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Revision 5
Page 1 of 11
SUMMARY SHEET
GENERAL INFORMATION
SUPPLIER INFORMATION
SUPPLIER NUMBER: N/A
SUPPLIER: Equistar Chemicals, LP
ADDRESS: Texas Highway 60; 13 miles South of Bay City
CITY: Bay City
STATE:
TX
ZIP CODE:
77414
PHONE: n/a
TITLE: QA Manager
PHONE: n/a
SURVEY INFORMATION
MEMBER SURVEY ID NO.: N/A
REVISION/DATE:
NAME
PHONE
EMAIL:
CHECKLIST
SECTIONS
SURVEYED
TEAM LEADER
Daryl Montie
404-247-9588
dmontie@NQA-1.com
All
TEAM MEMBER
Dudley Burwell
dudley.burwell@isco-pipe.com
All
800-345-4726 x 6720
TEAM MEMBER
TECHNICAL SPECIALIST
(SPECIFY DISCIPLINE)
Daryl Montie
DATE: 5/12/10
REFERENCE
CRITICAL CHARACTERISTICS (CC) TO
SAT./
CHECKLIST
CC NO.
BE EVALUATED
ACCEPTANCE CRITERIA
UNSAT.
FIGURE
SAT
B.11
SAT
Density, g/cm3
C.2
B.11
C.2
Tensile Strength
SAT
B.11
C.2
SAT
B.11
Sampling Techniques
SAT
B.11
Traceability
SAT
B.7
CONCLUSIONS
Do Commercial Grade Quality Controls adequately control all identified critical characteristics? Yes
No
1.Material may be accepted outside of those limits established by Case N-755.A review of the Inspection Plan Report (ZQRINSP1) determined
that batch acceptance limits do not always coincide with the acceptance limits determined by Case N-755.
Example: Density requirements from N-755 state 0.949 to 0.955, however, the acceptance requirements from Equistar specify an accept of
0.947 to 0.950. Test data from actual batch acceptance testing needs to be reviewed to ensure that the requirements of Case N-755 are met.
Alternately, Equistar may revise acceptance criteria to meet the requirements of Case N-755.
2. A change in product specification does NOT initiate a change in the product designation. The product characteristics need to be verified to
meet the critical characteristics of the product to be procured.
3. Records that verify QC data for the critical characteristics are maintained for 5 years. The records retention period does not meet
requirements.
CRITICAL
CHARACTERISTIC
(CC)
METHOD OF CC
CONTROL
AND
ASSOCIATED
CHECKLIST
ITEM(S)
ITEM REVIEWED
AND
WORK ORDER/
TRAVELER NO.
CONTROLLING
PROCEDURE
AND
REV./DATE
Final QC
QC Sample
C.2
Demonstration
PERSONNEL
NAME/STAMP
MATLAB 280
Cald 11/18/09 Due: 11/18/10
Thermometer
Cald 4/30/10
Due: 5/30/10
Timer
Cald 4/14/09
Due: 5/14/10
Density
Final QC
QC Sample
C.2
Demonstration
Luan Tran
Due: 4/09/11
Timer
MATLAB 108
Cald 3/22/10
Due: 3/22/11
Due: 4/21/11
QC Sample
C.2
Demonstration
Noel Orr
DSC Thermal
Stability
Final QC
C.2
QC Sample
Demonstration
Cassandra
Cohea
Due: 7/30/10
Final QC
Lot# 40050510
MAT 265
Donny Jordy
Micrometer, Starrett
C.2
Molded 5/9/10
R.2 4/7/09
MATLAB 440
(M Lambert)
Cald 7/23/09
Due: 7/23/10
Due: 4/9/11
Thermometers
MATLAB 399
Cald 4/9/10
Due: 4/9/11
Describe the suppliers controls which assure that items and services provided comply with the specifications set forth in the
manufacturers published product description. Identify source of pertinent published product description.
SUMMARY OF INVESTIGATION:
Alathon L4904 - Equistar provides a product data sheet for the material - High Density Polyethylene
Resin; Pipe and Sheet Grade. The data sheet provides a list of the properties that the material is
produced to meet and additional quality control activities are performed in order to verify the product
meets the specifications determined in the data sheet.
Area of Concern: Material may be accepted outside of those limits established by Case N-755.A review
of the Inspection Plan Report (ZQRINSP1) determined that batch acceptance limits do not always
coincide with the acceptance limits determined by Case N-755.
Example: Density requirements from N-755 state 0.949 to 0.955, however, the acceptance requirements
from Equistar specify an accept of 0.947 to 0.950.
Test data from actual batch acceptance testing needs to be reviewed to ensure that the requirements of
Case N-755 are met. Alternately, Equistar may revise acceptance criteria to meet the requirements of
Case N-755.
