To those who have decided to return for another episode of Devine Guidance, thank you! Once again, I hope you find some reading enjoyment and value in this third installment.
For this adventure, I plan to dive into the importance of a clear and concise specification to support the design, development, and procurement processes. Remember, a specification, because it is a part of the overall design and development process, must be retained in the Design History File (DHF).
Additionally, I will begin framing my position on defensive-receiving inspection, another antediluvian process near and dear to my heart. Ah, yes, just in case you are wondering, I coined the phrase defensive-receiving inspection as part of my doctoral dissertation process to create some differentiation from existing studies. It also sounds like a more formidable process. Furthermore (and you can quote me), “I find little value in pursuing defensive-receiving inspection; although, at times, it is an unavoidable evil.”
Warning letter violation
In keeping with the structure presented in the previous installment of Devine Guidance, I have cut and pasted another FDA no-no, extracted from a warning letter issued in September of 2009 and focusing on the lack of a documented defensive-receiving inspection process.
Failure to establish and maintain procedures for acceptance of incoming product that ensures incoming product is inspected, tested, or otherwise verified as conforming to specified requirements; and acceptance or rejection shall be documented as required by 21 CFR § 820.80(b). For example:
a. There are no procedures or specifications for the acceptance of incoming gel foam electrodes that are supplied inside the SOLO Therapy Supply Kit, and fabric electrodes supplied in the Duet Therapy Garment Kit;
b. Incoming lead wires are (b)(4) according to your procedure Product Verification Lead Wires-Work Instruction, Doc: 05-88-013, Rev A1. According to instruction 3.4, a summary of results are documented in the acceptance records for lead wire testing but individual test results, which would provide an accurate snapshot of actual testing, are not required; and
c. Acceptance criteria for pass-fail of incoming battery chargers has not been defined in procedure, Incoming Product Verification Work Instruction-Battery Chargers Doc No.: 05-88-011 Rev C-1.
Regulations and requirements
Once again, the Quality System Regulation (QSR), Medical Device Directive (MDD), and EN ISO 13485:2003/AC2007 are sufficiently vague when delineating requirements for specification construction and the inspection of procured product. This continues to allow organizations to develop specifications and inspection strategies that can be quickly be incorporated into their existing quality system procedures; and remember, medical device manufacturers are legally mandated to adhere to these regulations.
I will continue to make the point of mandatory compliance every week; until it is a concept that becomes deeply rooted in your daily quality lives. Please remember, compliance is not optional and should be viewed as the cost of admission to participate in the world of medical device manufacturing. That said, the key regulations providing oversight for the inspection of procured product are:
1. QSR – Subpart H – Acceptance Activities
(a) General: Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.
(b) Receiving acceptance activities: Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
2. MDD (no change from installment 2)
Article 3 – Essential Requirements
The devices must meet the essential requirements set out in Annex I, which apply to them, taking account of the intended purpose of the devices concerned.
Where a relevant hazard exists, devices, which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.
Annex II.3 EC Declaration of Conformity – Full Quality Assurance System
The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Section 3.3 and 4 and to Conformity surveillance as specified in Section 5.
3. EN ISO 13485 – 7.4 Purchasing
7.4.3 Verification of Purchased Product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. Records of the verification shall be maintained.
So why is the specification so important? For starters, you cannot give the proverbial napkin drawing to a supplier or potential supplier and expect them to meet any quantified requirements or quality expectations. In fact, I dare you to give a napkin drawing to the FDA, MHLW, Health Canada, Competent Authorities in the EU, or your notified body. If you are willing to do so, please commit the following question to memory: Where do I sign the deviation form? Besides, it is 2010, and an engineering notebook is the new napkin, rhetorically speaking.
A good specification not only facilitates an effective procurement process, it supports the sometimes necessary evil known as defensive-receiving inspection and the entire 1st Article process (look out for this topic in the next instalment of Devine Guidance). A well-defined specification should employ proper dimensional tolerancing techniques in accordance with ASME Y14.5M, when appropriate. Furthermore, the specification should contain sufficient granularity to ensure the supplier has enough technical information to manufacture and supply a product meeting all quality and technical requirements.
Secondary processes such as plating, electro-polishing, chemical cleaning, material type, special testing requirements, and similar subsidiary processing require consideration for inclusion into the specification. Finally, the specification should be reviewed and approved by a cross-functional team and placed under revision control, within your document control system. Why? Because if the specification is not documented – in writing, it does not exist.
