Company Name
Division or Address
Division or Address
Process Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 1 of x
ISO Procedure
Process Control
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
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Company Name
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Division or Address
1.
2.
Process Control
Doc. No.
Date: 6/28/2016
Rev. No.
Page 2 of x
Purpose
•
To control process through appropriate approvals, verification, and
documented instructions and through adequate documentation and
training.
•
To prepare for the production of a part or product by generating a work
order for the production and by ensuring delivery of parts, the work order
(with necessary documentation), and any machine instructions.
•
To schedule production of assemblies and subassemblies to meet
anticipated customer needs, as determined by sales and marketing.
•
To initiate a change in a process that is not meeting 100% quality by
providing a mechanism to deviate temporarily from accepted standards
for materials, processes, components or products and a means by which
any employee can stop a process or shipment when 100% quality is not
being achieved.
Scope
This procedure applies to:
3.
•
the manufacture and assembly of piece-part, subassemblies, and final
assemblies from the issuance of a work order through package.
•
the rework of nonconforming product.
•
temporary changes to the manufacture process which may be required
when parts are no longer available or the design of a part requires change
due to an improper fit or malfunction.
Responsibilities
<Job title> creates the routings, bill of materials, and approves ECOs; assembles
ECO kits and updates associated documents. <Job title> revises drawings and
specifications when the process requires change due to improper fit or the
malfunction of an assembly or subassembly.
<Job title> maintains the drawings, prints, and specifications and attaches these
documents to the work order, ensuring the current revision levels of the
attachments.
<Job title> provides on-the-job training.
<Job title> supervises the assembly and ensures controls are in place.
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Division or Address
Process Control
Doc. No.
Date: 6/28/2016
Rev. No.
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<Job title> plans production and ensures appropriate inventory levels.
<Job title> issues work orders outlining the sequence of manufacturing steps
required for the completion of each manufacturing job.
<Job title> orders raw materials listed on the Materials Requirement Plan.
<Job title> ensures that the quality levels required by contract specification are in
place and that compliance to documentation is met.
<Job title> inspects operations, assemblies, and subassemblies that are
manufactured or processed to ensure that the product meets the product
specification.
<Job title> controls a temporary change to the process.
4.
Procedure
4.1
Written Procedures
See Document and Data Control, xxx.
<Job title> develops the written manufacturing procedures, determines
the required equipment, and determines the required operator skills.
The procedures indicate workmanship criteria using <items> which are
under document control. <Job title> is responsible for maintaining the
examples of workmanship. <Job title> is responsible for ensuring only
the current revision is distributed to the shop floor.
The following is a list of documentation used for process control and the
person responsible for the document.
Documentation
Engineering drawings
Functional specs
Instruction sheets
Manufacturing Engineering Instructions
Routings
Bill of Materials
Test Specifications
Work Instructions
Engineering Change Notice
NC machine instructions
Setup Sheet
other
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Division or Address
4.2
Process Control
Doc. No.
Date: 6/28/2016
Rev. No.
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Training
See Training, xxx.
<Job title> provides training. Trainers are certified through <activity>.
The <name of training record> identifies <items>. <Job title> approves
and signs the training record. The training record is stored <location>.
Operators are trained <activity>. <Job title> certifies that an operator is
qualified to assemble parts. The following lists the classification of skill
level:
•
<list>
•
<list>
•
<list>
Special training is provided for <items>. The training involves
<description>. <Job title> certifies that special training has been received.
4.3
Control of Environment
The following indicates the areas in which controls are in place and the
type of control.
Area of Control
ESD
temperature / humidity
waste disposal
protective apparel
other
4.4
Implementation
ESD mats, wrist straps, heel straps
Control of Equipment
See Inspection, Measuring, and Test Equipment, xxx
The process machinery carries the following compliance <list>. <Job
title> maintains the records of compliance. The records of compliance are
stored <location> for <length of time>.
The following equipment requires evaluation prior to being used
<equipment>. Records verifying the evaluation are maintained by <job
title> and are stored <location> for <length of time>.
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Process Control
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<Job title> is responsible for preventive maintenance on the equipment.
Records of preventive maintenance are maintained by <job title> and are
stored <location>.
When necessary <job title or source> is responsible for ensuring the
repair of equipment.
4.5
Process Revision Control
<Job title> can initiate a change to a part or process by completing the
<name of form>. <Job title> approves the form.
Responsibility to resolve the problem is assigned at <activity> to be
resolved <timeframe>.
<Job title> is responsible for resolving the problem. <Job title> reviews
and approves the resolution. <Name of record> indicates the resolution.
The <name of record> is stored <location>.
<Job title> is responsible for ensuring changes to affected documentation.
<Job title> can initiate a temporary change when necessary due to
<activity>. <Job title> completes the <name of form> to initiate a
temporary deviation. <Job title> approves the <name of form>. The
<name of form> is stored in <location> for <length of time>.
4.6 Temporary Deviations
If temporary deviations need to be converted to permanent changes, <job
title> approves the permanent change. Permanent changes are indicated
on <documents>.
When necessary, temporary deviations are extended. <Job title> approves
the extension.
<Job title> maintains a status report of deviations. The <name of status
report> indicates <items>. <Job title> reviews the status of deviations
and reviews expired deviations to determine closure.
4.7
Production Hold
<Job title> has authority to initiate a hold to production or shipment
because of a problem.
To initiate a stop to production <job title> completes the <name of form>
and enters the following information: <data>.
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<Job title> approves the form. <Job title> stores the <name of form> in
<location> for <length of time>.
<Job title> logs the <name of form> into the <name of logbook>.
<Job title> issues the stop to production within <timeframe>. <Job title>
is responsible for resolving the problem. The <name of record> indicates
the result of the corrective action.
<Job title> is responsible for resuming production.
<Job title> measures the progress of the resolution through <activity>.
4.8
Verify Process
See Inspection and Test, xxx and Corrective and Preventive Action, xxx.
Steps in the process are verified through <activity>. The verification
quantity is <quantity>. <Frequency>, <job title> is responsible for
verifying the work and checks <list>.
<Job title> completes the <name of record> to indicate verification. <Job
title> approves the inspection record. <Job title> is responsible for storing
<name of record> in <location> for <length of time>.
The following data is collected on problem processes: <type of data>.
<Job title> reviews the data. <Job title> audits processes according to an
audit plan. Corrective actions follow the corrective action process.
Where applicable, <job title> verifies processes to assess compliance to
reference standards and codes, to evaluate implementation of quality
plans, and to determine adequacy and accuracy of written procedures.
4.9
Special Processes
The following special processes are used in production: <processes>.
<Job title> generates written procedures that are controlled by
<department>.
Special processes are verified by <activity>.
<Job title> provides training for special processes. The <name of record>
identifies the completion of training. <Job title> signs the training record.
<Job title> stores training records in <location> for <length of time>.
5.
Related Documentation
<Production Plan>
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Process Control
Doc. No.
Date: 6/28/2016
Rev. No.
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<Materials Requirement Plan>
<Master Production Schedule>
<Training Record>
<Work Instructions>
<Discrepant Materials Report>
<Inspection Data Sheet>
Document and Data Control
Inspection and Testing
Inspection, Measuring, and Test Equipment
Inspection and Test Status
Control of Nonconforming Product
Corrective and Preventive Action
Handling, Storage, Packaging, Preservation, and Delivery
Quality Records
Internal Quality Audits
Training
Statistical Techniques
<list work instructions>
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