Describe the controls the supplier implements to assure that design changes, including material substitutions, are evaluated
commensurate with the original design. NA
SUMMARY OF INVESTIGATION:
Original design requirements are not applicable to the material being produced. This is a commercial
grade product where manufacturer specifications are provided.
SUMMARY OF INVESTIGATION:
The manufacturer is responsible for providing the formulation and product to be procured. There may be
changes in the formulation that could result in slight changes in the products chemical characteristics.
This change is analyzed by the plant and it is ensured that the chemical characteristics are clearly
indicated as part of the new product specification.
Area of Concern: A change in product specification does NOT initiate a change in the product
designation. The product characteristics need to be verified to meet the critical characteristics of the
product to be procured.
Describe any methods (e.g. CGI surveys, source verifications, material verification, receipt inspection) this supplier uses to control
critical characteristics of items, material, and/or services provided by sub-tier suppliers.
How is equipment calibrated? Equipment is calibrated according to scheduled controls for QC operations
SUMMARY OF INVESTIGATION:
Controls of incoming materials are acceptable. Any variations in raw materials would be addressed during
processing in order to develop the requirements and maintain the needed chemical reaction.
Materials are generally accepted based upon a review of the certificate of conformance upon receipt.
Suppliers have a history of supplying acceptable material. Alternate suppliers can be used in cases of
any problems, however, this is an infrequent occurrence.
Are there satellite manufacturing locations associated with this supplier? If yes, describe the controls this facility has over the piece/parts
that are obtained from the satellite location? (i.e., Controls through receipt inspection, testing, and/or internal audits?) NA
SUMMARY OF INVESTIGATION:
N/A
Are items drop shipped from satellite or sub-tier locations? If yes, explain. NA
SUMMARY OF INVESTIGATION:
N/A
Describe the controls the supplier implements to maintain lot/material identification throughout manufacturing operations.
Describe manufacturing process(a)
(b)
Identify any unique coding system or practices used by the supplier to identify lots/batches.
SUMMARY OF INVESTIGATION:
Plantelligence data management system is used to issue batch numbers. A 10# bag of material is
collected and used for the test sample.
This facility runs a continuous production flow. Material is collected upon final into a 400,000 lb batch
blender. There is internal agitation to ensure that batches are homogeneous. Pellets are identified by the
time of sample collection and given a control number to identify the material collection. Lot traceability is
traced to the time of railcar loading.
Identification by this number is provided and used for certification processes. Railcars are identifiable as
to the lot#, time of fill, and production final testing information.
If applicable to the product, describe the cure data/shelf life control processes that affect critical characteristics.
SUMMARY OF INVESTIGATION:
N/A
There are no shelf life items associated with the raw materials for the product. For finished product,
polyethylene pellets have a 1 year shelf life due to discoloration, however, the material properties are
stable and would not be affected by any reasonable age limitations.
Describe the controls the supplier implements for handling, storage and shipping.
SUMMARY OF INVESTIGATION:
Doc # 50P-05 Hopper Car Inspection and Cleaning; Approved by Bruce Norton
Procedures are focused on the preparation of railcars for loading. This includes the cleaning of cars and
inspection to ensure that no foreign objects are present and only acceptable materials are provided to the
customer. This includes controls such as protection from debris.
Describe the manufacturing/ special processes that affect the critical characteristics. Include a description of applicable procedure,
equipment and personnel certifications.
SUMMARY OF INVESTIGATION:
Product formulations are defined that include process parameters for achieving the critical characteristics.
This includes the reactor recipe that provides directions for process settings such as
temperature/pressure, control limits, ratios, materials, and properties that are acceptable in resulting
product.
Describe inspections (receipt, in-process and/or final) and tests performed which verify critical characteristics. If sampling is used,
describe the sampling plan used and its technical basis.
SUMMARY OF INVESTIGATION:
There are defined checks, tests, inspection and other verification activities that are performed during the
production process and upon completion of materials.
These are defined in Document Number 1200, Rev 10, 02/10/10. This document provides information for
the collection frequency of samples, reactor line, samples, and retention times.
Blended lots are creating through the manufacturing output. Pellets are placed into hopper that can hold
approximately 400k lb of product (4 rail cars). Constant physical mixing of the product ensures that
pellets are homogeneously distributed throughout the batch.
Samples include requirements for obtaining samples from blended lots for testing of final product. This
includes test and results for certifying materials meet the critical requirements.
Verify that the suppliers M&TE controls include provision for the following:
(a)
Labeling/identification of M&TE?
(b)
(c)
Environmental conditions?
(d)
Adequacy of standards to assure accuracy, stability, range, and resolution required for their intended use?
(e)
(f)
(g)
SUMMARY OF INVESTIGATION:
A MATLAB number is used for identification of the equipment. All equipment is calibrated on a periodic
basis by an accredited source.
Reviewed measuring and test equipment used for the tests and/or inspections to be performed.
A review of this equipment is listed on pages 3 and 4 and provides identification and due dates.
