Jan 2013
Performance Criteria for Monitoring the In-Plant Quality Control Systems of Factory Built Plants
State of Colorado Division of Housing
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TABLE OF CONTENTS Page
A.
GENERAL .................................................................................................................
1
B.
OVERVIEW - SURVEILLANCE VISITS ................................................................
1
C.
DEFINITIONS ...........................................................................................................
2
D.
PLANT CERTIFICATION INSPECTION ................................................................
3
E.
ROUTINE INSPECTION (100% LEVEL) ...............................................................
7
F.
INCREASED FREQUENCY INSPECTION (200% LEVEL)..................................
9
G.
REVALIDATION INSPECTION ..............................................................................
9
H.
IPIA INSPECTION PROCEDURES ......................................................................... 13
1.
RED TAG PROCEDURES ....................................................................................... 17
J.
EXIT INTERVIEW ................................................................................................... 18
K.
IPIA QUALITY ASSURANCE REPORT ................................................................ 18
L.
MANUFACTURER RESPONSE TO IPIA'S QUALITY ASSURANCE REPORT ......................................................................................... 19
M.
MANUFACTURERS PLAN APPROVAL RESPONSIBILITY .............................. 20
N.
IPIA PRODUCTION LINE UNIT REPORT............................................................. 20
O.
AUDIT OF IPIA INSPECTORS AND IPIA REPORTS ........................................... 21
P.
INSPECTION FEES .................................................................................................. 21
Q.
LABEL CONTROL ...................................................................................................
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EXHIBITS
Page
1.
SCORE SHEETS…………………………………………………………………… 23
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COLORADO DIVISION OF HOUSING PERFORMANCE CRITERIA FOR MONITORING THE IN PLANT QUALITY CONTROL SYSTEMS OF FACTORY BUILT PLANTS
A.
GENERAL: The primary function of the IPIA is EVALUATION and SURVEILLANCE. It is not the IPIA's function to provide quality control to the plant. Inspections are carried out for the purpose of continually assuring that the manufacturer adheres to his approved designs, model building codes, manufacturer instructions and approved Q.A. manual.
B.
OVERVIEW - SURVEILLANCE VISITS: 1.
Routine inspections are from 7:00am to 3:30pm, or as required by production volume. From 1 hour to 2 hours of each visit should be spent reviewing different portions of approved plans and verifying in detail those portions of the design for production line conformance with that design.
2.
At least half the time of each visit should be spent inspecting for conformance of every phase of production, every visible part of every home in production, and inspecting other homes for failures to conform that are identified in any one home.
3.
The surveillance visit should include a complete review of the entire quality assurance system over a period of several visits and include the following: a)
Quality control monitoring or inspecting to assure conformance to Q.A. Manual.
b)
Follow-up of previous inspection reports and Q.C. responses to assure that all non-conformances found on homes are corrected before these homes leave the facility.
c)
Inspection to assure that each labeled home inspected has the appropriate labels that reflect the correct information for that unit.
d) Verification of proper location, handling and control of all factory built labels in the possession of the manufacturer.
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C.
DEFINITIONS: 1.
Certification Inspection - Inspection of every cut, every joint, every connection, every aspect and function of the unit being certified. Inspection of the entire plant will occur when there is a new production facility or when revalidation inspections fail.
2.
Routine Inspection (100% Level) - In the course of each visit, a complete inspection of every phase of production and of every visible part of each floor which is at each stage of production. Failure to pass routine inspections will result in the plant being placed on increased frequency inspection status. Areas with recurring nonconformance or system of control issues will be placed on additional frequency inspection status.
3.
Increased Frequency Inspection (200% Level) - Inspection of some portion of every unit twice. Will occur when routine inspections fail. Failure to pass increased frequency inspections will result in plant being placed on revalidation inspection status.
4.
Revalidation Inspection - Inspections will occur on every unit when additional or increased frequency inspection fail. This will be accomplished by assigning a minimum of two inspectors to evaluate every unit under surveillance to ensure compliance with all applicable requirements. Plant revalidation inspection can be full (cover the entire plant) or partial (cover individual subassembly area(s) or station(s)). Failure to pass revalidation inspection will require the plant to be recertified.
