How I understand this issue is as below:
You know, when you look into design, ensure and implement all system in place to confirm your system ability to built quality in => it will be your quality assurance. When you tests for conformity to your ability through testing (on line or off line) => it will quality control.
Now let see about maintained records, which is may be Tier 3 documents. All your documents will be evidence of your work done. It reflects your quality system in place. Once you review it (like supervisor review and sign, calibration with traceability, approved like internal customer that may be QC release) it will be verifications. Once your external customer accepts it or once you do the internal audit with successful audit result it will be validation. But latter might not possible prior shipment. Thus a system of reviewing pre shipment finished products have been introduced for validation and it is expected to do by qualified personnel.
Let see the case where is no involvements of external customer (i.e. most favorably the end user). Like ability of your test methods during method development? In this case once you produce result it will be first datum of your result. When second time also you produce consistent result => it will assume as accidental outcome hopping or may due co-incident. When third time also you concurrently achieve same precision, now it will said to be validated practically. Though there is lengthy validation procedures in place that we supposed to follow. However bottom line is same with some magnification issues.
On other cases, help of few objective based evidences are taken (like in internal audit - what you see by eye, what documents says and what the operator says - are they supports each other or are in contradictions) to validate.
Let see your case:
ISO 7.3.6 "Wherever practicable validation is completed prior to the delivery or the implementation of the product"
=> Said Review to conformance to design and specifications through QC are the verifications. Before shipment review and products audit by your designated but qualified person confirming the product quality under review are fit for intended purposes and are with in specifications agreed will be the prior to delivery validation.
=> Note in true sense, unless your products will accepted by your end user verifying they were with in specifications desired confirming fit for intended purposes (after that you normally receive payment and re-order), it will not be validated. Mean time your internal audit also validate your job completing your cycle.
a) What to validate? => Yours products ability to satisfy intended use and specifications
b) Normally bins can´t be tested before to be installed in field, so It can´t be validated => I hope when you design it, you did it at the time of design validation. Based on that your customer satisfied to use it and reached into an agreement to use your service of specified specifications. Every time you need not to do it. And no one do it every time.
c) Validate is to ensure equipment was built according to drawings? => It is partially true but it covers design validation part. It is not true that all products as per specified design will meet specifications you agreed with your customer. Because product is only a part of your system. There might be other issues like delivery time, handling environment, presentation requirements etc
D) Or it is To evaluate its performance, ? (solid into the bins flowing fine, no clogging, etc) but when, if ISO states "Prior" => It is also already done during design validation period. However you shall cover this issues in each pre-shipments review.
E) Or means to validate the Drawings production, I mean, if my process is to develop Engineering Drawings, my process is to produce drawings or should I focus on the products which are built based on the drawings? => Here I prefer to forgot other things and just like to look on what is your commitment to your client, what are expectation already established as anticipated needs and what is intended use of your products? Did you meet it? yes as per your internal review - it is verified. When your customer says - yes I am satisfied - it is validated.
ISO normally concern in your ability and system in place with appropriate documentations for job verification.
Please comment if some one has some objection on what I explain.
Narayan Ghimire
Canada
