A-5E Reference

Appropriate handwriting paper record manner
Refer WHO Guidance, PIC/S Guideline

1. Standard Operating Procedure（SOP)(1) Both of handwriting and digital data shall be satisfied requirements of dataintegrity.
Through the data life cycle period, handwriting data shall maintain attributable,legible, contemporaneous, original, accurate, complete, indelible/durable andavailable, (ALCOA+). SOP(Standard Operating Procedure) to realize above
requirements shall be created.
(2) SOP to overview appropriate documentation and document management shallbe prepared in quality management system. These procedures shall include asbelow.
a. Creation, reviewing and approval of documents and procedure.
b. Creation, distribution and management of blank formats (masters, logs, etc.) to use
to record data.
c. Records retrieval and disaster recovery processes.
d. Operator/recorder identification method, data entry format, record of corrections
and periodic reviews for accuracy, reliability and completeness shall be definedand completed handwriting paper record.
(3) Stipulate below items in SOP, be complied, be recorded and be reviewed.
(4) The operation and management of handwriting paper documents arecomplicated, so it is important to educate the person in charge on SOP.
2. Basics of recording(1) Requirements for ink
a. For paper records, the ink should be indelible.
b. No use of pencil or erasures, erasable objects, or erasable ballpoint pens.
(2) Record changea. Use of single-line cross-outs ( to read the original description) and record changes
with name, date and reason. To be recorded these to record set (i.e. the paper
equivalent to the audit trail)
b. No use of opaque correction fluid or otherwise obscuring the record(3) Recording paper requirements
a. Create a dedicated blank form for the records. It must be properly designed sothat the blank form/document on which the activity is recorded meets all
requirements and has sufficient space to fill in.
Manage and publish sequentially numbered pages.
Have a unique identity (including version number).

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Controlled issuance of sequentially numbered copies of blank forms (i.e. thatallow all issued forms to be accounted for)Must be checked, approved, signed and dated. And there is an entry for it.
Controlled issuance of bound, notebooks with sequentially numbered pages(i.e. that allow detection of missing or skipped pages)
Provide enough space in the blank form to write all necessary data.
b. Issuance of blank form/document
Issuance management must be managed thoroughly and avoided
unnecessary printing.
Assign the desiccated person to issue, and the personnel of testing can not beallowed to issue or copy.
Make it clear to record the detail of who and when copied.
Apply clear method to distinguish authorized copy(e.g. using stamps, color
coding on paper not in the work area, or other appropriate system)
Version control is required and manage no use old version or to utilize itillegally.
(4) Record manner requirements
a. Original data must be recorded on official controlled document ( Lab-note, batchrecord, report format) at the same time and place to be generated or observed
any activity.
b. The hand writing record shall be created by the person who conducts it.
c. Any unused blank spaces in the document should be voided (e.g., strike-throughlines), dated, and signed.
d. Handwritten entries should be in clear, legible.
c. It is unacceptable to record data first in unofficial documentation (e.g. on a scrapof paper) and later transfer the data to official documentation (e.g. the laboratory
notebook).
d. Some paper output from the system, such as thermal paper, will fade over time.
These records should be signed and dated indelible true copies and kept.
3.

Signature and date/time are important to provide attribution to data in paper
records.

(1) Signatures can be of the following types
a. Basis is complete handwritten signature.
b. Filling in initials (defined in the procedure for use)c. The use of personal seals is discouraged generally, but if used, they should be kept
and controlled to be used by the person only.（The date must be handwritten to
be recognized as the principal).
(2) Write the date by hand. If the activity is time-related, also write the time.
a. The activity is recorded on paper, accompanied by the date of the activity (andtime as well, if time sensitive).

