Defining Record Retention Times - Is 5 years long enough?

Raffy

Quite Involved in Discussions
#1
We currently set our record retention for all documents as five years, now we haven't reach the five year mark and our record retention area is now approaching to be full. Slowly, we are transferring some of the records in an electronic format. However, we would like to reduce it to three years retention plus one year in the active file?Would it be okay? Does our auditor would clearly agree with us? How do we define this? How do we classify the following documents to be retained? Please comment.

Thanks,

Raffy
 
Elsmar Forum Sponsor

SteelMaiden

Super Moderator
Super Moderator
#2
Record retention is best looked at by your document types, life cycle of your product(s), importance of the information and impact on your, and your customers', business. Also get your financial/legal people involved to help identify items that need to be kept for legal or tax purposes, etc.

If you have records that contain information that is transferred to another form, you may not have to keep them as long as some others. An example might be if you are keying information into your computer systems from forms filled in by hand. Maybe you only want to keep the hand-written records for one year (or less) and the computer record becomes your "official" record. Use your history of data entry accuracy to help you here.

Obviously, if you work in a sector where product life cycles are long and impact on safety is high, you may want to keep records a longer time. But you are not going to add any value by keeping your internal audit records for five years. A typical audit cycle is three years, why hang on to those records for 5, for example.

The problem that I have seen most often is that too many companies just say "we will keep the records for 5, 7, 10 or how many ever years." If you spend a little time up front and figure out how long you really need the records, you can reduce costs dramatically in record retention. 1) man-hours spent moving files to different locations as you run out of room. 2) Additional storage areas, new construction or remodeling. 3) Reduced number of filing cabinets/boxes, etc. 4) If you are really into the tree-hugging (I am) you can often times re-use the folders for items with a less-lengthy retention.

I hope this helps somewhat, I remember the first ISO system I did and record retention seemed like an overwhelming menace. Just look at things with the viewpoint of "How many times do I reference this after 1 year, after 3 years, after 7 years, etc. etc." It's kind of like cleaning out the closets or the utility shed!
 
D

Dan Larsen

#3
I agree wholeheartedly. A lot of places take the shortcut and blanket their entire system with a retention period that's way too long for many records. I've had situations where the retention period has been defined as short as one week (the daily data was transferred to a summary report each week).

I think the best approach is a record master list that identifies each record in the system. For each record, critically evaluate how far back you really use them. I think you'll be surprised at how infrequently some records are really used.

Remember that you as the supplier have every right to dictate the retention period (as long as your retention doesn't violate a customer requirement). If your retention period is too short and starts affecting the integrity of your quality system, your internal control systems should catch the problem.
 

Raffy

Quite Involved in Discussions
#5
Record Retention

Hi,
Were having a problem in keeping our records. Since in our procedures it must be kept for five years. Our company starts five years ago, and now our retention area for all quality records and documents are all full. What could be the exact retention years we have to specify? Please help me.
Thanks in advance,
Raffy
[email protected]
 
J

Jim Biz

#6
In our case - we select retention timeframes according to the importance of the document.

Some are kept 5 years - some are kept for 3 some are "Archived" to computer files every year (which reduces the ammount of space needed) Some are boxed up - identified by date period and stored after 1 years retention. From an ISO viewpoint things like Management review meeting minutes - Ncr files etc. the timeframe for registration is 3 years - so we keep them no longer that that.

Regards
Jim
 
V

venkat

#7
The retention of records depends on the organisational policy. This can be described in the company's apex manual. It varies from two years to five years.
 

E Wall

Just Me!
Super Moderator
#8
Don't forget you also need to consider: Customer Contract req, regulatory and statuatory req, as well as the direct value of the informaiton.

We use an off-site Records Management Storage for long-term retention. But you should evaluate the $/benefit as well as consider if you are keeping records in the best 'format type'. If you enter any data into computer - you should only have short-term need for hardcopy retention (presuming, of course, that you have proper file back-up systems in place).
 
L
#9
Hello!
In our organisation , we have a problem with retention period because of lack of space.
When implementing ISO 17025, the retention period has to follow the requirements of the accrediating body. We will be applying to NATA for medical testing . To quote a example, the retention period for wax blocks, slides is 20 years!!.but we do not have the space. Has anyone such problems?
 