Intervals are appropriate for the equipment listed. Most equipment was well maintained and in laboratory
conditions justifying a 1 year calibration interval.
The observed accuracies were appropriate for the measurements being taken.
The calibration certificates contained as-found/as-left condition of the equipment.
There were no items observed as being found out-of-tolerance. Equistar has a recall policy for material
found that does not meet requirements.
An external, A2LA accredited calibration source is being used for the calibration of equipment
Allometrics. This facility has the ability to calibrate all the observed equipment with a level of accuracy
appropriate to the measurements being taken. Allometrics maintains a scope of accreditation that
includes all the equipment that was observed as being calibrated. Reports issued by Allometrics include
all the required information and traceability to national standards.
Describe the documented quality control program (instructions, procedures, and drawings, as applicable) and the program basis? (ISO,
MIL STD, ANSI)
SUMMARY OF INVESTIGATION:
The quality control system is well documented. There is a quality manual that is written to consistent with
the requirements of ISO 9001. The company is certified to ISO 9001 by ABS, a recognized registrar.
Describe the suppliers controls to assure that sufficient records are available to furnish evidence of activities affecting quality.
SUMMARY OF INVESTIGATION:
There is a LIMS system that maintains laboratory data. Additional data is kept regarding lot traceability
and materials used.
Area of Concern: Records that verify QC data for the critical characteristics are maintained for 5 years.
The records retention period does not meet requirements.
Describe the controls the supplier implements over contract review of a customers P.O./Contract.
a.
When multiple supplier manufacturing facilities are involved, are the P.O./Contract requirements being completely and correctly
transmitted?
b.
If a distributor is involved between the utility and this supplier, are the P.O./Contract requirements being completely and correctly
transmitted from the distributor to the supplier?
SUMMARY OF INVESTIGATION:
No special requirements are being requested from Equistar. The customer service center receives the
purchase orders from customers. Orders are entered as to the catalog number and quantity.
Describe the controls the supplier implements over the certification process (C of C and/or CMTR) for the products supplied.
NOTE: Compliance to utility P.O./Contract requirements should be documented on the certification.
SUMMARY OF INVESTIGATION:
Equistar issues a Certificate of Analysis with each shipment. The Certificate of Analysis contains
information regarding the batch and data for each of the critical characteristics identified.
This meets the requirements of Table IV-141(b)2. Supporting information and full test results may be
obtained if requested from Equistar.
Describe the controls the supplier implements to identify, document, disposition (accept, reject, repair or rework), and segregate
nonconforming items to prevent unauthorized use or shipment.
SUMMARY OF INVESTIGATION:
Review manufacturer/supplier/distributor returned goods or returned material authorization logs for significant recurring issues
requiring products to be returned for evaluation. Look for any products with a high number of returns, and/or comments indicating
generic problems or manufacturing defects. Document any such issues and the actions taken or being taken by the supplier to
address the issue(s).
NOTE: Isolated returns do not necessarily indicate that a problem exists.
SUMMARY OF INVESTIGATION:
Equistar has a customer service method that identifies and resolves any quality issues.
Quality complaints are logged and tracked until resolution. There have not been any occurrences of
nonconforming items being shipped to customers.
Describe the suppliers indoctrination and training program for personnel performing activities affecting quality (welding, NDE, tests and
inspections, etc.).
SUMMARY OF INVESTIGATION:
Reviewed employee training records for process operators, inspection/test personnel, and management
positions.
Marsha Lambert, Velva Johnson, Luan Tran, Donny Jordy, Cassandra Cohea, Noel Orr
Additionally, performance of testing operations are monitored by the use of quality checks for all the
processes observed.
This generally includes the used of retained artifacts run periodically with data maintained and
statistically analyzed in order to ensure process controls are adequate in obtaining repeatable and
reproducible results.
Evaluate the adequacy of design/configuration controls relative to the identified critical characteristics.
Reference Checklist Items B.1 through B.3.
SUMMARY OF INVESTIGATION:
Evaluate the adequacy of inspection/testing/process controls the supplier performs during receipt, manufacturing and final product
acceptance with regard to identified critical characteristics, including the use of specified acceptance criteria.
Reference Figure A Items and Checklist Items B.10 and B.11
SUMMARY OF INVESTIGATION:
The is a very defined testing sequence for finished product. This is performed on a sample that has
been positively identified and placed into a railcar to avoid any possibility of misidentification. The
quality control test that are performed include those listed on figures B.10 and B.11 and address the
critical characteristics of melt flow rate, density, and tensile strength.
Evaluate the overall adequacy of the suppliers controls and acceptance criteria applicable to the identified critical characteristics.
SUMMARY OF INVESTIGATION:
The suppliers controls include testing of each batch for the consistency and compliance with stated
requirements for the critical characteristics identified. Controls for testing ensure accurate and suitable
testing is performed.
Date: 6/11/10