Professional Documents
Culture Documents
TKO001000Manufacturers
manualTKO001000
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TABLE OF CONTENTS
Manufacturing and Assembly Operations-Manufacturing Operations Plans and Goals
Our manuafacturing system overview
Manufacturing Goals and objectives
New Products
Internal and external R&D
Test Market
Supply Chains
Develop Production and Material Strategies
Supplier Management
Select Suppliers
Confirming Receipt of Goods and Conformity of Supply
Goods Received Conformance
Warehousing
Handling Policy
Physical Inventory
Product Storage
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Our manuafacturing system overview
Authors Helper notes
· Replace sample text bounded by [] square brackets with your own content
· Remove any of the authors helper text coloured RED where required
· Delete these helper notes from your documents when finished
Units produced xx xx xx
other xx xx xx
Qualitative goals
Recalls as a percentage % % %
of products sold
Purpose
· Identify accurately Customer Property
· Secure Customer Property
Background
A significant cause of customer dissatisfaction is when their property is not effectively cared
for or is lost.
Scope
Procedure
(WHO) is responsible for logging customer property to the customer property register
The company has provision in its insurances for "Customers Property in Care Custody and
Control" adequate to cover such property
Customer property is stored (WHERE) before being worked on and (WHERE) after being
worked on pending collection
Outcome
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Production System Access
Purpose
The purpose of this policy is to define proper controls to production systems and
applications. This policy also ensures that any changes made to the production system are
documented.
Background
Limiting access to production systems and applications is a significant aspect of security and
integrity of the [enter-your-company-name-here] computing resources. Unrestricted access
to production systems and applications could adversely impact [enter-your-company-name-
here]’s business and financial's.
For this reason, access to production systems and applications is strictly controlled.
Scope
The scope of this policy applies to non-end users who have access to [enter-your-company-
name-here]’s internal production systems and applications.
Definitions
· Technology Resources - [enter-your-company-name-here]’s technology resources
comprise of computing, networking, and software applications that can be accessed by
authorised [enter-your-company-name-here] users.
· User - For the purposes of all Information Security Policies, a user is defined as anyone
with authorised access to [enter-your-company-name-here]’s technology resources
including permanent and temporary employees or third party personnel such as
contractors, consultants, and other parties with valid [enter-your-company-name-here]
access accounts.
Procedure
Production Support
Production Support at [enter-your-company-name-here] includes the following
elements:
· The Network Operations Center (NOC);
· Elements of the IT Operations Group whose primary responsibility is production support;
· Elements of the IT Applications Group whose primary responsibility is production
support.
Production Support is responsible for monitoring and maintaining all production systems and
networks.
Accounts Administrator
The Accounts Administrator ensures that all properly requested changes to user accounts
are carried out in an appropriate and timely manner, and that all the required procedures
are followed.
Administrator
An Administrator is anyone designated by [enter-your-company-name-here]’s IT
Management that may have controlling access to some facets of the operating system,
databases, application-platforms, or applications for which they are responsible.
Administrators are responsible for ensuring that user access to sensitive settings or data is
restricted to authorised activity levels and for ensuring that security of the data and
integrity of the application is maintained at all times.
Developer
Developers, including Business System Analysts, develop code or operations to be run on a
production system and may have some production access.
Business Owner
The Business Owner provides approvals and reviews of access on a periodic basis for their
area of ownership.
Section 4 Exceptions
Requests for policy exceptions must have a valid business justification. The exception must
be documented and approved by the system owner or department manager. Information
Security Services will evaluate, approve and store exception requests.
NOTE: Each exception request must be justified, documented, and approved separately. ISS
maintains the right to deny any exception from this policy.
Section 5 Enforcement
Network activities may be monitored and logged to ensure compliance with the rules
established in this and other ISS policies, procedures, standards, and guidelines.
Any user found to have violated this policy may be subject to disciplinary action, up to and
including termination of employment, or legal action as appropriate, or both. No provision of
this policy will alter the at-will nature of the employment relationship at [enter-your-
company-name-here].