J

Jim Biz

#10
Originally posted by lily:
Hello!
In our organisation , we have a problem with retention period because of lack of space.
To quote a example, the retention period for wax blocks, slides is 20 years!!.but we do not have the space.
How much space would 20 years worth fill up?

Regards
Jim
 
Thread starter Similar threads Forum Replies Date
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
T Defining sampling plan for different AQL AQL - Acceptable Quality Level 3
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
G Defining performance metrics for DFMA implementation Design and Development of Products and Processes 2
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
khotchandrakant Defining Acceptance Quality Level, I need clarity on AQL 1.5, 2.5, 4.0 AQL - Acceptable Quality Level 5
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
C AS9100 rev D 8.5.1 c 2 - Defining the Machine in-process frequency per ANSI/ASQ Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
V Defining Safety Precautions for Category 4,5 Molecules Occupational Health & Safety Management Standards 2
E European Regulations defining the terms Repair and Refurbish EU Medical Device Regulations 5
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
GStough Adequately Defining Which Suppliers to Audit and Frequency Supplier Quality Assurance and other Supplier Issues 8
E Quality Techucuan (Technician) in Electronics - Defining Postion Requirements Career and Occupation Discussions 4
moritz Defining a good Scope for Critical SOPs ISO 13485:2016 - Medical Device Quality Management Systems 7
T Standards for defining audible alarms/warnings for OR instruments IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Defining Critical Vs. Non-Critical Suppliers/Service Providers (API Q1, 9th. Ed.) Oil and Gas Industry Standards and Regulations 2
B IEC 60601-2-24 - Defining Storage Volume IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Defining Sub-Disciplines for Chemical Testing Laboratory Employee Proficiency Testing General Measurement Device and Calibration Topics 1
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Defining Reliability and Confidence Levels Reliability Analysis - Predictions, Testing and Standards 3
J Defining Martial Arts and Gymnastics Statistical Techniques Statistical Analysis Tools, Techniques and SPC 4
V Defining the criteria for equipment to be qualified or requalified Qualification and Validation (including 21 CFR Part 11) 2
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Defining CCP (Critical Control Points) in a Rice Mill Plant Food Safety - ISO 22000, HACCP (21 CFR 120) 9
S Process Map and defining KPIs Misc. Quality Assurance and Business Systems Related Topics 5
5 Major Nonconformance for not "clearly" defining the "device lifetime" ISO 13485:2016 - Medical Device Quality Management Systems 2
E Defining the lifetime of an Implantable Medical Device Other Medical Device and Orthopedic Related Topics 5
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Defining Post Mold Cure Ramp-Down Temperature Manufacturing and Related Processes 2
K Audit Nonconformity on Defining 'Outsourced' Infrastructure Maintenance Quality Manager and Management Related Issues 21
G Points to consider while defining the Quality Policy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Developing Documentation and Defining Processes as Subcontractor IATF 16949 - Automotive Quality Systems Standard 6
C Defining ISO 9001:2008 Scope for a Sterilization Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Defining Skilled vs. Semi-Skilled vs. Unskilled Labor Manufacturing and Related Processes 1
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Product Specification vs. Information Defining Product - The differences? 7.3.3.1 IATF 16949 - Automotive Quality Systems Standard 6
R Defining Interaction of Processes in a Software Company Software Quality Assurance 3
N Where to begin defining and monitoring Quality Metrics in a Machine Shop Manufacturing and Related Processes 9
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
R Defining the type of Applied Part - Metal Probe (Applied Part) employs Water Cooling IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Defining Security Interfaces for Scope for ISMS - Need help IEC 27001 - Information Security Management Systems (ISMS) 10
A Defining the differences between Prototype vs. Production Guidelines? Contract Review Process 5
R Help defining Eyewear Customer Complaint Categories Customer Complaints 5
G Quality Objectives - Where to start defining Quality Objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Criteria for defining FMEA & Control Plan Critical and Significant Characteristics FMEA and Control Plans 10
V Defining Policies and Standards for In-License of Products US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom