PP SantasQManual

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.
Denise’s 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 20% 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, there’s still a lot of work to keep the elves busy.
Santa’s 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 Santa’s 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 Santa’s Workshop registered to ISO 9001.
In preparation for the pre-assessment audit, Santa has sent his organization’s 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 Santa’s
Workshop. See if Santa’s documentation is adequate and if it will pass a registrar’s assessment. Pick
up a few tips and a fresh perspective on documenting your own QMS from the jolly fellow at the
North Pole.
Santa’s Workshop
Quality Manual
A pproved: Santa Claus, President

Date: 10/24/09
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

Santa’s 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, Santa’s Workshop provides gifts to children of any
and all denominations, cultures, and ethnicities.
Customer-specified requirements are defined as those described in children’s letters, made while sitting
on Santa’s knee or expressed through comparable communiqus. 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 Santa’s “NICE” list. It is understood that inclusion on the “NAUGHTY” list prohibits
delivery of gifts or proportionately decreases quantity delivered.
1
Organizational Chart
Santa Claus
Elfin Director Senior Master Elf Chief

of Toy Design Purchasing Elf of Toy Financial
Production Officer
(Mrs. Claus)
Outsourcing
contract Steward of
supervisory elf letter-sorting
elves
Receiving/ Toy Sleigh and Elf training

inventory production reindeer
maintenance
2
Interrelation of Quality Processes

Customer
request
approved
Yes No
Refer to Purchase from
Manufacture
engineering approved
in-house?
outsource
Review design:
revise if needed
No Initiate
Supplier approval
on approved process
list?
Refer to Yes
engineering
Placer order
with approved
Check parts supplier
inventory
Purchase
materials
Receive and inspect

materials
Contact supplier
No refer for possible
corrective action
OK?
No
Component/
materials
Put in stock
stockroom
Finished Issue
goods? materials to
manufacturing
To finished goods
stockroom
Manufacture
toys
Prep sleigh and
reindeers
Inspect
Pull inventory/
stock sleigh
Deliver toys
3
Monitoring and Measurement Activities
Monitoring and Measurement

Activities
Audits Improvement Process Customer

initiatives monitoring feedback
Internal audits Corrective action Production Complaints

performance
2nd and 3rd-party Letters to Santa

Preventive action Scrap rate
audits
Market research
Supplier
performance
Nonconforming
material
Analysis
Management
review
4
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 Santa’s 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 children’s
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
5
❅ 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 Santa’s 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
6
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 encompasses—as appropriate to each meeting—the 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
7
Quality System
The scope of the quality management system is the design, manufacture, and distribution of gifts
during the holiday season.
Santa’s 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
Santa’s 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
organization’s fulfillment of these objectives.
8
Documents
and Procedures
9
Allowable Exclusions
The following ISO 9001 requirements are excluded from the scope of Santa’s Workshop’s quality
system.
ISO 9001 reference Requirement Justification for exclusion
7.5.1 Control of Santa’s 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
A 5/23/09 Initial release
B 2/14/09 Added description of