Section 6 Policy Update and Notification
[enter-your-company-name-here] reserves the right to revise the conditions of this policy at
any time by giving notice. Users are responsible for understanding or seeking clarification of
any rules outlined in this document and for familiarising themselves with the most current
version of this policy.
Inspecting and Testing
Purpose
The purpose of this procedure is to ensure that materials and products are inspected and
tested for conformance or non-conformance before a product is released, used or installed.
Background
Documented procedures shall be established and maintained to ensure all materials and
products used in the manufacturing process are inspected and tested prior to use and
release.
Scope
This policy applies to the testing of materials and products used in the manufacturing
process, including product received from suppliers, in-process product and/or final product.
Definitions
“Responsible Manager” means the individual directly responsible for ensuring a high quality
organisation by complying with policies or procedures.
Procedure
Inspection and Testing – General
5. All products and materials used in the manufacturing process shall be identified and any
required test criteria identified. Inspection may be visual, functional, dimensional,
specification or other.
6. An inspection and testing sample plan shall be prepared, identifying number, frequency
and type of test required.
7. Identified products shall be tested and results recorded prior to release, use or
installation.
8. All incoming material and product shall be received in accordance with What do we do
with Defective Product. Received product and materials that do not pass receiving
and/or testing shall not be released to manufacturing.
9. Test records shall identify the test method, test criteria, result, test status and person
conducting the test, at a minimum.
10.Tested product and material shall be clearly labelled or segregated to differentiate it
from untested or un-inspected product and material. A tab, label, traveller, checklist,
lot or other appropriate method may be used to document the status.
11.Products and materials tested and found to be non-conforming must be clearly identified
and placed in a specified area labelled for non-conforming material to avoid any mix-
ups. See What do we do with Defective Product.
12.Personnel performing identified tests shall be trained on the equipment and test method.
Training records shall be maintained and the re-certification cycle identified.
Purpose
Agree on key deliverables in the customers requirements and document them
Background
· Creating and agreeing on the REQUIREMENTS for a project is only part of the story
(what the project is going to do - is the important part!)
· It’s equally important to agree what the BOUNDARIES are of any undertaking and these
must show what the project is NOT going to do.
· These elements are bound together and are called the Project Scope Statement which
details the project objectives, end-products (deliverables), and requirements.
· The Scope must be agreed with all concerned, and used to create the project plan
‘baseline’. Once agreed, the scope sets the expectations of all stake holders so they are
clear about what they are going to get when the project is finished.
· The last thing we want is a disagreement at project hand over about what we have or
haven't done – and what was expected.
· Many projects fail - not because Requirements were not met - but because of difference
of opinion about what the project was to deliver.
· Most projects are triggered by some form of requirements document. These are central
to success and lead to the project developing some form of functional specification
against which the project outcome is designed. But not enough effort is spent getting a
joint agreement on these documents, and that is where a scope planning and scope
development play a key part.
· "Scope creep" is seen as an industry-wide evil, instead as being viewed as the natural
corollary to change control.
· There is a little-known technique that beats all others hands-down for laser-focussed
scope planning and development.
· It's this. At the very beginning of project planning, agree what the end-product along
with the major products are to be.
Scope
[e.g. who will this apply to]
Procedure
· Project Objectives – what the project is to do. These should be quantified and
measurements agreed. Typically the measurements will include one or more of, cost,
time scale, quality, or business benefits. You will have heard of the SMART acronym for
each objective: Specific, Measurable, Accurate, Realistic and tangible, Time bound (time
frame plus date).
· Deliverables (End-Products). Each should have a Product Description written. This
contains descriptions of the purpose, composition, derivation, and the quality criteria for
it to be acceptable to the customer.
· Requirements. This is a specific skill, almost certainly done by specialist team, the
customer, users, etc. But it is the responsibility of the project manager to make sure
they are captured and agreed. Requirements quantify and prioritise the wants, needs
and expectations. They may also describe some aspects of functionality of the project
deliverables.
· Project Boundaries. Care must be taken here. This should focus on what is to be
excluded from the scope in terms of requirements, objectives, and deliverables. It’s a
good idea to create a draft boundary document and circulate it for comments. Or
perhaps generate the document from within a meeting with key stake holders.
