4-22-13-ams2750e-update 472w55
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AMS2750 E Changes from AMS2750D Feb 2013
Overview on Changes • AMS2750 Specification Updated to Revision E - New Revision of Spec – 2750E revised July 2012; - Replaces Spec - 2750D (revised Sept 2005) - Updated to include wireless sensor technology - Added requirements to document “As found” instrument calibration and offset conditions (procedural impacts) - Calibration changes like check min. of 6 simulated sensor @ min. 4 points, calibrated for each type input/output used - Provides more details on Temperature Uniformity Survey Testing (TUS) procedures, furnace repairs and modifications, data collection requirements, survey frequency, number and location of sensors, /Fail requirements - Added Refrigeration & Quench Furnace class to tables
General Update 2
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Standards • AMS2750E Pyrometry - Covers Temperature Sensor, Instrumentation, Thermal processing equipment, System Accuracy Tests, Temperature Uniformity Survey requirements - Ensures that parts or raw material are heat treated in accordance to applicable specifications
• AS7102 Nadcap Requirements for Heat Treating - Documents the requirements for the accreditation program - Industry managed program for continuous improvement Standard industry audit program for special processes Focuses on overall supplier performance Auditing overseen by PRI (Performance Review Institute)
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AMS 2750E Section 2 Definitions Changes - Par. 2.2.15 DIGITAL INSTRUMENT: Clarification was added to definition of digital instruments with digital temperature display and with temperature trace on paper chart: An instrument that presents process measurements in a digital (numeric) display format. Typical examples are mechanical recorders with digital displays, digital indicators, controllers with digital displays, etc. In the case of a recorder with digital temperature display and a recorder trace (line) the record (recorder trace) is analog while the display is digital. A recorder trace on a paper chart is an analog record.
- Par. 2.2.25 INTERVAL Interval definition was added to AMS2750E to avoid confusion by some suppliers. 4
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AMS 2750E Section 2 Definitions Changes - Par. 2.2.27 LOAD SENSORS : Clarification regarding correct usage of load sensors/ thermocouples. (in rev. D it was not included in the load sensor definition but stated in par. 3.1.8.1): Sensors that are attached to or in with production material, a representation of production material, or are buried in the load of production material and which supply temperature data of the production material to process instrumentation.
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AMS 2750E Temp Sensor Changes • Temperature Sensor - Section 3.1 Changes - This section deals with the requirements for the temperature sensors used in these heat treatment processes AMS2750E Section Reference 3.1.1.5.1 3.1.2.2.1 3.1.2.2.6
3.1.2.5.2
6
AMS2750E Change Allows use of Wireless transmitters as alternative to extension wire Certs for sensors now require “Date of Calibration” Correction factor for each calibration temperature traceable to NIST or other recognized National Standard. Alternatively, deviation (error) for each calibration temperature may be listed. The certificate shall clearly state if it shows deviation or correction factor. Extrapolation of calibration correction factors above the highest calibration temperature and below the lowest calibration temperature is prohibited by any calibration source except NIST or other National Standards calibration agency.
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Comment New New
Added this
Added “except NIST or other National Standards calibration agency.”
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AMS 2750E Temp Sensor Changes • Temperature Sensor - Section 3.1 Changes AMS2750E Section Reference 3.1.2.6
3.1.3.5
3.1.5.2
3.1.5.3
7
AMS2750E Change When calibrating thermocouples rolls, AMS2750 Rev. E requires sampling from both ends regardless of roll length. (1000 feet/305 meters limit from AMS2750D for one end sampling only is no longer acceptable). Other requirements for rolls calibration remains the same. Nonexpendable base metal TUS TCs used below 1200F (650C) do not need to be permanently installed on TUS rack between its usage like it was stated in Rev. D Added time of 90 days “Expendable base metal load sensors may be used for up to 90 calendar days after first use and for no more than 30 uses” Changed the requirement on the life of nonexpendable base metal load thermocouples 2200 °F (1205 °C) to 2299 °F (1260 °C) – 3 months or 10 uses 1801 °F (980 °C) to 2199 °F (1205 °C) – 3 months or 90 uses HONEYWELL - CONFIDENTIAL
Comment Added “Rolls shall be sampled at both ends of the roll”
TUS T/C’s can be reinserted for each TUS through ports in the furnace; need to be used at the same location and depth of insertion. Previously was just 30 uses
Previously for 2200˚F was just 10 uses, no time period specified 1801˚F was 30 days or 90 uses; now 90 days or 90 uses File Number
AMS 2750E Temp Sensor Changes • Temperature Sensor - Section 3.1 Changes AMS2750E Section Reference Figure 1
Comment
Added Table of Reuse and Recalibration of Test & Load Sensors Sensor - Secondary Standard – Max. Permitted Error changes
Summarizes Reuse & Recalibration Primarily for clarification Increased max. permitted error
Figure 1
Sensor – System Accuracy Test – • Max. Permitted Error changes • Recalibration permited if Types E & K are used below 500F (260C) only (Note 11)
Increased max. permitted error
3.4.5.2.1
Type B TCs are allowed as resident SAT TCs for temperatures above 500F (260C)
Type B T/C’s were not allowed by Rev D.
Figure 1
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AMS2750E Change
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AMS 2750E Instruments Controlling, Monitoring or Recording Instruments
• Instrumentation - Section 3.2 Changes - This section deals with the requirements of the instrumentation used in these heat treatment processes AMS2750E Section Reference 3.2.1
3.2.1.1.1
3.2.1.1.2
9
AMS2750E Change
Comment
AMS2750D allowed to use instruments meeting requirements of AMS2750C (but not meeting rev D requirements) if these instruments were purchased before September 2006 (one year after rev. D issue). If you have such instruments, now you have 3 years you upgrade your equipment to meet Rev. E requirements Temperature resolution requirements for chart recorders shall be in accordance with Table 4. (See next slide for table)
Exemption will run out for older instrumentation, now have to upgrade within 3 years of issuing of AMS2750E (issued July 2012)
Process Recorder Print and Chart Speeds shall be in accordance with Table 5. (See next slide for table)
Added metric speeds and updated notes
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New requirements for refrigeration & quench system recorders added
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AMS 2750E Instruments Controlling, Monitoring or Recording Instruments
New - requriements for refrigeration and quench system recorders were not defined in rev D.
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AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Secondary Standard & Field Inst. Calibration Changes AMS2750E Section Reference 3.2.1.5.4
3.2.1.5.4.1
3.2.1.5.4.2
11
AMS2750E Change
Comment
Calibration of secondary standard instruments and field test instruments shall be performed in accordance with the manufacturer’s instructions. These instruments shall be tested at a minimum of 6 simulated sensor inputs. These shall include the minimum and maximum of the operating range used for test or calibration and a minimum of 4 points in between either representing areas of normal operation or spaced at approximately equal intervals across the range in which the instrument is used for test or calibration. The instrument shall be calibrated for each type of input and/or output used (e.g., each thermocouple type in use and for mV, mA, etc. if the instrument is used for these methods). Calibration shall be performed on each channel in use that can be altered or adjusted individually, or on each group of channels that can be altered or adjusted as a group. It is recommended that channels not in use be blocked or tagged to stop unintentional use.
