SOP FTWZ RB 03 Good Documentation Practices

SOP Title – Good Documentation Practices
Document ID :
Version no - 0.0 Total no of Pages : 9
SOP/FTWZ/RB/03
Prepared By: Approved By :
Planned Review Date :
Vignesh P Sasi Kumar
12-09-2020
(Operation Incharge) (Operation Manager)
Effective Date : Approved Date : Revision principle - Process
13-09-2019 06-09-2019 revision or annual schedule
Document ID SOP/FTWZ/RB/03
SOP Title Good Documentation Practices
Prepared By Name : Sign : Date :
Approved By Name : Sign : Date :
Effective Date 13-09-2019
 TVS Toyota Tsusho Supply Chain Solutions Ltd – Internal use only Page 1
Document ID :
SOP/FTWZ/RB/03
12-09-2020
1. Purpose:
This procedure describes the Good Documentation and Data Integrity Practice to be followed during
documentation of product or non-product related documents, records and forms associated with the Quality
Management System.
2. Scope:
This procedure is applicable to all employees (include sub-contractors) working at TVS Site operations , related
documents, records and forms associated with the Quality Management System, hereafter known as
documents.
3. Responsibilities:
 Key Account Manager / Site QA / Operations Manager – Should Ensure the Implementation, Training
and Reporting of violations against Good Documentation and Data Integrity Practices.
4. Procedure:
1. Data Integrity
1.1 Data integrity is key to ensure that the end products meet the required quality standards. It is the
process of maintenance and assurance of accuracy and consistency of the data over its entire life
cycle.
1.2 Data Integrity shall be maintained in all manual or system generated electronic data.
1.3 Data should be complete and accurate without any alteration.
1.4 Any identified data integrity issue shall be handled as per the quality management system and proper
corrective and preventive action shall be taken according to risk assessment.
1.5 Action shall be taken on the generation of false data or modification of data.
1.6 Data generation and processing should follow the time sequence.
1.7 Data shall follow the rules of ALCOA i.e. attributable, legible, contemporaneous, original and
accurate.
1.8 Data should be readable and complete.
1.9 Data shall be verified and approved by a competent technical person.
1.10 Instruments having audit trial shall be reviewed daily before approval of data and shall be checked
for any abnormalities.
1.11 Data generation and recording or processing on behalf of another person shall be avoided.
1.12 All clocks used to record time data should be synchronized and controlled (time and date should not
be changed).
Document ID :
SOP/FTWZ/RB/03
12-09-2020
1.13 Software’s and computer systems used in data recording and processing should be validated.
1.14 Processed and computer-generated data must have the electronic signature of the user, reviewer
and approver and signature must be secured.
1.15 All data should be traceable to its processing and modification. All original raw data shall be stored.
1.16 For instruments those have only printed data output, print out shall be considered as raw data and
for the instruments store electronic data, the stored data files shall be considered as raw data.
1.17 Data error found during the review shall be corrected with proper justification.
1.18 Any paper or electronic data modification shall be attributable.
1.19 Data can be excluded only after proper scientific justification and original data shall be stored for
traceability.
1.20 Reconciliation of issued documents like logbooks, protocols, batch manufacturing records, change
control and deviation forms shall be done wherever it is applicable.
1.21 Unauthorized access to the computer systems shall be prevented by giving the assess rights as per
the responsibility and role of the user.
1.22 User department shall not have rights to alter the data files only IT person shall have rights to alter
and delete the data files.
1.23 Computer system users shall not share their logins and shall not access computer systems on behalf
of others.
1.24 Backup of data shall be taken periodically and the backup and recovery process shall be validated.
1.25 Proper training on data integrity and usages of the computer systems shall be provided to all
concerned personnel
1.26 A framework for ensuring that data security and integrity (data protection) is observed and maintained
– ALCOA –plus methodology is to be understood and followed.
1.27 ALCOA Plus – Definition - The term Alcoa is an Acronym, which stands for Attributable, Legible,
Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa. Plus (Alcoa +), by the
addition of a few more concepts which are; Complete, Consistent, Enduring and Available. Below is
the definition for each part of the Acronym.
1.27.1 Attributable - Attributable dictates that any data should be easily identified to the
person who did the data collection, place of origin and the time of data collection
should also be noted down in the case of alteration of data, the person making the
corrections should also be noted down.
1.27.2 Legible- Legible data means the data can be easily read. This attribute should be
ensured both in the short and long term, therefore the materials used in recording and
collecting the data should be durable.
1.27.3 Contemporaneous- Data recorded should be contemporary in nature. This dictates
that the time of data collection should correspond accurately with the time of data
recording. Any data collection should have a date and time, and the same should be
ensured in the case of any later corrections.
1.27.4 Original- In order to preserve the meaning and integrity of data, the original records
should be preserved, meaning the material used should be durable. In the case of
duplicates, the creator of the original records should confirm the authenticity of the
copies.
Document ID :
SOP/FTWZ/RB/03
12-09-2020
1.27.5 Accurate- For any data to be viable, it should be error free. In the case of any
amendments, there should be accompanying documents to support the changes. The
data should be complete and viable. Data quality must be maintained.
1.27.6 Complete-When data is complete in nature, it means there is no deletion that has
taken place from the date of documenting. This includes any changes that have been
made during the life of the data.
1.27.7 Consistent - The data should be chronologically arranged, with time stamps included
for any addition to the original data. Consistency should be ensured by applying
various audits over the life of the data.
1.27.8 Enduring -The material used to record the data should be in a manner which will last
a long duration of time without losing the readability.
1.27.9 Available - Data should be accessible whenever needed, over the life of the data.
Availability ensures the data meets its use, since it can be applied when the need
arises.
2. Ink
2.1 All handwritten signatures and entries of data/information in documents associated with Quality
Management System must be made in indelible Blue/Black ink. Red ink may be used to mark up
changes in draft copies of documents associated with Quality Management System, eg. SOP,
engineering drawing, recipes, etc.
3. Signatures.
3.1 Along with signature person should write date.

