“It isn’t over unless it is over” — Yogi Berra
While purchasing vegetables and fruits from the grocery shop, we do a quick review of whether they are fresh and suitable to purchase. While purchasing medicine from a medical store, we always check whether it is within expiry life. Even while we write our comments on social media, we do a spell check to ensure that message is grammatically appropriate. Before I release any blog, I do check in detail about anything which may have missed or spell check through Grammarly etc.
The same happens in any organization where product and services are released to their internal and external customer.
All the 7 Quality Management Principles specified in ISO 9000: 2015 (Customer Focus, Leadership, Engagement of People, Process approach, Improvements, Evidence-based decision making and Relationship management) are relevant for effective release of product/service to the end customer. The controls related to product/Service release will depend upon the clarity about the context of the organization and relevant risks of the interested parties.
As per ISO 9000: 2015, following is the definition
Inspection (Clause- 3.11.7): Determination of conformity to specified requirements.
IATF subscribing OEM has its specific requirements related to Product Release
Ford: Use of independent Third-Party Inspector where needed
VW: As per Formel Q (chapter 3.2)
As per ISO 9001 and IATF 16949, clause 8.6 & 8.6.1, there are few specific requirements which are stated below.
- Planned Arrangement: There may be a requirement from the customer (internal/external) to follow their guidelines. Example:
- Despatch of material based on the result of lab testing like Salt Spray test results (120 hours) or Destructive Test (500 hours).
- Inspection of the incoming and final product by approved Third party inspector.
- Inspection of the first 5 lots by the customer at the organization’s end.
- Appropriate stages: It means the release of the product at different stages as per agreement with the customer (internal or external) as per timeline-like after
- Design Verification & Validation
- Prototypes
- Simulation study
- Trial production
- Function/performance testing
- Incoming inspection
- Onsite Supplier inspection
- In-process inspection/First Piece Inspection
- Final inspection
- Laboratory testing
- Field return inspection
- Third-party qualification etc.
- Evidence & Traceability: Whenever any product/service is released to the next process/customer, evidence has to be generated to demonstrate that it has been approved based on some criteria like inspection report. These criteria’s can be based on customer requirement, statutory/regulatory requirement or organization requirements. Also, depending upon the requirement, traceability has to be maintained. It can be in the form of
- Operator unique code
- Signature
- Bar code generated from an automated system
- Date/month/year code
- Batch number
- Stamp impression etc.
- Control Plan: As per IATF 16949, the qualification criteria to approve the product/service has to be as per the Control Plan. So, the control plan should define clear guidelines for release at different stages. Example:
- Sample Size like 100% inspection, after 50 pieces, Every lot
- Inspection frequency like after every 2 hours, once in a shift
- Type of inspection: Visual, Measuring instrument, Gauge, Fixture etc.
- Minimum Light intensity for inspecting Appearance items
- Competency of inspectors inspecting at different stages
- Control of Changes: Organization should ensure that whenever there are any changes in the process/product and if it is resulting in a change in inspection criteria like sample size, frequency and additional parameter, it must be incorporated accordingly. Example
- Based on customer complaint, the possible corrective action could be to increase the frequency of inspection from 4 hours to one hour, increase in sample size from 5 to 10 pieces and addition of 2 more parameters for next 3 months. Whether these changes are incorporated into the inspection process or not?
- Documented information: At different stages, when product/service is released, it must be documented and retained as per agreement with the customer (internal/external) like inspection report, laboratory certificate, SPC study etc. The inspection report should be as per acceptance criteria agreed with the customer. Whenever there is approval from customer for not inspecting any stage, it also has to be documented like ‘Direct on Line (DOL)’ at Incoming Inspection.
Some question to ponder:
- How often variation in the ‘Change control process’ results in actual change in the inspection criteria?
- How often Final Inspection is carried out by a competent person?
- How often the inspection is carried out as per sample size/frequency defined in the control plan?
- How many organizations maintain traceability record of the personnel conducting the inspection?
References:
ISO 9000: 2015
ISO 9001: 2015
IATF 16949:2016
This is the 52nd article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.
Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.
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