It is an undisputed fact that Quality is the number one most important aspect of manufacturing.
That’s why you’ll find many quality standards throughout industries and the world.
Any industry where more criticality or complexity is involved, the same way more stringent and stricter compliance requirements exist in terms of the applicable industry standard.
And why not? For instance, without FDA quality standards; life-saving equipment may fail to save a life! In the same way, without FAA quality standards, the airplanes pose risks that are not worth being taken!
Therefore, the fact always remains agreeable about the importance of quality and industry standards.
This importance extends to the fact that industries that are involved with the manufacturing of high-risk products such as medicine and aircraft etc. are also investing heavily in product compliance to avoid consequences of product failures.
DIY giant Ronseal gave us a term that Quality is doing “exactly what it says on the tin.”
But what if you don’t want to? Or what if you “knowingly” choose to act in a different way! Will you be allowed to do so? Presumably, we won’t be allowed. Right?
Well, I suppose you might be wrong. The answer should be a “Yes.” Quality Management shouldn’t be a straight jacket!
Here we meant to say that, if you are dealing with high criticality or high-risk areas, there will always be certain restrictions that are set up to non-negotiable. But sometimes situation demands to deliberate non-following of standards or processes.
And the right way to do it is called a “Deviation” and also termed as “Concession.”
Well, what’s in the name? Based on the industry, a word may differ or can have an exact meaning, but the intent will remain the same. For example, ISO 9001:2015 termed such requirements as Concession and Standards for the Pharmaceutical Industry such as EU GMP, ICH or FDA have termed such requirements as “Deviation.”
A deviation is any takeoff from approved guidance, procedure, specification, or standard.
The Pharma industry applies deviation under ‘Unexpected’ form and further related in ‘Planned’ and ‘Unplanned’ deviation.
Deviation management is an extremely important aspect of Quality Management. If not done or done sloppily, it may result in costly circumstances.
This blog is not to be treated as “How-to” of Deviation Management about which a lot of information is already available on the internet. Instead, this article is written to let you know about an approach to Deviation Management concerning “internal processes” related activities within an organization leading to the product realization process. Usually, an aspect about which lesser has been talked about.
There are various ways to manage deviations. However, it pays to remember that deviations don’t just fall under material changes. Deviations can be literally on any change or process activities.
And that’s why we attempted in this blog to let you know to consider your various inter-related process activities to be also scrutinized under an effective Deviation Management.
So what is the Golden Rule? Well, they say that the golden rule is that there is no golden rule!
But as far as the internal process specific deviations are concerned the best practices say that it must be pre-approved by a competent authority and must have a specific time frame defined. The basis of it will be a thorough risk assessment with the evaluation of the impact of the intended deviation.
A risk management process must be in place to determine the impact of the deviation on quality, safety and efficacy.
It must be kept in mind that deviation is, in principle, a nonconformity. Now, when you approach the customer (it can be internal or external) with this situation, they may allow you to proceed further. That’s called a “concession.” Even “Use as is” is an example of a concession.
Let’s take a classic example of the automotive supply chain. Let’s assume that considering sales profitability, an Automotive manufacturer’s After Sales department laid out the procedure for Minimum Order Quantity (MOQ) of a particular Spare Part. A distressed customer who drives the car is looking to purchase a part and expecting to pay only the unit price of the said part and not at the entire MOQ. Since MOQ is something between the Automaker’s After Sales department and the Dealership, the end customer is not supposed to be concerned with their ordering process or routine.
Now imagine that because of any possible issues at Manufacturer’s or Dealership’s communication system (such as unrealistic ordering strategy), the part quantity is not maintained at Dealership, increasing the end customer’s wait time is and dissatisfaction. And what if the dealer is not ready to take entire MOQ considering lesser consumption of that particular part? Here a customer-centric carmaker may would like to send a single part or less no. of parts than as per pre-defined MOQ.
So, what should be the ideal practice? Now considering CSAT stats that a happy customer tells 9 people about good experiences, but a dissatisfied customer is going to tell more than 20 people about the bad experiences. (courtesy: White House Office of Consumer Affairs)
And here Technical/Production people in the factory are just not concerned about what is happening at the Sales front. The growing number of dissatisfied customers may lead to a decrease in demand resulting in an adverse effect on production processes, and so the chain goes on. We haven’t talked about Brand image yet! After-sales services are a high-margin business, and the organizations have begun realizing this fact. At the same time, it is tougher to compete in the aftermarket. And ignoring the promises or expectation of after-sales services is really imprudent, to say the least.
Now, what if the organization has not considered a deviation management process other than production processes then a situation like above may result either in the increasing level of customer dissatisfaction or non-following of organizational procedures and resulting losses in the After Sales division imagining that issue stated above becomes an everyday story and After Sales representative at Dealer end pressurizing logistics people to sell the parts every now and then by non-following of the MOQ process.
Therefore situation like this will require a thorough Risk Assessment and an unbiased Deviation Management process to be followed.
Thus, it is imperative that manufacturing organizations must look beyond the manufacturing activity to cascade the Quality System methodologies in other associated processes to ensure better control over operational matters.
Now coming to the solution for the above-stated issue, the organization must set up a Deviation Management Process, which can include risk assessment, impact assessment, approval requirement and duration of the deviation. Additionally, the process should consist of the steps to monitor such repeated issues and escalate it for addressing using the CAPA process.
Now in the above case, the investigation should be performed about the failure of the strategy about spare part ordering that must require an introspection at the organizational level or the dealer’s end. Also, adopting a new method for part delivery may require special packaging, thus an increasing packaging cost. And, for a premium brand automaker, they find it more challenging to afford customer dissatisfaction.
Thus, if the organization follows a customer-friendly policy then, to address all such issues considering the operational viability, an integrated Deviation Management is a must-have.
Thus, a progressive organization must have a well-structured deviation management process that can be adopted throughout its functions. Any requesting department can initiate a deviation request by performing a risk assessment. The deviation is then verified by the concerned for its impact or repetitiveness to segregate between concerns about the regular issues or repeat cases and, accordingly, to follow a due approval process by taking approval. Further to it, monitoring of the approved deviation as per the defined time frame is to be followed.
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