Purchasing Control

Some of the key requirements in purchasing controls are always have procedures to evaluate and select potential suppliers, contractors and consultants. Sponsor are advised to have an ‘Approved Supplier List’ where the detail of each sponsor evaluation. How and when it is being evaluated. What is the outcome of each evaluation?

Qualified auditor should physically go to the site to audit thoroughly the whole site and should also re-audit per schedule. Ideally, each supplier must be audited once in two years.

Update the Approved Supplier List regularly. Should any supplier disqualified, inform all purchasing department of the sponsor’s status.

Another key issue is that sponsor must sign a quality agreement with the supplier so that part/parts must be made accordingly to sponsor specification. The quality agreement must be detail to ensure the supplier performs according to the supplier agreement. For example, the sponsor should state specifically that all medical device components must be made per 21 CFR 820 or ISO 13485 etc.

One of the quality problem I had experienced was that sponsor has very poor control of the medical device components suppliers. The suppliers are behaving like the ‘boss’ and not the way around.

Sponsor must have a supplier evaluation form to ‘evaluate’ each supplier. Example of items in the form are: Name, Contact Information, Supplier Quality Certification like ISO 13485, Job/Part Description, Initiation Date, on-time delivery, evaluation results etc.

Of course, another element is the proper documentation of all the purchasing control. I will blog a little bit more detail about purchasing in subsequent blog.

Reference	Criteria
ISO 13485, 7.4.2.a	Does purchasing information describe the product to be purchased, including (where appropriate) requirements for approval of product, procedures, processes and equipment?
ISO 13485, 7.4.2.b	Does purchasing information describe the product to be purchased, including (where appropriate) requirements for qualification of personnel?
ISO 13485, 7.4.2.c	Does purchasing information describe the product to be purchased, including (where appropriate) quality management system requirements?
ISO 13485, 7.4.2	Has the company ensured the adequacy of specified purchase requirements prior to their communication to the supplier?
ISO 13485, 7.4.2	Does the company, to the extent needed for the traceability required, maintain relevant purchasing information, i.e. documents and records?.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.