5.
Non-Conformance/Deviation - A failure to comply with the approved design, code standards, manufacturers instructions or approved quality assurance manual procedures.
6.
System of Control Item - Nonconforming findings that are grouped together and identified as systematic compliance problems. The grouping of these findings may be found in and include one or more sub assembly areas or stations.
7. Repeat Non-Conformance/Deviation - Recurrence of the same non-conformance recorded against the same code violation, manufacturer instruction or approved quality assurance manual procedure.
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8. Repeat System of Control Item - Recurrence of the same system of control item recorded against the same code standard, manufacturer instruction or approved quality assurance manual procedures found in the same subassembly area, same work station, same foreman responsibility, etc.
D.
9.
Responsible Station, i.e., (work process area) - Specific work site location responsible for accomplishing assigned work. The hard card is signed off at this station.
10.
Additional Inspection – Inspection of station(s) and/or subassembly area(s) a minimum of 3 times during the inspection day.
PLANT CERTIFICATION INSPECTION 1.
IPIA STAFF: Monitoring the production process will require at least a 2-member team. IPIA staff will consist of two or more inspectors and/or an engineer who is familiar with the approved quality control manual so that when conducting their certification inspections, they can verify that the QC process is applicable and has been implemented in each production station.
2.
QC MANUAL/PLAN REVIEW: The approved plans, specifications, and quality assurance manual are reviewed by the IPIA staff. The manufacturers quality control system and production procedures must be written in a quality control manual. This QC manual will be evaluated to ensure that the manufacturer is operating as specified in the manual. The manufacturer must also have a Quality Assurance Inspection Sheet (traveler). The traveler will be evaluated to ensure that the manufacturer requires work to be properly performed, signed off and inspected in each station and subassembly area. All test procedures necessary to perform testing required by the adopted codes and amendments must be completed satisfactorily using test equipment calibrated within the last twelve months.
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If the QC manual or traveler is not correct, unclear or incomplete, the manufacturer must make the necessary changes and have these changes approved before completing the certification process. As the plan review is being conducted, any unusual or special requirement(s) will be noted and verified when conducting inspections. Once the plan review process has been completed, the plant inspection process can begin. 3.
QC PROGRAM EVALUATION: At a minimum the manufacturers QC program will be evaluated to assure: 1) that the work described in the QC manual for each production station agrees with the work that is actually conducted at each station; 2) that the manufacturer makes all required inspections designated in the QC manual at each production station or phase of production; 3) that the work process permits those inspections required in the QC manual to be made at the required production station.
4.
CERTIFICATION REQUIREMENTS: Certification inspections will establish the initial certification report for a manufacturing plant. This certification will be periodically updated and kept current by revalidation or increased frequency inspection reports. A complete plant certification/recertification is required under any of the following conditions: a)
A new production facility including facility relocation.
b)
A change in IPIA.
A complete plant certification/recertification may be required under any of the following conditions: a)
When major changes are being made to the production process. For example, the addition of a new production line or when a manufacturer wants to produce double-wide units in the same production facility which has only previously produced single wide homes.
b)
When major changes in factory personnel occur (i.e., addition of a second shift, wholesale changes due to strikes, wholesale changes due to long-term shutdowns, or layoffs, wholesale problems or write ups due to inadequate training of foreman or line staff, etc. 4
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c)
When major changes are made to elements of the QC program including changes in key personnel in the quality assurance program or other key personnel changes.
d)
When there is a sudden and uncontrolled increase in production or personnel that causes a significant increase in the number of non-conformance or system of control items.
e) When increased frequency or revalidation inspections fail. When any of the above conditions arise, this IPIA; 1) will verify/decide that a certification procedure is required; 2) may defer the certification procedure decision for up to 90 days to determine actual plant performance under the new conditions; 3) will document the certification decision(s) and, if applicable, the reasons for deviating from these certification requirement procedures. 5.