responsibilities for senior
purchasing elf
C 10/24/09 Included normative

references on page one
10
Master Document List
Procedures
Number Title Rev. Level Rev. Date
-- Quality Manual C 10-24-09
QP 4.2.3 Document and Data Control B 11-6-09
QP 4.2.4 Control of Records A 6-12-08
QP 6.2.2 Training D 11-22-08
QA 6.3 Equipment Maintenance C 10-17-09
QA 7.3 Toy Design F 11-6-09
QA 7.4.1 Supplier Qualification and Monitoring D 10-17-09
QA 7.4.2 Receiving and Inspection D 10-17-09
QA 7.5.1 Toy Manufacturing B 6-29-08
QA 7.5.5 Toy Packaging A 9-13-09
QA 7.6 Control of Measuring & Test Devices C 5-30-10
QA 8.2.2 Internal Auditing A 11-6-07
QP 8.3 Nonconforming Material B 6-12-09
QA 8.5.2 Corrective Action B 9-29-08
QA 8.5.3 Preventive Action B 9-29-08
Work Instructions
WI 6.3.1 Reindeer Stable Maintenance B 9-13-09
WI 6.4.1 Christmas Tree Decoration J 10-05-10
WI 7.4.3 Receiving of Subcontracted Toys & Gifts B 8-05-10
WI 7.3.7 Design Change Control B 11-6-09
WI 7.5.1.1 Dolly Construction A 6-25-07
WI 7.5.1.2 Wagon Assembly B 7-18-08
WI 7.5.1.3 Rocking Horse Fabrication B 7-18-08
WI 7.5.1.4 Teddy Bear Assembly B 8-29-09
WI 7.5.1.5 Sled and Toboggan Manufacture B 8-05-10
WI 7.5.1.6 Chemistry Kit Assembly F 8-05-10
11
Training Guides
TG 6.3 Stable Cleaning B 6-25-06
TG 6.4 Christmas Caroling C 1-29-10
TG 7.5.1.1 Department Store Santas C 11-03-09
TG 7.5.1.2 Woodshop Elf Level I A 6-25-06
TG 7.5.1.3 Woodshop Elf Level II A 6-25-06
TG 7.5.1.4 Woodshop Elf Level III A 6-25-06
TG 7.5.1.5 Machine Shop Elf Level I B 7-06-09
TG 7.5.1.6 Machine Shop Elf Level 1I B 7-12-09
TG 7.5.1.7 Machine Shop Elf Level 1II C 7-12-09
TG 7.5.1.8 Sewing and Needlework Basic Skills A 6-25-06
Other Documentation
Category Location or Owner Comments
Toy specification Blitzen drive
Santa’s 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
Form Number Form Name Rev.

F5.6 Agenda: Management Review B
F6.3.1 Reindeer Care Schedule A
F7.4.1 Vendor Self-Assessment A
F8.3.1 Nonconformance ID tag A
F8.3.2 Material Review Board (MRB) Record B
F8.5.2 Corrective Action Form B
12
Documents of External Origin
Number or Name
Category Location/Owner Comments
(if applicable)
ISO 9001: 2000 QMS standard ISO Rep Revision by issuing
body
(various) Equipment manuals Master elf of toy (for reference only)
production
Consumer Safety/statutory Elfin director of Accessed from official
Product Safety requirements toy design CPSC Web site
Commission
(CPSC) regs
Olaf’s Care Reindeer care Master reindeer

and Grooming custodian
of Ruminants,
Second Edition
OSHA documents Safety protocols Safety elf On shared drive

MSDS sheets Material safety Production area
The Corrective Guidance for Two copies in Kringle Re-order from Paton
Action Handbook problem solving Memorial North Pole Professional
Library. One copy
each production and
purchasing.
The Preventive Guidance for Two copies in Kringle Re-order from Paton
Action Handbook managing risk and Memorial North Pole Professional
potential problems Library. One copy
each production and
purchasing.
The Management Guidance on strategic Two copies in Kringle Re-order from Paton
Review Handbook planning and Memorial North Pole Professional
management issues Library. One copy
each production and
purchasing.
Document Guidance on how Two copies in Kringle Re-order from Paton

Control: A to keep track of Memorial North Pole Professional
Simple Guide Santa’s Workshop Library. One copy
to Managing documentation each production and
Documentation purchasing.
13
Number or Name
Category Location/Owner Comments
(if applicable)
Root Cause Guidance on Two copies in Kringle Re-order from Paton
Analysis: Basic problem-solving Memorial North Pole Professional
Tools and investigation Library. One copy
Techniques each production and
purchasing.
Managing Guidance on Two copies in Kringle Re-order from Paton

Supplier-Related purchasing, Memorial North Pole Professional
Processes outsourcing, and Library. One copy
monitoring suppliers each production and
purchasing.
PROCEDURE: QP 4.2.3 Revision: B
Document and Data Control
Approval: Santa Date: 11/6/09

Quality Approval: Mrs. Claus 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 Santa’s 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 Master elf of toy production
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 Santa’s 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

B 11/6/09 Added documents of external origin to master
document list
16
PROCEDURE: QP 4.2.4 Revision: A
Control of Records