3.2 Write Name along with signature for the first time writing/filling a document then Signatures (along
with the date) may be used throughout a single document. This is to ensure that the document or
record shows traceability of the signature to its author.
4. Date Requirements
4.1 DD/MM/YYYY, DD/MM/YY , DD/MMM/YY or DD/MMM/YYYY

4.2 Where DD = (01-31), MM = 01-12, MMM = Jan –Dec, YY = last 2 digits of year, YYYY – 4 digits
of the year.
4.3 it is acceptable that the first zero in DD and MM may be omitted, it is acceptable to separate the
day, month and year formats with a forward slash ( /) or with a dot ( .) or with a dash (-) eg 05/01/10
or 05.01.10 or 05-01-10.
5. Recording of Time
5.1 The handwritten time shall be in Military time (24 hour clock), e.g. 1400 hrs or 14:00 hrs.
5.2 The time recorded shall be the actual time the task is performed.
5.3 For computer systems, the time format shall be based on the system requirements.
Document ID :
SOP/FTWZ/RB/03
12-09-2020
6. Document Entries
6.1 All entries made shall be neat, clear and legible.

6.2 Only ball point pens with blue / black ink shall be used (applicable to corrections too).
6.3 Pencils, gel pens, fountain pens or highlighters shall not be used.
6.4 Complete words shall be written instead of abbreviations but if abbreviation words are repetitive,
their long form shall be written once and there after abbreviations can be used.
6.5 Write “NA” (Not Applicable), where options do not apply. Give full form of “NA” at the bottom of
the page. NA (Not Applicable) shall be written and initialed with date.
6.6 Enough space shall be provided for manual entries while designing forms / documents so that
they are legible and do not spill over into the next steps.
6.7 Spaces and columns shall not be left blank and shall be stroked out diagonally by covering the
entire empty space from first column to last and first blank row to last row, signed and dated.
6.8 When more than one option is available, the incorrect option shall be scored off
e.g. G /Kg (In case ‘G’ is the correct option).
6.9 All documents shall have page numbers in the format Page X of Y where X is the current page
number and Y is the total number of pages for that document.
6.10 Rough calculations shall not be carried out on official / Quality documents. Wherever required
space and formula shall be provided for calculation. Blank spaces shall not be used for scribbling.
6.11 Any stamping or writing shall not obscure the initial text matter.
6.12 Loose sheets / printouts, charts of equipment’s such as temperature – RH recorders, Electronic
balance etc. shall be completed for all required entries. These shall be stored securely until
attached to the file.
6.13 If any Memo/Justification document is created then it shall reference the affected
document/procedure/process with justification/rationale in place and signed, dated with name of
person authoring, reviewing and approving the document.
6.14 Bracketing of the data or observations and signing once is not allowed. Every entry made shall
be signed and dated as demonstrated
6.15 Words like “ditto”, or signs like “ “ OR --- shall not be used for repeat text matter.
6.16 Ditto Marks “” , Same as above , Arrows or continuation lines are not acceptable
Document ID :
SOP/FTWZ/RB/03
12-09-2020
WRONG METHOD
7. Document/Record Error Correction
7.1 Over writing / scribbling shall not be done. If any document errors are made, the word or words
shall be scored off with a single line so that the original text matter is legible. Correct text matter
shall be written and duly initialed with date. Appropriate reasons shall be given wherever
applicable.
7.2 Whiteners shall not be used to conceal pre-printed or written text matter. Erasers, blades, cello
tape shall not be used to erase the written or pre-printed text matter.
7.3 Pre-printed text shall not be altered without the approval and authorization of QA .
7.4 Changes to a document shall follow the appropriate document change control
8. Approvals and signatures
8.1 Entries shall be signed only by the person carrying out the operation.
8.2 The signee shall sign with date. No person other than the signee is authorized to put the date on
behalf of the signee.
8.3 The signatures on the documents shall be only those that appear in the master signature list.
8.4 Documents that are required to be signed by responsible staff for “checked by” and “authorized
by” shall be signed in following sequence i.e. first “prepared by” or “done by”, then “checked by”
and lastly “approved by” or “authorized by”.