CERTIFICATION PROCESS: Prior to the release of any labels to the manufacturer, a complete inspection of the manufacture of at least one unit will be accomplished. As the unit being certified moves through each production station, it will be completely inspected at each station (every cut, every joint, every connection, every aspect and function, etc.) to determine that it conforms in every way to the requirements of the Factory-Built program standards. Each subsequent home that is introduced into production will also be completely inspected in all phases of production until the certification process is complete. This process will continue until one home is completely inspected in each phase of production and until the IPIA is satisfied that the manufacturer's quality control procedures, plant equipment, and personnel, assure that conformance continues in compliance with the approved design or standards and quality assurance manual.
6.
ADEQUATE PERFORMANCE: Certification inspections are considered successful with: a) "No system of control items" on the unit being certified; b) "No non conformance" on the unit being certified; c) Strict adherence to quality control and plan review requirements and;
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d)
Satisfactory completion of all required test and test procedures using calibrated test equipment.
Upon completion of the certification, a written certification report will be completed and submitted to the General Manager. 7.
INADEQUATE PERFORMANCE: When the IPIA determines that the performance of a manufacturer is not adequate to justify the issuance of labels and a satisfactory certification report, the IPIA will perform complete inspections of all phases of production of each manufactured home being produced and labeling only those determined, after any necessary corrections, to be in conformance with the design and, as appropriate, with the standard. This procedure will continue until this IPIA determines that the manufacturer’s performance is adequate to justify the issuance of a certification report. f) CERTIFICATION REPORT: The certification report will be submitted to the manufacturer by the Program Administrator of the Colorado Division of Housing (IPIA). The manufacturers performance will be evaluated as to its ability to assure homes are produced in compliance with the approved plans and the adopted construction codes. The following information will be included in the certification report: g) The name and address of the manufacturer and IPIA. h) The approval dates of the certification unit plan and Quality Assurance Manual. i) The names and titles of the IPIA personnel that performed the certification evaluation. j) All discrepancies and non-conformance identified and the corrective actions taken to bring the home into compliance. This will include all of the Design Approval Comments, Quality Assurance Reports and other corrective action reports. k) The inclusive dates of the certification process.
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l) A statement that at least one factory-built structure has been completely inspected in all phases of its production in the plant, that the manufacturer is performing in conformance with the approved designs and Quality assurance manual, with the adopted building codes, and that this IPIA is satisfied that the manufacturer can produce factory-built structures in conformance with the approved plans and adopted building codes on a continuing basis.
E.
ROUTINE INSPECTION (100% Level): 1.
Non-Conformance Deviations, System of Control Items and Deviations Per Station: Manufacturers are considered on routine inspection when they: a)
Average less than 8 non-conformance deviations on any 3 consecutive inspections. AND
b)
Average less than 2 systems of control items on any 3 consecutive inspections. AND
c)
Average less than 3 deviations and/or system of control items in any station on any 3 consecutive inspections.
Once any of the above criteria is exceeded, the manufacturer will be placed on plantwide increased frequency inspection status. 2.
Additional Inspections for Repeat Non-Conformance, Repeat System of Control Items and Deviations Per Station: Inspections in subassembly areas or stations with recurring minor or other nonconformance or system of control items will receive additional attention during inspections. Additional inspections in these areas will occur when: a)
There is a repeat of the same non-conformance deviation, 3 times within the last 10 or less inspections. OR 7
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b)
There is a repeat of the same system of control item, 2 times within the last 10 or less inspections. OR
c)
There is a repeat of the same deviations and/or system of control items, 4 times within the last 10 or less inspections.
Additional inspections will continue in the affected subassembly area for three consecutive inspections to assure that there are no additional repeats of the same nonconformance or system of control item. If there is a repeat of any deviation or system of control item in the station(s) on additional inspections, the entire plant will be placed on increased frequency inspection status. It shall be the responsibility of both the IPIA and the manufacturer to maintain and track information on repeat failures to conform or systems of control issues. The IPIA shall inform the manufacturer when areas of the plant are placed on additional, increased frequency, or revalidation inspection status. The manufacturer shall inform the IPIA when units are ready for required additional, increased frequency, or revalidation inspections.