I strongly recommend attaching a copy of the specification to the contract or purchase order, prior to the issuance of these documents to your supplier. Also, send a copy of the specification to the supplier every time a change order is issued. This will ensure your supplier always as the most current and hopefully, the correct revision of the specification.
Employing an effective strategy, including the implementation of three-dimensional modeling and geometric dimensioning and tolerancing early in the specification process saves money. In today’s design-to-manufacture environment, drawing changes can cost anywhere from several hundred to several thousand dollars. The current model employed by most organizations is premised on: (a) recognition of need; (b) conceptual design; (c) computer aided design (CAD) with only a limited number of nominal dimensions; (d) best shot in producing samples; (e) the testing and tweaking of prototypes; and (f) feedback requiring changes to the original drawing. Employing geometric dimensioning and tolerancing from design inception will result in manufacturing organizations circumventing potential design pitfalls early in the development phase.
Another feature, found on a well-defined specification, is the identification of key features that can be measured by a supplier, and the statistical data provided for review, in lieu of performing defensive-receiving inspection. These same key features can be categorized within the specification as critical, major, minor, or audit. The categories drive the sampling sizes required, if defensive-receiving inspection becomes necessary. Not wanting to over-simplify the process, key features, when held within their specification limits, can be measured and the data analyzed, to gauge the overall conformance to a specification, without having to measure every feature. This data can also be employed to establish some minimum level of process capability by the supplier. The employment of an effective supplier statistical data program will be explored, in detail, in the next installment.
As previously stated, I believe that there is no value in performing defensive-receiving inspection. In today’s medical device industry, medical device manufacturers pay top dollars, usually, for services, materials, supplies, etc. that conform to approved written specifications. The expectation is that the medical device suppliers provide conforming materials that meet every detail depicted within a well-defined specification. Considering the supplier has managed to pass muster and make it onto your approved vendors list (AVL), there should be no surprises.
However, this is a far from perfect world; and some level of defensive-receiving inspection may be warranted, at least initially. Remember, the standards and regulations require the creation and maintenance of procedures to determine the acceptance of purchased goods. The standards and regulations do not state; “thou shall purchase a $250K coordinate-measurement machine, optical comparator, vision system, or other pieces of expensive measurement equipment to perform 100 percent inspection.” Sure, these are all nice toys to have and fun to play with, however, let your suppliers pay for these capital expenditures.
Once some level of conformity has been achieved, the use of supplier statistical data, in lieu of defensive-receiving inspection, becomes a viable and fiscally attractive option. However, if a supplier is providing non-conforming material, a 100-percent inspection approach may be the only option to prevent a line-down scenario and a potential interruption of the supply chain. Remember, the 100-percent inspection option is expensive, tedious, time consuming, and only about 80 percent effective.
If you choose to employ defensive-receiving inspection, establishing a consistent and uniform approach to the inspection process will reduce inspection hours attributed to measuring characteristics that do not influence form, fit or function. Another option for dealing with a supplier that continues to supply nonconforming product, short of supplier replacement, might be source inspection. Although this can also be an expensive option, at least the bad material remains in the possession of the supplier.
In closing, I hope you have found some value in this installment of Devine Guidance. Next week, I will continue with defensive-receiving inspections and present a feasible approach to a supplier-generated statistical program. Supplier-generated statistical data can significantly reduce the defensive-receiving inspection burden, while improving the overall quality.
Additionally, I will explore the 1st Article process and the overall importance of this step. Finally, other inspection reduction activities will be discussed. Once again, thank you for taking the time to read my quality rants and I look forward to having you join me in the next installment of Devine Guidance.
- Chase, N. (1999, October). Reports standardize receiving inspection. Quality, 38(6).
- Code of Federal Regulation. (2008, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Dimensioning and tolerancing. (1994). American Society of Mechanical Engineers. ASME Y14.5M-1994. New York, NY.
- Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
- Foster, M. (2003, August). 3-D and G D & T takes a concept to production. Quality, 42(8). Retrieved November 3, 2008, from http://proquest.umi.com.
- FDA – U.S. Food and Drug Administration Website. (2009). Warning letters. Retrieved January 18, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm193670.htm.
- Ghinato, P. (1998, August). Quality control methods: towards modern approaches through well-established principles. Total Quality Management, 9(6).
- Medical Device Directive. (1993). Council Directive 93/42/EEC. Medical Device Safety Service. Retrieved January 11, 2010, from http://directive93-42-eec.htm.
- Medical devices – quality management systems – requirements for regulatory purposes. (2007). EN ISO 13485:2003/AC:2007.