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 Santa’s 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 Santa’s Workshop has identified records that need to be controlled and defined the method of
retention in the record retention matrix.
3.8 Santa’s Workshop complies with statutory requirements for retention and storage of records
relating to product safety.
17
Revision History
PROCEDURE: QP 7.4.1 Revision: D
Supplier Qualification and Monitoring
Approval: Bigelow, senior purchasing elf 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 Santa’s Workshop’s 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 Santa’s Workshop maintains an approved vendor list (AVL) for vendors, suppliers, and sub-
contractors who provide services and products that directly affect the workshop’s 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 Santa’s 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:
Method of
Method of monitoring
Criteria for qualification
Class Product/service (as appropriate to
selection (may be one or more
category)
methods)
1. • Outsourced • Ability • On-site visit • Delivery

processes, to fulfill • (After initial visit • Receiving records
including require- may accept copy • Certificates or final
fabrication of ments of certification to inspection reports
toys, games, • Delivery recognized QMS • Nonconforming
and gifts standard) material reports
• Training of • Response to corrective
department action requests
store Santas
2. • Raw • Ability • Copy of certification • Delivery

materials and to fulfill to recognized QMS • Receiving records
components require- standard • Certificates or final
• Reindeer food ments • Customer/associate inspection reports
• Delivery recommendation • Nonconforming
• Historical Material Reports
performance • Response to corrective
action requests
3. Services such • Ability • Copy of certification • Assessed at time

as calibration, to fulfill to recognized service is delivered
testing, and require- standard (Ex: ISO (observations noted
veterinary care ments 17025) in supplier file, by
• Availability • Customer/associate default only, record
recommendation of failure to provide
• Historical specified service)
performance • Response to corrective
action requests
19
Method of
Method of monitoring
Criteria for qualification
Class Product/service (As appropriate to
selection (may be one or more
category)
methods)
4. Machine parts/ • Price and • None • By default only;

supplies delivery 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 Santa’s Nice List and removal from the AVL.
4.0 Forms
7.1 F7.4.1 Vendor Self-Assessment

B 3/06/09 Removed description of purchasing activities to separate
procedure
C 6/12/09 Added chart to better explain process
D 10/17/08 Added 3.8 dealing with response to request for self-assessment
20
PROCEDURE: QP 8.2.2 Revision: A
Internal Auditing

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 organization’s 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 representative’s area.
22
PROCEDURE: QP 8.3 Revision: B
Control of Nonconforming Material
Approval: Randy, master elf, toy production 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
❅ Master elf of toy production
❅ 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 elf’s 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
Segregated location Process
detection
Incoming/receiving Designated area in • Receiving elf logs in receipt of material

(purchased material stockroom • QC elf initiates MRB form
and outsourced • Gives form to purchasing
finished goods) • Purchasing contacts supplier, dispositions
material, and records action taken on MRB
form
Purchased material Designated area in • Production group leader elf logs defective parts
detected at first point stockroom in Vixen database (found on Prancer drive)
of use (usually in • Stockroom elves issue replacement
production) 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
Segregated location Process
detection
In-process or at final Designated area in • QC level III elf logs defective parts in
inspection QC 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
B 6/12/09 Added chart to better explain process
25
Corrective Action

QP 8.5.2 Corrective Action
Identify problem
Evaluate situation
• Repair defect
• Quarantine inventory
• Contact vendor
Take appropriate • Scrap material
action
No CA
Monitor for required?
recurrence Yes
Take corrective
action
Assemble team
Conduct root cause

analysis
Develop plan of
action
Close out
Implement plan
No
Did it
work? Assess results
Yes

A 6/12/08 Initial Release
B 9/29/08 Added notation for appropriate actions
26
Preventive Action

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 Santa’s 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.
Defined
in what Verification Method of
Preventive
To prevent procedure, of Records reporting to
action
process, or effectiveness management
requirement
Equipment Equipment Various Internal Various Results

preventive failure maintenance audits, maintenance analyzed
maintenance manuals periodic forms (including
monitoring cost) and
by supervisor summarized
for manage-
ment review
Reindeer Sick Various Performance Reindeer Detailed

wellness reindeers on during dry- Care reports once
program Christmas runs and on Schedule a week,
Eve Big Night form F6.3.1A summarized
for
management
review
Min/max Material MRP Daily Inventory Data

inventory shortages, database production database summarized
levels late deliveries meetings and
to customers reported, if
appropriate,
during
management
review
28
Defined
in what Verification Method of
Preventive
To prevent procedure, of Records reporting to
action
process, or effectiveness management
requirement
Electronic Loss of data IT backup Management On electronic Not required

data backup and security review back up unless there
protocols media is a problem
Safety Injury, scrap, OSHA Number of Supervisor Not required

program liability manuals accidents & accident unless there
issues injuries reports is a problem
Other Addressing QP 8.5.3 Unique Unique Regular

preventive potential to each to each part of
action problems not preventive preventive management
initiatives identified action action review
through initiative initiative
established
processes
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
B 9/29/08 Added notation for OSHA programs
Reindeer Care Schedule
Initial and date when

