Record is defined as a “Document stating results achieved or providing evidence of activities performed”. It means any document which having some kind of information on it which was generate during perform any activity in process is in storage or kept for recall the evidences while required. Basically the term record is co related to document. Because initially document is created to retrieve the information with respect to any activity. As we know while any activity is carried out in any process there is some kind of inputs and output are required to perform those activities. It is necessary to capture those information related to that particular process so that we can make decision that our process is running Ok or not. So the documents are created which are used to capture those information related to particular processes. While the information is captured and update in document it is called as records because it is an evidences based on which we can say under what condition the process was carried out. The term retention means to retain something, it means retaining the records. As we understand about records are the evidences of information collected during an activity. After creation of record it is necessary to retain those records s that the records can be used in future while it is required to cross verification of any issue related to process. The term retention is focuses on retain the records for future references so that it can be easily made available and play help to analyse the situation. The term Period (Time) means the time period which is identified for keeping something. Time period is the duration of time, we can say that in current context if we talk about retention period of records that generated during an activity it will tell about how long we have to store the records generated during process. Retention Period is define as the period of time frame for which an organization have to keep the records generated during performing its activities. Each records having its defined standard record retention period based on its importance, generally the record retention period is varies from minimum one year to 15 to 20 year .As per international standard the retention period is minimum one year and any customer specific time as per mentioned in the customer specific requirement. So the organization need to follow the retention period requirement to fulfil the standard requirements.
Clause 7.5.3.2.1 Record retention
The organization must define, document, and implement a record retention policy which should satisfy statutory, regulatory, organizational, and customer requirements. Production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments shall be retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency. Production part approval documented information may include approved product, applicable test equipment records, or approved test data.
Organization need to define, document, and implement a record retention policy for managing the records in organization system. The process of control which his defied for record shall satisfy all related statutory, regulatory, organizational, and customer requirements which ever applicable. As per IATF 16949:2016 some key document which are listed below need to retain for identified specific retention period:
- PPAP (Production part approvals), tooling records, product and process design related records, purchase orders as per applicability, or contracts and amendments if any shall be retained for the N+1 calendar year.
- N is related to the life of product under production or service. 1 is additional one calendar year after the product service periods
- After consideration of above mentioned inputs one more important thing which is need to consider by organization is customer specific requirement.Organization need to focus on Customer specific requirement for retention period of records.
A record retention policy is an essential component of a Quality Management System (QMS) in compliance with the IATF 16949 standard. While the specific details may vary depending on the organization’s requirements and applicable legal/regulatory obligations, here’s an example of a record retention policy for IATF 16949:
Example of Record Retention policy
- Purpose: The purpose of this record retention policy is to define the guidelines and requirements for the retention and disposal of records within the organization, in accordance with the IATF 16949 standard and applicable legal/regulatory requirements.
- Scope: This policy applies to all records generated or received by the organization as part of its Quality Management System, including but not limited to quality planning, design and development, production, monitoring, measurement, and analysis activities.
- Responsibilities: The following responsibilities are established regarding record retention:
- Quality Manager: Responsible for overseeing the implementation and maintenance of the record retention policy.
- Process Owners: Responsible for ensuring that records related to their respective processes are appropriately retained and made available for audit or inspection as required.
- Record Custodians: Responsible for the proper storage, maintenance, and disposal of records within their designated areas.
- Record Retention Periods: The organization shall retain records for a specified period based on legal/regulatory requirements, customer-specific requirements, and the organization’s needs for evidence of conformity to IATF 16949. The following are examples of retention periods (Please note that these periods are examples only and should be adjusted based on the organization’s specific requirements):
- Management Review Records: 3 years.
- Internal Audit Records: 3 years.
- Corrective Action Records: 5 years.
- Design and Development Records: 10 years.
- Product and Process Validation Records: 10 years.
- Customer-Specific Requirements: Comply with the specified customer requirements.
- Record Storage and Accessibility:
- Records shall be stored in a secure, controlled environment to prevent damage, loss, or unauthorized access.
- Records shall be organized, labeled, and indexed to facilitate easy retrieval when needed.
- Access to records shall be provided to authorized personnel, auditors, and regulatory authorities as required.
- Electronic records shall be protected against unauthorized access, alteration, or deletion through appropriate security measures such as access controls, data backups, and regular system maintenance.
- Record Disposal:
- Records shall be disposed of in a manner that ensures confidentiality and prevents unauthorized retrieval.
- Disposal methods may include shredding, secure electronic erasure, or other approved means.
- Disposal shall be documented to provide evidence of proper record destruction.
- Training and Awareness:
- Employees shall be trained on the record retention policy and their responsibilities regarding record management and retention.
- Awareness programs shall be conducted periodically to reinforce the importance of proper record retention and disposal.
- Review and Revision:
- This record retention policy shall be periodically reviewed and updated to ensure its ongoing suitability, effectiveness, and compliance with applicable requirements.
- Revisions to the policy shall be communicated to relevant personnel and stakeholders.
Note: It is important to consult with legal counsel and consider specific legal and regulatory requirements applicable to your organization while developing or adopting a record retention policy.
Record retention for Production part approvals
- PPAP Records:
- The organization shall retain all PPAP documentation, including the submission package and associated records, as evidence of initial product approval.
- PPAP records shall be retained for a period of at least the production life of the part or as specified by the customer requirements, whichever is longer.
- Retention Period:
- The organization shall retain the PPAP records for a minimum of the production life of the part, which typically corresponds to the duration that the part is actively produced and supplied to customers.
- In some cases, the customer may specify a longer retention period for PPAP records. In such instances, the organization should comply with the customer requirements.
- Storage and Accessibility:
- PPAP records shall be stored in a secure and controlled environment to ensure their integrity, confidentiality, and protection against damage or unauthorized access.
- The records should be organized, labeled, and indexed for easy retrieval when needed.
- Access to PPAP records shall be provided to authorized personnel, auditors, and regulatory authorities as required.
- Disposal:
- At the end of the required retention period, PPAP records may be disposed of in a manner that ensures confidentiality and prevents unauthorized retrieval.
- Disposal methods may include shredding, secure electronic erasure, or other approved means.
- Disposal shall be documented to provide evidence of proper record destruction.
- Review and Revision:
- The organization should periodically review and update its record retention policy, including the retention period for PPAP records, to ensure ongoing suitability, effectiveness, and compliance with applicable requirements.
- Any revisions to the policy should be communicated to relevant personnel and stakeholders.
It’s important to note that the specific retention periods for PPAP records may vary depending on customer requirements, contractual agreements, and any applicable legal or regulatory obligations. Therefore, it is essential to consult with your organization’s legal counsel, customer requirements, and any other relevant stakeholders to determine the exact record retention period for PPAP documentation in your specific context.