New requirements regarding secondary standard instruments and field instruments calibration
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New requirements regarding secondary standard instruments and field instruments calibration New requirements regarding secondary standard instruments and field instruments calibration
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AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Calibration Controlling/Monitoring/Recording Inst. Changes AMS2750E Section Reference 3.2.5.5
3.2.5.5.1
3.2.5.5.2
12
AMS2750E Change Calibration shall be performed on instrument(s) defined under the Instrument Type column in Table 3. Regardless of the calibration procedure used, it shall comply with the requirements of Table 3. Prior to any instrument alteration or calibration, document the instrument(s) “as-found condition” Check as-found condition at a minimum of three simulated sensor inputs which represent the minimum, maximum and at least one point in the middle 1/3rd of the furnace Qualified Operating Temperature Range. If necessary, calibrate the instrument in accordance with the manufacturer’s instructions. Following any adjustments test the instrument at a minimum of three simulated sensor inputs which represent the minimum, maximum and at least one point in the middle 1/3 rd of the furnace Qualified Operating Temperature Range to document the as-left condition. HONEYWELL - CONFIDENTIAL
Comment Not documenting “as found” condition is often an audit failure point during Nadcap audits
New requirements regarding calibration of controlling, monitoring and recording instruments
New requirements regarding calibration of controlling, monitoring and recording instruments
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AMS2750E Instruments and Instrument Calibration Table 3 – Instruments and Instrument Calibration –updates compared to rev. D:
New
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Table 3 Notes (1) Instruments of equivalent or greater accuracy are acceptable. (2) Comparison checks among the cells shall be performed monthly. (3) Cells having temperature control of ±0.02 °F (±0.01 °C). (4) Furnace class 1 & 2 instruments shall have a minimum sensitivity of 1 °F (1 °C). Furnace class 3 through 6 instruments shall have a minimum sensitivity of 3 °F (2 °C). (5) Controlling, monitoring and recording instrument calibration interval shall be: Digital Electromechanical Furnace Class 1 - Monthly Furnace Class 1 - Monthly Furnace Class 2 - Quarterly Furnace Class 2 - Monthly Furnace Class 3 - Quarterly Furnace Class 3 - Quarterly Furnace Class 4 - Quarterly Furnace Class 4 - Quarterly Furnace Class 5 - Semiannually Furnace Class 5 - Quarterly Furnace Class 6 - Semiannually Furnace Class 6 – Quarterly Refrigeration and quenchant monitor (digital or analog) – semiannually. Exception: If the quenchant/refrigerator sensor is connected to a channel in a furnace process recorder, the interval for calibration of that channel in the instrument shall be the same interval as for the other channels of the instrument. New (6) Furnace Control, Recording, Monitoring or Data Acquisition Instruments. (7) Field Test instruments meeting accuracy requirements of secondary standards may be used to calibrate SAT and TUS test instruments in the field. (8) Over-temperature instruments used solely for furnace over temperature protection do not need to be calibrated. (9) NIST or other equivalent National Standard. New (10) Includes wireless transmission systems (11) Instruments are operated in a controlled environment and are not used on the shop floor.
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AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Calibration Controlling/Monitoring/Recording Inst. Changes AMS2750E Section Reference 3.2.5.5.3
3.2.5.5.5
3.2.5.5.6
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AMS2750E Change Chart recorder (circular and strip) speed(s) shall be verified annually and shall be accurate within 3 minutes per hour. Result of chart speed measurement shall be documented. For furnaces used only at a single temperature, the calibration of controlling, monitoring or recording instruments may either be performed per manufacturer’s instructions at the single temperature of use, or with a minimum of 3 points: the temperature of use, and two (or more) points bracketing the temperature of use. Wireless equipment which performs the analog to digital conversion at the furnace and transmits a digital signal to the recorder are allowed, but require use of the complete wireless system (wireless sender, wireless receiver and associated controlling, monitoring and recording instruments) during the calibration process (See 3.1.1.5.1).
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Comment Added Chart Speed documentation requirement
New requirement
New requirement
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AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Electronic Records Changes AMS2750E Section Reference 3.2.7.1
3.2.7.1.1.3.1
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AMS2750E Change
Comment
An “electronic record” is any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. When using a system (furnace control, recording, monitoring or data acquisition) that creates electronic records, systems purchased after Sept 2006 or any electronic record created after 2015 (3 years after release of this revision) shall meet the following requirements detailed in section 3.2.7.1.3 The system shall be capable of providing evidence the record was reviewed – such as by recording an electronic review, or a method of printing the record for a physical marking indicating review.
Added additional requirement, 3.2.7.1.3.1, to provide a means of providing evidence that the electronic record was reviewed. This can be accomplished in the Trendview recorder by the mark on chart feature.
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New requirement This can be accomplished in the Trendview recorder by the mark on chart feature.
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AMS 2750E Instruments - Thermal Processing • Furnace Instrumentation Type Classification Changes AMS2750E Section Reference 3.3.2 Table 3
3.3.2 Table 3
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AMS2750E Change The temperature indicated by the control sensor in each control zone shall be recorded by a recording instrument. Alternatively, the recording instrument may be connected to a second sensor contained in the same sheath or holder as the control sensor, and separated from the control sensor by no more than 0.38 inch (10 mm). At least 1 recording load sensor in each zone During production in multi-zone furnaces, empty zones (i.e., no material is placed in or intrudes into the zone) do not require a load sensor. However, a notation must be made to the furnace load record that the zone was entirely empty.
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Comment For Instrument Types A, B, C, D Added alternative means of connecting a control sensor, this was not allowed in AMS 2750 D
For Instrument Types A, B, C, D Added clarification for multi-zone furnaces
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AMS 2750E Instruments - Thermal Processing • Furnace Instrumentation Type Changes AMS2750E Section Reference 3.3.4
3.3.5
3.3.6
17
AMS2750E Change Additional Sensors - There is no limit on additional recording or load sensors in any control zone, but their use must be defined in controlled operating instructions. High and low temperature sensors, when required (instrument types A and C – See Figure 3), may be inserted in heat sinks (See 2.2.24), positioned at the high and low temperature locations of the control zone based on the most recent TUS when heat sinks of similar configuration are used during the TUS. For multiple zone vacuum furnaces with 225 cubic feet (6.4 m3) or less in working volume that are instrumented with Types A, B, or C instrumentation, it is acceptable to treat the furnace working volume as a single work zone for the purpose of locating high and low temperature recording thermocouples and determining the number of load thermocouples required regardless of the number of control thermocouples or instruments within the vacuum furnace. The minimum sensors required are shown in Figure 4. Each furnace shall have over-temperature protection in the work zone. HONEYWELL - CONFIDENTIAL
Comment Added clarification for use of additional sensors Improvement to aid the heat treater Also refer to Section 2.2.24 definition of a heat sink
Added clarification multi-zone furnaces
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AMS 2750E Instruments - Thermal Processing • Furnace Instrumentation Type Changes AMS2750E Section Reference 3.3.6.1
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AMS2750E Change
Comment
Vacuum furnaces of volume greater than 225 cubic feet Added clarification multi-zone (6.4 m3) may be treated in the same fashion by dividing furnaces the furnace into working zones that shall not exceed 225 cubic feet (6.4 m3) – each of these zones shall contain all the required sensors as outlined in Figure 4 for a single zone.
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AMS 2750E Instruments - Thermal Processing • Instrumentation for Refrigeration & Quench Systems AMS2750E Section Reference 3.3.3.1
3.3.3.2
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AMS2750E Change
Comment
Refrigeration equipment shall have a temperature controller. This temperature controller requirement is not applicable to liquid nitrogen, dry ice and dry ice/liquidcooled containers. All refrigeration equipment shall be equipped with a temperature recorder where time-attemperature (minimum or maximum) is required. The above requirements are not applicable during transportation of materials at sub-ambient temperatures. Quench systems used for heat treatments that include a quenchant temperature requirement (minimum, maximum or both) shall be equipped with a recording instrument. Existing installations installed prior to September 2005 do not require recording instruments until 3 years after the release of this revision.
AMS2750D did not require to have temperature recording instrument for quench systems that were set up before AMS2750D
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AMS2750D did not require a temperature recording instrument for quench systems that were set up before (Sept. 2005). If you still have a quench system without a recording instrument, you have 3 years to upgrade per AMS2750E to include a recorder.
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AMS 2750E – System Accuracy Test • System Accuracy Test Changes – Section 3.4
- Defines what equipment requires SAT, the frequency, waiver conditions and the Test Procedure to use
- The SAT is an on-site comparison of the instrument/leadwire/ sensor readings or values, with the readings or values of a calibrated test instrument/leadwire/sensor to determine if the measured temperature deviations are within applicable requirements. The SAT is performed to assure the accuracy of the furnace control and recording system in each control zone.