3.
Responsible Station(s)Deviations. Deviations found in sub-assembly area(s) that create systematic problem(s), may be written as a System of Control Item and be subject to the criteria outlined for routine, additional, and increased frequency inspections.
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F.
INCREASED FREQUENCY INSPECTION (200% Level): Increased frequency inspections are required when the criteria for routine inspection is exceeded. Increased frequency inspections impact all subassembly areas and stations in the plant. When in increased frequency status, the IPIA can control the Factory-Built labels. Increased frequency inspections will continue until the following time lines and criteria is accomplished: a)
Average less than 4 non-conformance deviations for a minimum of 5 consecutive inspection visits. AND
b)
Average less than 1 system of control items for a minimum of 5 consecutive inspection visits. AND
c)
Average less than 3 deviations and/or system of control items in all stations within a minimum of the last 5 inspections. AND
d)
Average less than 1 repeat non-conformance deviations and/or system of control items within a minimum of the last 5 inspections.
If routine frequency status is not regained in the above noted time frame, unless otherwise notified, the manufacturer will be placed on revalidation inspection.
G.
REVALIDATION INSPECTION 1.
IPIA STAFF: Monitoring the production process will require at least a 2-member team. IPIA staff will consist of two or more inspectors and, when necessary, an engineer who is familiar with the approved quality control manual so that when conducting their revalidation inspections, they can verify that the QC process is applicable and has been implemented in each production station.
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2.
QC MANUAL/PLAN REVIEW: The approved plans, specifications, and quality assurance manual are reviewed by the IPIA staff. The manufacturers quality control system and production procedures must be written in a quality control manual. This QC manual will be evaluated to ensure that the manufacturer is operating as specified in the manual. The manufacturer must also have a Quality Assurance Inspection Sheet (traveler). The traveler will be evaluated to ensure that the manufacturer required work to be properly performed, signed off and inspected in each station and subassembly area. All tests procedures necessary to perform test required by the adopted construction codes and ammendments must be completed satisfactorily using test equipment calibrated within the last twelve months. If the QC manual or traveler is not correct, unclear or incomplete, the manufacturer must make the necessary changes and have these changes approved by the Colorado Division of Housing, Housing Technology & Standards Section. As the plan review is being conducted, any unusual or special requirement(s) will be noted and verified when conducting inspections. Once the plan review process has been completed, the plant inspection process will begin.
3.
QC PROGRAM EVALUATION: At a minimum the manufacturers QC program will be evaluated to assure: 1) that the work described in the QC manual for each production station agrees with the work that is actually conducted at each station; 2) that the manufacturer makes all required inspections designated in the QC manual at each production station or phase of production; 3) that the work process permits those inspections required in the QC manual to be made at the required production station.
4.
PLANT REVALIDATION REQUIREMENTS: Revalidation inspections may occur when additional or increased frequency inspections fail and will assist this IPIA in updating and keeping the certification report current. Plant revalidation can be full (cover the entire plant) or partial (cover individual subassembly area(s) or station(s)). A revalidation may be required under any of the following conditions: a)
A change in plant ownership. 10
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f)
b)
When significant changes are being made to the production process. For examples, relocation of existing production lines and inspection stations and adding or deleting items from the traveler or inspection stations.
d)
When significant changes are made to elements of the QC program including changes in key personnel in the quality assurance program or other key personnel changes.
e)
When increased frequency inspection(s) fail.
e)
When additional frequency inspections in individual subassembly areas or stations fail.
When there is a gradual but uncontrolled change in production or personnel that causes an increase in the number of non-conformance or system of control items. When any of the above conditions arise, this IPIA; 1) will verify/decide that a revalidation procedure is required; 2) may defer the revalidation procedure decision for up to 90 days to determine actual plant performance under the new conditions; 3) will document the revalidation decision(s) and, if applicable, the reasons for deviating from these certification requirement procedures.
5.
