The international standards provide a world of wisdom enabling robust planning to achieve results by the organizations. In this global economy, often doing all the work in-house is not a cost-effective solution. Moreover, with super-specialized industry requirements, perhaps a lot of quality products and services can be procured at reasonable prices. Yet it seems organizations fail to act in the spirit of the standard when putting in place requirements for monitoring outsourced processes. Clause 8.1 of ISO 9001:2015 in operational planning and control has a sting in the tail with a clear whip requiring that “the organization shall ensure that outsourced processes are controlled.”
Statutory requirements are created to provide the required oversight, maintain customer focus and protect the interests of the customer when products and services are cleared for use. The caveat is that the statutory body should be well resourced, have the infrastructure, maintain organizational knowledge levels (Clauses 126.96.36.199, 7.1.3 & 77.1.6 of ISO 9001) with competent manpower (Clause 7.2). This often is not possible or with time not sustainable due to budgetary constraints, knowledge level dropping with time, Leadership forgetting their primary role (Clause 5.1.1) of taking accountability for the effectiveness of the QMS (Quality Management System). As such, the resources (5.1.1 e) needed for the QMS are not provided or budgets not available. The statutory bodies rationalize it by their helplessness since the government does not provide the funding and budgetary support for this.
Whatever the reasons, the question is who suffers? A ship is sunk, and aircraft with all on board has crashed, dangerous drugs are in use. It is the customer who suffers. In helplessness on their ability to do their duties, the statutory bodies outsource the work to contracted parties or worst to the manufacturer itself! The whole logic of creating a statutory body is lost with this.
What then is the remedy? The essential rulemaking that implements compliance requires competence, resources, and infrastructure with a committed Leadership ensuring continuing suitability, adequacy and effectiveness of the system. When budgetary constraints do not allow this role to be fulfilled, the risk to the system along with the products and services it provides must be assessed and mitigated or the opportunity for improvement taken (Clause 6.1 of the ISO 9001). This would require the authority to appreciate the FMEA (Failure Mode Effect and Analysis) and take measures to remedy this. If this risk is not appreciated as NC (Non-conformity) the CA (Corrective Action) will not take place nor will the government know of the consequences of underfunding or of recognizing the failure and finding alternatives/ considering options. If the manufacturer has the resources, the government may consider this an asset and avoid duplication of resources, thinking in national terms. Outsourcing to the manufacturer as has been seen can mean losing customer focus and is strict counter to the very philosophy of statutory work. It would call for aggressive, proactive and strict monitoring of the outsourced processes.
In my opinion, monitoring the outsourced processes diligently, as clearly prescribed in the standard is the answer. New options may not be necessary, if the existing clauses of ISO 9001 and related industry-specific standards, where applicable, are understood in the spirit of the standard and vigorously implemented.
- Dr. IJ Arora