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AMS 2750E – System Accuracy Test • System Accuracy Test Changes AMS2750E Section Reference
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AMS2750E Change
Comment
3.4.2.1
Two sensors in each control zone are Type B, N, R, or S.
3.4.5.2.1
Resident SAT thermocouples shall be restricted to Type B, “B” Type T/C added N, R or S at temperatures exceeding 500 °F (260 °C) and shall be nonexpendable if exposed to temperatures above 1000 °F (538 °C).
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“B” Type T/C added
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AMS 2750E – System Accuracy Test AMS2750 rev. E updates Tables 6 and 7 for SAT requirements:
New
In rev D there was mistake and Monthly/Quarterly was stated
New
AMS 2750E – System Accuracy Test Records AMS2750 rev. E par. 3.4.8: SAT Records 3.4.8.1 The system accuracy test report for each sensor shall include: a.
Identification of the sensor being tested
b.
Identification of the test sensor
c.
Identification of the test instrument
d.
Date and time of day of the test
e.
Set point of the furnace during test
f.
Observed furnace instrument reading
g.
Observed test instrument reading
h.
Test sensor and test instrument correction factors
i.
Corrected test instrument reading
j.
Calculated system accuracy difference
k.
Indication of test acceptance or failure
l.
Identification of technician performing the test
New
m. SAT company (if not performed in-house) n.
Signature of the calibration company (if not performed in-house)
o.
Quality Organization approval. HONEYWELL - CONFIDENTIAL
AMS 2750E – Temp Uniformity Survey • TUS Data Collection Changes AMS2750E Section Reference 3.5.13.2
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AMS2750E Change Once data collection begins, temperature data shall be recorded from all TUS sensors at a frequency of at least one set of all readings every 2 minutes for the duration of the survey. Data from furnace sensors required by the applicable instrumentation type (See 3.3) shall be recorded as follows. (Sensors whose only function is overtemperature protection do not need to be recorded.) If the normal frequency of temperature data recording in production is 2 minutes or less, or is continuous as in the case of analog recorders, the data shall be documented in the normal production format. If the normal frequency of temperature data recording in production is greater than 2 minutes, the recording frequency interval during the TUS shall not exceed 6 minutes.
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Comment No change with this part of the requirement
Added statement for those processes that record at less than 2 minutes
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AMS 2750E – Temp Uniformity Survey Records AMS2750 rev. E par. 3.5.21: Temperature Uniformity Survey Report 3.5.21.1 The following items shall be included in the temperature uniformity survey report: a. b. c.
Furnace identification name or number Survey temperatures TUS sensor and location identification including a detailed diagram, description or photograph(s) of any load or rack used d. Time and temperature data from all recorded sensors required for furnace instrumentation type for all zones tested (3.5.13.3.2) e. Correction factors for TUS sensors at each survey temperature. New f. As found and as left TUS offsets (if used in production) g. Corrected or uncorrected readings of all TUS sensors at each survey temperature. Readings shall be identified as corrected or uncorrected. h. Testing company identification (if not performed in-house) i. Signature for the testing company (if not performed in-house) j. Identification of technician performing survey k. Survey start date and time l. Survey end date and time m. Survey test instrument identification number n. Indication of test or test fail o. When required, documentation of furnace survey sensor failures (See 3.5.16) p. Summary of corrected plus and minus TUS readings at each test temperature after stabilization. q. Quality Organization approval. HONEYWELL - CONFIDENTIAL
AMS 2750E – Temp Uniformity Survey Records AMS2750 rev. E par. 3.5.21: Temperature Uniformity Survey Report – (continued) 3.5.21.2 Although not a required part of the uniformity survey report, the following shall be accessible on site: a. b. c. d.
Control instrument tuning parameters TUS sensor calibration report Control and recording sensor calibration report Diagrams of control and recording sensors, load and TUS sensor locations in three dimensional space.
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AMS 2750E – Rounding AMS2750 rev. E par. 3.8: Rounding Added: Rounding shall be in accordance with ASTM E 29 or other national standard a. b. c. d.
Control instrument tuning parameters TUS sensor calibration report Control and recording sensor calibration report Diagrams of control and recording sensors, load and TUS sensor locations in three dimensional space.
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AMS 2750E Instruments 3.2.4 Controlling, Monitoring or Recording Instruments Requirements for Controlling, Monitoring or Recording Instruments AMS 2750E Ref.
Requirement
Comment
Readability 3.2.3.1
At least one recording and/or controlling instrument for each zone shall have a minimum readability of 1°F or 1°C
Honeywell Recorders (X-Series Paperless, DR4500, DPR180, DPR250), HC900 OI and Controllers (UDC2500, UDC3200 & UDC3500) have a readability of at least 1°F or 1°C, most read down to 0.1°.
Installation 3.2.3.2
Installation shall conform to manufacturer’s recommendation
Manuals provide detailed information on proper installation for each product.
Signal Inputs 3.2.3.3
Instruments shall receive an unmodified signal from sensors except for A to D and D to A conversions, or a digitally processed, error-checked equivalent representation of a direct measured value.
Honeywell Recorders, Controllers and HC900 all accept direct sensor inputs of the T/C listed in Table 2 of AMS 2750D, many of the recorders can accept and document input values over communications.
Offsets 3.2.3.4
If offsets are used, a documented procedure shall exist describing when and how to perform offsets.
Honeywell Recorders, Controllers and HC900 allow offsets to be easily entered and shows the offsets as part of the configurations.
Honeywell Instruments meet the requirements for readability, installation, offsets & signal input 28
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AMS 2750E Instruments 3.2.5 Instrument Calibration Requirements for Instrument Calibration AMS 2750E Ref.
Requirement
Comment
Calibration compliance 3.2.5.1
Calibration shall be performed on the instruments in the Instrument Types listed in Table 3 & comply with the Table 3 requirements. Prior to any instrument alteration or calibration, document the instrument(s) “as-found condition”
Honeywell Recorders (X-Series Paperless, DR4500, DPR180 & DPR250), HC900 and Controllers (UDC2500, UDC3200 & UDC3500) are considered control, monitoring and recording instruments.
Accuracy & Freq. 3.2.5.2
Calibration accuracy & frequency shall be in accordance with Table 3
Recorders, HC900 & Controllers can meet the 2°F (1.1°C) for Digital Instruments or 2°F (1.1°C) /0.3% of Max Survey Temp for electro-mech. inst.
Calibration Performance 3.2.5.4
Calibration shall be to Mfg’s instructions or a minimum of 6 simulated sensor inputs at the Min. & Max. of the Operating Range used for test or calib. and a minimum of 4 points in between …...
Honeywell Recorders, HC900 & Controllers are typically calibrated at the zero and span values for each range. The calibration procedure is documented as part of the product manual.
Calibration Performance 3.2.5.5.4
Calibration may be performed with a load in process if furnace temp remains within the processing tolerance and the record is appropriately annotated to indicated that a calibration occurred.
Honeywell Recorders (X-Series Paperless and DPRs) provide easy annotation of the chart to aid the documentation process.
The recorders can also be used as Field Test instruments for doing Temp Uniformity Surveys.
We can meet the requirements
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AMS 2750E Instruments 3.2.5 Instrument Calibration Requirements for Instrument Calibration AMS 2750E Ref.
Requirement
Comment
Calibration Performance 3.2.5.5.2
Calibration shall be performed on each channel or group of channels that can be altered or adjusted.
Honeywell Recorders, HC900 & Controllers allow each individual channel to be calibrated.
Chart Speed 3.2.5.5.3
Chart recorder (circular & strip) speed(s) shall be verified annually and shall be accurate within ± 3 minutes per hour
DR4500 – Clock accuracy 32PPM (~1.4 min/mo), DPR180 & DPR250 – Clock accuracy – 10PPM (~45sec/mo) X-Series Paperless – 30PPM (~1.3min/mo) – These clock accuracies are @ reference conditions.
