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Main modifications
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The Changes
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The obvious . . .
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HOME PAGE
• The obvious
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HOME
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Section 6.2: Human Resources
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“All employees are trained on the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives.”
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6.3: Resource Management
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7.1 Planning of Product Realization
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7.6 Title Control of Monitoring and Measuring Devices Equipment
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8.1 To demonstrate conformity of the product to product
requirements
8.2.2 The management responsible for the area being audited
is responsible for ensuring that actions any necessary
correction and corrective action are taken without undue
delay to eliminate detected
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8.2.4 Par (3) Product release and service delivery to the customer does
not proceed until all the planned arrangements have been
satisfactorily completed, . . .
8.3 Par (2) Where applicable, the organization shall deal with
nonconforming product by one or more of the following
ways:
8.3 Bullet (1) By containment of correction of the detected
nonconformity and corrective action appropriate to the
effects or potential effect to eliminate its cause to prevent
its recurrence.
8.3 Bullet (2) By authorizing its use, release or acceptance with the
approval of the relevant authority
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8.3 Par (3) TPI shall re-evaluate the result of the corrective action by
testing and inspection to demonstrate conformity to the
requirements.
8.3 Par (4) Records of the noted nonconformities and any
subsequent actions taken, including concessions obtained
shall be maintained.
8.5.2 Par (1) TPI takes action to eliminate the cause causes of
nonconformities in order to prevent recurrence.
8.5.2 Bullet (6) Reviewing the effectiveness of the corrective action taken
8.5.3 Bullet (5) Reviewing the effectiveness of the preventive action taken
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8.2.3 Monitoring and Measurement of
Processes
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Explanation
Paragraph 8.2.4
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8.3 Control of Non-conforming
Product
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19.Non conforming product
(8.3)
• Dealing with non conforming product now
includes the analysis of potential effects of non
conformity after the use has started.
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HOME
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Section 4: General Requirement
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4.1 Bullet (1) Identified Determined the processes needed for the QMS . . .
4.1 Bullet (2) TPI shall ensure control of all outsourced processes that
affects product conformity to the requirement.
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Explanation
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Explanation
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TC 176 Interpretation:
– No exclusion on outsourced process
Interpretation:
Yes
Example:
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Explanation
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Explanation
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Section 4.1: General Requirement
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Section 4.2: Documentation
Requirements
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Section 4.2.3: Control of Documents
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Section 4.2.4: Control of Records
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Section 5.5.2: Management
Representative
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Explanation
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HOME
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Section 7: Product Realization
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7.2.1 Customer requirements include those:
Bullet (4) • Statutory and regulatory requirements related
applicable to the product
Bullet (5) • Additional requirements determined considered
necessary by TPI
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Explanation
Clause 7.5.1 Control of Production and Service
Provision
Bullet (4) – the word equipment' replaced devices„
corresponds to the change in the title of Clause 7.6: Control
of Monitoring and Measuring Devices Equipment
Bullet (6) – the insertion of the word “product” clarifies the
subject being discussed
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8.2.1 Customer Satisfaction
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Explanation
Formula for
Delighting
Customers 47
HOME
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Section 7: Product Realization
PROCEDURE CHANGES
02-423 The author is responsible for writing the document,
creating related forms, getting a number and submitting
the documents to all concerned department/division
heads for review
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Section 7: Product Realization
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02-424 . . .. At the end of the project, all project records
concerning the project shall be transferred to the Central
Document/Data Controller (CDDC) for storage.
02-424 After records are no longer needed and the retention
period has been reached, the records are archived or
disposed of in coordination with CDDC.
02-424 DCC101 - Controlled Document Master List.
02 - 710 HSE – Health Safety and Environment
02 - 710 As new processes or projects are introduced, quality
objectives and product requirements and documents are
determined as appropriate and provide resources specific
to the product.
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Section 7: Product Realization
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02 - 710 Engineering – Senior Manager assigns responsibility to
initiate a project quality plan or design project. The Design
and Estimate Manager initiates the project quality plan
and a project manager completes it before the project is
started.
