Lab&production quality controll manual

SCIENCE LABORATORY TECHNICIAN, QUALITY CONTROL & DOCUMENT
CONTROLLER (HUMPHREY MUIRURI MUHIU)
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DOCUMENT TITLE
LABORATORY AND PRODUCTION QUALITY
CONTROL MANUAL
DOCUMENT NO(DCN); 01-001-00
SIGNITORIES AND AUTHORIZATION TO BE IMPLEMENTED
Rev,No: Date: Title: Prepared By: Checked by: Approved by:
00 19-Mar-15 Lab &Production
Quality Control
Humphrey

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TABLE OF CONTENT
1.0TERMS & DEFINATION................................................................................................. 3
2.0GENERAL..................................................................................................................... 4
2.1QUALITY OBJECTIVES & POLICY. .................................................................................. 4
2.2SCOPE & PURPOSE ...................................................................................................... 4
2.3MASTER LIST OF QC RECORDS ..................................................................................... 5
3.0CONTROL OF MATERIAL & STORAGE ........................................................................... 7
3.1MATERIAL MANAGEMENT........................................................................................... 8
3.2MATERIAL TRACEBALITY.............................................................................................. 8
3.3PROCEDURE FOR PMI.................................................................................................. 9
3.4ACCEPTANCE & REJECTION.......................................................................................... 9
3.5DOCUMENTATION RESULT ........................................................................................ 10
4.0TESTING PROGRAMME.............................................................................................. 10
4.1CALIBRATION,MEASURING & TESTING EQUIPMENT................................................... 10
4.2NON-CONFIMANCE REPORT ...................................................................................... 11
4.3IDENTIFICATION AND SEGREGATION ......................................................................... 11
4.4DETERMINATION OF DEPOSITION.............................................................................. 11
5.0PRODUCTION AT GLANCE NON-CONFIRMANCE ......................................................... 12
5.1CONTROLLING NON-CONFIRMANCE .......................................................................... 12
6.0LAB/PRODUCTIONQUALITY AUDIT .......................................................................... 12
6.1SCOPE....................................................................................................................... 12
6.2PROCEDURES ............................................................................................................ 13
6.3QC DOCUMENTATION ............................................................................................... 13

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1. TERMS& DEFINITIONS.
The purpose of this quality plan and supporting procedures with the following
definitions, which, in some instances, clarify those, contained Quality Management and
Quality Assurance shall apply.
Quality The totality and characteristics of product or
service that bear on its ability to satisfy
stated or implied needs & requirements.
Quality Management The aspect of the overall management
functions that determines and implements
the quality policy.
Quality Assurances All those planned and systematic activities
and functions necessary to provide adequate
confidence that a product or service shall
satisfy given requirements for quality.
Quality Control The techniques and activities that
demonstrate compliance with specified
requirements. This includes inspection,
testing, etc.
Project Quality Plan A document derived from the quality
management system, modified as necessary
to accommodate particular requirements.
QC Inspection & Test Plan A Key documents which supports the project
quality plan and lists in a logical sequence
key activities such as contract review,
engineering, procurement etc. it identifies
individual activities controlling procedures
/standards verifying documentation,
inspection and test requirements etc.
Quality Audit A systematic and independent examination
to determine whether quality activities and
related results comply with planned and / or
documented arrangements and whether
these arrangements are implemented and
effective in achieving stated objectives.