Sensitivity 3.2.5.3
Sensitivity shall be checked during calibration per Table 3 footnote 4
Sensitivity for Honeywell Recorders, HC900 & Controllers is negligible and is covered by the accuracy specification.
Class 1 & 2 minimum sensitivity of 1°F (1°C), Classes 3 – 6 a minimum sensitivity of 3°F (2°C),
“Sensitivity” is the temperature change in the input that is require to activate a change, either upscale or downscale on the instrumentation. It is normally one-half the numerical value of the dead band, such as a sensitivity of 1°F (0.6°C) is equivalent to a dead band of 2°F (1.1°C).
Honeywell Recorders & Controllers can meet the requirements 30
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AMS 2750E Instruments 3.2.6 Instrumentation Records Requirements for Documentation of Instrument Calibration AMS 2750E Ref.
Requirement
Comment
Instrument Sticker 3.2.6.1
A sticker affixed to the instrument shall indicate the most recent successful calibration. As a minimum the sticker shall include:
The must establish adequate traceability that the instrumentation has been calibrated. The X-Series Paperless Recorder Status Maintenance & Diagnostic screens can provide an aid for doing this.
Date Cal performed, Due date of next Calibration, Technician who performed calibration, and any limits or restrictions of the calibration Calibration Results 3.2.6.2
The results of calibration shall be documented. Minimum requirements:
The must establish a report format to satisfy these requirements.
Inst or Furnace No., Make & Model of instrument, Standard used, method of calibration, Required Accuracy, As Found & as Left data for each cal point, Offset as found & as left, Sensitivity, Statement of acceptance or rejection, Any limitations or restriction, Date of Cal, Next Due Date, Technician name, Calibration Co Name (if not done in house, Signature of Calibration Co , Quality Organization approval
The must document instrument calibrations 31
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AMS 2750E Instruments 3.2.7 Electronic Records Requirements for Electronic Data Recording AMS 2750E Ref.
Requirement
Electronic Record Definition 3.2.7.1
An electronic record is any combination of text, graphics, data, audio, pictorial or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Record Security 3.2.7.1.1
The system must create electronic records that cannot be altered without detection
The X-Series Paperless recorders & HC900 OI create encrypted write-once, read only records. Requires TrendManager Software to read data.
Software & Playback 3.2.7.1.2
The system software and playback utilities shall provide a means of examining and/or compiling the record data, but shall not provide any means for altering the source data.
The TrendManager Pro software provides means to import data, review & examine data, export to other spreadsheets and generate graphs and reports. The Software cannot alter the source data.
Review Copies of records 3.2.7.1.3
The system shall provide the ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copying
The TrendManager Pro software can generate graphs and reports of the data. The graphs use the data as received from the recorder for completeness and accuracy. These are in human readable form or readable using TrendManager Software
Comment
X-Series Recorders create secure electronic data 32
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AMS 2750E Instruments 3.2.7 Electronic Records Requirements for Electronic Data Recording AMS 2750E Ref. Review evidence 3.2.7.1.4
Requirement The system shall be capable of providing evidence the record was reviewed – such as by recoding an electronic review, or a method of printing the record for a physical marking indicating review
Comment
Retention & retrieval 3.2.7.1.4
The system shall protection, retention, and retrieval of accurate records throughout the record retention period. The hardware and/or software shall operate throughout the retention period as specified in section 3.7
The TrendManager Software does not alter the source information and s the protection, retention and retrieval of records. A data base Management Tool provides the means to move, copy and mange the files for storage on secure servers. TrendManger Software is compatible with current PC Operating Systems and can read data from all generations of Trendview Paperless recorders
System Access – (s) 3.2.7.1.5
The system shall provide methods (e.g. s) to limit system access to only individuals whose authorization is documented
The X-Series Paperless Recorders provides full system to comply with 21CFR Part 11. 50 s with unique ID & , time outs, expirations of s, definitions and audit trail info. The HC900 OI provides for secured access via a specified numerical code.
The X-Series Paperless Recorders provides mark on chart, ability to create a report or data can be imported to the AMS2750 Report Tool to create a report.
TMP provides secure analysis & data archiving 33
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Section 3.3 Thermal Processing Equipment • Furnace Class Uniformity & Recorder Resolution - Classes based on Temperature Uniformity requirements - Resolution requirements affect the recorder and chart used - Paperless recorders record actual values eliminating issues with the chart and the chart resolution
34
Furnace Class
Temp Uniformity °F
Temp Uniformity °C
Max ° per Inch (CM) of Chart °F/Inch
Max ° per Inch (CM) of Chart °C/CM
Max Chart Recording Increment °F/Line
1
±5
±3
50
11
2
1
2
±10
±6
150
33
5
3
3
±15
±8
150
33
5
3
4
±20
±10
250
55
10
5
5
±25
±14
250
55
10
5
6
±30
±28
350
77
25
15
HONEYWELL - CONFIDENTIAL
Max Chart Recording Increment °C/Line
File Number
AMS 2750E System Accuracy Tests 3.4.1 System Accuracy Tests AMS 2750E Ref.
Requirement
Comment
Requirement 3.4.1
SAT shall be performed on the temperature control and recording systems in each control zone of each piece of thermal processing equipment used for production heat treatments
System accuracy checks are required for the controllers and recorders used for production heat treating.
SAT’s shall also be performed on additional systems that qualify instrumentation as Types A, B, or C Requirements 3.4.1.1
SAT shall be performed using a test instrument meeting requirements of Table 3 and a test sensor meeting the requirements of Table 1
A test instrument is one used to perform system accuracy tests, temperature uniformity surveys or calibrations of controllers, recorders, data acquisition instruments or monitoring instruments. The Test Instrument calibrated accuracy allowed is ±1°F (0.6°C) or ±0.1% of reading in °F, which ever is greater Based on this requirement Mintitrend QX, Multitrend SX, DPR180, DPR250 and DR4500 could be used as a test instrument, field calibration is typically required to meet this.
Instruments used for System Accuracy tests have a higher accuracy requirement 35
HONEYWELL - CONFIDENTIAL
File Number
Recorders That Meet AMS 2750E • Honeywell has Paper and Paperless Recorders that meet AMS 2750E requirements for Controlling, Monitoring and Recording Instruments & Field Test - Key requirement for Controlling, Monitoring & Recording instruments is a calibrated accuracy of (± 2°F/1.1°C) or 0.2% of reading whichever is greater for digital instruments, ±2 °F (±1.1 °C) or ±0.3% of the maximum survey temperature of the equipment, whichever is greater for electromechanical
- Key requirement for Field Test instruments is a calibrated accuracy of (±1°F/0.6°C)
DPR 180
DPR 250
TrendManager Software DR4500 Circular Chart 36
X-Series Paperless HONEYWELL - CONFIDENTIAL
File Number
UDC Controllers That Meet AMS 2750E • Honeywell has Controllers that meet AMS 2750E requirements for Controlling, Monitoring and Recording Instruments - Key requirement for Controlling, Monitoring & Recording instruments is a calibrated accuracy (± 2°F/1.1°C) or 0.2% of reading whichever is greater for digital instruments UDC 3200 UDC 3500
UDC 2500
37
HONEYWELL - CONFIDENTIAL
File Number
HC900 Meets AMS 2750D • The Honeywell HC900 and associated 559 & 1042 Operator Interfaces (OI) meet AMS 2750D requirements for Controlling, Monitoring and Recording Instruments - Key requirement for Controlling, Monitoring & Recording instruments is a calibrated accuracy (± 2°F/1.1°C)
38
HONEYWELL - CONFIDENTIAL
File Number
www.honeywell.com
Overview on Changes • AMS2750 Specification Updated to Revision E - New Revision of Spec – 2750E revised July 2012; - Replaces Spec - 2750D (revised Sept 2005) - Updated to include wireless sensor technology - Added requirements to document “As found” instrument calibration and offset conditions (procedural impacts) - Calibration changes like check min. of 6 simulated sensor @ min. 4 points, calibrated for each type input/output used - Provides more details on Temperature Uniformity Survey Testing (TUS) procedures, furnace repairs and modifications, data collection requirements, survey frequency, number and location of sensors, /Fail requirements - Added Refrigeration & Quench Furnace class to tables
General Update 2
HONEYWELL - CONFIDENTIAL
File Number
Standards • AMS2750E Pyrometry - Covers Temperature Sensor, Instrumentation, Thermal processing equipment, System Accuracy Tests, Temperature Uniformity Survey requirements - Ensures that parts or raw material are heat treated in accordance to applicable specifications
• AS7102 Nadcap Requirements for Heat Treating - Documents the requirements for the accreditation program - Industry managed program for continuous improvement Standard industry audit program for special processes Focuses on overall supplier performance Auditing overseen by PRI (Performance Review Institute)
3
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Section 2 Definitions Changes - Par. 2.2.15 DIGITAL INSTRUMENT: Clarification was added to definition of digital instruments with digital temperature display and with temperature trace on paper chart: An instrument that presents process measurements in a digital (numeric) display format. Typical examples are mechanical recorders with digital displays, digital indicators, controllers with digital displays, etc. In the case of a recorder with digital temperature display and a recorder trace (line) the record (recorder trace) is analog while the display is digital. A recorder trace on a paper chart is an analog record.