· Product Acceptance Criteria. This should document the WHAT and the HOW that will be
carried out as part of agreeing successful project closure. It must be the Customer/Users
perspective. The actual criteria used can be taken from a wide choice of aspects, and
may include elements such as ease of use, reliability, operating costs, performance data,
etc. This should also include HOW the objectives, deliverables and other outcomes of
the project are to be approved.
· Constraints. All projects have constraints – often put there by humans – sometimes by
the rules of physics! A constraint is anything which impedes the project team's work.
The obvious choices may include, time, cost, quality, key milestone dates or logistics,
standards, procedures, directives, compliance, legal and law, health and safety,
technology, etc. Whatever. Get them down and agreed – then plan accordingly.
· Assumptions. In a nutshell, anything you believe to be true. Do not use this section to
capture a load of disguised risks (although stated assumptions may lead to generated
risks). Documenting them at the start of a project helps test these assumptions and get
them agreed. Should these assumptions prove to be false at a later date, these
captured statements can be used as a basis to plan and manage the way forward.
· Project Organisation. Well, as it is initially – it is likely that changes may be necessary to
the roles and responsibilities assigned to individuals.
· Initial Risks. Any known risks at this time. It is helpful to include an initial risk analysis
so that readers can get a ‘feel’ for each risk.
· Milestones. These may be externally dictated and/or internally created as a result of
planning by the project manager. Be sure to have them represent significant points of
achievement (or key decision points such as an end-stage assessment).
· Funding Limitations. This is different to cost constraints. It refers to the availability of
money to finance the project, and this may have an impact on cash flow. It may state
key dates when funds are available, these may be dictated by certain completion
criteria, and it also state the amount of funds released at a given point.
· End Product Description. This should include the quality criteria for the product to be
acceptable for the customer/user.
· Specification Document. This is usually derived directly from the Requirements
document. It is usually highly detailed and created by the specialist team along with
input from the customer and users.
·
Confirming Scope of Order
Purpose
To process orders in requirement with the customers orders
Background
This procedure may or may not be necessary as a separate procedure for your business...
You should always have some checking mechanism to ensure that customers orders are
processed accurately and according to requirements.
The degree of emphasis you place on this procedure will vary according to your product
value and processes. For ideas refer to the process for tenders and quotes for large orders.
Scope
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Procedure
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What do we do with defective Product
Purpose
Ensure that product which is defective or non-conforming is dealt with effectively.
Background
This procedure is similar to the procedure for dealing with defective supply in purchasing.
Scope
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Procedure
· Inspection and testing reveals product is defective or non-conforming
· Product is set aside (WHERE?)
· Product is tagged or clearly marked "DEFECTIVE - NOT TO BE USED"
· Arrange for product to be disposed of
· Note in Defective product log
Steps
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Identifying Root Causes when things go wrong
Background
Proper root cause analysis identifies the basic source or origin of your problem. Root cause
analysis is a step by step approach that leads to the identification of a fault's first or root
cause. Every system, equipment, or component failure happens for a reason.
There are specific succession of events that lead to a failure. A root cause analysis
investigation follows the cause and effect path from the final failure back to the root cause.
Procedure
What happened Caused by
[e.g product failed to be delivered] [e.g delivery docket was not sent to dispatch, but merely
passed over the phone]
Suggested Improvements
[] []
Suggested Improvements
[]
[] []
Suggested Improvements
[]
[] []
Suggested Improvements
[]
Purpose
To properly handle the delicate task of recalling goods
Background
Recalling goods is a delicate task and needs to be handled openly and professionally.
Scope
(who)
Procedure
Steps
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Internal and external R&D
Purpose
Manage R&D processes to ensure:
· Scope of R&D not exceeded
· Proper accountability
· Effective deliverables
· Return on Investment measurable
· Correct record keeping
R&D TIMING
· First mover
· Follower
How?