Supporting done and record
Frequency Nature of care
documents concerns for chief
veterinary elf
Daily Feed per individual Plans in individuals N/A

nutritional plan folders on Comet
drive
(Record daily care in Short flying exercise North Pole reindeer
database on Comet routine exercise manual
drive)
Coat brushing N/A

Weekly Antler grooming Olaf’s Care and
Grooming of
Ruminants, Second
Edition
Hoof pedicure Olaf’s Care and

Grooming of
Ruminants, Second
Edition
Nose polishing N/A

(Rudolph only)
Monthly Long flight exercise North Pole reindeer
exercise manual
Annual Checkup with chief N/A
veterinary elf
Review of nutritional Plans in individual’s
plan folders on Comet
drive
30
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
Assign research and • Manufacturing engineering elf: Need for changes to
schedule review routers/instructions
Review results
Compliance Yes Refer to engineering

issues?
No
Colors, features, Yes
fads issues?
No
Availability of No
materials OK?
Yes
Need to change Yes
routers?
No
Release to toy test lab for
mini validation
Results OK?
No
Yes
Release to production
31
A Special Offer
From Santa
Surveying his customers, Santa knows you like a bargain. So Santa’s giving you 20% off all Paton
Professional books if you order online by Dec. 31, 2010.
Hurry—this is a limited-time offer. Your SANTA discount code is good on all orders placed now
through December 31, 2010.
To Save
1. Place your orders online at: www.patonprofessional.com
2. Simply enter the special promotional code SANTA when you check out. Your 20%
discount will automatically be applied to every one of the books you orde.
3 Call Santa’s helpers at (530) 342-5480 if you need any help with your order.
Thank you for being a Paton Professional customer—

we wish you a whole year of nice!
32

PP SantasQManual

Hochgeladen von

Dokumentinformationen

Originalbeschreibung:

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

PP SantasQManual

Hochgeladen von

Copyright:

Verfügbare Formate

Denise Robitaille

About the Author

A pproved: Santa Claus, President

Cover Page with Approval...................................................................................................... ii

Interrelation of Quality Processes................................................................................. 3

Monitoring and Measurement Activities Flowchart............................................. 4

Management Responsibilities and Review..................................................................... 5

Overview of Quality Management Review.................................................................... 7

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

requirements and to operating within a quality management system that conforms

holiday season. We are all responsible for quality.

Elfin Director Senior Master Elf Chief

Receiving/ Toy Sleigh and Elf training

Interrelation of Quality Processes

Receive and inspect

Monitoring and Measurement Activities

Monitoring and Measurement

Audits Improvement Process Customer

Internal audits Corrective action Production Complaints

2nd and 3rd-party Letters to Santa

Management Responsibilities and Review

❅ Staff training and personnel development (except administrative staff)

Overview of Quality Management Review

The review encompasses—as appropriate to each meeting—the following activities:

ISO 9001 reference Requirement Justification for exclusion

7.5.1 Control of Santa’s Workshop excludes It does not provide any

A 5/23/09 Initial release

B 2/14/09 Added description of

C 10/24/09 Included normative

Master Document List

Form Number Form Name Rev.

Olaf’s Care Reindeer care Master reindeer

OSHA documents Safety protocols Safety elf On shared drive

Document Guidance on how Two copies in Kringle Re-order from Paton

Managing Guidance on Two copies in Kringle Re-order from Paton

PROCEDURE: QP 4.2.3 Revision: B

Document and Data Control

Approval: Santa Date: 11/6/09

Documents Revision level and history

Documents Responsible personnel/department

Revision Date Nature of Change

PROCEDURE: QP 4.2.4 Revision: A

Approval: Santa Date: 6/12/08

PROCEDURE: QP 7.4.1 Revision: D

Supplier Qualification and Monitoring

Approval: Bigelow, senior purchasing elf Date: 6/12/08

3.0 Vendor qualification procedure

Supplier Classification and Qualification

1. • Outsourced • Ability • On-site visit • Delivery

2. • Raw • Ability • Copy of certification • Delivery

3. Services such • Ability • Copy of certification • Assessed at time

4. Machine parts/ • Price and • None • By default only;