initiative
is determined by top management or various process owners with input from supervisory elves or
managers, when appropriate.
3.7.1 Records of the decision to initiate a preventive action are reliant on the nature of the
perceived problem and are typically found in:

3.7.1.1 Minutes of management review
3.7.1.2 Preventive action initiative forms
3.7.1.3 Memos and e-mails
3.8 It is the responsibility of the elf team to which the preventive action has been issued to:
3.8.1 Identify the root cause of the potential nonconformance
3.8.2 Describe and implement a plan for preventive action
3.8.3 Ensure that the plan is implemented
3.8.4 Provide records for review
3.9 Preventive action requests are a regular item at management minutes.
29

Revision
Date
Nature of Change
6/12/08
Initial release
9/29/08
Added notation for OSHA programs
Reindeer Care Schedule
Supporting
documents
Frequency
Nature of care
Daily
Feed per individual

nutritional plan
Plans in individuals
folders on Comet
drive
(Record daily care in

database on Comet
drive)
Short flying exercise

routine
North Pole reindeer

exercise manual
Coat brushing
N/A
Weekly
Antler grooming
Hoof pedicure
Olafs Care and

Grooming of
Ruminants, Second
Edition
Nose polishing
(Rudolph only)
N/A
Monthly
Long flight exercise
North Pole reindeer

exercise manual
Annual
Checkup with chief

veterinary elf
N/A
Review of nutritional
plan
Plans in individuals
folders on Comet
drive
30
Olafs Care and

Grooming of
Ruminants, Second
Edition
Initial and date when

done and record
concerns for chief
veterinary elf
N/A

WI 7.3.7 Design Change Control
Elfin director of toy design
assigns team
Team leader distributes

specs and relevant data
to team
Compliance elf: Product safety and regulatory issues

Market research elf: New colors, features, fads
Purchasing elf: Availability of materials components
Manufacturing engineering elf: Need for changes to
routers/instructions
Assign research and

schedule review
Review results
Compliance
issues?
Yes
Refer to engineering
No
Colors, features,
fads issues?
Yes
No
Availability of
materials OK?
No
Yes
Need to change
routers?
Yes
No
Release to toy test lab for
mini validation
Results OK?
No
Yes
Release to production
31
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32

Santas Manual

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Denise Robitaille

About the Author

enise Robitaille is the author of numerous books on various quality topics.

Santa Claus, President

Santas Workshop Quality Manual

Santas Workshop Quality Manual

Santas Workshop Quality Manual

Prep sleigh and

Santas Workshop Quality Manual

Monitoring and Measurement

2nd and 3rd-party

Santas Workshop Quality Manual

ISO 9001 standard, is articulated in Santas Workshop Quality Policy.

Santas Workshop Quality Manual

and purchasing activities. Responsibilities include:

Availability of improved materials

Improved manufacturing capabilities

Safety and statutory requirements

Changes in the marketplace

Newly discovered colors

Santas Workshop Quality Manual

Internal audit reports

The review encompassesas appropriate to each meetingthe following activities:

1. Review of open items from previous meeting

Santas Workshop Quality Manual

during the holiday season.

organizations fulfillment of these objectives.

Santas Workshop Quality Manual

Justification for exclusion

Santas Workshop excludes

It does not provide any

from this section any language

and/or requirements that relate

Santas Workshop Quality Manual

Document and Data Control

Supplier Qualification and Monitoring

Receiving and Inspection

Control of Measuring & Test Devices

Reindeer Stable Maintenance

Christmas Tree Decoration

Receiving of Subcontracted Toys & Gifts

Design Change Control

Rocking Horse Fabrication

Teddy Bear Assembly

Sled and Toboggan Manufacture

Chemistry Kit Assembly

Santas Workshop Quality Manual

Department Store Santas

Woodshop Elf Level I

Woodshop Elf Level II

Woodshop Elf Level III

Machine Shop Elf Level I

Machine Shop Elf Level 1I

Machine Shop Elf Level 1II

Sewing and Needlework Basic Skills

Santas flight plan

Old revs archived

Old revs archived

Master elf of toy production

Printed weekly; updated daily

On Kringle drive. No one but Santa .

Reindeer care instructions

Master reindeer custodian;

Revise based on condition and health