02 - 710 The Project Manager initiate implements project quality
plan
02 - 710 Conduct the required verification, validation, monitoring,
measurement, inspection, and test activities, specific to
the product and the criteria for product acceptance.
02 - 710 Provide records as evidence that the processes and
resulting product meet requirements.
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Section 7: Product Realization
PROCEDURE CHANGES
02 - 710 Project Quality Plan includes but not limited to:
02 - 710 Quality objectives and project requirements for the project
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Section 7: Product Realization
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02 - 710 Testing Report Forms
02 - 710 HSE 105 - Job Safety Analysis
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Section 7: Product Realization
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02 - 720 Inquiry of document Request is received by e-mail,
phone, and fax or post mail or during pre-bid conference.
02 - 720 When Sales and Marketing representative receives a
request for quotation, client the representative he
identifies and documents customer‟s requirement.
02 - 720 Queries from Engineering Department (Technical) and
Sales and Marketing (Commercial) base based on the
Tender Documents are submitted and discussed to clients
during Pre Bid Conference.
02 - 720 Sales Department and Marketing and Engineering
Department prepare the proposal in accordance with
Tender Requirements incorporating if any all the changes
in the Tender Documents
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Section 7: Product Realization
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02 - 720 Whenever required by the Client, Sales and Marketing
together with or the Engineering Department
representative will discuss the Technical and Commercial
details of the Tender to Customer‟s Authorized
Representatives
02 - 720 Proposal shall have a unique identification using the
quotations job number order which will be provided by the
Management Data Control.
02 - 720 For closed sales, Sales and Marketing reviews and
evaluates Contract versus Tender Documents. . . .
Discusses deviations to Engineering Department and
other departments concerned. Contract Document with
comments of Department concerned are sent to Legal for
final comment. These comments deviations are discussed
and negotiated to the customer. . . .
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Section 7: Product Realization
PROCEDURE CHANGES
02 - 730 The Design Team shall be responsible for the preparation
of tender documents with the assistance of Sales
Department
02 - 730 Design Team Leader: Senior Engineer or Engineer III as
minimum required requirement
02 - 730 Estimates: Owner provides the design drawing,
specification and TPI to do an estimation work estimates
only
02 - 730 The Design Manager designates a Design Team Leader
for the project
02 - 730 Design outputs are documented and filed in the design
file. Design outputs are documented in a manner that
enables them are suitable to be verified against the
design inputs
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Section 7: Product Realization
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02-750 Site Safety Officer shall be responsible in the execution of
Project HSE indicators.
02-750 HSE Indicator: field of measurements and monitoring
how a project complies with the HSE program
02-750 Use the same unique identification of project provided by
the Management Data Control in the approved proposal
02-750 TPI preserves the product during internal processing and
installation in order to maintain conformity to
requirements. TPI also exercises care with customer
property while it is under the organization's control or
being used. Preservation includes identification,
verification, protection and safeguarding of customer
property provided for use. If any customer property is
lost, damaged or otherwise found to be unsuitable for use,
TPI shall report to the customer and maintains its records.
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Section 7: Product Realization
PROCEDURE CHANGES
02-750 The VP - Engineering - Senior Manager President or his
designee shall conduct a monthly project progress
meeting to discuss the progress of the project. The
following shall attend the meeting:
Chairman : Engineering - Vice President Senior Manager
President
Members : President or his designate
Project Managers / Project Engineers
Any other personnel deemed necessary
02-760 Calibrate and maintain equipment as assigned.
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Section 7: Product Realization
PROCEDURE CHANGES
02-750 All listed equipment that is out of calibration period can
only be used after being validated verified by a current
calibrated unit of the same type.
02-760 All Testing Equipment and Devices which are not
calibrated for more than a year can be used as
Preliminary Testing Equipment only prior to final testing.
by a calibrated equipment and device. Official Calibration
Certificate is no longer required for this preliminary
testing.
02-822 The management staff person responsible for the area
being audited shall take timely corrective action on
nonconformities found during the audit. The management
of the area being audited is responsible for ensuring that
any necessary corrections and corrective actions are
taken without undue delay to eliminate detected non
conformities and their causes.