- Par. 2.2.25 INTERVAL Interval definition was added to AMS2750E to avoid confusion by some suppliers. 4
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Section 2 Definitions Changes - Par. 2.2.27 LOAD SENSORS : Clarification regarding correct usage of load sensors/ thermocouples. (in rev. D it was not included in the load sensor definition but stated in par. 3.1.8.1): Sensors that are attached to or in with production material, a representation of production material, or are buried in the load of production material and which supply temperature data of the production material to process instrumentation.
5
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Temp Sensor Changes • Temperature Sensor - Section 3.1 Changes - This section deals with the requirements for the temperature sensors used in these heat treatment processes AMS2750E Section Reference 3.1.1.5.1 3.1.2.2.1 3.1.2.2.6
3.1.2.5.2
6
AMS2750E Change Allows use of Wireless transmitters as alternative to extension wire Certs for sensors now require “Date of Calibration” Correction factor for each calibration temperature traceable to NIST or other recognized National Standard. Alternatively, deviation (error) for each calibration temperature may be listed. The certificate shall clearly state if it shows deviation or correction factor. Extrapolation of calibration correction factors above the highest calibration temperature and below the lowest calibration temperature is prohibited by any calibration source except NIST or other National Standards calibration agency.
HONEYWELL - CONFIDENTIAL
Comment New New
Added this
Added “except NIST or other National Standards calibration agency.”
File Number
AMS 2750E Temp Sensor Changes • Temperature Sensor - Section 3.1 Changes AMS2750E Section Reference 3.1.2.6
3.1.3.5
3.1.5.2
3.1.5.3
7
AMS2750E Change When calibrating thermocouples rolls, AMS2750 Rev. E requires sampling from both ends regardless of roll length. (1000 feet/305 meters limit from AMS2750D for one end sampling only is no longer acceptable). Other requirements for rolls calibration remains the same. Nonexpendable base metal TUS TCs used below 1200F (650C) do not need to be permanently installed on TUS rack between its usage like it was stated in Rev. D Added time of 90 days “Expendable base metal load sensors may be used for up to 90 calendar days after first use and for no more than 30 uses” Changed the requirement on the life of nonexpendable base metal load thermocouples 2200 °F (1205 °C) to 2299 °F (1260 °C) – 3 months or 10 uses 1801 °F (980 °C) to 2199 °F (1205 °C) – 3 months or 90 uses HONEYWELL - CONFIDENTIAL
Comment Added “Rolls shall be sampled at both ends of the roll”
TUS T/C’s can be reinserted for each TUS through ports in the furnace; need to be used at the same location and depth of insertion. Previously was just 30 uses
Previously for 2200˚F was just 10 uses, no time period specified 1801˚F was 30 days or 90 uses; now 90 days or 90 uses File Number
AMS 2750E Temp Sensor Changes • Temperature Sensor - Section 3.1 Changes AMS2750E Section Reference Figure 1
Comment
Added Table of Reuse and Recalibration of Test & Load Sensors Sensor - Secondary Standard – Max. Permitted Error changes
Summarizes Reuse & Recalibration Primarily for clarification Increased max. permitted error
Figure 1
Sensor – System Accuracy Test – • Max. Permitted Error changes • Recalibration permited if Types E & K are used below 500F (260C) only (Note 11)
Increased max. permitted error
3.4.5.2.1
Type B TCs are allowed as resident SAT TCs for temperatures above 500F (260C)
Type B T/C’s were not allowed by Rev D.
Figure 1
8
AMS2750E Change
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments Controlling, Monitoring or Recording Instruments
• Instrumentation - Section 3.2 Changes - This section deals with the requirements of the instrumentation used in these heat treatment processes AMS2750E Section Reference 3.2.1
3.2.1.1.1
3.2.1.1.2
9
AMS2750E Change
Comment
AMS2750D allowed to use instruments meeting requirements of AMS2750C (but not meeting rev D requirements) if these instruments were purchased before September 2006 (one year after rev. D issue). If you have such instruments, now you have 3 years you upgrade your equipment to meet Rev. E requirements Temperature resolution requirements for chart recorders shall be in accordance with Table 4. (See next slide for table)
Exemption will run out for older instrumentation, now have to upgrade within 3 years of issuing of AMS2750E (issued July 2012)
Process Recorder Print and Chart Speeds shall be in accordance with Table 5. (See next slide for table)
Added metric speeds and updated notes
HONEYWELL - CONFIDENTIAL
New requirements for refrigeration & quench system recorders added
File Number
AMS 2750E Instruments Controlling, Monitoring or Recording Instruments
New - requriements for refrigeration and quench system recorders were not defined in rev D.
10
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Secondary Standard & Field Inst. Calibration Changes AMS2750E Section Reference 3.2.1.5.4
3.2.1.5.4.1
3.2.1.5.4.2
11
AMS2750E Change
Comment
Calibration of secondary standard instruments and field test instruments shall be performed in accordance with the manufacturer’s instructions. These instruments shall be tested at a minimum of 6 simulated sensor inputs. These shall include the minimum and maximum of the operating range used for test or calibration and a minimum of 4 points in between either representing areas of normal operation or spaced at approximately equal intervals across the range in which the instrument is used for test or calibration. The instrument shall be calibrated for each type of input and/or output used (e.g., each thermocouple type in use and for mV, mA, etc. if the instrument is used for these methods). Calibration shall be performed on each channel in use that can be altered or adjusted individually, or on each group of channels that can be altered or adjusted as a group. It is recommended that channels not in use be blocked or tagged to stop unintentional use.
