The difference between Want and Need is Self-Control: Unknown
Introduction
HOT has a different meaning depending upon its usage. Sometimes we say, serve the coffee Hot (warm), in other times when a vegetable has peppers, we call that this food is Hot. When someone dresses sharply, we tend to call that you are looking Hot! When someone is looking very attractive, we sometimes say that you are looking Smoking Hot!
Objective
For any manufacturing organization, the laboratory is the backbone for ensuring that products manufactured are meeting the requirements of the customer and measuring & test equipment are giving accurate results. Depending upon the requirements, the organization may have an internal or external laboratory or both. As per IATF 16949: 2016, each type of laboratory has specific specifications which need to be fulfilled so that customer requirements can be achieved consistently. By understanding the key difference between internal and external laboratories, its requirements can be effectively understood and implemented.
Definitions
Laboratory: facility for inspection, test, or calibration that may include but is not limited to the following: chemical, metallurgical, dimensional, physical, electrical, or reliability testing.
Laboratory scope: a controlled document containing
- specific tests, evaluations, and calibrations that a laboratory is qualified to perform;
- a list of the equipment that the laboratory uses to perform the above; and
- a list of methods and standards to which the laboratory performs the above
Detailed Information
Both internal and external laboratories play a significant role in ensuring that desired quality of the products is manufactured and delivered to the customer and other relevant interested parties.
Depending upon the requirement, all the testing measurement and calibration can be conducted internally but if the organization does not have the infrastructure or resources, these services can be outsourced to an external laboratory.
As per IATF 16949, there are specific requirements related to internal and external laboratories which need to be fulfilled.
Following are some of the key difference between Internal and External Laboratory:
S.No. | Internal Lab | External Lab |
1 | Internal Laboratory Scope: Prepared by the organization | External Laboratory Scope: Prepared by the lab and approved by the accreditation body |
2 | Not required / Optional to be certified by ISO 17025: 2017 | Certified as per ISO 17025: 2017 |
3 | No certificate needed | Valid Certificate required |
4 | There is no need for any accreditation body mark on the calibration, measurement, or test report | The certificate of calibration or test report should bear the accreditation body mark |
5 | Demonstrate the capability/competence to perform required Inspection, Testing, and Calibration | No need to demonstrate the specific capability |
6 | Laboratory Scope should be part of the Quality Management System documentation | Not needed |
7 | To meet customer requirement | Not required |
8 | IATF 16949 Clause 7.1.5.3.1 | IATF 16949 Clause 7.1.5.3.2 |
Present Challenges
- How often the top management links competence and laboratory conditions with the quality of products despatched to the customer?
- How often the internal calibration reports are genuine and calibration is conducted as per defined procedure?
- How often the process owner is aware of the requirements related to Lab scope and verify them before going ahead with testing or calibration?
References:
IATF 16949: 2016
ISO 17025
ILAC.org
Industry Experts
This is the 112th 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.
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