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Section 8: Measurement . . .
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02-824 In process checks on completed part of the work shall be
carried out together with the customer's representatives,
in case required.
02-824 The final inspection and commissioning shall be
authorized, monitored and approved for hand-over to the
customer by the Project Manager.
02-824 The final inspection and commissioning shall be
monitored by the GM - Engineering Project Engineer
02-830 The Area Project / Site Manager or Section Head may
determine to scrap the item. The scrap is logged on their
scrap report.
02-830 All reworked/repaired products/materials shall be re-
inspected with the approval of the authorizing body and
where applicable by the customer.
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Section 8: Measurement . . .
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02-830 The works must be identified as non-conforming and a
Non Conformance form is initiated. The work is identified:
a) The nonconformity is described
b) The location of the work is identified.
02-830 Quality control or Project/Site Manager reviews the NCR
form and identifies the disposition of the product or
material as:
a) Scrap
b) Rework to correct
c) Use as is
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Section 8: Measurement . . .
PROCEDURE CHANGES
02-830 If product will be “Used as is”, quality control or
management is responsible for determining and obtaining
any necessary customer concession. If there are certain
uses that are not appropriate it will be noted on the NCR
form.
02-830 If nonconforming product is detected after delivery or use,
sales representative or the project manager will contact
the customer and take appropriate correction and initiate
a corrective
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HOME
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The Changes to the Standard
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The Changes to the Standard
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The Changes to the Standard
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The Changes to the Standard
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4.2.3 Text added to clarify that external documents are those needed for
use in the QMS.
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The Changes to the Standard
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The Changes to the Standard
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7.1 c. – The word ‘measurement’ was added.
7.2.1 a. – Slightly reworded
c. - The word ‘related’ was replaced with ‘applicable.’
d. – The word ‘determined’ was replaced with ‘considered
necessary.’
Note added to clarify that post-delivery activities include actions
under warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as
recycling or final disposal.
7.3.1 Note added to clarify that design and development review,
verification and validation have distinct purposes and may be
performed separately or in any combination as suitable for the
product and the organization.
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The Changes to the Standard
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7.3.2 In last paragraph, ‘these’ changed to ‘the.’
7.3.3 First paragraph – The word ‘provided’ was omitted and the phrase
‘that enables’ was replaced by ‘suitable for.’
Note added to clarify that production and service provision may
include details for the preservation of product.
7.5.4 Note – The phrase ‘and personal data’ was added as part of
customer property.
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The Changes to the Standard
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7.5.5 Phrase ‘conformity of’ was changed to ‘in order to maintain
conformity to requirements’ and ‘where appropriate’ was changed
to ‘as applicable.’
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The Changes to the Standard
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8.1 a. – The word ‘requirements’ was added.
8.2.1 Note added to provide examples of how customer satisfaction data
can be measured.
8.2.2 Editorial changes to clause to clarify requirements.
Reworded requirement for documented procedure
Clarified record requirements by adding ‘records of the audits
and their results’
Clarified that management responsible for the area being
audited shall ensure that ‘any necessary corrections and
corrective actions are taken.’
Note – Reference to ISO 10011-1, 10011-2 and 10011-3
changed to ISO 19011.
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The Changes to the Standard
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8.2.3 The phrase ‘to ensure conformity of the product’ was deleted.
Note added to clarify that the organization should consider the
type of monitoring and measuring of processes and the extent to
which they effect conformity to product requirements and the
effectiveness of the QMS.
8.2.4 The phrase ‘for delivery to the customer’ was added to clarify that
the release of the product relates to the delivery to the customer.
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Summary
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Prepared and Presented by:
Sid Calayag - QMS Lead Auditor
Date: November 25, 2009
Venue:
TPI Conference Room No. 2
Attendees:
Mr. Enrico Concepcion – Vice President
Mr. Nelson Tan – Purchasing Manager and QA/QC
Manager
Ms. Wilma Corpuz - Sr. Personnel Officer
Mr. Norman Joseph – Sr. Info. Officer
Ms. Rose Llanera - Central Docs. and Data Controller
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References
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Thank You…
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