REVALIDATION PROCESS: Prior to the release of any labels to the manufacturer, inspection of every unit in the entire plant or subassembly area(s) or station(s) will be accomplished. As the unit(s) being inspected move through the production station(s), it (they) will be completely inspected to determine that it (they) conform in every way to the requirements of the adopted construction codes and ammendments. Each subsequent unit that passes through the station(s) being evaluated will also be completely inspected until the revalidation process is complete. This process will continue until the IPIA is satisfied that the manufacturer's quality control procedures, plant equipment, and personnel, assure that conformance continues in compliance with the approved design or standards and quality assurance manual.
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6.
ADEQUATE PERFORMANCE: Revalidation inspections are considered successful with: a)
"No system of control items" on the unit being inspected or on each subsequent home introduced into production during the revalidation process. - Applies for both full and partial plant revalidation inspections;
b)
Full Plant Inspection. - No more than "three non conformance" on each inspection day on all units inspected during that day;
c)
Partial Plant Inspection. - "No non conformance" on any unit being inspected while passing through station(s) undergoing partial revalidation inspection;
d)
Strict adherence to quality control and plan review requirements. Applies for both full and partial plant revalidation inspection and;
e)
Satisfactory completion of all required test and test procedures using calibrated test equipment - Applies for both full and partial plant revalidation inspections.
Revalidation inspection will be for 5-inspection days and may be extended once at the discretion of the IPIA Administrator, until all the above conditions are met unless, in a specific situation, this IPIA documents the reasons why this procedure was not followed. A written revalidation report will be completed and submitted to the General Manager. 7.
INADEQUATE PERFORMANCE: When this IPIA determines that the performance of a manufacturer is not yet adequate to justify the issuance of labels and a satisfactory revalidation report, we will continue to perform inspections on each home produced and labeling only those determined, after any necessary corrections, to be in conformance with the design and, as appropriate, with the standard. If an adequate performance level is not obtained, the manufacturer will be placed on full recertification inspection status.
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8.
REVALIDATION REPORT: The Program Administrator of the Colorado Division of Housing (IPIA) will submit the revalidation report to the manufacturer. The manufacturer’s performance will be evaluated as to its ability to assure homes are produced in compliance with the approved design and adopted codes. The following information will be included in the revalidation report: a)
The name and address of the manufacturer and IPIA.
b)
The approval dates of the plans and Quality Assurance Manual.
c)
The names and titles of the IPIA personnel that performed the revalidation evaluation.
d) All discrepancies and non-conformance identified and the corrective actions taken to bring the home into compliance. This will include all of the Plan Approval Comments, Quality Assurance Reports and other corrective action reports.
H.
e)
The inclusive dates of the revalidation process.
f)
A statement that inspection(s) of every home in the entire plant or subassembly area(s) or station(s) has occurred, that the manufacturer is performing in conformance with the approved designs and quality assurance manual, with the adopted construction codes, and this IPIA is satisfied, that the manufacturer can produce manufactured homes in conformance with the designs or with the standards on a continuing basis.
IPIA INSPECTION PROCEDURES: 1.
The Division of Housing representative will use the approved plans, adopted construction codes, manufacturers instructions, and approved Q. A. manual to evaluate the effectiveness of the plants quality control system.
2.
The IPIA representative will review the manufacturer’s response to the previous IPIA quality assurance inspection. An acceptable response should include the following: 1) Deviations found; 2) Identification of the performance issue, i.e., Personnel/Equipment/Material/Procedures; 3) Problem corrected; 4) Number of units affected. 13
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3.
IPIA acceptance of the responses and actions taken by the manufacturer to address the deviations or system of control items are shown by initialing /signing the manufacturer’s response report. Initialing/signing this report also means that the manufacturer has corrected the deviation. Any response or action deemed inadequate will not be approved and must be readdressed by the manufacturer. The IPIA will reinspect any corrections made by the manufacturer deemed necessary to assure compliance with the approved plans and adopted construction codes.
4.
If additional manufacturer responses or actions are deemed inadequate by IPIA inspector, all affected units shall be red tagged. These units will not leave the facility until the responses, actions and deviations are accepted.
5.
The IPIA inspector shall review the non-conformance and system of control reports to determine (and comply with) the required plant inspection frequency.
6.
