Storage and Maintenance of

Quality Records
What is Quality Record?

• These are records used to demonstrate conformance

to specified requirements and the effective operation
of the quality system.
• In the ISO 9000 Standard, quality records are kept to
demonstrate conformance to specified requirements
and to the effective operation of the Quality
Management System (QMS). The ISO Standard
clearly mandates that certain things must be
recorded and treated as "quality records”.
What is Quality Record?

• In the ISO 9000 Standard, quality records are kept to

demonstrate conformance to specified requirements
and to the effective operation of the Quality
Management System (QMS). The ISO Standard
clearly mandates that certain things must be
recorded and treated as "quality records”.
Classification of Records

• Physical records are those records, such as paper,

that can be touched and which take up physical
space.
• Electronic records, also often referred to as digital
records, are those records that are generated with
and used by information technology devices.
• Enterprise records
-Enterprise records represent those records
that are common to most enterprises,
regardless of their function, purpose, or
sector. Such records often revolve around the
day-to-day operations of an enterprise and
cover areas such as but not limited litigation,
employee management, consultant or
contractor management, customer
engagements, purchases, sales, and contracts.
• Industry records
-Industry records represent those records
that are common and apply only to a specific
industry or set of industries.
• Legal hold records
-Legal hold records are those records that are
mandated, usually by legal counsel or compliance
personnel, to be held for a period of time, either
by a government or by an enterprise, and for the
purposes of addressing potential issues
associated with compliance audits and litigation.
Such records are assigned Legal Hold traits that
are in addition to classifications which are as a
result of enterprise or industry classifications.
What to register in Quality Records?

The records shall include at least the following:

• Operating Logs
• Results of Reviews
• Inspections and Tests
• Audits
• Monitoring of Work Performance
• Materials Analyses
What to register in Quality Records?

The records shall also include closely-related data such

as qualifications of personnel, procedures, and
equipment. Inspection and test records shall, as a
minimum, identify the inspector or data recorder, the
type of observation, the results, the acceptability, and
the action taken in connection with any deficiencies
noted. Records shall be identifiable and retrievable.
• Consistent with applicable regulatory
requirements, the applicant shall establish
requirements concerning record retention,
such as duration, location, and assigned
responsibility.
• Good data and record management are critical
elements to assure quality and a systematic
approach should be implemented to provide a
high level of assurance that all throughout the
product life cycle, all records and data are
accurate, consistent, trustworthy and reliable.
• BUT, coordinating access to records internally and
outside of the organization, balancing the
requirements of business confidentiality, data,
privacy and public access.
Quality Records Storage

• Quality Records are stored in manner so that

the records will not be damaged (i.e. rain, fire,
direct sun light, high humidity, etc.) or lost.
Quality Records Storage

• Vital records may need to be stored in a disaster-

resistant safe or vault to protect against fire, flood,
earthquakes and conflict. In extreme cases, the item
may require both disaster-proofing and public
access, such as the original, signed US Constitution.
Civil engineers may need to be consulted to
determine that the file room can effectively
withstand the weight of shelves and file
cabinets filled with paper;
• Documented information are kept in appropriate
locations to minimize physical deterioration,
damage, and loss. As such, records may be
protected in accordance with the following:
-Use of expanded folders, protective sheets
and/or ring binders;
-Stored in shelves or steel cabinets to prevent
from deterioration;
-Regular back up of e-files; and,
-Access restriction, through password to
prevent from unauthorized use.
• Maintenance and Disposition of Inactive
Documented Information
-Maintenance and disposal are done in
accordance with the Records Disposition
Schedule
-PMs are required to turn over/submit to the
Records Office all project folios.
-All project related documented information must
be properly labeled prior to submission / turn-
over to the Central Records Unit