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2. GENERAL
The program is made to ensure that the quality of work is maintained as per the
Institution/companies, specifications and applicable local standards and codes.
2.1 QUALITY OBJECTIVE & POLICY
It is the policy of QC and Laboratory technician to provide a consistent level of
work performance that meets or exceeds the quality standards set forth in this
manual. Quality is herein defines as conforming to the requirements and
specifications cited within this manual in all matters of chemical analysis and
material control.
With regard to this job opportunity, the program set forth in this manual
becomes a mandatory, specific analysis of enforcing the policy of QA and
Laboratory Technician on this Institution.
The quality control program is established to ascertain that all chemical
analysisis performed in complete conformance with the approved
chemicalexperiments and all applicable standards and requirements.
The overall responsibility to maintain the quality program from quality control
manager and his delegated QA Supervisors. Their direct responsibility is to
ensure that all requirements for this institution together with the integral quality
program are strictly adhered to. The QA Department is authorized to stop any
work activity until compliance with manual is achieved.
The Quality Control Manager in his exercise of all functions controlling quality
of chemical products, test procedures, and the materials used, shall not be
overruled by any Manager.
QC and Lab Technician shall cooperate and coordinate in all matters related
to the Quality Control program, and all personnel directly involved in his Job
Description shall be continuously kept informed of Institution and companies
requirements as work progress.
2.2 SCOPE & PURPOSE.
This plan is provided for quality control procedure at the laboratory and
production line, to be applied on the activities, which will be implemented. The
purpose of Quality control program is to ensure the following basic objectives:
1. All the works adheres strictly to all requirements of the project and
governing agencies where the work is being performed.
2. To maintain QC procedure to ensure that works performed being
complied with the institution/companies requirements and the
specification.

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3. To prevent deficiencies through pre-production quality control
coordination.
4. To detect, correct and take preventive action for deficiencies in a
timely manner.
5. To maintain an auditable record of all tests, inspection, procedure,
non-compliance and corrections, and other pertinent data as required.
6. To verify compliance companies QC procedures, including those QC
procedures of sub-institutions and suppliers.
7. To provide basis for measuring QC and Laboratory performance for
input company resource database.
The plan covers as a minimum the quality control at the laboratory and
provides the following activities.
 Laboratory Document Control
 Laboratory and storage Material Control
 Laboratory and production process Inspection and Testing Control
 Inspection, measuring and equipment control
 Laboratory and production process Nonconformance Control
 Laboratory and production process Quality Audit Control
 Quality Record Control.
2.3 MASTER LIST OF QC RECORDS:
Record of all inspection and tests shall be maintained sequentially and by work categories. All
tests including but not limited to the following shall be controlled and properly documented
(Materials, chemicals products).
Record of daily/ weekly QC reports.
A record of all vendors and technical approvals lab/production correctively by submittal number
and index.
A file of correct and governing Institution/Companies plan and specifications, variation orders,
chemical experiments and technical standards issued for Production. A documents control
clerk on Production line will log and track the latest governing data and chemical process, and
ensure proper issuance of the same.
QA/QC inspection forms.
Institution/Companies materials receiving report file.
Record of properly logged non-conformance reports.
A separate set of production plans for noting changes for subsequent incorporation on the as
product reproducible.

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Approved QA/QC inspection report.
Approved QA/QC checklist.
Record of properly logged approved method statements
Record of properly logged approved production process inspection & test plan
Record of properly logged approved material & data sheet
Record of properly logged approved Technical Queries
Record of properly logged approved Third party test reports
Record of properly logged approved test packages
Deficiency log book
Record of properly logged material inspection report
Record of properly logged internal audit report
Record of weekly internal QC meetings
Record of properly logged As-production output
Record of properly logged interoffice Memo
Record of properly logged QC personnel’s CVs
Approved organization chart with name & contact numbers
Approved flow chart for inspection procedure
Approved flow chart for NCR procedure
Record of properly logged Daily QC report
Record of properly logged Punchlist
Record of properly logged list of inspection & test equipments
Record of properly logged internal work release note
Record of properly logged list of distribution of production methodology
Lab/productiondesign changes / deviations. (RFIs)

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Approved vendor list
Copy of original scope of work
Copy of Companies and institution specifications/ requirements
 QC Daily Reports.
The QC supervisor may prepare a daily report (if asked by CLIENT) at the end of each working
day containing all inspections and testing made including any work discrepancy, material NCR,
problem or obstruction encountered during inspection, change in production methodology due
to practical difficulties or any reason due to which the inspection was delayed or could not be
performed .
Location of inspections, highlighted nature of deficiencies observed and corrective actions
taken shall be submitted with this report.
The QC supervisor shall consolidate the above reports for submission to the head companies
Authority.
QC/QA manager shall prepare weekly QC report and submit to the head office during weekly
QC meeting. The report shall consist of material submittal, approval & procurement status, QC
documents (like TQ, proposed methodology, specific method statement, etc.) submittal &
approval status and inspections done during last week.
 Distribution and Review.
1. Documents Distribution log shall be prepared and maintained by DC to control the
document distribution.
3.0 Control Of Material and Storage.
All material delivered to the Lab/Companies store will be inspected and checked by QC
Inspectors to ensure that materials are not damaged or defective and in conformity with the
material approval, purchase order and packing lists. If discrepancies are found will be reported
to the Procurement Manager, who in turn will notify the vendor concerned for corrective
measures or replacement
Materials found acceptable shall be stored in a manner suited for the particular type of
material, or in accordance with the manufacturer and or supplier’s recommendations. The QC
Inspector will ensure proper storage of materials.
The QC and warehouse staff shall implement the following storage guidelines.
• Stocked items shall be suitably protected from damage by spacers or load
distribution supports and shall be safely arranged. No metal works or materials
shall be stored directly on the ground. Materials shall be properly stored so that

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they are not subjected to excessive stresses, and that protective coatings and
finishes are not damaged.
• All materials stored outside that may deteriorate or may be damaged as a result
of direct exposure to weather shall be adequately covered or protected as
recommended by the manufacturer
3.1Material management: The following material management plan shall be
applicable at the store, only in case, if the material supply is in the employer’s scope:
1. Issue of material and equipment authorized personnel:Company
representative shall submit a list of authorized personnel to request and sign for
the receipt of company/owner furnished materials.
2. Issue via electronic system: On project where client Material Manager System
or other company approved material management system is utilized; the issue of
material and equipment shall be requested by companies’ procurement manager
and issue via picking tickets generated by the system.
3. Issue of tagged material/equipment: Tagged materialand equipment, not on a
bill of material, will be requested by companies via a lab/production material
request (FMR) with the following information:
• Companies name, the required, and the authorized person receiving the
material or equipment must be indicated.
• The completed FMR will be presented to company's lab/production
material management group who will review, verify and generating a
picking ticket.
3.2Material traceability:
Material traceability shall be maintained in such a way that one can easily trace an
individual component back to the material certificate that represents it and able to
identify the installed location of any component of the material represented by the
material certificate through the use of traceability reference mentioned on the
component, cross referencing documentation or database, and the certificate.
QC Inspector will check and verify the identification / tags on the materials in
comparison with the list on the certified materials test reports or mill certificates. They
shall perform visual and dimensional inspection and prepare incoming material reports.
Comments shall be marked on the material items and shall be tractability of materials to
be used.
All material traceability activities shall be carried out in accordance with the guidelines as
given in production process conforming to the product specifications.
The following major points shall be kept in mind while maintaining the traceability
system:
1. Formaterial consisting of numerous parts with possibly many different types and
grades of material it is important that only the correct material are connected

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together in a system thereby allowing full material traceability to an original
material certificate of every component part.
• Surface preparation of components: the surface of the component
subjected to the test shall be free from grease, oil, paint and oxides. The
surface preparation shall be performed with a portable grinding machine or
any suitable equipment and the surface should represent the original surface
of the component
• Verification of testing instrument: Verification shall be performed at the
production line once daily by using standards reference samples before
commencing the actual testing or as and when required during the day.
2. Alloy material should be alloy verified prior to delivery to the store using PMI
process that makes an on the spot checking analysis. PMI testing may be done,
through a qualified and approved testing agency in accordance with the project
specifications, if QM (Quality Manager)asks to do so.
3.3Procedure for PMI:
The following procedure to carry out positive material identification ( PMI) which
is based on assumption to identify alloying elements in metal without destroying
the material by X-Ray fluorescence technique using XRF ALLOY ANALYSER
Model XLt 898 , make NITON shall be adopted :
• Surface preparation of components: the surface of the component
subjected to the test shall be free from grease, oil, paint and oxides. The
surface preparation shall be performed with a portable grinding machine or
any suitable equipment and the surface should represent the original surface
of the component
• Performed at lab/production line once daily by using standards reference
samples before commencing the actual testing or as and when required
during the day.
Material should be color coded to indicate the type and the fact that certification has
been checked and identity verified by performing PMI.
All the piping components should be ready marked and tagged with the purchase order,
item number, item code, heat numbering in accordance with the project requirements by
the vendor, prior to supply to the production line
All the material shall be inspected, including verification of material certificate and for
correct marking upon the receipt by the company.
Make sure that the cast/heat number, as marked by the manufacturer, provides
traceability back to the relevant material certificate that has to be stored by the recipient
at the store.