The IPIA inspector shall also review the previous inspection monitoring reports and manufacturer’s response reports for deviations or system of control items that may need to be reinspected or addressed.
7.
Production line inspection procedures.
8.
a)
The IPIA inspector shall inspect each home that is manufactured at least once during its production.
b)
The IPIA inspector shall inspect for compliance with the approved plans and adopted construction codes.
c)
Units in areas under increased frequency or revalidation inspection status shall be inspected each time before that unit clears that area. The inspector shall check all recurring non-conformance or system of control items for compliance. The inspectors report shall contain confirmation that such area inspections were made during the inspection.
When a non-conforming item has been identified, the following activities must occur before writing up an item as a deviation. a)
The Q.C. inspection has been conducted and the non-conforming item has not been identified.
b)
The non-conformance was signed-off as being corrected but it is still out of compliance. 14
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c)
It is obvious the work in the station or sub-assembly area has been completed and the home is in a stage of production where it is extremely unlikely Q.C. will find the non-compliance (i.e. prior to cover-up)
d)
The traveler was not signed off on in the appropriate station.
e)
Label is affixed to home with existing non conformance(s). NOTE: The above activities are not inclusive.
8. Once non-conforming item(s) are observed, it shall be investigated and recorded by the IPIA inspector. Non-conformances will be recorded against the responsible station. 9. The manufacturer is responsible for determining the source of the problem and the interim actions they will take to correct the non-conformance(s). However, the IPIA inspector shall be knowledgeable of what the source of the problem is and work with the manufacturer in determining the source of the problem and shall agree/disagree with the manufacturer's finding/response/resolution. The major causes for non-compliances fall into the following areas: training, supervision, material, design and quality control. 10.
When a deviation has been observed, the IPIA representative will inspect other units on the production line to determine the extent to which the non-conformance has occurred. The IPIA representative may determine that follow-up is required by the production manager on units in storage or on plant grounds, or by the service manager for units that have left the production facility.
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11.
The IPIA representative will assure that all noted non-conformances have been corrected. The IPIA representative may request reinspections of specific corrections, randomly reinspect corrective actions when completed, or accept the manufacturer’s written response documenting corrective actions. Any unit designated by the IPIA representative for specific reinspection, may not be covered-up or shipped without IPIA reinspection and approval. It is the manufacturer’s responsibility to ensure the IPIA representative is informed when the unit is ready for reinspection. If reinspection is not possible on the same day, the IPIA will note the reinspection requirement(s) for the next inspection day on the Quality Assurance Report. The IPIA will also document when reinspections have been completed on this report. During the course of routine plant inspections, the IPIA representative should reinspect 25% of all corrections made by the manufacturer. Reinspections made on the next inspection day shall be noted on the Quality Assurance Report.
12.
On some floors the non-conformance or system of control items may encompass several findings. These findings are to be evaluated to determine if a class of homes exists or if the frequency of inspection should be increased in the applicable sub assembly.
13.
Use the Quality Assurance Report to record all causes, observations, analysis, and interim corrections on all non-conformance, system of control and minor deviation items.
14.
The IPIA representative shall verify that production line tests are conducted in accordance with the manufacturer’s approved QA Manual. The responsible production foreman must sign off this testing in conformance with the QA Manual. If problems are identified they will be corrected immediately. Units that have been shipped with suspected deviations shall be referred to the service manager.
15.
Electrical, gas, drain, potable water, egress and materials production-line tests will be witnessed at least once a month. Each inspector will witness at least one of the above tests during each routine inspection. The dates on which these test are observed will be recorded on the Quality Assurance Report and the Production Line Unit Report.
16.
If the accuracy of a drawing is in question, appears to be incorrect, or the construction (design) is not included in the approved plans, and is questioned by the IPIA, the possible error or omission must be written up on the Quality Assurance Report for clarifications and response.
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If the referral is for clarification of an existing detail there will be no write-up for a non-conforming item during the initial 10-day waiting period. After the initial ten (10) day waiting period, all effected homes may be red tagged and referred for a possible class of homes determination if response does not agree with the way the homes affected were actually built. 17.