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A-5E ReferenceIt is unacceptable to go back or accelerate the time of record.
The date/time to be recorded shall be actual data input date/time.
b. Use as much as possible the paper outputs, etc., of measuring instruments thatrecord time.
It should be a time source that cannot be changed by unauthorized
personnel.
In this case only a paper record will be kept, so it is important that the signatureand date/time be handwritten.
c. Clocks at the test site and clocks of the equipment should be time aligned by using
the time provided by the National Institute of Information and Communications
Technology (NICT) in Japan Standard Time.
4. Record archives(1) Safe and managed paper archive
a. Records must be retained throughout the retention period. Retained Data anddocument should ensure to be protected from intentional or inadvertent change orloss.
b. The area where data are stored must be locked and access control (e.g., theability to capture who enters and exits).
c. Keep a record of documents taken out from the storing area, as stipulated in theSOP.
(2) Access to the archived data
a. Data management is performed by the personnel of quality assurance
management that is independent from business unit and he is given accessprivilege.
b. The access to archived data is defined in SOP.
c. The personnel who has interest can't access to the archived data.
(3) Retrieval of archived data
Index that can be retrieved is needed.
Data shall be managed to be able to retrieve the required data, and periodical
test is necessary to confirm it is achieved.
5. Review and approval of original data
Includes the initial or source capture of data or information and all subsequent
data necessary to fully reconstruct the implementation of the activity.
(1) Original data requirements
a. Original data shall be reviewed.
b. The verified true copy must be retained to keep contents and meanings.
c. Original data must be complete, persistent, and easily retrievable and readable
throughout the retention period of the record.
It is necessary for original data to be indelible/durable, easily retrievable andreadable.

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A-5E Reference(2) Review and approval by the person in charge
a. The person in charge conducts appropriate review and approval of original paperrecordsThe review must be performed on a test-by-test basis.
The review should be performed by a person in charge or an approverdifferent from the person who conducts the test. (Double check)b. Specific elements to check when reviewing records
Reviewers are expected to verify all entries, critical calculations, and makeappropriate assessments of the reliability of test results in accordance with theprinciples of data integrity.
c. Person in charge shall evaluate the data changes to original paper record andinvestigates as required.
Confirm these changes are documented properly.
Confirm that it is justified by empirical evidence.
d. Documentation of data review by the person in charge
It is indicated by signing the reviewed paper record.
If record approval is a separate process, it must be signed as well as reviewed.

(3) Review by quality assurance manager
a. Review as part of self-inspection by sampling or targeting.
Implement review on a planned and regular basis.
Confirm review by the person in charge is complied to SOP.
Verify the final data can be reconstructed from the primary data.
Check for temporal discrepancies, unauthorized modifications, and deletion ofdata.
b. Documentation the result of review

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6. Example of paper records(1) Temperature recorda. Temperature recorder
If a paper-based recorder is used, after
checking the time consistency, the date,time, and signature should be entered andthis paper record should be archived as
the original data.
b. Temperature logging table
When a new temperature logging table is created, it
can be made appropriate for each measurement
condition, such as the conditioning room (thermostaticchamber), test site, and fender body.

(2) Time management of aging test
In the accelerated aging test of JIS K 6257, temperature can be recorded on arecording sheet or data logger.
The controlled items are the time of sample entry/exit of conditioning room.
A dedicated format must be created and managed.
Photo capturing the time of entry/exit with a clock is also effective and requires asignature.
(3) Rubber tensile test
a. Automatic measurement
A type of testing machine that automaticallytracks between mark lines and records
elongation and load.
Since digital data will be recorded as primarydata, time management and signatures should
be managed with a well-defined procedure.
This level of equipment is necessary to meet JIS K6272.
b. Shopper typeThe maximum load is latched and the distance between chucks
can be measured.
Measuring the elongation between markers requires skill.
Significant improvement is needed to meet the requirements ofJIS K6272.
Measurement error between mark lines within 2%.
The elongation (deflection) must be displayed continuously
and the maximum elongation (deflection) must bedisplayed.
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A-5E Referencec. Autograph
Usually the load and the distance between chucks are recorded, but
measurement between mark lines is required.
Measurement between markers would require an automatic
instrument.
While the old ones were paper records, the newer ones can berecorded in digital data,
For paper records, enter the time and signature so that this paper
record chart can be maintained as primary data.
(4) Rubber hardness
Some digital display types can be connected to a PC to record data. In this case,the data is archived as primary data.

With conventional ones, the record will be handwriting on paper,and the only way to keep it in a state of control is to use a specialformat.

(5) Static ozone test
The ozone test performed according to JIS K 6259-1 requires data on the following
items
Ozone Concentration
Temperature
Elongation

50±5pphm
40±2℃
20±2%

Measured by the tester and output
digitally or on paper.

Time72hours

It would be effective to record thetime of entry/exit in a photo and aspecial format.

It would seem that formatting andphotographic documentation wouldbe useful.

pphm： parts per hundred million… ppmの1/100
Testing result recorded with photo is recommended.
(6) Fender compression test
It must be digital recorded.

Paper records are transitional and will eventually be replaced by digital records.
We should always aim to go digital.

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