· Formal or informal process
· Use prototypes
· Use product test
· Use design reviews
· Use test markets
· How to implement new design
· How to evaluate success of new design
External partners conducting R&D on our behalf
Who R&D being conducted
[] []
Test Market
Purpose
In this procedure, management conducts market testing to complete alignment of product
to market and company strategy.
The procedure starts with prototype release of product and ends with release of the product
to market.
Background
Whilst early research and market review will have indicated a requirement for this product,
as the product is preparing for release to market, it is necessary to confirm the product's
truly meets market requirements and obviously take such action as is necessary to align the
product to the company strategies and market requirements.
Scope
R&D, Management
Procedure
What procedure and/or rules apply?
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Receiving Orders
Purpose
Identify effective processes for receiving orders from customers to:
· ensure customer satisfaction
· eliminate wastage and rework
· ensure professional, effective and timely responses to requests
Outcome
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Preparing Order
Outcome
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Product Despatch and Delivery
Purpose
The purpose of this procedure is to ensure that product and materials shipped to customers
arrives correctly with quality uncompromised and that any product damaged during transit
is addressed.
Background
Product quality shall be maintained on all shipped product and materials to domestic and/or
international customers during delivery
Scope
Applies to product and materials being delivered from the company to either internal or
external customers.
Definitions
· “Packaging” means the final product shipping container, packing material and the
marking on the container.
· “Carrier” means a commercially available transportation specialist, such as a courier
service or trucking firm.
· “Handler” means the person who arranges product for delivery or receives,
manufactures, moves, stores or packages the product.
· “FOB” means Free On Board, a protocol for shipping goods in which the supplier bears
the risk associated with safe delivery of the goods up to the point where the goods are
passed into the hands of the shipper.
· “CIF” means Cost, Insurance and Freight, a protocol for shipping goods in which the
supplier bears the risk associated with the safe delivery of the goods up to the shipping
destination.
· “DDP” means Delivered Duty Paid, a protocol for shipping goods in which the supplier
bears the risk associated the safe delivery of the goods to the customer and also
ensures their safe delivery through customs, including loading and unloading fees,
import licensing and related duties payments.
· “Responsible Manager” means the individual directly responsible for ensuring a high
quality organization by complying with policies or procedures.
Procedure
Delivery – General
41.Subcontracted delivery carriers shall be identified through an approved vendor
evaluation process. See Supplier Management.
42.Common carriers shall be considered acceptable for delivery unless there are special
delivery requirements.
43.Finished products/goods awaiting delivery shall be stored in a designated area to avoid
mix-up with other products in accordance with Product Storage.
44.All product and materials for delivery shall be packaged in accordance with Packaging.
45.Deliveries are [FOB].
46.Damaged product received by customers shall be addressed as required. See Customer
Complaints. For damages resulting from transit, the delivery carrier shall maintain
liability and return the damaged product to the company.
47.Any damaged product returned to the company shall not be distributed for sale until
inspected and if suitable, released for distribution by the Responsible Manager.
Special Delivery
48. Special delivery procedures shall be used as determined by the Responsible Manager.
49.Special delivery procedures shall be prepared and implemented for delivering materials
that may be biological, radioactive, explosive, flammable, highly pressurised, corrosive
or reactive.
50.Proper training shall be implemented, as required, when following special delivery
procedures, to ensure a safe level of delivery.
51.Special delivery may be required for temperature-sensitive or time-sensitive materials
and product.
52.All special delivery conditions shall be clearly identified and communicated with the
delivery carrier in advance.
Packaging
Purpose
The purpose of this procedure is to ensure that packaging methods are undertaken to
prevent damage and/or deterioration. In addition, packaging shall be used to ensure lot
integrity, prevent contamination and ensure product traceability.
Background
Documented procedures shall be established and maintained to ensure packaged product is
not damaged or altered.
Scope
Applies to product and materials during manufacturing, warehousing, shipping and delivery
to internal and external customers.
Definitions
· “Packaging” means the product shipping container, packing material and the markings
on the container.
· “Carrier” means a commercially available transportation specialist, such as a courier
service or trucking firm.
· “Handler” means the person who arranges product for delivery or receives,
manufactures, moves, stores or packages the product.