New requirements regarding secondary standard instruments and field instruments calibration
HONEYWELL - CONFIDENTIAL
New requirements regarding secondary standard instruments and field instruments calibration New requirements regarding secondary standard instruments and field instruments calibration
File Number
AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Calibration Controlling/Monitoring/Recording Inst. Changes AMS2750E Section Reference 3.2.5.5
3.2.5.5.1
3.2.5.5.2
12
AMS2750E Change Calibration shall be performed on instrument(s) defined under the Instrument Type column in Table 3. Regardless of the calibration procedure used, it shall comply with the requirements of Table 3. Prior to any instrument alteration or calibration, document the instrument(s) “as-found condition” Check as-found condition at a minimum of three simulated sensor inputs which represent the minimum, maximum and at least one point in the middle 1/3rd of the furnace Qualified Operating Temperature Range. If necessary, calibrate the instrument in accordance with the manufacturer’s instructions. Following any adjustments test the instrument at a minimum of three simulated sensor inputs which represent the minimum, maximum and at least one point in the middle 1/3 rd of the furnace Qualified Operating Temperature Range to document the as-left condition. HONEYWELL - CONFIDENTIAL
Comment Not documenting “as found” condition is often an audit failure point during Nadcap audits
New requirements regarding calibration of controlling, monitoring and recording instruments
New requirements regarding calibration of controlling, monitoring and recording instruments
File Number
AMS2750E Instruments and Instrument Calibration Table 3 – Instruments and Instrument Calibration –updates compared to rev. D:
New
13
Table 3 Notes (1) Instruments of equivalent or greater accuracy are acceptable. (2) Comparison checks among the cells shall be performed monthly. (3) Cells having temperature control of ±0.02 °F (±0.01 °C). (4) Furnace class 1 & 2 instruments shall have a minimum sensitivity of 1 °F (1 °C). Furnace class 3 through 6 instruments shall have a minimum sensitivity of 3 °F (2 °C). (5) Controlling, monitoring and recording instrument calibration interval shall be: Digital Electromechanical Furnace Class 1 - Monthly Furnace Class 1 - Monthly Furnace Class 2 - Quarterly Furnace Class 2 - Monthly Furnace Class 3 - Quarterly Furnace Class 3 - Quarterly Furnace Class 4 - Quarterly Furnace Class 4 - Quarterly Furnace Class 5 - Semiannually Furnace Class 5 - Quarterly Furnace Class 6 - Semiannually Furnace Class 6 – Quarterly Refrigeration and quenchant monitor (digital or analog) – semiannually. Exception: If the quenchant/refrigerator sensor is connected to a channel in a furnace process recorder, the interval for calibration of that channel in the instrument shall be the same interval as for the other channels of the instrument. New (6) Furnace Control, Recording, Monitoring or Data Acquisition Instruments. (7) Field Test instruments meeting accuracy requirements of secondary standards may be used to calibrate SAT and TUS test instruments in the field. (8) Over-temperature instruments used solely for furnace over temperature protection do not need to be calibrated. (9) NIST or other equivalent National Standard. New (10) Includes wireless transmission systems (11) Instruments are operated in a controlled environment and are not used on the shop floor.
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Calibration Controlling/Monitoring/Recording Inst. Changes AMS2750E Section Reference 3.2.5.5.3
3.2.5.5.5
3.2.5.5.6
14
AMS2750E Change Chart recorder (circular and strip) speed(s) shall be verified annually and shall be accurate within 3 minutes per hour. Result of chart speed measurement shall be documented. For furnaces used only at a single temperature, the calibration of controlling, monitoring or recording instruments may either be performed per manufacturer’s instructions at the single temperature of use, or with a minimum of 3 points: the temperature of use, and two (or more) points bracketing the temperature of use. Wireless equipment which performs the analog to digital conversion at the furnace and transmits a digital signal to the recorder are allowed, but require use of the complete wireless system (wireless sender, wireless receiver and associated controlling, monitoring and recording instruments) during the calibration process (See 3.1.1.5.1).
HONEYWELL - CONFIDENTIAL
Comment Added Chart Speed documentation requirement
New requirement
New requirement
File Number
AMS 2750E Instruments Controlling, Monitoring or Recording Instruments • Electronic Records Changes AMS2750E Section Reference 3.2.7.1
3.2.7.1.1.3.1
15
AMS2750E Change
Comment
An “electronic record” is any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. When using a system (furnace control, recording, monitoring or data acquisition) that creates electronic records, systems purchased after Sept 2006 or any electronic record created after 2015 (3 years after release of this revision) shall meet the following requirements detailed in section 3.2.7.1.3 The system shall be capable of providing evidence the record was reviewed – such as by recording an electronic review, or a method of printing the record for a physical marking indicating review.
Added additional requirement, 3.2.7.1.3.1, to provide a means of providing evidence that the electronic record was reviewed. This can be accomplished in the Trendview recorder by the mark on chart feature.
HONEYWELL - CONFIDENTIAL
New requirement This can be accomplished in the Trendview recorder by the mark on chart feature.
File Number
AMS 2750E Instruments - Thermal Processing • Furnace Instrumentation Type Classification Changes AMS2750E Section Reference 3.3.2 Table 3
3.3.2 Table 3
16
AMS2750E Change The temperature indicated by the control sensor in each control zone shall be recorded by a recording instrument. Alternatively, the recording instrument may be connected to a second sensor contained in the same sheath or holder as the control sensor, and separated from the control sensor by no more than 0.38 inch (10 mm). At least 1 recording load sensor in each zone During production in multi-zone furnaces, empty zones (i.e., no material is placed in or intrudes into the zone) do not require a load sensor. However, a notation must be made to the furnace load record that the zone was entirely empty.
HONEYWELL - CONFIDENTIAL
Comment For Instrument Types A, B, C, D Added alternative means of connecting a control sensor, this was not allowed in AMS 2750 D
For Instrument Types A, B, C, D Added clarification for multi-zone furnaces
File Number
AMS 2750E Instruments - Thermal Processing • Furnace Instrumentation Type Changes AMS2750E Section Reference 3.3.4
3.3.5
3.3.6
17
AMS2750E Change Additional Sensors - There is no limit on additional recording or load sensors in any control zone, but their use must be defined in controlled operating instructions. High and low temperature sensors, when required (instrument types A and C – See Figure 3), may be inserted in heat sinks (See 2.2.24), positioned at the high and low temperature locations of the control zone based on the most recent TUS when heat sinks of similar configuration are used during the TUS. For multiple zone vacuum furnaces with 225 cubic feet (6.4 m3) or less in working volume that are instrumented with Types A, B, or C instrumentation, it is acceptable to treat the furnace working volume as a single work zone for the purpose of locating high and low temperature recording thermocouples and determining the number of load thermocouples required regardless of the number of control thermocouples or instruments within the vacuum furnace. The minimum sensors required are shown in Figure 4. Each furnace shall have over-temperature protection in the work zone. HONEYWELL - CONFIDENTIAL
Comment Added clarification for use of additional sensors Improvement to aid the heat treater Also refer to Section 2.2.24 definition of a heat sink
Added clarification multi-zone furnaces
File Number
AMS 2750E Instruments - Thermal Processing • Furnace Instrumentation Type Changes AMS2750E Section Reference 3.3.6.1
18
AMS2750E Change
Comment
Vacuum furnaces of volume greater than 225 cubic feet Added clarification multi-zone (6.4 m3) may be treated in the same fashion by dividing furnaces the furnace into working zones that shall not exceed 225 cubic feet (6.4 m3) – each of these zones shall contain all the required sensors as outlined in Figure 4 for a single zone.
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments - Thermal Processing • Instrumentation for Refrigeration & Quench Systems AMS2750E Section Reference 3.3.3.1
3.3.3.2
19
AMS2750E Change
Comment
Refrigeration equipment shall have a temperature controller. This temperature controller requirement is not applicable to liquid nitrogen, dry ice and dry ice/liquidcooled containers. All refrigeration equipment shall be equipped with a temperature recorder where time-attemperature (minimum or maximum) is required. The above requirements are not applicable during transportation of materials at sub-ambient temperatures. Quench systems used for heat treatments that include a quenchant temperature requirement (minimum, maximum or both) shall be equipped with a recording instrument. Existing installations installed prior to September 2005 do not require recording instruments until 3 years after the release of this revision.
AMS2750D did not require to have temperature recording instrument for quench systems that were set up before AMS2750D
HONEYWELL - CONFIDENTIAL
AMS2750D did not require a temperature recording instrument for quench systems that were set up before (Sept. 2005). If you still have a quench system without a recording instrument, you have 3 years to upgrade per AMS2750E to include a recorder.
File Number
AMS 2750E – System Accuracy Test • System Accuracy Test Changes – Section 3.4
- Defines what equipment requires SAT, the frequency, waiver conditions and the Test Procedure to use
- The SAT is an on-site comparison of the instrument/leadwire/ sensor readings or values, with the readings or values of a calibrated test instrument/leadwire/sensor to determine if the measured temperature deviations are within applicable requirements. The SAT is performed to assure the accuracy of the furnace control and recording system in each control zone.