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3.4Acceptance & rejection: All results within +/- 10 % of the requirements of
the relevant material specification shall be considered acceptable and the considerable
deviation of alloying elements / or absence of alloying elements with respect to the
required material specification shall be considered non acceptable. A detailed chemical
analysis may be performed in a laboratory for the materials having a very nominal
deviation of alloying elements from the acceptable limits, as a referee method, before
rejecting the material. In such cases a final decision to accept and or reject is left to the
client and their consultant. All rejected materials are identified and kept separately.
3.5Documentation of Results: A detailed report shall be made in a prescribed
format having all relevant data of the material tested.
4.0 TESTING PROGRAMME
4.1CALIBRATION, MEASURING&TESTING EQUIPMENT.
Following criteria for the selection of inspection, measuring and testing equipment will be
observed.
Criteria 1- Selection of Inspection, Measuring and Test Equipment
 IMTE will have manufacturer’s stated accuracy (and precision, where applicable) that
exceeds the company’s procedures, inspection, measurement and/or testing tolerance(s).
 IMTE will have durability, stability and appropriate measurement ranges consistent with
the intended use(s).
 Calibration standards that will be required for the initial and subsequent calibrations will be
identified when selecting IMTE. Such calibration standards will be requisitioned or the
services of a calibration facility with the calibration standards will be under surveillance.
Criteria 2 – Procuring Calibration Services.
Following guidelines shall be adhered to for preparing a purchase order for calibration
procedures used.
A. Limits of permissible error.
B. Calibration standards used (including serial number and certificates)
C. Details of any maintenance, servicing, adjustment, repairs or modifications carried out
D. Identification of person responsible for the correctness of the information provided.
E. Identification of person responsible for the correctness of the information provided.

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 The calibration supplier shall seal using a unique temper-resistant system, all adjustment
access points after calibration, where practical. The system used shall provide visual
evidence of tampering.
4.2Nonconformance Report.
1. When QC detects any nonconforming condition of any equipment or materials, that do not
conform to specified requirements at inspection or during chemical Mixing or in production
line whatsoever will be automatically subjected to NCR and reported immediately,
2. QC will keep nonconforming condition as it is and immediately report to the Companies
Quality Control Department, Production management and supplier.
3. When a nonconformance is reported, QC Department at large will check and identify the
nonconforming condition, and will approve the lab/production NCR and notice it to the
concerned department.
4.3Identification and Segregation.
1. Upon submitting the lab/production NCR, Production line Inspector will identify a
nonconforming item marking, tagging or other methods, which will not adversely affect the
end use of the items.
2. QC will segregate a lab/production nonconforming item or take other precaution to
preclude inadvertent installation, use of the items or proceeding further sequence until
proper disposition completed.
4.4Determination of Disposition.
1. QC will hold a lab/production nonconformance review meeting with procurement
department
2. QM (Quality Manager) will evaluate and provide a recommended disposition for
Production nonconforming characteristics against specified requirements to ensure that
performance, operability, maintainability, compatibility, Safety Quality and interface
conditions will be adequately maintained.
5.0 Production at Glance Non-Conformances.
 QC Supervisor would initiate a NCR (Non-conformance Report) for a portion of work or
material that does not conform to the approved production methodology and specification.
This written report is submitted to Companies headthat shall ensure that appropriate
action is taken to rectify the problem.
5.1CONTROL OF NON-CONFORMANCES

