Control of Records Procedure
1.
PROCEDURE
1.1.
Identification
1.1.1.
Lyra (Pvt) Ltd maintains records that are needed to provide evidence of conformity to requirements and of the effective operation of the quality management system. The records are identified in the table below, along with the controls for each record type.
1.2.
Storage
1.2.1.
Storage methods are indicated in the table below, for each record type.
1.2.2.
Softcopy records and data are stored on the company server or computers; in all cases, computers are subject to backup.
1.2.3.
Hardcopy records are stored in suitable cabinets that prevent damage or deterioration.
1.3.
Retention, Retrieval & Disposition
1.3.1.
Records shall be maintained a minimum of 3 years unless otherwise indicated below or as defined by customer, statutory or regulatory requirements.
1.3.2.
Training records and other records pertaining to employees must be retained at least one year beyond that employee’s end of employment.
1.3.3.
Records that are discarded after retention shall be permanently destroyed.
1.3.4.
When archived records are stored offsite or in another location, these shall be stored in a controlled environment that also protects them from damage or deterioration.
1.3.5.
As required by customer contract or regulatory requirements, quality records shall be made readily available for review by the requesting authority. Such review is limited to those records applicable to the customer or regulatory authority, and shall not allow for the accidental or intentional release of confidential information to an unauthorized party.
1.4.
Protection
1.4.1.
The listed “controller” shown in the table below must ensure their assigned records remain legible, readily identifiable and retrievable.
1.4.2.
In order to ensure protection of records, electronic records are subject to periodic backups, with the backup stored on a separate server.
1.4.3.
The Database Administrator is responsible for backup of data.
1.4.4.
Entries made by hand on hardcopy forms shall be made in ink.
1.4.5.
White-out or correction tape is not to be used on any quality records. The correct procedure for making corrections is to cross the error out, make the correction and initial it. Optionally, date-sensitive corrections should be dated as well.
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Note:
Optionally following records are maintained at www.companycertification.com/lyra
·
Quality Record List
·
Master List of Documents
QUALITY RECORDS LIST
Required Record or Document Type |
Lyra (Pvt) Ltd Record |
Retention Period |
Responsible Controller |
Type of Record |
Storage Location |
Discard Method |
Management Review Records |
Management Review Meeting Minutes |
3 year |
M.R |
Softcopy |
Server |
Secure delete |
Customer Satisfaction records |
Min 5 Years |
Sales Executive |
Hard copy / Softcopy |
Server / File Cabinet |
Secure delete or Obsolete |
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Training Records |
Training Matrix |
3 Years |
Department Head |
Hardcopy |
File Cabinet |
Obsolete |
Employee Training Records |
Min 3 Years |
Department Head |
Hardcopy |
Internet |
Secure delete |
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Records of realization process meeting requirements |
Preventive Maintenance Records |
Never |
Production Manager |
Hardcopy/ Internet |
Cabinet / Server |
None |
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Work Orders |
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Travelers |
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Purchase Orders |
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Packing Lists / Packing Slips |
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Process control records (incl. temp charts) |
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Design and Development Records |
Design plans |
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Design drawings |
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Design models |
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Specifications |
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Design change records |
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Design verification records |
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Design validation records |
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Contract Review Records |
Customer RFQs |
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Quotes |
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Customer POs |
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Customer drawings |
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Customer specifications |
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Vendor Evaluation |
Approved vendor list |
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Vendor survey reports |
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Suppler evaluation records |
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Calibration Records |
Calibration Master List |
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Calibration Records |
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Certificates of Calibration |
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Traceability records |
Travelers |
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Record of release of product |
First Article Inspection Reports |
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Receiving Inspection Forms |
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Final Inspection Sheets |
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Product Nonconformance record |
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Nonconformance Log |
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Record of nonconforming customer property |
Nonconforming Product Dispositions |
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Corrective & Preventive Actions |
CARs |
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CAR Log |
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Internal Audit records |
Internal audit Reports |
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Internal Audit Schedule |
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