AS9100D Clause 7.5.2.a) - What is considered to be "documented information"?

Kokolita

Starting to get Involved
#1
What is considered to be "documented information" as it pertains to para 7.5.2.a?
Do these type of postings have to be on our master forms list?
Mens bathroom cleaning sign-off form?
Internal telephone list with extensions listed?
Informational postings? (ie: in the shipping area: "Verify an ITAR stamp is used for the following jobs")
Sign near the fax machine (rapid dial shortcut numbers)
We have papers we print out to put on completed jobs that states, "DONE".

Any help in what needs to actually be given a form number and retained on our master doc list would be great!

Thanks in advance for your input.
 
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Big Jim

Trusted Information Resource
#3
What is considered to be "documented information" as it pertains to para 7.5.2.a?
Do these type of postings have to be on our master forms list?
Mens bathroom cleaning sign-off form?
Internal telephone list with extensions listed?
Informational postings? (ie: in the shipping area: "Verify an ITAR stamp is used for the following jobs")
Sign near the fax machine (rapid dial shortcut numbers)
We have papers we print out to put on completed jobs that states, "DONE".

Any help in what needs to actually be given a form number and retained on our master doc list would be great!

Thanks in advance for your input.
The answer is a little above where you are looking, in 7.5.1 a & b.

"The organization's quality management system shall include . . . documented information required by this International Standard . . . documented information determined by the organization as being necessary for the effectiveness of the quality management system . . "

So if it isn't required by the standard and your organization have not determined there is a need it looks like control isn't needed.

Mens bathroom cleaning sign-off form - doesn't look like a need for you system to me.

Internal telephone list with extensions listed - also doesn't look like a case could be made for being essential to your system to me.

Informational postings - in some instances I think a case could be make that they need to be controlled.

FAX machine instructions - doesn't seem likely to me.

DONE labels - some instances I think that should be controlled.

Others may have other opinions.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
What is considered to be "documented information" as it pertains to para 7.5.2.a?
Documented information, in the context of a quality management system is any piece of command media that can affect product conformity and/or customer satisfaction, as well as evidence that required operations, activities, etc. have been performed. Examples:

− Organization charts
− Process maps, process flow charts and/or process descriptions
− Procedures
− Work and/or test instructions
− Specifications
− Documents containing internal communications
− Production schedules
− Approved supplier lists
− Test and inspection plans
− Quality plans
− Quality manuals
− Strategic plans
− Forms

On the records side,

  • Documented information to the extent necessary to have confidence that the processes are being carried out as planned (clause 4.4).
  • Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1).
  • Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2).
  • Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS (clause 7.2).
  • Results of the review and new requirements for the products and services (clause 8.2.3).
  • Records needed to demonstrate that design and development requirements have been met (clause 8.3.2)
  • Records on design and development inputs (clause 8.3.3).
  • Records of the activities of design and development controls (clause 8.3.4).
  • Records of design and development outputs (clause 8.3.5).
  • Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6).
  • Records of the evaluation, selection, monitoring of performance and re-evaluation of external providers and any and actions arising from these activities (clause 8.4.1)
Seek more guidance on the ISO APG paper related to this:

Annotation 2019-09-05 102441.jpg

and for AS9100D specific guidance, access the document from the IAQG:

Annotation 2019-09-05 102816.jpg
 

Kokolita

Starting to get Involved
#6
Documented information, in the context of a quality management system is any piece of command media that can affect product conformity and/or customer satisfaction, as well as evidence that required operations, activities, etc. have been performed. Examples:

− Organization charts
− Process maps, process flow charts and/or process descriptions
− Procedures
− Work and/or test instructions
− Specifications
− Documents containing internal communications
− Production schedules
− Approved supplier lists
− Test and inspection plans
− Quality plans
− Quality manuals
− Strategic plans
− Forms

On the records side,

  • Documented information to the extent necessary to have confidence that the processes are being carried out as planned (clause 4.4).
  • Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1).
  • Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2).
  • Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS (clause 7.2).
  • Results of the review and new requirements for the products and services (clause 8.2.3).
  • Records needed to demonstrate that design and development requirements have been met (clause 8.3.2)
  • Records on design and development inputs (clause 8.3.3).
  • Records of the activities of design and development controls (clause 8.3.4).
  • Records of design and development outputs (clause 8.3.5).
  • Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6).
  • Records of the evaluation, selection, monitoring of performance and re-evaluation of external providers and any and actions arising from these activities (clause 8.4.1)
Seek more guidance on the ISO APG paper related to this:

and for AS9100D specific guidance, access the document from the IAQG:

Thanks Sidney! This helps a lot!
 
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