· “Responsible Manager” means the individual directly responsible for ensuring a high
quality organization by complying with policies or procedures.
Procedure
Packaging – General
53.Where possible, packaging solutions as recommended by the carriers shall be considered
acceptable unless special packaging is required.
54.Only product approved for release shall be distributed to customers.
55.The package shall be clearly identified with the following information:
56.shipping destination
57.company name and full return address
58.Special handling conditions, if required
59.Identifying number for traceability (e.g., Purchase Order number)
60.Markings and labels shall be legible, durable, in the required language(s) and tamper-
resistant.
61.Packaging instructions shall be prepared by the Responsible Manager. These
instructions shall include information on cushioning, blocking, crating, cleaning and
preserving (i.e., moisture elimination), as required.
62.The Handler shall verify the shipped contents against the relevant documentation (e.g.,
packing list or bill of lading) before sealing the package.
Special Packaging
63.Special packaging procedures shall be used as determined by the Responsible Manager.
64.Where customized packaging materials and/or containers are required, they shall be
designed and constructed to protect the product from alteration or damage during
distribution, storage and handling.
65.Special packaging procedures shall be prepared and implemented for handling materials
that may be biological, radioactive, explosive, flammable, highly pressurised, corrosive
or reactive.
66.Proper training shall be implemented, as required, when following special packaging
procedures, to ensure a safe level of packaging and handling.
67.Special packaging may be required for temperature-sensitive materials and product.
Heat-sensitive items under temperature control shall be monitored as required.
Develop Production and Material Strategies
Purpose
To identify broad strategies for production and materials management
Scope
This applies to Supply Chain Staff
Procedure
When developing this procedure, address the following perspectives:
· Define your manufacturing goals
· Consider your policies around Labour and Materials
· Define any Outsourcing Policies
· Consider your capital expenses approach relating to manufacturing plant and equipment
· Review your manufacturing capabilities, production network ability and supply
constraints.
Outcome
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Supplier Management
Purpose
The purpose of this procedure is to ensure that the company obtains the best possible
combination of quality and price from its suppliers.
Background
Comprehensive records will be maintained for all major suppliers. All suppliers will be
subject to periodic review to verify that they provide the best combination of quality and
price.
Scope
Applies to the purchasing department.
Definitions
· “Electronic Supplier Records” means information about all transactions, contacts, and
contracts with suppliers maintained in a database or other electronic format.
· “Supplier Payment Terms” means specific requirements for payments laid out in the
supply contract including timing of invoicing, time to pay and interest charges if
payment is delayed.
· “Supplementary Purchase Order” means a purchase order that relates to or modifies a
previously-issued purchase order.
Procedure
Purpose of Supplier Records
72.Good supplier records track locations, contact names and numbers, payment
preferences, contract provisions, purchase order and payment history as well as any
quality issues that may have arisen.
73.Electronic supplier records may be used as an electronic source for the completion of
purchase orders and for processing payables.
Periodically,
79.Purchase history by supplier shall be analysed for possible economies
80.Prices, discounts and payment terms shall be compared to those of alternate suppliers
81.Negotiations shall be undertaken with current or prospective suppliers to obtain better
prices, discounts and payment terms
82.Opportunities for supply contracts offering the best terms shall be identified
83.Information about preferred suppliers, new suppliers and good deals shall be provided to
operating departments to keep them abreast of purchasing opportunities
Purpose
· Select suitable suppliers
· Comply with agreed standards.
· Purchase competitively.
Procedure
ASSESSING SUPPLIERS
Suppliers include both material suppliers and service providers.
SUPPLIER LIST
Include details of preferred suppliers on the Supplier List.
list goes here
Suppliers of critical materials and services, should be qualified with reference to:
· agreed / special prices
· compliance with agreed Standards
· Whenever possible, preference must be given to suppliers on the Supplier List.
·
Confirming Receipt of Goods and Conformity of Supply
Purpose
· Ensure that product received has actually been received
· Ensure that product received conforms to our requirements
· segregate product that does not conform
Background
If appropriate we can request the right to inspect products and services at the supplier's
premises, at agreed stages.