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Scope
This procedure describes the methods and responsibilities for controlling non-conforming
items to prevent their inadvertent use when other control methods, inspection reports,
surveillance reports, etc are used considered inadequate. This procedure provides for the
identification, documentation, evaluation, disposition, notification, segregation, (prevention of
inadequate use), and re-inspection of these non-conformance items.
Items Requiring NCR:
 Chemical Material, and laboratory items which are found not to be compliance with the
approved production methodology requirements, specification, , codes and standard shall
require the generation of Non-conformance report, when any of the following conditions
exists:
 When other control methods, inspection/testing reports, and surveillance reports are
considered inadequate to initiate correction and control of the problem.
 The disposition would allow its use without conformance to the design requirements
(methodology& specifications).
QC will adopt the following procedures for documentation of non-conformance.
For materials and equipment identified as non-conforming generate a Non-conformance
report to document the non-conforming item(s). The report is to be processed as follows:
 Enter the date the non-conformance is documented.
 Enter the name of the organization responsible for the non-conforming work.
 Use these entries in the heading of the form to provide unique traceability and
identification to the nonconforming item.
 Identify the work package affected by the non-conformance.
 Enter a complete description of the nonconforming condition.
6.0LAB/PRODUCTION QUALITY AUDIT.
6.1 Scope
This procedure provided for control of the lab/production quality audit to be planned and
conducted during Production stage, to verify the quality activities of work.
6.2 Responsibility.
QC will be responsible for exhibiting indispensable objective documentary evidence to the
Auditor to certify the conformance of quality activities.
QC will be responsible for planning and conducting lab/productionquality audits, assigning the
auditor and reporting audit results to the Administration or head.

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An internal audit in the production line shall be performed by the QC manager, head
management and QC supervisor to verify control activities are in accordance with this
manual, production methodology and specifications. The audit includes but not limited to:
 Personnel certification
 Material tracing
 Document control records
 Test equipment calibration records
 Daily reports
The frequency of scheduled internal quality audit shall be every three month and may be
changed as and when required by head depending upon the administration satisfaction to the
workers performance of implementing and maintaining required quality documentation
following all specifications and standards. Frequency and scheduling of internal audit shall be
approved by the head.
External audit/ surveillance shall be performed by the head to review documentation, action
on inspection and testing results, action on identified corrective action within required
timescale. Frequency and scheduling of external audit shall be determined by the head and
shall be notified to the production Department well in advance.
Surveillance for the production quality control as shall be performed by the head without any
advance notice to the contractor.
The QC Supervisor shall investigate corrective procedures within his terms of responsibility or
inform the QC Manager accordingly for further action. The QC Manager, production head,
and QC Supervisor shall perform a minimum of three random audits.
Random audits shall be performed any time, especially when circumstances change, such as
major change in QC program, new personnel and to verify corrective actions are properly
performed and documented.
Audit procedure shall be carried out according to checklist prepared to suit each particular
case and activity or facility to be audited. A report shall be issued on completion of each audit
giving a summary of findings and recommendations for corrective action, if necessary.
When corrective actions are recommended, the time limit for their implementations shall be
started. The activity covered shall be re-audited at the expiration of time given to rectify the
nonconformance.
6.3Procedure
The procedure is provided for control of preparation and maintenance of evidence of quality
related to the lab/production.
6.4QC Documentation
1. Production head in conjunction with QC shall define the records, required to be
required to be turned over to the head, which will be created during production
QA/QC inspection forms.

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Contract materials receiving report file.
Approved QA/QC inspection report.
Approved QA/QC checklist.
Record of properly logged approved method statements
Record of properly logged approved inspection & test plan
Record of properly logged approved material & data sheet
Record of properly logged approved Technical Queries
Record of properly logged approved Third party test reports
Record of properly logged approved test packages
Deficiency log book
Record of properly logged material inspection report
Record of properly logged internal audit report
Record of properly logged As-built drawings
Record of properly logged interoffice Memo
Record of properly logged QC personnel’s CVs
Approved organization chart with name & contact numbers
Approved flow chart for inspection procedure
Approved flow chart for NCR procedure
Record of properly logged Daily QC report
Record of properly logged Punchlist
Record of properly logged list of inspection & test equipments
Record of properly logged internal work release note
Record of properly logged list of distribution of doc/drawings
Approved copies of bar bending schedules

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Approved vendor list
Copy of original scope of work
Copy of client specifications/ requirements

Lab&production quality controll manual

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