I.
Copies of the following documents are provided to the Program Administrator by the 15th of each month: IPIA Quality Assurance Reports, Manufacturers Response Reports, report of Non Compliance and System Of Control Items and the Production Line Report.
RED TAG PROCEDURES Red Tags shall be issued as described within this document. Any deviation that is red tagged shall be included on that day’s write-up of the IPIA Quality Assurance Report and shall be written in the applicable columns on the Production Line Unit Report. The manufacturer’s quality control manager shall be informed that: 1) A unit has a deviation that was red tagged 2) They have to correct the deviation and 3) Reinspection is required by the IPIA prior to the deviation being covered and the unit being moved or shipped During each inspection day, the IPIA inspector is responsible for determining if there are units with red tags that need to be re-inspected. The date that the deviation passed re-inspection shall be recorded in the applicable column on the Production Line Unit Report. The red tags contain two parts. Each part is to be completely filled out and attached to that day’s Production Line Unit Report.
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J.
EXIT INTERVIEW: At the completion of each inspection day, the IPIA inspector will discuss all non conformance and system of control items with the General Manager, Q. C. Manager or Production Manager. The inspector will inform management of any frequency of inspection change that is anticipated.
K.
IPIA QUALITY ASSURANCE REPORT: At the completion of each inspection day, the IPIA inspector will give the manufacturer a copy of the Quality Assurance Report and the Manufacturers Report. The Quality Assurance Report is used by the IPIA to record the following: a)
The name of manufacturing facility.
b)
The date of the inspection.
c)
The type of inspection - Routine, Increased Frequency, Revalidation or Certification.
d)
The time (In) and (Out) of the plant.
e)
Failures to conform, with the serial number, model, work station number that is responsible for causing deviation, work station number where IPIA found the deviation, plan and/or code reference, Q. A. Manual section, manufacturer’s instructions and complete legible description of the failure to conform.
f)
Optional: Causes/sources for non-compliance or systems of control items and corrective actions taken. (NOTE: Identification of causes/sources for noncompliances is the responsibility of the manufacturer. IPIA representative can also identify such causes/sources in their write-up. Major sources are: training, material, supervision, design and quality control.)
f)
If a system of control item, record it as clearly and specifically as possible noting all conditions observed. Record as many observations as possible for each item that illustrates the problem and its scope.
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h)
Record results of follow-up inspections by use of the following: TCO - Taken Care Of (corrective action taken by manufacturer to bring deviation into compliance is approved and IPIA reinspection of deviation has been performed.) RT - Red Tagged (Unit has deviation that manufacturer shall correct; reinspection required by IPIA.) ISO - Isolated. A deviation has been cited and verified that it is limited to the number of units as stated in the Quality Assurance Report. ANS. “Answered”. This is used to closeout a system of control item.
L.
MANUFACTURER RESPONSE TO IPIA'S QUALITY ASSURANCE REPORT: After each inspection the manufacturer is required to fill out and complete the Manufacturer’s Response To IPIA's Quality Assurance Report. In their response the manufacturer must address/identify: a)
Personnel Performance Issues;
b)
Equipment/Material/Procedures Performance Issues;
c)
Was the problem was corrected?;
d)
How many units were affected? (Note: At a minimum, the two preceding and two following units will be checked to determine if they have the identical deviation);
e)
What caused the problem? Were recurring causes reevaluated?
f)
What sustained actions management has taken or intends to take, by date certain, to prevent the problem(s) from reoccurring?
The manufacturers response must be returned by 9:00 am on the next inspection day. It must be signed by at least two of the three following managers: The Quality Control Manager, Production Manager, or the General Manager.
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Any response or action deemed inadequate will not be approved and must be readdressed by management. If additional manufacturer responses or actions are still deemed inadequate, the IPIA inspector may red tag all affected units. These units will not leave the manufacturers facility until the responses and actions are satisfactorily resolved. IPIA approval and acceptance of management responses to the non-conformance, and action taken by them to correct the(se) non-conformance is shown by the IPIA initialing/signing the response report. IPIA acceptance of the manner that management has corrected the nonconformance is also shown by the IPIA initialing/signing the response report.