Where specified, our customers may also be given the right to verify at our supplier's
premises, that the product to be supplied confirms to their specified requirements.
Scope
Good Receivable and Accounts Payable Staff
Procedure
Receive Materials
· check against delivery docket/purchase order
· initial delivery docket
· staple delivery docket to purchase order and hand to accounts payable
Inspect
· check quantity
· check damage
· check specifications
· check for documentation (MSDS or other)
Steps
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Goods Received Conformance
Purpose
The purpose of this procedure is to ensure that all incoming materials and products are
inspected and received in a consistent manner prior to processing.
Background
All incoming product and material shall be inspected and verified for conformance to
specified requirements prior to use or processing
Scope
The Receiving policy applies to all employees who receive products and materials at any
stage of production.
Definitions
· “MSDS” means Material Safety Data Sheet. This is designed to provide both employees
and emergency personnel with the proper procedures for handling a particular
substance. MSDSs include information such as physical data (melting point, boiling
point, flash point etc.), toxicity, health effects, first aid, reactivity, storage, disposal,
protective equipment, and procedures to be followed in the event of a leak or spill.
· “Certificate of Analysis” means a supplier-provided statement of the incoming
product’s specification as detailed in a contractual arrangement.
· “Handler” means the person who arranges the product for delivery or receives,
manufactures, moves, stores or packages the product.
· “Requisitioner” means the person who originally requested the received goods and
materials and is typically the intended recipient of the package.
· “Responsible Manager” means the individual directly responsible for ensuring a high
quality organization by complying with policies or procedures.
Procedure
Receiving – General
88.All product and material(s) must be received either electronically or manually with a
signature and date on the bill of lading .
89.All received packages shall be inspected for:
a. Completeness
b. Handling damage
c. Transportation damage
d. Deterioration
e. Documentation
f. Accurate paperwork
90.In addition, specified materials and products shall also be inspected for conformance to
specified requirements.
91.Received products and materials shall be placed in secure and safe storage.
92.Receiving areas shall be clearly identified for incoming goods or forwarded to the
recipient within [X] hours. Non-conforming product and material shall be placed in a
designated area or quarantine.
Non-conforming Product
94. Product and materials found to be non-conforming during receiving must be identified
with a label and handled in accordance What do we do with Defective Product
95.
Handling Policy
Purpose
The purpose of this procedure is to ensure that methods are instituted to prevent damage
and/or deterioration when handling product and materials. The Handling procedure applies
to product and material from initial receipt until final shipping and delivery.
Background
The handling of products and materials shall be monitored and controlled from the point of
receipt, through storage and shipping.
Scope
Applies to product while on company property during manufacturing, warehousing and
shipping.
Definitions
· “Handler” means the person who arranges product for delivery or receives,
manufactures, moves, stores or packages the product.
· “Responsible Manager” means the individual directly responsible for ensuring a high-
quality organisation by complying with policies or procedures.
Procedure
Handling – General
96.Standard handling practices shall be considered acceptable unless special handling is
required.
97.Handling through manufacturing and warehousing shall:
a. Preserve lot integrity
b. Prevent mix-ups
c. Protect from damage and/or deterioration
d. Prevent contamination or other adverse effects
e. Prevent unauthorized release
98.Care shall be taken when handling product to prevent any damage and/or deterioration.
Special Handling
99.Special handling procedures shall be used as determined by the Responsible Manager.
100. Special handling procedures shall be prepared and implemented for handling
materials that may be biological, radioactive, explosive, flammable, highly pressurised,
corrosive or reactive.
101. Proper training shall be implemented, as required, when following special handling
procedures, to ensure a safe level of handling.
102. Special handling may be required for temperature-sensitive materials and product.
Heat-sensitive items under temperature control shall be monitored as required.
Physical Inventory
Purpose
This purpose of this procedure is to provide guidance for [enter-your-company-name-here]
and its subsidiaries regarding the need to take regular physical inventories of the
Company’s raw material, work in process, finished goods, and stores inventories.
[enter-your-company-name-here] uses various types of inventory in the course of its
business. Maintaining adequate controls over inventory is important to ensure proper
balance sheet valuation and recognition of cost of products sold.