8.5 Documents shall be signed only after verifying the correctness of the entries. Incomplete document
shall not be signed.
8.6 If the person responsible for signing the documents is absent, only authorized deputy shall sign at
place as “Signing for”.
8.7 Electronic signatures are accepted in records/forms etc. along with manual signature and date.
8.8 Non Electronic – When a written approval is received by fax, the hand written version is not
required to be retained. The fax copy may be considered original and retained as the approval
document.
8.9 Electronic - Email correspondence should be printed (Without change), signed and dated by the
recipient. Alternatively, correspondence may be signed and dated by the author/approver and
rendered to an un-editable electronic file for transmission
Document ID :
SOP/FTWZ/RB/03
12-09-2020
9. Signatures for Others (Non-Electronic)
9.1 Signatures for original data entries must be made by the originator. Someone may “sign for” a
person when authorized by that person, but must not represent that they are the originator if they
did not make the original entries. Such delegated authorization should be documented as eg. “as
per telephonic conversation, signing for xxx due to …”. Once delegated, signature authority should
not be further delegated.
9.2 When delegated, the signature should be documented as: Eg. When Ravi Sharma is signing for
Rajeev Mathur, Mark a “F” beside the Printed Name (Rajeev Mathur) and sign with name and date.
9.3 One function may not sign for others, eg. Engineering for Manufacturing, unless such
circumstances are defined by written procedures. Other functions must not sign for Quality
Assurance function.
10. Re-writes
10.1 Do not re-write quality records. If re-write is necessary due to deface, wrong form used, missing
document that can be reconstructed, etc., indicate “Re-write” on the copy and attach the original
copy (not applicable when the original is missing). Re-write must be verified by 2nd person (the
Front Line Manager or Department Manager), signed and dated by both persons, with the reason
for the re-write documented.
11. Data Rounding Guidelines
11.1 Rounding of numbers used in calculations can cause the final value to differ from its original
value. Therefore, rounding numbers during calculations should be avoided. Rounding should be
done at the final step of the calculation to produce numeric results. Once a number has been
rounded, it should not be rounded again.
11.2 For numerical data generated from an instrument, the setup in the instrument shall follow the
number of decimal places stipulated in the specifications, wherever possible. However, in
instances that the numerical data generated from the instrument has more decimal places than
the required specification, personnel shall record the data with the same decimal places as seen
on the instrument. Usage decision (UD) shall be performed based on the decimal places stated
in the specification.
11.3 E.g., Specification: 23.00 °C to 27.00 °C
 Instrument generated value: 26.887 Record as: 26.887 °C

 Usage Decision: 26.89°C (this means its within specification)
 Note: When rounding, only consider the number to the right of the last required digit:
 If the digit to be rounded is followed by number 4 or less then rounding should not be
performed.
 If the digit to be rounded is followed by number 5 or more, then previous number should be
increased by 1.
Document ID :
SOP/FTWZ/RB/03
12-09-2020
11.4 The following are examples of rounding numbers:
 E.g. 1. Specification: 25.5 °C to 27.5 °C

 Display Value: 26.26 °C
 Record as: 26.26°C
 Usage Decision : 26.3 °C (this means its within specification)
5. Definitions:
N/A
6. Annexure:
N/A
Document ID :
SOP/FTWZ/RB/03
12-09-2020
7. Revision history:
Version No. Reason Effective Date

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SOP Title – Good Documentation Practices

SOP Title Good Documentation Practices

Prepared By Name : Sign : Date :

Approved By Name : Sign : Date :

Effective Date 13-09-2019

3.1 Along with signature person should write date.

4.1 DD/MM/YYYY, DD/MM/YY , DD/MMM/YY or DD/MMM/YYYY

6.1 All entries made shall be neat, clear and legible.

7. Document/Record Error Correction

8. Approvals and signatures

9. Signatures for Others (Non-Electronic)

11. Data Rounding Guidelines

11.3 E.g., Specification: 23.00 °C to 27.00 °C

 Instrument generated value: 26.887 Record as: 26.887 °C

11.4 The following are examples of rounding numbers:

 E.g. 1. Specification: 25.5 °C to 27.5 °C

Version No. Reason Effective Date

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