20
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E – System Accuracy Test • System Accuracy Test Changes AMS2750E Section Reference
21
AMS2750E Change
Comment
3.4.2.1
Two sensors in each control zone are Type B, N, R, or S.
3.4.5.2.1
Resident SAT thermocouples shall be restricted to Type B, “B” Type T/C added N, R or S at temperatures exceeding 500 °F (260 °C) and shall be nonexpendable if exposed to temperatures above 1000 °F (538 °C).
HONEYWELL - CONFIDENTIAL
“B” Type T/C added
File Number
AMS 2750E – System Accuracy Test AMS2750 rev. E updates Tables 6 and 7 for SAT requirements:
New
In rev D there was mistake and Monthly/Quarterly was stated
New
AMS 2750E – System Accuracy Test Records AMS2750 rev. E par. 3.4.8: SAT Records 3.4.8.1 The system accuracy test report for each sensor shall include: a.
Identification of the sensor being tested
b.
Identification of the test sensor
c.
Identification of the test instrument
d.
Date and time of day of the test
e.
Set point of the furnace during test
f.
Observed furnace instrument reading
g.
Observed test instrument reading
h.
Test sensor and test instrument correction factors
i.
Corrected test instrument reading
j.
Calculated system accuracy difference
k.
Indication of test acceptance or failure
l.
Identification of technician performing the test
New
m. SAT company (if not performed in-house) n.
Signature of the calibration company (if not performed in-house)
o.
Quality Organization approval. HONEYWELL - CONFIDENTIAL
AMS 2750E – Temp Uniformity Survey • TUS Data Collection Changes AMS2750E Section Reference 3.5.13.2
24
AMS2750E Change Once data collection begins, temperature data shall be recorded from all TUS sensors at a frequency of at least one set of all readings every 2 minutes for the duration of the survey. Data from furnace sensors required by the applicable instrumentation type (See 3.3) shall be recorded as follows. (Sensors whose only function is overtemperature protection do not need to be recorded.) If the normal frequency of temperature data recording in production is 2 minutes or less, or is continuous as in the case of analog recorders, the data shall be documented in the normal production format. If the normal frequency of temperature data recording in production is greater than 2 minutes, the recording frequency interval during the TUS shall not exceed 6 minutes.
HONEYWELL - CONFIDENTIAL
Comment No change with this part of the requirement
Added statement for those processes that record at less than 2 minutes
File Number
AMS 2750E – Temp Uniformity Survey Records AMS2750 rev. E par. 3.5.21: Temperature Uniformity Survey Report 3.5.21.1 The following items shall be included in the temperature uniformity survey report: a. b. c.
Furnace identification name or number Survey temperatures TUS sensor and location identification including a detailed diagram, description or photograph(s) of any load or rack used d. Time and temperature data from all recorded sensors required for furnace instrumentation type for all zones tested (3.5.13.3.2) e. Correction factors for TUS sensors at each survey temperature. New f. As found and as left TUS offsets (if used in production) g. Corrected or uncorrected readings of all TUS sensors at each survey temperature. Readings shall be identified as corrected or uncorrected. h. Testing company identification (if not performed in-house) i. Signature for the testing company (if not performed in-house) j. Identification of technician performing survey k. Survey start date and time l. Survey end date and time m. Survey test instrument identification number n. Indication of test or test fail o. When required, documentation of furnace survey sensor failures (See 3.5.16) p. Summary of corrected plus and minus TUS readings at each test temperature after stabilization. q. Quality Organization approval. HONEYWELL - CONFIDENTIAL
AMS 2750E – Temp Uniformity Survey Records AMS2750 rev. E par. 3.5.21: Temperature Uniformity Survey Report – (continued) 3.5.21.2 Although not a required part of the uniformity survey report, the following shall be accessible on site: a. b. c. d.
Control instrument tuning parameters TUS sensor calibration report Control and recording sensor calibration report Diagrams of control and recording sensors, load and TUS sensor locations in three dimensional space.
HONEYWELL - CONFIDENTIAL
AMS 2750E – Rounding AMS2750 rev. E par. 3.8: Rounding Added: Rounding shall be in accordance with ASTM E 29 or other national standard a. b. c. d.
Control instrument tuning parameters TUS sensor calibration report Control and recording sensor calibration report Diagrams of control and recording sensors, load and TUS sensor locations in three dimensional space.
HONEYWELL - CONFIDENTIAL
AMS 2750E Instruments 3.2.4 Controlling, Monitoring or Recording Instruments Requirements for Controlling, Monitoring or Recording Instruments AMS 2750E Ref.
Requirement
Comment
Readability 3.2.3.1
At least one recording and/or controlling instrument for each zone shall have a minimum readability of 1°F or 1°C
Honeywell Recorders (X-Series Paperless, DR4500, DPR180, DPR250), HC900 OI and Controllers (UDC2500, UDC3200 & UDC3500) have a readability of at least 1°F or 1°C, most read down to 0.1°.
Installation 3.2.3.2
Installation shall conform to manufacturer’s recommendation
Manuals provide detailed information on proper installation for each product.
Signal Inputs 3.2.3.3
Instruments shall receive an unmodified signal from sensors except for A to D and D to A conversions, or a digitally processed, error-checked equivalent representation of a direct measured value.
Honeywell Recorders, Controllers and HC900 all accept direct sensor inputs of the T/C listed in Table 2 of AMS 2750D, many of the recorders can accept and document input values over communications.
Offsets 3.2.3.4
If offsets are used, a documented procedure shall exist describing when and how to perform offsets.
Honeywell Recorders, Controllers and HC900 allow offsets to be easily entered and shows the offsets as part of the configurations.
Honeywell Instruments meet the requirements for readability, installation, offsets & signal input 28
HONEYWELL - CONFIDENTIAL
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AMS 2750E Instruments 3.2.5 Instrument Calibration Requirements for Instrument Calibration AMS 2750E Ref.
Requirement
Comment
Calibration compliance 3.2.5.1
Calibration shall be performed on the instruments in the Instrument Types listed in Table 3 & comply with the Table 3 requirements. Prior to any instrument alteration or calibration, document the instrument(s) “as-found condition”
Honeywell Recorders (X-Series Paperless, DR4500, DPR180 & DPR250), HC900 and Controllers (UDC2500, UDC3200 & UDC3500) are considered control, monitoring and recording instruments.
Accuracy & Freq. 3.2.5.2
Calibration accuracy & frequency shall be in accordance with Table 3
Recorders, HC900 & Controllers can meet the 2°F (1.1°C) for Digital Instruments or 2°F (1.1°C) /0.3% of Max Survey Temp for electro-mech. inst.
Calibration Performance 3.2.5.4
Calibration shall be to Mfg’s instructions or a minimum of 6 simulated sensor inputs at the Min. & Max. of the Operating Range used for test or calib. and a minimum of 4 points in between …...
Honeywell Recorders, HC900 & Controllers are typically calibrated at the zero and span values for each range. The calibration procedure is documented as part of the product manual.
Calibration Performance 3.2.5.5.4
Calibration may be performed with a load in process if furnace temp remains within the processing tolerance and the record is appropriately annotated to indicated that a calibration occurred.
Honeywell Recorders (X-Series Paperless and DPRs) provide easy annotation of the chart to aid the documentation process.
The recorders can also be used as Field Test instruments for doing Temp Uniformity Surveys.
We can meet the requirements
29
HONEYWELL - CONFIDENTIAL
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AMS 2750E Instruments 3.2.5 Instrument Calibration Requirements for Instrument Calibration AMS 2750E Ref.
Requirement
Comment
Calibration Performance 3.2.5.5.2
Calibration shall be performed on each channel or group of channels that can be altered or adjusted.
Honeywell Recorders, HC900 & Controllers allow each individual channel to be calibrated.