M.
MANUFACTURERS PLAN APPROVAL RESPONSIBILITY The manufacturer is responsible for ensuring that all plan approval comments are available, in writing, to quality assurance and production personnel. If the accuracy of An approved drawing is in question, appears to be incorrect, or the construction (design) is not included in the plans, and is questioned by the IPIA, the possible error or omission must be written up on the Quality Assurance Report for clarifications and response. If the referral is for clarification of an existing detail or for clarification for a detail that is missing or does not exist, there will be no write-up for a non-conforming item during the initial 10-day waiting period. From the date of initial referral until a satisfactory and acceptable response is received by the IPIA, the manufacturer is responsible for correcting all homes that may be affected by the response. After the initial ten (10) day waiting period, all affected homes may be red tagged and referred for a possible class of homes determination if response does not agree with the way the homes affected were actually built.
N.
IPIA PRODUCTION LINE UNIT REPORT: This report is used by the IPIA to record the following: a) The production numbers, serial numbers and model of units on line in their respective stations and relative positions. b) All materials, tests, and equipment that were inspected and record calibration date of test equipment. 20
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c) Dates red tags were issued/removed. d) Beginning/ending inspection dates of units with recurring non-conformance/system of control items.
O.
AUDIT OF IPIA INSPECTORS AND IPIA REPORTS: Inspections are performed by IPIA inspectors on a rotating basis. One of these inspectors is assigned work leader responsibility. A primary responsibility of the work leader is to monitor each inspector’s performance for accuracy and compliance as required by the program standards and the in-plant quality control procedures. This is accomplished by monitoring the weekly activities of each inspector and by reviewing the IPIA Quality Assurance Reports, Manufacturers Response Reports, Log of non-conformance and system of Control items and the Production Line Report. The Program Administrator will visit the plant periodically to review the performance of the IPIA inspectors and to spot check each of the above forms for accuracy and compliance. Additionally, the lead inspector will perform field audits on each inspector. The program administrator or designee will perform Field audits of the lead inspector. Each month copies of the IPIA Quality Assurance Reports, Manufacturers Response Reports, Report of Non conformance and System of Control items and the Production Line Report are reviewed by the Program Administrator for compliance with the IPIA monitoring procedures and program standards. The non-conformance and system of control item report is analyzed for recurring trends that are presented to the manufacturer for correction and elimination.
P.
INSPECTION FEES Inspection fees will be assessed as adopted in the program resolution. These fees are: ACTIVITY
FEE
Plant Certification/ Revalidation Inspection:
$350 per inspector per trip
Oversight Inspection:
$230 per inspector
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Red Tag:
$250 per Red Tag
Fees may be waived at the discretion of the Director, Division of Housing, State of Colorado.
Q
LABEL CONTROL 1.
Upon receipt of a label order, the IPIA will verify the total quantity and consecutive numbering prior to recording labels received in the Label Control Log. Certification labels will be kept in a locked and secure location at the IPIA’s main office or at the manufacturer’s plant when the manufacturer is allowed to control or affix labels.
2.
Manufacturer’s will submit a label request application with a check to cover the fee for the requested labels. Upon receipt of the application, the IPIA will verify number of labels requested, check for proper amount paid. After verification, the IPIA will record assignment of labels in the Label Control Log and arrange to hold or deliver labels based on the manufacturer’s program status.
3.
After receipt of manufacturer’s label request and verification that proper fees have been paid, the IPIA will check the manufacturer’s production for the previous month to determine that the quantity of labels ordered is appropriate. Should the quantity ordered appear to be to high, the IPIA will contact the manufacturer to verify that the quantity ordered is appropriate for the manufacturer’s planned production level.
4.
Manufacturer’s under routine and additional inspection status may possess and affix certification labels. The IPIA may repossess and control labels for manufacturers under increased frequency inspection status. The IPIA will control and affix certification labels for manufacturers under certification or recertification status.
5.
The IPIA will review manufacturers label reports to track open labels and may require written documentation from the manufacturer to identify why labels remain open.
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