Additionally, a physical inventory provides the Company with an opportunity to maintain the
accuracy of its perpetual inventory records
Background
This procedure assures that one un-audited semi-annual and one audited annual physical
inventory should be taken of raw materials, work in process, and finished goods.
Procedures should ensure that all physical inventory results are summarised, discrepancies
are investigated, and necessary adjustments are recorded to adjust the balances on the
Company’s records to reflect the results of the physical inventory.
Cycle counts or other periodic verifications can be used in place of an inventory, as long as
they provide for the counting of all groups of inventory at least once during the year. In
the event a business elects to utilise cyclical counts in lieu of a complete inventory, the
business is required to request and receive approval from the Accountant.
The taking of a physical inventory must be properly supervised and controlled by the
Accounting department.
At least one physical inventory should be taken in close proximity to year-end and
coordinated with the independent external auditors’ mutual agreement.
Scope
Accounts covered by this procedure include Raw Materials, Work in Process, Finished Goods,
and Stores Inventory.
Procedure
The following procedures are intended to assist the business in applying this procedure. The
procedures are not intended to address specific control activities applied by the business or
statements of operating procedures.
The intent is to provide supporting guidelines to assist operating units in developing
necessary activities to ensure that the procedure is understood and being followed.
Inventory should be maintained in a manner that facilitates physical counting and should be
conducted by personnel who are familiar with the inventory being counted.
In cases in which a second team recounts inventory, the recount should be promptly
reconciled to the initial count and all differences reconciled.
All sheets or tags used during the physical count should be accumulated and accounted for
before completion of the inventory of a specific area. A process, such as sequential
numbering, should be utilised to assure all physical inventory documents are accounted for.
Purpose
The purpose of this procedure is to ensure that stored product and materials are not
damaged or altered prior to use or delivery. Storage procedures apply to product and
material from initial receipt until final shipping and delivery.
Background
Only designated storage areas shall be identified and used to prevent damage or
deterioration of the product pending use or delivery.
Scope
Applies to product and materials while on company property during manufacturing,
warehousing and shipping.
Definitions
· “Handler” means the person who arranges product for delivery or receives,
manufactures, moves, stores or packages the product.
· “Responsible Manager” means the individual directly responsible for ensuring a high-
quality organisation by complying with policies or procedures.
Procedure
Storage – General
103. Standard warehousing storage conditions shall be considered acceptable unless
special storage is required.
104. Storage through manufacturing and warehousing shall:
a. Preserve lot integrity
b. Prevent mix-ups
c. Protect from damage and/or deterioration
d. Prevent contamination or other adverse effects
e. Prevent unauthorised release
105. Inventory shall be kept in a secure location that is locked when not in use.
106. For product that deteriorates over time, the product shall be stored to facilitate
proper stock rotation. Expiry dates for product shall be clearly marked. In addition,
the condition of the product in stock shall be assessed at appropriate intervals.
107. Where possible, labelling in storage areas shall identify the contents and any
relevant physical characteristics (e.g., expiry date, temperature limits).
108. If storage areas other than designated areas (warehouse, laboratory and
manufacturing area) are used, the Responsible Manager shall designate these areas and
specify any limitations and/or restrictions on storage.
109. Access to the storage and/or stock room shall be restricted as noted. [Add any
affected job descriptions and/or security clearances].
110. If a problem is identified during the manufacturing process, any affected parts shall
be identified and segregated in accordance with What do we do with Defective Product.
Special Storage
111. Special storage procedures shall be used as determined by the responsible manager.
112. Special storage procedures shall be prepared and implemented for storing materials
that are biological, radioactive, explosive, flammable, highly pressurised, corrosive or
reactive.
113. Proper training shall be implemented, as required, when following special storage
procedures, to ensure a safe level of storage.
114. Special handling and storage may be required for temperature-sensitive materials
and product. Heat-sensitive items under temperature control shall be monitored as
required.
Manufacturing - list of attached files
Corrective_Action_Required.doc
Incident_Report_Form.doc