Chart Speed 3.2.5.5.3
Chart recorder (circular & strip) speed(s) shall be verified annually and shall be accurate within ± 3 minutes per hour
DR4500 – Clock accuracy 32PPM (~1.4 min/mo), DPR180 & DPR250 – Clock accuracy – 10PPM (~45sec/mo) X-Series Paperless – 30PPM (~1.3min/mo) – These clock accuracies are @ reference conditions.
Sensitivity 3.2.5.3
Sensitivity shall be checked during calibration per Table 3 footnote 4
Sensitivity for Honeywell Recorders, HC900 & Controllers is negligible and is covered by the accuracy specification.
Class 1 & 2 minimum sensitivity of 1°F (1°C), Classes 3 – 6 a minimum sensitivity of 3°F (2°C),
“Sensitivity” is the temperature change in the input that is require to activate a change, either upscale or downscale on the instrumentation. It is normally one-half the numerical value of the dead band, such as a sensitivity of 1°F (0.6°C) is equivalent to a dead band of 2°F (1.1°C).
Honeywell Recorders & Controllers can meet the requirements 30
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments 3.2.6 Instrumentation Records Requirements for Documentation of Instrument Calibration AMS 2750E Ref.
Requirement
Comment
Instrument Sticker 3.2.6.1
A sticker affixed to the instrument shall indicate the most recent successful calibration. As a minimum the sticker shall include:
The must establish adequate traceability that the instrumentation has been calibrated. The X-Series Paperless Recorder Status Maintenance & Diagnostic screens can provide an aid for doing this.
Date Cal performed, Due date of next Calibration, Technician who performed calibration, and any limits or restrictions of the calibration Calibration Results 3.2.6.2
The results of calibration shall be documented. Minimum requirements:
The must establish a report format to satisfy these requirements.
Inst or Furnace No., Make & Model of instrument, Standard used, method of calibration, Required Accuracy, As Found & as Left data for each cal point, Offset as found & as left, Sensitivity, Statement of acceptance or rejection, Any limitations or restriction, Date of Cal, Next Due Date, Technician name, Calibration Co Name (if not done in house, Signature of Calibration Co , Quality Organization approval
The must document instrument calibrations 31
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments 3.2.7 Electronic Records Requirements for Electronic Data Recording AMS 2750E Ref.
Requirement
Electronic Record Definition 3.2.7.1
An electronic record is any combination of text, graphics, data, audio, pictorial or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Record Security 3.2.7.1.1
The system must create electronic records that cannot be altered without detection
The X-Series Paperless recorders & HC900 OI create encrypted write-once, read only records. Requires TrendManager Software to read data.
Software & Playback 3.2.7.1.2
The system software and playback utilities shall provide a means of examining and/or compiling the record data, but shall not provide any means for altering the source data.
The TrendManager Pro software provides means to import data, review & examine data, export to other spreadsheets and generate graphs and reports. The Software cannot alter the source data.
Review Copies of records 3.2.7.1.3
The system shall provide the ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copying
The TrendManager Pro software can generate graphs and reports of the data. The graphs use the data as received from the recorder for completeness and accuracy. These are in human readable form or readable using TrendManager Software
Comment
X-Series Recorders create secure electronic data 32
HONEYWELL - CONFIDENTIAL
File Number
AMS 2750E Instruments 3.2.7 Electronic Records Requirements for Electronic Data Recording AMS 2750E Ref. Review evidence 3.2.7.1.4
Requirement The system shall be capable of providing evidence the record was reviewed – such as by recoding an electronic review, or a method of printing the record for a physical marking indicating review
Comment
Retention & retrieval 3.2.7.1.4
The system shall protection, retention, and retrieval of accurate records throughout the record retention period. The hardware and/or software shall operate throughout the retention period as specified in section 3.7
The TrendManager Software does not alter the source information and s the protection, retention and retrieval of records. A data base Management Tool provides the means to move, copy and mange the files for storage on secure servers. TrendManger Software is compatible with current PC Operating Systems and can read data from all generations of Trendview Paperless recorders
System Access – (s) 3.2.7.1.5
The system shall provide methods (e.g. s) to limit system access to only individuals whose authorization is documented
The X-Series Paperless Recorders provides full system to comply with 21CFR Part 11. 50 s with unique ID & , time outs, expirations of s, definitions and audit trail info. The HC900 OI provides for secured access via a specified numerical code.
The X-Series Paperless Recorders provides mark on chart, ability to create a report or data can be imported to the AMS2750 Report Tool to create a report.
TMP provides secure analysis & data archiving 33
HONEYWELL - CONFIDENTIAL
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Section 3.3 Thermal Processing Equipment • Furnace Class Uniformity & Recorder Resolution - Classes based on Temperature Uniformity requirements - Resolution requirements affect the recorder and chart used - Paperless recorders record actual values eliminating issues with the chart and the chart resolution
34
Furnace Class
Temp Uniformity °F
Temp Uniformity °C
Max ° per Inch (CM) of Chart °F/Inch
Max ° per Inch (CM) of Chart °C/CM
Max Chart Recording Increment °F/Line
1
±5
±3
50
11
2
1
2
±10
±6
150
33
5
3
3
±15
±8
150
33
5
3
4
±20
±10
250
55
10
5
5
±25
±14
250
55
10
5
6
±30
±28
350
77
25
15
HONEYWELL - CONFIDENTIAL
Max Chart Recording Increment °C/Line
File Number
AMS 2750E System Accuracy Tests 3.4.1 System Accuracy Tests AMS 2750E Ref.
Requirement
Comment
Requirement 3.4.1
SAT shall be performed on the temperature control and recording systems in each control zone of each piece of thermal processing equipment used for production heat treatments
System accuracy checks are required for the controllers and recorders used for production heat treating.
SAT’s shall also be performed on additional systems that qualify instrumentation as Types A, B, or C Requirements 3.4.1.1
SAT shall be performed using a test instrument meeting requirements of Table 3 and a test sensor meeting the requirements of Table 1
A test instrument is one used to perform system accuracy tests, temperature uniformity surveys or calibrations of controllers, recorders, data acquisition instruments or monitoring instruments. The Test Instrument calibrated accuracy allowed is ±1°F (0.6°C) or ±0.1% of reading in °F, which ever is greater Based on this requirement Mintitrend QX, Multitrend SX, DPR180, DPR250 and DR4500 could be used as a test instrument, field calibration is typically required to meet this.
Instruments used for System Accuracy tests have a higher accuracy requirement 35
HONEYWELL - CONFIDENTIAL
File Number
Recorders That Meet AMS 2750E • Honeywell has Paper and Paperless Recorders that meet AMS 2750E requirements for Controlling, Monitoring and Recording Instruments & Field Test - Key requirement for Controlling, Monitoring & Recording instruments is a calibrated accuracy of (± 2°F/1.1°C) or 0.2% of reading whichever is greater for digital instruments, ±2 °F (±1.1 °C) or ±0.3% of the maximum survey temperature of the equipment, whichever is greater for electromechanical
- Key requirement for Field Test instruments is a calibrated accuracy of (±1°F/0.6°C)
DPR 180
DPR 250
TrendManager Software DR4500 Circular Chart 36
X-Series Paperless HONEYWELL - CONFIDENTIAL
File Number
UDC Controllers That Meet AMS 2750E • Honeywell has Controllers that meet AMS 2750E requirements for Controlling, Monitoring and Recording Instruments - Key requirement for Controlling, Monitoring & Recording instruments is a calibrated accuracy (± 2°F/1.1°C) or 0.2% of reading whichever is greater for digital instruments UDC 3200 UDC 3500
UDC 2500
37
HONEYWELL - CONFIDENTIAL
File Number
HC900 Meets AMS 2750D • The Honeywell HC900 and associated 559 & 1042 Operator Interfaces (OI) meet AMS 2750D requirements for Controlling, Monitoring and Recording Instruments - Key requirement for Controlling, Monitoring & Recording instruments is a calibrated accuracy (± 2°F/1.1°C)
38
HONEYWELL - CONFIDENTIAL
File Number
www.honeywell.com
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